FDA Adverse Event
Death
Summary report: N
PELVILACE T0 NEEDLE
MDR report key: 2343176
·
Received November 9, 2011
Report
- Report Number
- 9617613-2011-00068
- Event Type
- Death
- Date Received
- November 9, 2011
- Date of Event
- January 12, 2009
- Report Date
- January 12, 2016
- Manufacturer
- TISSUE SCIENCE LABORATORIES, PLC
- Product Code
- FTL
- PMA / PMN Number
- K042949
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- ATTORNEY
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE TYPE: UROLOGICAL AND GYNECOLOGICAL. ACCORDING TO THE REPORTER, THE PT UNDERWENT TREATMENT FOR HER PELVIC ORGAN PROLAPSE AND STRESS URINARY INCONTINENCE. THE PT SUFFERED PAIN, INJURY AND HAS UNDERGONE CORRECTIVE SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PELVILACE T0 NEEDLE | PELVILACE TO TRANS-OBTURATOR BIOURO | FTL | TISSUE SCIENCE LABORATORIES, PLC | CVSH0015 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | Female | Required Intervention| O| D |