FDA Adverse Event
Injury
Summary report: N
PHYSIOMESH OVAL
MDR report key: 3202068
·
Received July 2, 2013
Report
- Report Number
- 2210968-2013-11892
- Event Type
- Injury
- Date Received
- July 2, 2013
- Report Date
- June 20, 2013
- Manufacturer
- ETHICON INC.
- Product Code
- FTL
- PMA / PMN Number
- K093932
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- 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.
Description of Event or Problem · 1
IT WAS REPORTED THAT A PATIENT UNDERWENT A HERNIA REPAIR PROCEDURE ON (B)(6) 2012 AND MESH WAS IMPLANTED. THE PATIENT EXPERIENCED A RECURRENT HERNIA. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6)/2013. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 300710 | PHYSIOMESH OVAL | MESH | FTL | ETHICON INC. | UNK | DM8KKMA0 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |