FDA Adverse Event
Injury
Summary report: N
C-QUR MESH
MDR report key: 3624695
·
Received February 4, 2014
Report
- Report Number
- 1219977-2014-00001
- Event Type
- Injury
- Date Received
- February 4, 2014
- Report Date
- January 7, 2014
- Manufacturer
- ATRIUM MEDICAL CORPORATION
- Product Code
- FTL
- PMA / PMN Number
- K050311
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE STUDY APPEARS TO INCLUDE VARIOUS SYNTHETIC AND BIOLOGIC MESHES IN VENTRAL HERNIA REPAID, INCLUDING C-QUR. PROCEDURES, SUCH AS OPEN COMPONENT SEPARATION, ARE ASSOCIATED WITH A HIGH RISK OF COMPLICATIONS. INFECTION AND HERNIA RECURRENCE ARE HIGH ESPECIALLY ON HIGH RISK PATIENTS WITH PREVIOUS INFECTIONS, OBESITY, DIABETES, MULTIPLE RECURRENCES, ETC. WE ARE UNCERTAIN IF ANY EVALUATION HAS BEEN PERFORMED ON THE DEVICES USED IN THE (B)(6) STUDY BECAUSE NO DEVICES WERE RETURNED TO THE MANUFACTURER.
Description of Event or Problem · 1
ATRIUM HAS BECOME AWARE OF A STUDY ON HERNIA REPAIR WITH PREPERITONEAL PLACEMENT INVOLVING DIFFERENT MESH TYPES, INCLUDING C-QUR, WITH REPORTS OF INFECTION AND RECURRENCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 72844 | C-QUR MESH | FTL | ATRIUM MEDICAL CORPORATION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |