MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2015-12-03 for PRIMATRIX MESHED 10CM X 25CM 607-005-125 manufactured by Tei Biosciences Inc.
[32596604]
It was reported a patient had delayed wound healing due to the thickness of the product. Conversation with the surgeon revealed, "the product is too thick. The interstices are too wide. It delays healing by 2-3 weeks. Poor graft take and areas of poor to no neo dermis (were identified). " it was reported there was no patient injury alleged. It was reported the complaint is in regard to product attributes and performance.
Patient Sequence No: 1, Text Type: D, B5
[33265281]
Additional information received 20nov15: there is no specific patient associated with this complaint. The product is being used in the or and dr. (b)(6) feels that the primatrix 2:1 meshed product is thicker and takes longer to achieve the results he was getting when using primatrix solid and just meshing the product himself.
Patient Sequence No: 1, Text Type: N, H10
[40431507]
Integra completed its internal investigation 26feb2016. The investigation included: results: lot information was not provided. Dhr review could not be conducted. No other complaint in the past 12 months has specified thickness issues based on the md's preference. No indication that a product was returned; a failure analysis is not performed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004170064-2015-01125 |
| MDR Report Key | 5263402 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2015-12-03 |
| Date of Report | 2015-11-09 |
| Date Mfgr Received | 2016-02-26 |
| Date Added to Maude | 2015-12-03 |
| 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 |
| Reporter Occupation | DENTAL HYGIENIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | USER MARIA LEONARD |
| 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 10CM X 25CM |
| Generic Name | PRIMATRIX |
| Product Code | KGN |
| Date Received | 2015-12-03 |
| Catalog Number | 607-005-125 |
| 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 | 2015-12-03 |