FDA Adverse Event
Malfunction
Summary report: N
PERMACOL 15X20 1.5MM
MDR report key: 3416068
·
Received September 9, 2013
Report
- Report Number
- 9617613-2013-00875
- Event Type
- Malfunction
- Date Received
- September 9, 2013
- Date of Event
- July 12, 2013
- Report Date
- August 12, 2013
- Manufacturer
- COVIDIEN, FORMERLY TISSUE SCIENCE LABORATORIES, PLC
- Product Code
- FTL
- PMA / PMN Number
- K992556
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE: HERNIA. ACCORDING TO THE REPORTER: HEMATOMA (MILD).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 451016 | PERMACOL 15X20 1.5MM | PERMACOL MESH | FTL | COVIDIEN, FORMERLY TISSUE SCIENCE LABORATORIES, PLC | 11B11-8 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |