FDA Adverse Event
Injury
Summary report: N
IVS TUNNELLER
MDR report key: 2922136
·
Received January 11, 2013
Report
- Report Number
- 6000141-2013-00006
- Event Type
- Injury
- Date Received
- January 11, 2013
- Date of Event
- April 29, 2003
- Report Date
- December 14, 2012
- Manufacturer
- BALLYMONEY - USS
- Product Code
- FTL
- Adverse Event
- Yes
- Product Problem
- 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
PROCEDURE: UROGYNECOLOGICAL. ACCORDING TO THE REPORTER: THE PT ALLEGES INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 18126 | IVS TUNNELLER | IVS TUNNELLER | FTL | BALLYMONEY - USS | 0211016-04 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR |