MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2017-08-08 for PRIMATRIX FENESTRATED 4 X 4CM 607-004-440 manufactured by Tei Biosciences Inc.
[82043276]
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
[82043277]
It was reported by the sales rep that while he was attending a pmx assessment for possible reapplication, patient's wound and peri-wound were inflamed, the dr. Removed the fluid and suggested patient have an x-ray because of concerns of osteomyelitis. The sales rep contacted the dr. And he immediately suggested that patient be taken to or, debrided and cleaned. He passed on the recommendation to the np clinician. They did not reapply pmx. (patients wife is a rn in the wcc). While in the wcc attending a different pmx patient, the nurse/wife (of patient) told the sales rep that her husband was admitted to hospital and has osteomyelitis and has had a partial foot amputation. She said? Everything was fine with him until primatrix was applied. Then he had pain all week? She then walk away. She did not say that primatrix was at fault.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004170064-2017-00008 |
| MDR Report Key | 6773625 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2017-08-08 |
| Date of Report | 2017-07-17 |
| Date Mfgr Received | 2017-09-11 |
| Date Added to Maude | 2017-08-08 |
| 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 | 8700 CAMERON ROAD STE 100 NULL |
| Manufacturer City | AUSTIN TX 78754 |
| Manufacturer Country | US |
| Manufacturer Postal | 78754 |
| 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 FENESTRATED 4 X 4CM |
| Generic Name | PRIMATRIX |
| Product Code | KGN |
| Date Received | 2017-08-08 |
| Catalog Number | 607-004-440 |
| Lot Number | 1702063 |
| 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 | 2017-08-08 |