MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2018-04-09 for BIODESIGN POSTERIOR PELVIC FLOOR GRAFT J-PF-POST manufactured by Cook Biotech.
[104735867]
Date of event not provided by the complainant. Surgeon name not provided by the complainant. Implant date not provided by the complainant. *the device is no longer marketed in the us or ous as the device is no longer manufactured. * *this mdr is related to (b)(4). * a review of the device lot history record indicated the device was manufactured to specifications. The non-conformance would not have contributed to the reported occurrence. One device was produced from the lot. A review of the cbi complaint database did not reveal any additional complaints involving the reported lot number. A review of the ifu revealed "the following complications are possible with the use of surgical graft materials: bleeding, infection, adhesions, sterile effusion, chronic inflammation, allergic reaction, and delayed or failed incorporation of graft. If conditions of infection, inflammation, or allergic reaction cannot be resolved, consider removal of the graft. " based on the information provided by the complainant, details regarding a specific correlation between the biodesign surgisis posterior pelvic floor graft's performance and the reported injury remain unknown. A root cause of the reported injury is inconclusive due to the lack of details provided by the complainant.
Patient Sequence No: 1, Text Type: N, H10
[104735868]
(b)(4) a patient reported directly to tga that she had an operation for a prolapse of the womb. Since the device was fitted, the patient reports having constant pain in legs, pelvic area, and buttocks, hot flushes, aching joints and back, and burning sensation in her feet. Her memory is affected as is her ability to walk, sit, sleep, and drive. The patient's anxiety and depression have increased and she also has skin conditions. She also reported having strong pain in both of her hips, lack of energy, and constant tiredness.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1835959-2018-00006 |
| MDR Report Key | 7408122 |
| Report Source | OTHER |
| Date Received | 2018-04-09 |
| Date of Report | 2018-04-09 |
| Date Mfgr Received | 2018-04-05 |
| Device Manufacturer Date | 2011-04-01 |
| Date Added to Maude | 2018-04-09 |
| 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 | MR. PERRY GUINN |
| Manufacturer Street | 1425 INNOVATION PLACE |
| Manufacturer City | WEST LAFAYETTE IN 47906 |
| Manufacturer Country | US |
| Manufacturer Postal | 47906 |
| Manufacturer Phone | 7654973355 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIODESIGN POSTERIOR PELVIC FLOOR GRAFT |
| Generic Name | PELVIC FLOOR POSTERIOR |
| Product Code | PAI |
| Date Received | 2018-04-09 |
| Catalog Number | J-PF-POST |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK BIOTECH |
| Manufacturer Address | 1425 INNOVATION PLACE WEST LAFAYETTE IN 47906 US 47906 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2018-04-09 |