FDA Adverse Event
Injury
Summary report: N
ACTICON NEOSPHINCTER
MDR report key: 2922352
·
Received January 11, 2013
Report
- Report Number
- 2183959-2013-00202
- Event Type
- Injury
- Date Received
- January 11, 2013
- Date of Event
- December 14, 2012
- Report Date
- December 18, 2012
- Manufacturer
- AMERICAN MEDICAL SYSTEMS, INC.
- Product Code
- MIP
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFO. BALLOON: CATALOG # 72402106, LOT EG834001, EXP. 02/2004, MFG 02/1999. PUMP: CATALOG # 72402287, LOT CP757008, EXP 11/1996. RETURNED DEVICE ANALYSIS INDICATES DEVICE FAILURE OCCURRED WITH A LEAK IN THE CUFF THAT WAS DUE TO WEAR. THE BALLOON THAT WAS FUNCTIONAL, BUT THE PRESSURE WAS ABOVE SPECIFICATIONS. THE PUMP PERFORMED WITHIN SPECIFICATIONS. SHOULD ADDITIONAL INFO BECOME AVAILABLE REGARDING THIS EVENT, TI WILL BE RE-EVALUATED AND A FOLLOW-UP REPORT WILL BE SENT.
Description of Event or Problem · 1
IT WAS REPORTED THAT PT HAD HIS DEVICE REMOVED DUE TO INFECTION, DEVICE FLUID LOSS, AND RECURRENT INCONTINENCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 18014 | ACTICON NEOSPHINCTER | ARTIFICIAL BOWEL SPHINCTER | MIP | AMERICAN MEDICAL SYSTEMS, INC. | DI235005 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | Hospitalization| R |