FDA Adverse Event
Injury
Summary report: N
SOFRADIM PRODUCT
MDR report key: 2600583
·
Received June 1, 2012
Report
- Report Number
- 9615742-2012-00231
- Event Type
- Injury
- Date Received
- June 1, 2012
- Report Date
- May 4, 2012
- Manufacturer
- SOFRADIM PRODUCTION
- Product Code
- FTL
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
(B)(4)
Description of Event or Problem · 1
ACCORDING TO THE REPORTER: THE DEVICE WAS IMPLANTED TWICE IN 2010. THE PT ALLEGEDLY UNDERWENT REVISION SURGERY IN 2010. THE MESH BECAME LOOSE AND INFECTED AND CAUSED HER SEVERE PAIN AND SUFFERING. IT MADE HER SICK ALL THE TIME AND NOW HER ABDOMEN IS SEVERELY PROTRUDED AND SHE NOW REQUIRES 3RD SURGERY.
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 | Other |