FDA Adverse Event
Injury
Summary report: N
PERMACOL 20X30 1.5MM
MDR report key: 2031060
·
Received March 16, 2011
Report
- Report Number
- 9617613-2011-00008
- Event Type
- Injury
- Date Received
- March 16, 2011
- Date of Event
- October 15, 2010
- Report Date
- February 15, 2011
- Manufacturer
- TISSUE SCIENCE LABORATORIES, PLC
- Product Code
- FTL
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE TYPE: HERNIA. ACCORDING TO THE REPORTER: SURGERY DATE OF (B)(6) 2010, DUE TO ABDOMINAL PAIN AND RECURRENT INFECTIONS, REVISION PROCEDURES WERE PERFORMED ON (B)(6) 2010, (B)(6) 2011. RECURRENT TISSUE NECROSIS FOUND AND PT DEVELOPED SEVERE PAIN AND PERITONITIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PERMACOL 20X30 1.5MM | PERMACOL IMPLANT | FTL | TISSUE SCIENCE LABORATORIES, PLC | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 41 YR | Other |