FDA Adverse Event
Other
Summary report: N
C-QUR MESH (8X10)
MDR report key: 2549038
·
Received April 19, 2012
Report
- Report Number
- 1219977-2012-00008
- Event Type
- Other
- Date Received
- April 19, 2012
- Date of Event
- March 12, 2012
- Report Date
- April 18, 2012
- Manufacturer
- ATRIUM MEDICAL CORPORATION
- Product Code
- FTL
- PMA / PMN Number
- K100076
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HISTORY RECORD WAS REVIEWED. THE DEVICE MET SPECS AT THE TIME OF MANUFACTURE.
Description of Event or Problem · 1
PT UNDERWENT THREE INCISIONAL HERNIA REPAIRS. TWO WERE FOR UMBILICAL AND ONE MIDLINE SLIGHTLY HIGHER THAN UMBILICAL. THE PROCEDURE STARTED AS A LAPAROSCOPIC AND WAS SWITCHED TO OPEN. THERE WERE MULTIPLE ADHESIONS, NO INJURIES, NO OBVIOUS BREAK IN TECHNIQUE. PT HAD POSTOPERATIVE COMPLICATION OF WOUND/INFECTION AND ENTEROTOMY/BOWEL INJURY AND THE MESH WAS EXPLANTED ON (B)(6) 2012.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | C-QUR MESH (8X10) | FTL | ATRIUM MEDICAL CORPORATION | 31536 | 10811772 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR |