FDA Adverse Event
Injury
Summary report: N
T-SLING
MDR report key: 3012325
·
Received March 7, 2013
Report
- Report Number
- 3003990090-2013-00019
- Event Type
- Injury
- Date Received
- March 7, 2013
- Date of Event
- June 27, 2007
- Report Date
- January 29, 2013
- Manufacturer
- HERNIAMESH S.R.L.
- Product Code
- PAH
- Adverse Event
- Yes
- Report Source
- Distributor report
- Reporter Location
- TX, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
EVENT WAS REPORTED TO CALDERA MEDICAL BY AN ATTORNEY. LEGAL COMPLAINT STATES THAT PT SUFFERED PAIN, EROSION AND INFECTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 98400 | T-SLING | SURGICAL MESH | PAH | HERNIAMESH S.R.L. | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |