MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,other report with the FDA on 2014-01-25 for MERSILENE MESH UNK RML manufactured by Ethicon Inc..
[4188506]
It was reported that the patient underwent a gynecological procedure on (b)(6) 2005 and mesh were implanted into the patient. It is reported that the patient experienced pain, mesh erosion, infection, bleeding, vaginal scarring/shrinkage and exposure/extrusion/protrusion, and has undergone additional surgeries and revisionary procedures. It was also reported that following insertion the patient experienced erosion, urinary problems, bleeding, dyspareunia. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
[11444963]
(b)(4). Conclusion: no conclusion can be drawn at this time. Should additional information be obtained, a supplemental 3500a form will be submitted accordingly.
Patient Sequence No: 1, Text Type: N, H10
[54770103]
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2210968-2014-00859 |
| MDR Report Key | 3592144 |
| Report Source | 00,OTHER |
| Date Received | 2014-01-25 |
| Date of Report | 2016-09-08 |
| Date Mfgr Received | 2016-09-08 |
| Date Added to Maude | 2014-01-25 |
| 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 | ELLEN REUSS |
| Manufacturer Street | ROUTE 22 WEST PO BOX 151 |
| Manufacturer City | SOMERVILLE NJ 08876 |
| Manufacturer Country | US |
| Manufacturer Postal | 08876 |
| Manufacturer Phone | 9082183095 |
| 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, POLYMERIC |
| Product Code | GAO |
| Date Received | 2014-01-25 |
| Model Number | UNK |
| Catalog Number | RML |
| Lot Number | UNK |
| 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 | 2014-01-25 |