FDA Adverse Event
Injury
Summary report: N
PARIETENE LIGHT PP 15X10CM X3
MDR report key: 2133730
·
Received June 9, 2011
Report
- Report Number
- 9615742-2011-00051
- Event Type
- Injury
- Date Received
- June 9, 2011
- Date of Event
- September 1, 2009
- Report Date
- May 17, 2011
- Manufacturer
- SOFRADIM PRODUCTION
- Product Code
- FTL
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE: INGUINAL HERNIA REPAIR. ACCORDING TO THE REPORTER: RECURRENCE OF HERNIA. PROCEDURE WAS PERFORMED ON (B)(6) 2010. THE PATIENT WAS ADMITTED FOR ONE DAY, NO OVERNIGHT STAY REQUIRED FOR THE REPAIR. OTHER TREATMENT WAS GIVEN FOR POST-OPERATIVE PAIN, CO-CODAMOL 30/500 X 2 FOUR TIMES DAILY UNTIL PAIN STOPPED, DICLOFENAC 50MG X 1 THREE TIMES DAILY UNTIL PAIN STOPPED. THE PATIENT RECOVERED WITHOUT SEQUELAE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PARIETENE LIGHT PP 15X10CM X3 | PARIETENE LIGHT MESH | FTL | SOFRADIM PRODUCTION | SIK00664 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 45 YR | Other |