MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-10-27 for TVT manufactured by Ethicon J&j.
[58916212]
I was implanted with a transvaginal bladder mesh device for incontinence. The device has eroded through my vaginal walls, requiring surgical removal and what was left behind after that surgery is now hardening and contracting on my bladder. I have suffered horrendous pain in my pelvic area. I am hoping to have this mesh fully removed soon.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5065687 |
| MDR Report Key | 6066659 |
| Date Received | 2016-10-27 |
| Date of Report | 2016-10-27 |
| Date of Event | 2011-01-07 |
| Date Added to Maude | 2016-10-31 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | TVT |
| Generic Name | TVT |
| Product Code | PAI |
| Date Received | 2016-10-27 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ETHICON J&J |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2016-10-27 |