MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2016-11-16 for BIODESIGN ANTERIOR PELVIC FLOOR GRAFT J-PF-ANT manufactured by Cook Biotech.
[59989519]
Date of event not provided by the complainant. Product common name - anterior pelvic floor graft; product code pag. A review of the device history records indicated the device was manufactured to specifications. Two 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. The ifu notes that 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 device. 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 surgisis biodesign anterior pelvic floor grafts 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
[59989520]
The patient was reportedly implanted with a surgisis biodesign anterior pelvic floor graft on (b)(6) 2010, at (b)(6) hospital in (b)(6) , by dr. (b)(6). The patient and her attorney have alleged that as a result of this product 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 | 1835959-2016-00631 |
| MDR Report Key | 6105609 |
| Report Source | CONSUMER |
| Date Received | 2016-11-16 |
| Date of Report | 2016-11-14 |
| Date Mfgr Received | 2016-11-03 |
| Device Manufacturer Date | 2010-01-01 |
| Date Added to Maude | 2016-11-16 |
| 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 | 3 |
| Brand Name | BIODESIGN ANTERIOR PELVIC FLOOR GRAFT |
| Product Code | PAI |
| Date Received | 2016-11-16 |
| Catalog Number | J-PF-ANT |
| 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 | 2016-11-16 |