FDA Adverse Event
Injury
Summary report: N
SOFRADIM PRODUCT
MDR report key: 2355962
·
Received November 28, 2011
Report
- Report Number
- 9615742-2011-00143
- Event Type
- Injury
- Date Received
- November 28, 2011
- Date of Event
- December 24, 2007
- Report Date
- November 21, 2011
- Manufacturer
- SOFRADIM PRODUCTION
- Product Code
- FTL
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- ATTORNEY
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE TYPE: HERNIA. ACCORDING TO THE REPORTER: THE PT UNDERWENT A HERNIA REPAIR PROCEDURE. THE PT ALLEGEDLY EXPERIENCED PAIN AND INJURY. PT HAS EXPERIENCED INFECTIONS AND HOSPITALIZATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SOFRADIM PRODUCT | PARIETEX MESH | FTL | SOFRADIM PRODUCTION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other| R |