MAUDE Report

margadia · Mar 4, 2022

Hi All,

Looking for best practices for a situation I find myself in. I'm fairly new to the company I currently work for. Prior to joining, they had no quality presence. We are an Initial Importer/Distributor of Medical Devices, we do not manufacture anything. During Post-Market Surveillance activity, I found under our company name, an adverse event reported by a patient in May-2021. Again, we are not a manufacturer. The report says it was submitted by a patient but there is no identifying information to determine whom it was the reported the event or where it occurred. Going through our complaint records and database, there is no evidence of this having been reported to the company (as I was not working here at this point). I don't want to leave this hanging, but there is no information for us to even begin an investigation into this report. Does anyone have any suggestions on how to address this, from a regulatory standpoint? Thanks in advance for any feedback!

Ed Panek · Mar 7, 2022

If you were responsible for reporting this event you probably should start opening a CAPA if it is a missed event. On the other hand, if you are not the manufacturer of the product can you explain your relationship further with the manufacturer?

margadia · Mar 8, 2022

Ed Panek said:
If you were responsible for reporting this event you probably should start opening a CAPA if it is a missed event. On the other hand, if you are not the manufacturer of the product can you explain your relationship further with the manufacturer?

Manufacturer is in SK. We are the Initial Importer for the mfr in US. We are required to report complaints and events to mfr and if the mfr deems event reportable, then both the mfr and my company report to FDA. To our knowledge, no customer or patient reported this event to us. A review of our complaint logs and reporting system show no such event reported. Our name is not displayed on the device, so it is unknown why the patient would report it under our name and not the mfr, whose name is on the device. We sell the devices to physician's offices, and all are traceable through serial numbers. As no identifying information, like the serial number, was provided in the report in MAUDE, we aren't able to determine where the device is and since we've gotten no communication from a physician about a similar event, there is little else we can do. We did open a CAPA when I searched MAUDE and found the report. But unfortunately, with no information, we cannot determine a root cause. The event itself was mostly common, known side effects after treatment with the device.

Ed Panek · Mar 8, 2022

" ...both the mfr and my company report to FDA. " Is this written into a Supplier agreement?

Here is the FDA requiement

TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES

SUBCHAPTER H - MEDICAL DEVICES

PART 803MEDICAL DEVICE REPORTING

Subpart D - Importer Reporting Requirements
Sec. 803.40 If I am an importer, what reporting requirements apply to me?
(a) Reports of deaths or serious injuries. You must submit a report to us, and a copy of this report to the manufacturer, as soon as practicable, but no later than 30 calendar days after the day that you receive or otherwise become aware of information from any source, including user facilities, individuals, or medical or scientific literature, whether published or unpublished, that reasonably suggests that one of your marketed devices may have caused or contributed to a death or serious injury. You must submit the information required by § 803.42. Reports sent to the Agency must be submitted in accordance with the requirements of § 803.12(a).
(b) Reports of malfunctions. You must submit a report to the manufacturer as soon as practicable but no later than 30 calendar days after the day that you receive or otherwise become aware of information from any source, including user facilities, individuals, or through your own research, testing, evaluation, servicing, or maintenance of one of your devices, that reasonably suggests that one of your devices has malfunctioned and that this device or a similar device that you market would be likely to cause or contribute to a death or serious injury if the malfunction were to recur. You must submit the information required by § 803.42. Reports to manufacturers may be made in accordance with § 803.11(b).

I am not sure if the FDA requires the manufacturer report to the importer unless recall activity is planned.

margadia · Mar 8, 2022

Ed Panek said:
" ...both the mfr and my company report to FDA. " Is this written into a Supplier agreement?

Here is the FDA requiement

TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H - MEDICAL DEVICES

PART 803MEDICAL DEVICE REPORTING

Subpart D - Importer Reporting Requirements
Sec. 803.40 If I am an importer, what reporting requirements apply to me?
(a) Reports of deaths or serious injuries. You must submit a report to us, and a copy of this report to the manufacturer, as soon as practicable, but no later than 30 calendar days after the day that you receive or otherwise become aware of information from any source, including user facilities, individuals, or medical or scientific literature, whether published or unpublished, that reasonably suggests that one of your marketed devices may have caused or contributed to a death or serious injury. You must submit the information required by § 803.42. Reports sent to the Agency must be submitted in accordance with the requirements of § 803.12(a).
(b) Reports of malfunctions. You must submit a report to the manufacturer as soon as practicable but no later than 30 calendar days after the day that you receive or otherwise become aware of information from any source, including user facilities, individuals, or through your own research, testing, evaluation, servicing, or maintenance of one of your devices, that reasonably suggests that one of your devices has malfunctioned and that this device or a similar device that you market would be likely to cause or contribute to a death or serious injury if the malfunction were to recur. You must submit the information required by § 803.42. Reports to manufacturers may be made in accordance with § 803.11(b).

I am not sure if the FDA requires the manufacturer report to the importer unless recall activity is planned.

Yes, in a supplier agreement, if its been determined to be a serious injury or malfunction. Neither apply in this case. So, since it's been addressed in both our Management Review and CAPA program, and have reported to the manufacturer the finding on MAUDE, I assume we have covered our bases.

MAUDE Report

margadia

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Ed Panek

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Ed Panek

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