FDA Adverse Event
Injury
Summary report: N
GYNECARE TVT RETROPUBIC SYSTEM
MDR report key: 3177840
·
Received June 19, 2013
Report
- Report Number
- 2210968-2013-10541
- Event Type
- Injury
- Date Received
- June 19, 2013
- Report Date
- March 15, 2016
- Manufacturer
- ETHICON INC.
- Product Code
- OTN
- PMA / PMN Number
- K012628
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- RI, 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). IT WAS REPORTED THAT THE PATIENT UNDERWENT GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED ALONG WITH THE CONCURRENT PROCEDURES LAVH AND LSO DUE TO SUI.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2004 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT SHE EXPERIENCED PAIN, EROSION OF HER INTERNAL BODILY TISSUE AND OTHER INJURIES FOLLOWING THE PROCEDURE. IT WAS REPORTED THAT THE PATIENT HAS UNDERGONE MULTIPLE SURGERIES AND REVISIONARY PROCEDURES. NO ADDITIONAL INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 278064 | GYNECARE TVT RETROPUBIC SYSTEM | MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC | OTN | ETHICON INC. | UNK | 1126607 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 38 YR | Required Intervention |