FDA Adverse Event
Injury
Summary report: N
UNKNOWN PARIETENE MESH PRODUCT
MDR report key: 4143025
·
Received October 6, 2014
Report
- Report Number
- 9615742-2014-00315
- Event Type
- Injury
- Date Received
- October 6, 2014
- Date of Event
- July 13, 2010
- Report Date
- September 18, 2014
- Manufacturer
- SOFRADIM PRODUCTION
- Product Code
- FTL
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
ACCORDING TO THE REPORTER: THIS COMPLAINT IS A CLAIM RECEIVED FROM A LAWYER FIRM. ON (B)(6) 2010, A GYNAECOLOGIST PLACED A PROPYLENE LIGHT PARIETENE MESH IMPLANT WITH A PATIENT. IMMEDIATELY AFTER THE SURGERY THE PATIENT RECEIVED SEVERE COMPLICATIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 624553 | UNKNOWN PARIETENE MESH PRODUCT | UNKNOWN PARIETENE | FTL | SOFRADIM PRODUCTION | UNKNOWN PARIETENE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |