FDA Adverse Event
Malfunction
Summary report: N
INVANCE
MDR report key: 3121570
·
Received May 10, 2013
Report
- Report Number
- 3121570
- Event Type
- Malfunction
- Date Received
- May 10, 2013
- Date of Event
- March 29, 2013
- Report Date
- May 7, 2013
- Manufacturer
- AMERICAN MEDICAL SYSTEMS, INC.
- Product Code
- OTM
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- MI, US
Narratives
Description of Event or Problem · 1
LOOSE PERINEAL SLING WHICH WAS EXCISED. URETHRAL STRICTURE EXTENDING TO THE PROSTATIC URETHRA JUST DISTAL TO LIKELY VERU. ABLE TO RESECT DOWN TO VIABLE URETHRA TO PERFORM A PRIMARY REPAIR. FIXED WIDE/PATENT BLADDER NECK. WHILE WE WERE FOLLOWING OUR SKIN INCISION AND DURING THE PROCESS OF DISSECTION OF THE URETHRA, WE CAME ACROSS THE BONE-ANCHORED INVANCE SLING WHICH DID NOT APPEAR TO BE PLACING ANY TENSION ON THE URETHRA ITSELF. THE BONE-ANCHORED SLING WAS COMPLETELY REMOVED.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?REMOVAL OF INVANCE BONE-ANCHORED URETHRAL SLING, POSTERIOR URETHROPLASTY, SUBTOTAL PERINEAL PROSTATECTOMY.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 207997 | INVANCE | MESH, SURGICAL, POLYMERIC | OTM | AMERICAN MEDICAL SYSTEMS, INC. | * | 687011 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR |