FDA Adverse Event
Injury
Summary report: N
GMD UNIVERSAL SLING
MDR report key: 1409579
·
Received July 1, 2009
Report
- Report Number
- 3006142121-2009-00001
- Event Type
- Injury
- Date Received
- July 1, 2009
- Date of Event
- June 2, 2009
- Report Date
- June 2, 2009
- Manufacturer
- GENERIC MEDICAL DEVICES, 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
EVAL (OTHER): THERE WAS NO DEVICE MALFUNCTION DURING THE PROCEDURE. DEVICE FUNCTIONED ACCORDING TO SPECIFICATIONS.
Description of Event or Problem · 1
PHYSICIAN WAS PERFORMING A STANDARD TRANSOBTURATOR OUTSIDE-IN PROCEDURE, PLACING THE GMD UNIVERSAL SLING, USING THE GMD SPIRAL SHAPED REUSABLE TROCAR. WHILE INSERTING THE TROCAR NEEDLE OUTSIDE-IN, THE PHYSICIAN PUNCTURED THE VAGINAL WALL ON BOTH SIDES WITH A REUSABLE TROCAR. THERE WAS NO REMEDIAL ACTION TAKEN BY THE PHYSICIAN. THERE WERE NO ADVERSE AFFECTS ON THE PT AT THE TIME OF THE SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GMD UNIVERSAL SLING | FTL - SURGICAL MESH | FTL | GENERIC MEDICAL DEVICES, INC. | 1010-06 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |