FDA Adverse Event
Injury
Summary report: N
ACTICON NEOSPHINCTER
MDR report key: 2002354
·
Received February 15, 2011
Report
- Report Number
- 2183959-2011-00076
- Event Type
- Injury
- Date Received
- February 15, 2011
- Date of Event
- February 11, 2011
- Report Date
- February 11, 2011
- Manufacturer
- AMERICAN MEDICAL SYSTEMS, INC.
- Product Code
- MIP
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ADD'L CATALOG #S: 72402106, 72402287. (B)(4). SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE REGARDING THIS REVISION SURGERY, IT WILL BE RE-EVALUATED AND A FOLLOW-UP REPORT WILL BE SENT.
Description of Event or Problem · 1
ON (B)(6) 1999, THE PATIENT HAD AN ACTICON BOWEL SPHINCTER (ABS) IMPLANTED. ON (B)(6) 2011, THE PATIENT HAD THE DEVICE REMOVED DUE TO EROSION ON THE CUFF THROUGH THE PERINEAL TISSUE, AND EXPOSURE THROUGH THE SKIN. THE ABS WAS REMOVED TO PREVENT FURTHER EROSION AND POSSIBLE INFECTION. THE ENTIRE DEVICE WAS REMOVED.
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 | 74 YR | Hospitalization| R |