FDA Adverse Event
Injury
Summary report: N
ACTICON NEOSPHINCTER
MDR report key: 2070962
·
Received April 19, 2011
Report
- Report Number
- 2183959-2011-00136
- Event Type
- Injury
- Date Received
- April 19, 2011
- Date of Event
- March 11, 2011
- Report Date
- March 22, 2011
- Manufacturer
- AMERICAN MEDICAL SYSTEMS, INC.
- Product Code
- MIP
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
CONTINUED: CATALOG #: 72402105, 72402287. SERIAL #: (B)(4). SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE REGARDING THIS SURGERY, IT WILL BE REEVALUATED AND A FOLLOW-UP REPORT WILL BE SENT.
Description of Event or Problem · 1
ON (B)(6) 2004, AN ACTICON NEOSPHINCTER DEVICE WAS IMPLANTED. ON (B)(6) 2011, THE ENTIRE DEVICE WAS REMOVED AND REPLACED DUE TO FLUID LOSS - REPORTER STATED THAT THE LOCATION OF FLUID LOSS WAS UNKNOWN. NO PATIENT COMPLICATIONS REPORTED.
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 | 42 YR | Hospitalization| R |