FDA Adverse Event
Injury
Summary report: N
PELVILACE T0 NEEDLE
MDR report key: 2234088
·
Received August 29, 2011
Report
- Report Number
- 9617613-2011-00025
- Event Type
- Injury
- Date Received
- August 29, 2011
- Date of Event
- June 2, 2008
- Report Date
- December 21, 2015
- Manufacturer
- TISSUE SCIENCE LABORATORIES, PLC
- Product Code
- FTL
- PMA / PMN Number
- K042949
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- ATTORNEY
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE: UROLOGICAL/GYNECOLOGICAL. ACCORDING TO THE REPORTER: THE PT UNDERWENT A BIOURETHRAL SUPPORT SYSTEM PROCEDURE FOR TREATMENT OF PELVIC ORGAN PROLAPSE AND STRESS URINARY INCONTINENCE. 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 | PELVILACE T0 NEEDLE | TRANSOBTURATOR BIOURETHRAL SYSTEM | FTL | TISSUE SCIENCE LABORATORIES, PLC | CVSB0001 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Female | Required Intervention| O |