FDA Adverse Event
Other
Summary report: N
C-QUR V PATCH
MDR report key: 2640612
·
Received June 21, 2012
Report
- Report Number
- 1219977-2012-00015
- Event Type
- Other
- Date Received
- June 21, 2012
- Date of Event
- November 4, 2011
- Report Date
- June 21, 2012
- Manufacturer
- ATRIUM MEDICAL CORP.
- Product Code
- FTL
- PMA / PMN Number
- K090909
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE CURRENTLY UNDER EVAL.
Description of Event or Problem · 1
PT PRESENTED WITH (B)(6) MONTH POST-OP REDNESS AND BLISTERS ON SKIN (OPENED AND CULTURED BLISTER), REDDISH FLUID, FISTULA TO MESH. FLUID CULTURE WAS NEGATIVE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | C-QUR V PATCH | FTL | ATRIUM MEDICAL CORP. | 31201 | 10752138 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR | Hospitalization |