FDA Adverse Event
Injury
Summary report: N
AMS SPHINCTER 800 URINARY PROSTHESIS
MDR report key: 2111773
·
Received May 25, 2011
Report
- Report Number
- 2183959-2011-00183
- Event Type
- Injury
- Date Received
- May 25, 2011
- Date of Event
- August 25, 2010
- Report Date
- August 25, 2010
- Manufacturer
- AMERICAN MEDICAL SYSTEMS, INC.
- Product Code
- EZY
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TU
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ADD'L CATALOG #: 72400024, 72404127. ADD'L SERIAL #: (B)(4).
Description of Event or Problem · 1
ON (B)(6) 2010, AN AUS WAS IMPLANTED. ON (B)(6) 2010, INFO WAS RECEIVED THAT INDICATED A REVISION SURGERY WAS NEEDED; REASON NOT INDICATED. F/U INFO RECEIVED ON (B)(6) 2011 INDICATED THERE WERE PROBLEMS WITH THE PUMP "BUT AFTER RESETTING THE PUMP, IT WAS FIXED BY ITSELF." THE DEVICE REMAINS IMPLANTED. NO PT COMPLICATIONS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AMS SPHINCTER 800 URINARY PROSTHESIS | ARTIFICIAL URINARY SPHINCTER | EZY | AMERICAN MEDICAL SYSTEMS, INC. | AMS 800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Hospitalization| R |