MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-07-01 for PRIMATRIX BOVINE manufactured by Tei Biosciences Inc..
[49063776]
Had a skin graft (primatrix bovine) on front of foot. Now almost a year ago, wound still has not healed. Saturday, the front of my foot just peeled off, it was foul. It separated at the graft level. I could still make out the diamond pattern of the graft material. I had my doubts about not having rejection issues with non-human products. Turns out i was right, and pissed over (b)(6) dollars for this garbage. Dates of use: (b)(6) 2016. Diagnosis or reason for use: open surgical wound.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5063247 |
| MDR Report Key | 5774801 |
| Date Received | 2016-07-01 |
| Date of Report | 2016-07-04 |
| Date of Event | 2016-07-02 |
| Date Added to Maude | 2016-07-07 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | PRIMATRIX BOVINE |
| Generic Name | PRIMATRIX BOVINE |
| Product Code | KGN |
| Date Received | 2016-07-01 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TEI BIOSCIENCES INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Other; 3. Required No Informationntervention | 2016-07-01 |