FDA Adverse Event
Injury
Summary report: N
PHYSIOMESH
MDR report key: 3875330
·
Received June 16, 2014
Report
- Report Number
- 2210968-2014-07699
- Event Type
- Injury
- Date Received
- June 16, 2014
- Report Date
- May 27, 2014
- Manufacturer
- ETHICON INC.
- Product Code
- FTL
- PMA / PMN Number
- K093932
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- 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 A PATIENT UNDERWENT HERNIA REPAIR PROCEDURE ON AN UNKNOWN DATE AND MESH WAS IMPLANTED. THE PATIENT EXPERIENCED HERNIA RE-OCCURRENCE. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 352954 | PHYSIOMESH | MESH, SURGICAL | FTL | ETHICON INC. | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |