MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,other report with the FDA on 2013-12-23 for MERSILENE MESH UNK RML manufactured by Ethicon Inc..
[4099766]
It was reported by an attorney that the patient underwent a gynecological procedure on (b)(6) 2001, and a mesh was 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
[11387884]
(b)(4). Conclusion: no conclusion can be drawn at this time. Should additional information be obtained, a supplemental 3500a form will be submitted accordingly. Mfr date is 08/01/1999.
Patient Sequence No: 1, Text Type: N, H10
[11700368]
(b)(4). It was reported that the patient underwent a gynecological procedure and mesh was implanted along with concurrent tah/bso due to uterine prolapsed, rectocele, cystocele, enterocele. No additional information was provided.
Patient Sequence No: 1, Text Type: N, H10
[21605317]
It was reported that the patient underwent a gynecological procedure on (b)(6) 2001 and mesh was implanted. It was reported that the patient underwent excision of vaginal cuff sinus and repair of the vaginal cuff on (b)(6) 2002, due to graft erosion with graft abscess of the vaginal cuff. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[21911869]
In addition, 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
[63696896]
Date sent to fda: 01/02/2017.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2210968-2013-33450 |
| MDR Report Key | 3535089 |
| Report Source | 00,OTHER |
| Date Received | 2013-12-23 |
| Date of Report | 2016-12-20 |
| Date Mfgr Received | 2016-12-20 |
| Device Manufacturer Date | 1999-08-01 |
| Date Added to Maude | 2013-12-23 |
| 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 | KATHY RICE |
| Manufacturer Street | 4545 CREEK RD |
| Manufacturer City | CINCINNATI OH 452422803 |
| Manufacturer Country | US |
| Manufacturer Postal | 452422803 |
| Manufacturer Phone | 5133373299 |
| Manufacturer G1 | ETHICON INC. - SAN LORENZO PR |
| Manufacturer Street | 982 ROAD 183 KM 8.3 |
| Manufacturer City | SAN LORENZO PR 00754 |
| Manufacturer Postal Code | 00754 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MERSILENE MESH |
| Generic Name | MESH, SURGICAL |
| Product Code | GAO |
| Date Received | 2013-12-23 |
| Model Number | UNK |
| Catalog Number | RML |
| Lot Number | MJP386 |
| Device Expiration Date | 2004-08-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2013-12-23 |