FDA Adverse Event
Injury
Summary report: N
C-QUR VPATCH
MDR report key: 2963685
·
Received January 2, 2013
Report
- Report Number
- 1219977-2012-00213
- Event Type
- Injury
- Date Received
- January 2, 2013
- Report Date
- May 3, 2012
- Manufacturer
- ATRIUM MEDICAL CORP.
- Product Code
- FTL
- PMA / PMN Number
- K090909
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
BECAUSE THE EXPLANT WAS NOT RETURNED TO ATRIUM, NEITHER A VISUAL EXAMINATION NOR HISTOLOGICAL EVALUATION OF THE DEVICE COULD BE PERFORMED. THE MANUFACTURING RECORDS FOR THIS LOT OF V-PATCH WERE EXAMINED AND NO DEVIATIONS WERE NOTED. POST-OPERATIVE INFECTION AFTER HERNIA REPAIR USING MESH IS A COMMON OCCURRENCE AND THE RATE OF INFECTION CAN BE INFLUENCED BY A VARIETY OF SURGICAL AND PATIENT FACTORS. THE RATE OF INFECTION IS KNOWN TO BE INCREASED DURING OPEN HERNIA REPAIRS, IN PATIENTS WHO ARE IMMUNOSUPPRESSED, SMOKERS, DIABETIC, AND/OR OBESE.
Description of Event or Problem · 1
PROSTHESIS INFECTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1429 | C-QUR VPATCH | FTL | ATRIUM MEDICAL CORP. | 31201 | 10808462 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |