FDA Adverse Event
Injury
Summary report: N
PERMACOL 18X28 1.5MM
MDR report key: 3170141
·
Received June 6, 2013
Report
- Report Number
- 9617613-2013-00317
- Event Type
- Injury
- Date Received
- June 6, 2013
- Date of Event
- August 19, 2012
- Report Date
- May 15, 2013
- Manufacturer
- COVIDIEN, FORMERLY TISSUE
- Product Code
- FTL
- PMA / PMN Number
- K992556
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BE
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE TYPE: HERNIA. ACCORDING TO THE REPORTER: ON (B)(6) 2012, THE PATIENT HAD PERMACOL IMPLANTED. ON (B)(6) 2012, THE PATIENT DEVELOPED A SEROMA. ON (B)(6) 2012, THE SEROMA RESOLVED. THE PATIENT WAS TREATED WITH MEDICATION. THERE IS A POSSIBLE RELATIONSHIP TO THE DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 252021 | PERMACOL 18X28 1.5MM | PERMACOL MESH | FTL | COVIDIEN, FORMERLY TISSUE | 09B30-9 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 87 YR | Other |