FDA Adverse Event
Injury
Summary report: N
GYNECARE TVT EXACT CONTINENCE SYSTEM
MDR report key: 3190643
·
Received June 26, 2013
Report
- Report Number
- 2210968-2013-11232
- Event Type
- Injury
- Date Received
- June 26, 2013
- Report Date
- June 12, 2013
- Manufacturer
- ETHICON INC.
- Product Code
- OTN
- PMA / PMN Number
- K100485
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, 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
(B)(4).
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) 2011 AND MESH WAS IMPLANTED. THE PATIENT EXPERIENCED PAIN, EROSION OF HER INTERNAL TISSUES, 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 |
|---|---|---|---|---|---|---|---|
| 290112 | GYNECARE TVT EXACT CONTINENCE SYSTEM | MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC | OTN | ETHICON INC. | UNK | 3465616 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |