MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2017-04-19 for PRIMATRIX MESHED 4 X 4CM 607-005-440 manufactured by Tei Biosciences Inc.
[73101685]
The device involved in the reported incident is not available for evaluation. An investigation has been initiated based on the reported information.
Patient Sequence No: 1, Text Type: N, H10
[73101686]
It was reported by the patient that she has a bump on her right ankle after a muscle hernia repair with primatrix. Medical intervention was required to remove the primatrix on (b)(6) 2017. Additional information received on april 16, 2017 from the patient: "for the right leg i still have it in my left leg without problem. My problem is mainly scar tissue build up which may or may not have been caused by the product. I am starting to think it's not. But my concern is that i have 4 more muscle hernias from rollerblading and i switched doctors but if they choose to repair id much rather have the primatrix biodegradable versus a plastic mesh because it's working very well in the left leg. Only the right leg had the problem. I was actually going to ask them to try it again on the other hernias that are causing me pain. Like i said i had primatrix in both ankles and it was only removed in one but the doctor didn't see that it was causing a problem rather just a bunch of scar tissue building up around the surgery site where the muscle was removed and the primatrix placed. " additional information has been requested.
Patient Sequence No: 1, Text Type: D, B5
[74800072]
Additional information received from the patient on (b)(6) 2017: - age: (b)(6) - reason for implantation: muscle hernia repair. - date of initial surgery: (b)(6) 2017. - date noticed bump: (b)(6) 2017. - description of bump: red, shiny, size of a fingernail. - is it painful? - very. - discharge? - no. - did you went to the doctor? I did go to the doctor. - treatment plan prescribed- removal of device ((b)(6) 2017). - additional studies performed- none. - additional procedure scheduled- not at the moment but possible in few months - how are you doing now? I am with the same problem around the area where the device was as scar tissue filled the areas.
Patient Sequence No: 1, Text Type: N, H10
[75839027]
Integra has completed their internal investigation on may 10, 2017. Results: device has not been returned for evaluation, therefore failure analysis cannot be performed. Dhr review; all product specifications were met. There are no non-conformances or capas associated with this product lot. Complaints history; a trackwise search was conducted for complaints specifying "bump" for this trend analysis; this is the only complaint of a bump related to primatrix within the past year. Complaint rate: one complaint of (b)(4) units sold within the past year; (b)(4). Conclusion: device has not been returned for evaluation, therefore root cause analysis cannot be performed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004170064-2017-00002 |
| MDR Report Key | 6502949 |
| Report Source | CONSUMER |
| Date Received | 2017-04-19 |
| Date of Report | 2017-04-03 |
| Date of Event | 2017-03-22 |
| Date Mfgr Received | 2017-05-10 |
| Date Added to Maude | 2017-04-19 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | USER SONIA IRIZARRY |
| Manufacturer Street | 311 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362393 |
| Manufacturer G1 | TEI BIOSCIENCES INC |
| Manufacturer Street | 7 ELKINS STREET |
| Manufacturer City | BOSTON MA 02127 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02127 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PRIMATRIX MESHED 4 X 4CM |
| Generic Name | PRIMATRIX |
| Product Code | KGN |
| Date Received | 2017-04-19 |
| Catalog Number | 607-005-440 |
| Lot Number | 1509057 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TEI BIOSCIENCES INC |
| Manufacturer Address | 7 ELKINS STREET 7 ELKINS STREET BOSTON MA 02127 US 02127 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-04-19 |