FDA Adverse Event
Injury
Summary report: N
ACTICON NEOSPHINCTER
MDR report key: 2963214
·
Received February 12, 2013
Report
- Report Number
- 2183959-2013-00660
- Event Type
- Injury
- Date Received
- February 12, 2013
- Date of Event
- January 22, 2013
- Report Date
- January 29, 2013
- Manufacturer
- AMERICAN MEDICAL SYSTEMS, INC.
- Product Code
- EZY
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
BALLOON CATALOG# 72402106, LOT 540198004, EXP: 03/17/2013, MFG: 03/2008. PUMP CATALOG# 72402287, LOT 544786005, EXP: 04/24/2013, MFG: 04/2008. SHOULD ADDITIONAL INFO 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 THAT PT HAD HER DEVICE REMOVED DUE TO DEVICE FLUID LOSS. THE PT WAS REIMPLANTED WITH A NEW ACTICON NEOSPHINCTER DEVICE AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 61638 | ACTICON NEOSPHINCTER | ARTIFICIAL BOWEL SPHINCTER | EZY | AMERICAN MEDICAL SYSTEMS, INC. | 554610003 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Hospitalization| R |