FDA Adverse Event
Other
Summary report: N
C-QUR V-PATCH MESH
MDR report key: 2428905
·
Received January 20, 2012
Report
- Report Number
- 1219977-2012-00002
- Event Type
- Other
- Date Received
- January 20, 2012
- Date of Event
- January 3, 2012
- Report Date
- January 20, 2012
- Manufacturer
- ATRIUM MEDICAL CORP.
- Product Code
- FTL
- PMA / PMN Number
- K090909
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NH, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
DEVICE IS CURRENTLY BEING EVALUATED AND RESULTS WILL BE FORTHCOMING.
Description of Event or Problem · 1
THE PT'S BODY REJECTED THE MESH. THE PT EXHIBITED LOTS OF PAIN, WITH CLEAR, RED DRAINAGE, UNRESOLVED FOR MANY MONTHS. THE PT IS (B)(6), HEALTHY, NO DOCUMENTED ALLERGIES, ACTIVE CAREER (B)(6). NOTHING OF NOTE IS IN HIS HISTORY THAT WOULD SEND UP A RED FLAG ACCORDING TO THE PHYSICIAN. UPON EXPLANTING, THE PATCH WAS INCORPORATED WELL ON ONE HALF OF THE V-PATCH AND THE OTHER SIDE CAME OUT WITH LITTLE OR NO DISSECTION, SO IT WAS CLEAR IT HADN'T REALLY INCORPORATED. THERE WAS A FISTULA PRESENT ON THE MESH THAT THE PHYSICIAN SUSPECTED WAS THE SOURCE OF THE DRAINAGE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | C-QUR V-PATCH MESH | FTL | ATRIUM MEDICAL CORP. | 31201 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Required Intervention |