FDA Adverse Event
Injury
Summary report: N
ACTICON NEOSPHINCTER
MDR report key: 2850590
·
Received November 16, 2012
Report
- Report Number
- 2183959-2012-03012
- Event Type
- Injury
- Date Received
- November 16, 2012
- Date of Event
- October 24, 2012
- Report Date
- November 7, 2012
- Manufacturer
- AMERICAN MEDICAL SYSTEMS, INC.
- Product Code
- MIP
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ADD'L DEVICES: CATALOG# 72402287, SERIAL# (B)(4), EXPIRATION DATE- 11/23/2010, IMPLANT DATE- (B)(6) 2006, MANUFACTURE DATE- 11/2005. CATALOG# 72402104, SERIAL# (B)(4), EXPIRATION DATE- 06/05/2012, IMPLANT DATE- (B)(6) 2011, MANUFACTURE DATE- 06/2007. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE REGARDING THIS EVENT IT WILL BE RE-EVALUATED AND A FOLLOW-UP REPORT WILL BE SENT.
Description of Event or Problem · 1
IT WAS REPORTED THE PATIENT HAD THE DEVICE 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. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | Hospitalization| R |