FDA Adverse Event
Injury
Summary report: N
GMD UNIVERSAL SLING
MDR report key: 1422429
·
Received July 27, 2009
Report
- Report Number
- 3006142121-2009-00007
- Event Type
- Injury
- Date Received
- July 27, 2009
- Date of Event
- June 29, 2009
- Report Date
- June 29, 2009
- Manufacturer
- GENERIC MEDICAL DEVICE, INC.
- Product Code
- FTL
- PMA / PMN Number
- K083471
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
EVALUATION CODES: OTHER - THERE WAS NO DEVICE MALFUNCTION DURING THE PROCEDURE. DEVICE FUNCTIONED ACCORDING TO SPECIFICATIONS.
Description of Event or Problem · 1
PHYSICIAN WAS PERFORMED A RETROPUBIC OUTSIDE-IN PROCEDURE FOR URINARY INCONTINENCE USING THE GMD UNIVERSAL SLING IN 2009 WITHOUT INCIDENT. A WEEK LATER, PT EXPERIENCED RETENTION. PHYSICIAN DILATED THE PT TO LOOSEN TENSION ON THE SLING. NO FURTHER INFORMATION ON PT IS KNOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GMD UNIVERSAL SLING | FTL-SURGICAL MESH | FTL | GENERIC MEDICAL DEVICE, INC. | UNK | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |