MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2020-03-19 for GYNECARE TVT OBTURATOR 810081 manufactured by Ethicon Inc..
[184261448]
(b)(4). To date, the device has not been returned. If the product is returned for evaluation, any further information derived from the evaluation will be submitted in a supplemental 3500a form. A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.
Patient Sequence No: 1, Text Type: N, H10
[184261449]
It was reported by an attorney that the patient underwent a gynecological surgical procedure on (b)(6) 2008 and mesh were implanted. It was reported that she experienced pain, erosion of her internal bodily tissue and other injuries following the procedure. It was reported that the patient has undergone multiple surgeries and revisionary procedures. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2210968-2020-02006 |
| MDR Report Key | 9856692 |
| Report Source | OTHER |
| Date Received | 2020-03-19 |
| Date of Report | 2020-03-11 |
| Date Mfgr Received | 2020-03-11 |
| Device Manufacturer Date | 2007-08-15 |
| Date Added to Maude | 2020-03-19 |
| 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 | KARA DITTY-BOVARD |
| Manufacturer Street | P.O. BOX 151, ROUTE 22 WEST |
| Manufacturer City | SOMERVILLE NJ 08876 |
| Manufacturer Country | US |
| Manufacturer Postal | 08876 |
| Manufacturer Phone | 6107428552 |
| Manufacturer G1 | ETHICON SARL-NEUCHATEL |
| Manufacturer Street | PUITS-GODET 20 |
| Manufacturer City | NEUCHATEL |
| Manufacturer Country | SZ |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GYNECARE TVT OBTURATOR |
| Generic Name | MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC |
| Product Code | OTN |
| Date Received | 2020-03-19 |
| Model Number | 810081 |
| Catalog Number | 810081 |
| Lot Number | 3063336 |
| Device Expiration Date | 2008-07-31 |
| 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 08876 US 08876 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-19 |