FDA Adverse Event
Injury
Summary report: N
C-QUR V-PATCH
MDR report key: 3072393
·
Received April 19, 2013
Report
- Report Number
- 1219977-2013-00029
- Event Type
- Injury
- Date Received
- April 19, 2013
- Date of Event
- March 15, 2013
- Report Date
- March 25, 2013
- Manufacturer
- ATRIUM MEDICAL CORP.
- Product Code
- FTL
- PMA / PMN Number
- K090909
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AU
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
CURRENTLY IN THE PROCESS OF BEING EVALUATED.
Description of Event or Problem · 1
MESH IMPLANTED ON (B)(6) 2013, FOR A UMBILICAL HERNIA REPAIR. INFECTION NOTED, AND CULTURED. ATTENDED ANTIBIOTIC THERAPY IMPLEMENTED. MESH WAS REMOVED ON (B)(6) 2013.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 170536 | C-QUR V-PATCH | FTL | ATRIUM MEDICAL CORP. | 31202 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR | Other |