MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2018-04-19 for PRIMATRIX MESHED 4 X 4CM 607-005-440 manufactured by Tei Biosciences Inc.
[106008382]
The device will not be returned to the manufacturer for analysis. The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[106008383]
Sus voluntary event report number: mw5075762: "a sales rep present in the surgery room sold a product called primatrix tei biosciences to be used to close a fascia defect in someone with suspected chronic exertional compartment syndrome in which the company manufacturer website claims it was not meant to be sold except as a skin graft to be used on the skin for wound healing and that is entirely contraindicated for the condition. The product wasn't supposed to be sold. There was no consent via consent form for the implant and it was contraindicated for the present condition. " on (b)(6) 2017, a revision surgery was performed to explant the device. No further patient complications were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004170064-2018-00002 |
| MDR Report Key | 7444873 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-04-19 |
| Date of Report | 2018-03-26 |
| Date of Event | 2017-02-21 |
| Date Mfgr Received | 2018-05-02 |
| Date Added to Maude | 2018-04-19 |
| 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 VIVIAN NELSON |
| 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 | 2018-04-19 |
| 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. Required No Informationntervention | 2018-04-19 |