MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-17 for FORTIVA PORCINE DERMIS manufactured by Tutogen Medical, Gmbh.
[188689025]
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 manufacturing of xenografts from lot pd18100001. Manufacturing records indicated that serial id (b)(4) met all specifications and release criteria prior to distribution. There are two related complaints for the lot, both associated with the appear trial. The name of the physician was not provided. Porcine dermis xenografts 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 one or more extrinsic factors, rather than in intrinsic property of the fortiva porcine dermis xenograft.
Patient Sequence No: 1, Text Type: N, H10
[188689026]
Rti surgical, inc (rti) and tutogen medical gmbh (tmi), a wholly subsidiary of rti, received a complaint on (b)(6) 2020, as part of the fortiva appear trial. The reported complaint indicated that a female patient, age (b)(6), was enrolled in the appear trial on (b)(6) 2019 at (b)(6). The patient has a history of stage iia breast cancer of the right breast. A single stage reconstruction of the right breast was performed on (b)(6) 2019, nipple removing, skin sparing with a transverse incision around the nipple. No skin reduction was performed and three lymph nodes were removed. A fortiva implant graft was used in an epipectoral procedure. A saline implant of 420ccs was placed. No drains were placed and the patient was discharged on (b)(6) 2019 on prophylactic antibiotics, analgesics and enoxaparin. At the one month follow-up visit on (b)(6) 2019 there were no significant changes noted. On (b)(6) 2002, the patient experienced wound dehiscence on the right side after a three day history of feeling unwell with flulike symptoms, loss of appetite, a temperature of 37. 4 degrees celsius. On (b)(6) 2020, the patient noted fluid dripping from right breast. Inflammation and wound dehiscence were observed upon examination. The patient was hospitalized and on (b)(6) 2020, the silicone implant was removed. The fortiva graft remains implanted. To date, no additional information has been provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002924436-2020-00014 |
| MDR Report Key | 9842092 |
| Date Received | 2020-03-17 |
| Date of Report | 2020-03-17 |
| Date of Event | 2020-01-27 |
| Date Mfgr Received | 2020-02-17 |
| Date Added to Maude | 2020-03-17 |
| 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 |
| Product Code | FTM |
| Date Received | 2020-03-17 |
| Lot Number | PD18100001 |
| 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 | 2020-03-17 |