MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2016-08-30 for GYNECARE MESH UNKNOWN manufactured by Ethicon Inc..
[53479598]
(b)(4). To date, the device has not been returned. If the product is returned for evaluation, any further info derived from the evaluation will be submitted in a supplemental 3500a form.
Patient Sequence No: 1, Text Type: N, H10
[53479599]
It was reported by an attorney that the patient underwent a gynecological surgical procedure on an undisclosed date and mesh was implanted. It was reported that she experienced undisclosed injuries. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2210968-2016-11788 |
| MDR Report Key | 5913875 |
| Report Source | OTHER |
| Date Received | 2016-08-30 |
| Date of Report | 2016-08-22 |
| Date Mfgr Received | 2016-08-10 |
| Date Added to Maude | 2016-08-30 |
| 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 | KENNETH CLARK |
| Manufacturer Street | ROUTE 22 WESTP O BOX 151 |
| Manufacturer City | SOMERVILLE NJ 08876 |
| Manufacturer Country | US |
| Manufacturer Postal | 08876 |
| Manufacturer Phone | 9082183547 |
| Manufacturer G1 | ETHICON INC.-PENDING DETERMINATION |
| Manufacturer Street | P.O. BOX 151, ROUTE 22 WEST |
| Manufacturer City | SOMERVILLE NJ 088760151 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 088760151 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GYNECARE MESH UNKNOWN |
| Product Code | FTT |
| Date Received | 2016-08-30 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ETHICON INC. |
| Manufacturer Address | P.O. BOX 151, ROUTE 22 WEST SOMERVILLE NJ 088760151 US 088760151 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-08-30 |