MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2016-10-20 for UNKNOWN manufactured by Unknown, Unk.
[58018380]
(b)(6). Date of event not provided by the complainant. Product code pag / pai. Lot number not provided by the complainant. Surgeon name not provided by the complainant. Implant date not provided by the complainant. As requested by the fda, we have made note of the product code. The product code listed is not necessarily the product code assigned to the device 510(k), but rather the product code that seems the most appropriate based on the surgical procedure in which the product was implanted. Based on the information provided by the complainant, details regarding a specific correlation between a cook biotech incorporated manufactured product? 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 received.
Patient Sequence No: 1, Text Type: N, H10
[58018381]
The patient was reportedly implanted with an unspecified manufacturer's pelvic mesh product(s). The patient and her attorney have alleged that as a result of this/these product(s) 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 | 1835959-2016-00577 |
| MDR Report Key | 6045132 |
| Report Source | CONSUMER |
| Date Received | 2016-10-20 |
| Date of Report | 2016-10-19 |
| Date Mfgr Received | 2016-09-30 |
| Date Added to Maude | 2016-10-20 |
| 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 | UNKNOWN |
| Product Code | PAG |
| Date Received | 2016-10-20 |
| Catalog Number | UNKNOWN |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNKNOWN, UNK |
| Manufacturer Address | UNKNOWN UNKNOWN UNKNOWN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2016-10-20 |