FDA Adverse Event
Injury
Summary report: N
NOVASILK FLAT MESH 15
MDR report key: 2892117
·
Received January 2, 2013
Report
- Report Number
- 2125050-2013-00015
- Event Type
- Injury
- Date Received
- January 2, 2013
- Report Date
- January 2, 2013
- Manufacturer
- COLOPLAST A/S
- Product Code
- FTL
- PMA / PMN Number
- K053414
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- ATTORNEY
Narratives
Additional Manufacturer Narrative · 1
COLOPLAST HAS NOT BEEN PROVIDED ANY CORROBORATING EVIDENCE TO VERIFY THIS REPORT. (B)(4): DEVICE STILL IMPLANTED.
Description of Event or Problem · 1
AS REPORTED TO COLOPLAST THOUGH NOT VERIFIED, THE PATIENT IMPLANTED WITH NOVASILK ON (B)(6) 2009. LATER, PATIENT EXPERIENCED MENTAL AND PHYSICAL PAIN, HAS UNDERGONE AND WILL LIKELY UNDERGONE CORRECTIVE SURGERY OR SURGERIES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1635 | NOVASILK FLAT MESH 15 | SURGICAL MESH | FTL | COLOPLAST A/S | 5196101000 | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |