FDA Adverse Event
Injury
Summary report: N
UNKNOWN MESH PRODUCT
MDR report key: 4232027
·
Received November 6, 2014
Report
- Report Number
- 1219930-2014-01011
- Event Type
- Injury
- Date Received
- November 6, 2014
- Date of Event
- May 25, 2004
- Report Date
- October 15, 2014
- Manufacturer
- COVIDIEN, FORMERLY US SURGICAL A DIVISON
- Product Code
- FTL
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
ACCORDING TO THE REPORTER: THE PATIENT ALLEGED INJURY. MEDICAL HISTORY: RECURRENT STRESS URINARY INCONTINENCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 715810 | UNKNOWN MESH PRODUCT | UNKNOWN MESH | FTL | COVIDIEN, FORMERLY US SURGICAL A DIVISON | UNKNOWN MESH | NOT AVAILABLE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 47 YR | Other |