FDA Adverse Event
Injury
Summary report: N
GYNECARE TVT RETROPUBIC SYSTEM
MDR report key: 3193366
·
Received June 27, 2013
Report
- Report Number
- 2210968-2013-11343
- Event Type
- Injury
- Date Received
- June 27, 2013
- Report Date
- June 12, 2013
- Manufacturer
- ETHICON INC.
- Product Code
- OTN
- PMA / PMN Number
- K012628
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). 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
(B)(4). IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2004 AND MESH WAS IMPLANTED. THE PATIENT EXPERIENCED MULTIPLE COMPLICATIONS, INCLUDING EROSION, FORMATION OF SCAR TISSUE, ADDITIONAL SURGERIES AND NEUROLOGIC COMPROMISE TO HER STRUCTURES AND TISSUES. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 293590 | GYNECARE TVT RETROPUBIC SYSTEM | MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC | OTN | ETHICON INC. | UNK | 1200761 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |