FDA Adverse Event
Injury
Summary report: N
AMS SPECTRA CONCEALABLE PENILE PROSTHESIS
MDR report key: 2850560
·
Received November 16, 2012
Report
- Report Number
- 2183959-2012-03016
- Event Type
- Injury
- Date Received
- November 16, 2012
- Date of Event
- November 9, 2012
- Report Date
- November 12, 2012
- Manufacturer
- AMERICAN MEDICAL SYSTEMS, INC.
- Product Code
- FAE
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
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 SPECTRA DEVICE REPLACED WITH A INFLATABLE PENILE PROSTHESIS DUE TO A FUNGAL INFECTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AMS SPECTRA CONCEALABLE PENILE PROSTHESIS | PENILE PROSTHESIS | FAE | AMERICAN MEDICAL SYSTEMS, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Hospitalization| R |