FDA Adverse Event
Injury
Summary report: N
GYNECARE TVT-AA ABDOMINAL
MDR report key: 3260585
·
Received August 1, 2013
Report
- Report Number
- 2210968-2013-15436
- Event Type
- Injury
- Date Received
- August 1, 2013
- Report Date
- August 10, 2016
- Manufacturer
- ETHICON SARL
- Product Code
- OTN
- PMA / PMN Number
- K033568
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.
Additional Manufacturer Narrative · 1
IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL SURGICAL PROCEDURE AND A MESH WAS IMPLANTED CONCURRENTLY WITH CYSTOURETHROSCOPY. NO ADDITIONAL INFORMATION WAS PROVIDED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE TO TREAT SUI AND POP ON AN UNDISCLOSED DATE AND MESH WAS IMPLANTED INTO THE PATIENT. IT IS REPORTED THAT THE PATIENT EXPERIENCED PAIN, EROSION OF HER INTERNAL BODILY TISSUE AND OTHER INJURIES, AND SHE HAS UNDERGONE ADDITIONAL SURGERIES AND REVISIONARY PROCEDURES. NO ADDITIONAL INFORMATION IS PROVIDED AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 359709 | GYNECARE TVT-AA ABDOMINAL | MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC | OTN | ETHICON SARL | UNK | 3592196 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 33 YR | Required Intervention |