MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-04 for FORTIVA PORCINE DERMIS manufactured by Tutogen Medical Gmbh.
[188685963]
The graft remains implanted. Therefore, a comprehensive records re-review was conducted. There were no departures noted during records re-review that would negatively impact the processing of xenografts manufactured from lot pd17270001. Manufacturing records indicated that serial id (b)(4) met all specifications and release criteria prior to distribution. To date, tmi has manufactured and distributed a total of 24 xenografts from the lot without related complaints. Porcine dermis allografts undergo a validated sterilization method: tutoplast? , which includes terminal sterilization by gamma irradiation after packaging. To date, our investigation indicates that the reported complications are more likely associated with a source or event extrinsic to the xenograft implant.
Patient Sequence No: 1, Text Type: N, H10
[188685964]
Rti surgical, inc. (rti) and tutogen medical gmbh (tmi), a wholly owned subsidiary of rti, received a complaint as part of hte fortiva appear trial. The reported complaint indicated that a patient underwent left breast reconstruction with implantation of a fortiva porcine dermis graft and a silicone implant on (b)(6) 2019. The patient developed nipple necrosis to left breast requiring surgical debridement on (b)(6) 2020. She was treated with antibiotics. The affected area continued to break down leading to dehiscence on (b)(6) 2020. On (b)(6) 2020, further nipple debridement was performed, as well as removal of the silicone implant and changed to a tissue expander. The fortiva xenograft remains implanted. The patient was discharged on (b)(6) 2020. To date, no additional information has been provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002924436-2020-00007 |
| MDR Report Key | 9785538 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-04 |
| Date of Report | 2020-03-04 |
| Date of Event | 2020-01-09 |
| Date Mfgr Received | 2020-02-04 |
| Date Added to Maude | 2020-03-04 |
| 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 | MRS LEILA KELLY |
| Manufacturer Street | 11621 RESEARCH CIRCLE |
| Manufacturer City | ALACHUA, FL |
| Manufacturer Country | US |
| Manufacturer Phone | 4188888436 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FORTIVA PORCINE DERMIS |
| Generic Name | PORCINE DERMIS GRAFT |
| Product Code | FTM |
| Date Received | 2020-03-04 |
| Lot Number | PD17270001 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TUTOGEN MEDICAL GMBH |
| Manufacturer Address | INDUSTRIESTRABE 6 NEUNKIRCHEN AM BRAND 97077 GM 97077 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-04 |