FDA Adverse Event
Injury
Summary report: N
GYNECARE TVT OBURATOR SYSTEM
MDR report key: 4782028
·
Received May 19, 2015
Report
- Report Number
- 2210968-2015-06055
- Event Type
- Injury
- Date Received
- May 19, 2015
- Report Date
- April 24, 2015
- Manufacturer
- ETHICON INC.
- Product Code
- OTN
- PMA / PMN Number
- K033568
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- 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.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT UNDERWENT SLING PROCEDURE IN (B)(6) 2013. DURING THREE-MONTH POST-OPERATIVE REVIEW, THE PATIENT EXPERIENCED EXPOSURE OF THE MESH AND THE EXPOSED MESH WAS REMOVED. IT WAS REPORTED THAT THE PATIENT¿S SYMPTOMS IN THE AREA SETTLED BUT THE PATIENT CONTINUED TO REPORT RIGHT GROIN PAIN AND REQUESTED REMOVAL OF THE MESH. THE PATIENT UNDERWENT MESH REMOVAL ON (B)(6) 2014. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 326769 | GYNECARE TVT OBURATOR SYSTEM | MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGICAL | OTN | ETHICON INC. | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |