MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-11-17 for BIODESIGN POSTERIOR PELVIC FLOOR GRAFT J-PF-POST manufactured by Cook Biotech.
[60288076]
Product common name - posterior pelvic floor graft; product code - pag. A review of the device history records indicated the device was manufactured to specifications. A total of five devices were produced from the lot. A review of the cbi complaint database did not reveal any previously reported 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 the 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 alleged injury remain unknown. A root cause of the claim allegations is inconclusive due to the lack of details provided by the complainant. All other matters relating to this litigation are being handled by our attorney. A follow-up mdr will be filed if additional details are obtained.
Patient Sequence No: 1, Text Type: N, H10
[60288077]
The patient was reportedly implanted with a bard align and a biodesign surgisis posterior pelvic floor graft on (b)(6) 2011, at (b)(6), by dr. (b)(6). The patient and her attorney have alleged that as a result of these products being implanted in the patient, the patient has experienced pain, injury, and has undergone medical treatment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1835959-2016-00630 |
| MDR Report Key | 6110788 |
| Date Received | 2016-11-17 |
| Date of Report | 2016-11-14 |
| Date Mfgr Received | 2016-11-03 |
| Device Manufacturer Date | 2010-10-01 |
| Date Added to Maude | 2016-11-17 |
| 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 |
| Reporter Occupation | ATTORNEY |
| 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 | 0 |
| Brand Name | BIODESIGN POSTERIOR PELVIC FLOOR GRAFT |
| Product Code | PAG |
| Date Received | 2016-11-17 |
| Catalog Number | J-PF-POST |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2016-11-17 |