FDA Adverse Event
Other
Summary report: N
C-QUR MESH
MDR report key: 1613170
·
Received February 12, 2010
Report
- Report Number
- 1219977-2010-00001
- Event Type
- Other
- Date Received
- February 12, 2010
- Date of Event
- December 11, 2009
- Report Date
- February 11, 2010
- Manufacturer
- ATRIUM MEDICAL CORP.
- Product Code
- FTL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
SOFT TISSUE INFECTIONS LEADING TO MESH INFECTIONS ARE NOT INFREQUENT OCCURRENCES IN HERNIA REPAIR, ESPECIALLY OPEN ABDOMINAL REPAIR. (B)(4) REPORTS AN 8.7% WOUND INFECTION AFTER HERNIA SURGERY USING MESH. THE CAUSES OF THESE INFECTIONS ARE NUMEROUS BUT ARE MOSTLY RELATED TO SURGICAL TECHNIQUE AND PT HEALTH. WITH THE INFO AVAILABLE, WE WERE UNABLE TO DETERMINE A CAUSE OF INFECTION, HOWEVER, ALL MESH IS STERILIZED BEFORE LEAVING ATRIUM.
Description of Event or Problem · 1
PT ADMITTED WITH AN ABSCESS ON HER ABDOMINAL WALL WHERE A HERNIA REPAIR TOOK PLACE. A J VALVE WAS PUT IN PLACE TO DRAIN THE ABSCESS. PT IS RECEIVING BLOOD TRANSFUSION DUE TO LOW RED COUNT. DOCTOR SAYS LAST RESORT IS THE MESH IS INFECTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | C-QUR MESH | NONE | FTL | ATRIUM MEDICAL CORP. | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |