FDA Adverse Event
Malfunction
Summary report: N
SOFRADIM PRODUCT
MDR report key: 2645927
·
Received June 28, 2012
Report
- Report Number
- 9615742-2012-00271
- Event Type
- Malfunction
- Date Received
- June 28, 2012
- Report Date
- May 29, 2012
- Manufacturer
- SOFRADIM PRODUCTION
- Product Code
- FTL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
ACCORDING TO THE REPORTER: PATIENT COMPLAINTS INCREASING PAIN IN THE AREA OF THE SCAR WHERE DEVICE WAS IMPLANTED. THE PAIN IS ABOVE THE IMPLANTED MESH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SOFRADIM PRODUCT | SOFRADIM MESH | FTL | SOFRADIM PRODUCTION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |