FDA Adverse Event
Injury
Summary report: N
CQUR TACSHIELD
MDR report key: 3020597
·
Received March 21, 2013
Report
- Report Number
- 1219977-2013-00021
- Event Type
- Injury
- Date Received
- March 21, 2013
- Date of Event
- January 23, 2013
- Report Date
- March 1, 2013
- Manufacturer
- ATRIUM MEDICAL CORP.
- Product Code
- FTL
- PMA / PMN Number
- K100076
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CURRENTLY IN THE PROCESS OF PERFORMING AN EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORDS, INCLUDING THE STERILIZATION RECORDS, INDICATED THAT THE MESH WAS PROCESSED AND INSPECTED ACCORDING TO PROCEDURES AND NO DEVIATIONS WERE FOUND. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION.
Description of Event or Problem · 1
SURGEON PLACED 6X8 TACSHIELD WITH PROLENE SUTURE AROUND PERIMETER AND CLOSED FASCIA OVER TOP. SEROMA POST OP AFTER TWO WEEKS, THEN AT 4 WEEKS PT CAME BACK WITH REDNESS/RASH, AND 'SOUPY' TISSUE. NO INFECTION PRESENT UPON MESH REMOVAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 118214 | CQUR TACSHIELD | FTL | ATRIUM MEDICAL CORP. | 31633 | 10740235 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Required Intervention |