FDA Adverse Event
Malfunction
Summary report: N
PARIETENE LIGHT PP 20X20CM X1
MDR report key: 1739732
·
Received June 9, 2010
Report
- Report Number
- 9615742-2010-00014
- Event Type
- Malfunction
- Date Received
- June 9, 2010
- Report Date
- May 11, 2010
- Manufacturer
- SOFRADIM PRODUCTION
- Product Code
- FTL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE TYPE: HERNIA. ACCORDING TO THE REPORTER: THE MESH COMES FOLDED IN ITS ORIGINAL BOX, THIS MAKES IT DIFFICULT TO HANDLE AND FIXATE THE PRODUCT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PARIETENE LIGHT PP 20X20CM X1 | SOFRADIM MESH | FTL | SOFRADIM PRODUCTION | SJL00149 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |