FDA Adverse Event
Death
Summary report: N
C-QUR V PATCH
MDR report key: 2733218
·
Received September 3, 2012
Report
- Report Number
- 1219977-2012-00023
- Event Type
- Death
- Date Received
- September 3, 2012
- Date of Event
- November 8, 2011
- Report Date
- May 25, 2012
- Manufacturer
- ATRIUM MEDICAL CORP.
- Product Code
- FTL
- PMA / PMN Number
- K090909
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HISTORY RECORDS FOR THE BATCH WERE REVIEWED. ALL MANUFACTURING AND QUALITY ASSURANCE TESTING WAS CARRIED OUT IN ACCORDANCE WITH OUR STANDARD PROCEDURES. THE DEVICE HISTORY RECORD FOR THIS BATCH SHOWS THAT THE PRODUCT MET ITS SPECIFICATIONS AT THE TIME OF RELEASE TO DISTRIBUTION AND THERE ARE NO SIMILAR INCIDENTS AGAINST THIS BATCH.
Description of Event or Problem · 1
PER MAUDE EVENT REPORT ((B)(4)) RECEIVED (B)(4) 2012. POST-OPERATIVE WOUND INFECTION AND CELLULITIS FOLLOWING VENTRAL HERNIA REPAIR WITH MESH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | C-QUR V PATCH | FTL | ATRIUM MEDICAL CORP. | 31201 | 10752136 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Death |