FDA Adverse Event
Other
Summary report: N
ATRIUM C-QUR MESH
MDR report key: 1244323
·
Received November 24, 2008
Report
- Report Number
- 1219977-2008-00009
- Event Type
- Other
- Date Received
- November 24, 2008
- Date of Event
- October 2, 2008
- Report Date
- October 3, 2008
- Manufacturer
- ATRIUM MEDICAL CORP.
- Product Code
- FTL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- RISK MANAGER
Narratives
Additional Manufacturer Narrative · 1
WE HAVE NOT RECEIVED ANY COMPLAINTS OF ALLERGIC REACTION IN THE HISTORY OF THE PRODUCT. THE ONLY COATING ON THE MESH HAS NO KNOWN ALLERGENS. WE HAVE NOT RECEIVED THE PRODUCT BACK AND WILL SEND A FOLLOW UP REPORT WHEN/IF WE HAVE IT TO ANALYZE.
Description of Event or Problem · 1
PT REPORTED ALLERGIC TYPE REACTION AFTER THE ATRIUM C-QUR MESH WAS APPLIED DURING A LAPAROSCOPIC INCISIONAL HERNIA REPAIR WITH MESH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ATRIUM C-QUR MESH | NONE | FTL | ATRIUM MEDICAL CORP. | 31237 | 10192501008 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 47 YR | Other |