FDA Adverse Event
Injury
Summary report: N
IVS TUNNELLER
MDR report key: 2762342
·
Received September 21, 2012
Report
- Report Number
- 6000141-2012-00108
- Event Type
- Injury
- Date Received
- September 21, 2012
- Report Date
- February 2, 2018
- Manufacturer
- BALLYMONEY - USS
- Product Code
- FTL
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 1
(B)(4). DATE OF INITIAL REPORT SENT: 09/21/2012.
Description of Event or Problem · 1
PROCEDURE: UROLOGICAL/GYNECOLOGICAL. ACCORDING TO THE REPORTER: THE PT UNDERWENT A REPAIR PROCEDURE AND THE PT ALLEGEDLY EXPERIENCED PAIN AND INJURY. PT HAS UNDERGONE OR WILL UNDERGO CORRECTIVE SURGERY OR SURGERIES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | IVS TUNNELLER | IVS TUNNELLER | FTL | BALLYMONEY - USS | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Female | Required Intervention |