FDA Adverse Event
Other
Summary report: N
C-QUR, TACSHIELD, 6X8 (15CM X 20.3CM)
MDR report key: 2573878
·
Received May 4, 2012
Report
- Report Number
- 1219977-2012-00009
- Event Type
- Other
- Date Received
- May 4, 2012
- Date of Event
- March 12, 2012
- Report Date
- May 1, 2012
- Manufacturer
- ATRIUM MEDICAL CORP.
- Product Code
- FTL
- PMA / PMN Number
- K100076
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
DEVICE HAS BEEN RETURNED AND IS BEING EVALUATED.
Description of Event or Problem · 1
PT WENT IN FOR A GALLBLADDER AND THE DOCTOR FOUND ADHESIONS TO THE IMPLANTED MESH THAT WAS IMPLANTED ON (B)(6) 2011, THE ORIGINAL SIZE OF THE MESH WAS 6X8 THE DOCTOR STATED IT WAS NOW 4X4. HE HAD TO CUT DOWN 8 OR 9 LOOPS OF BOWEL. HE FELT THE MESH GREW TO >1CM THICK WELL. HE ALSO THOUGHT THERE MIGHT HAVE BEEN A FOLD IN THE MESH HOLDING THE OMEGA 3 CAUSING THE ADHESIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | C-QUR, TACSHIELD, 6X8 (15CM X 20.3CM) | FTL | ATRIUM MEDICAL CORP. | 31633 | 10698746 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 79 YR | Required Intervention |