FDA Adverse Event
Malfunction
Summary report: N
ACTICON NEOSPHINCTER
MDR report key: 1972761
·
Received January 21, 2011
Report
- Report Number
- 2183959-2011-00051
- Event Type
- Malfunction
- Date Received
- January 21, 2011
- Date of Event
- December 21, 2010
- Report Date
- January 14, 2011
- Manufacturer
- AMERICAN MEDICAL SYSTEMS, INC.
- Product Code
- MIP
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ADD'L CATALOG #: 72402287, 72401956. ADD'L SERIAL #: (B)(4). SHOULD ADDITIONAL INFO BECOME AVAILABLE REGARDING THIS REVISION SURGERY IT WILL BE RE-EVALUATED AND A F/U REPORT WILL BE SENT. THIS EVENT IS CAPTURED IN OUR LABELING AS A FORESEEABLE EVENT.
Description of Event or Problem · 1
A (B)(6) FEMALE WITH OBSTETRIC TRAUMA WAS IMPLANTED WITH AN ACTICON DEVICE ON (B)(6) 2000. ON (B)(6) 2001 THE CUFF WAS ADJUSTED. ON (B)(6) 2002, THE CUFF WAS REVISED. ON (B)(6) 2010, THE ENTIRE DEVICE WAS REMOVED FROM THE PT AND REPLACED DUE TO FLUID LOSS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACTICON NEOSPHINCTER | ARTIFICIAL BOWEL SPHINCTER | MIP | AMERICAN MEDICAL SYSTEMS, INC. | ABS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Hospitalization| R |