FDA Adverse Event
Injury
Summary report: N
UNK
MDR report key: 3182242
·
Received June 21, 2013
Report
- Report Number
- 2210968-2013-10738
- Event Type
- Injury
- Date Received
- June 21, 2013
- Report Date
- June 19, 2013
- Manufacturer
- ETHICON INC.
- Product Code
- FTL
- PMA / PMN Number
- UNKNOWN
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- 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 SURGERY ON (B)(6) 2009 AND MESH WAS PLACED INTO THE PATIENT¿S BODY. THE PATIENT EXPERIENCED MULTIPLE COMPLICATIONS, INCLUDING EROSION, FORMATION OF SCAR TISSUE, ADDITIONAL SURGERIES AND NEUROLOGIC COMPROMISE TO HER STRUCTURES AND TISSUES. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 282205 | UNK | MESH, SURGICAL, SYNTHETIC | FTL | ETHICON INC. | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |