FDA Adverse Event
Injury
Summary report: N
AMS SPECTRA CONCEALABLE PENILE PROSTHESIS
MDR report key: 3182231
·
Received June 14, 2013
Report
- Report Number
- 2183959-2013-00869
- Event Type
- Injury
- Date Received
- June 14, 2013
- Date of Event
- May 7, 2013
- Report Date
- May 29, 2013
- Manufacturer
- AMERICAN MEDICAL SYSTEMS, INC.
- Product Code
- FAE
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PR, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
SHOULD ADD'L 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 THE PT HAD THE SPECTRA PENILE PROSTHESIS EXPLANTED DUE TO AN INFECTION AND REPLACED WITH ANOTHER SPECTRA. NO FURTHER PT COMPLICATIONS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 271616 | AMS SPECTRA CONCEALABLE PENILE PROSTHESIS | PENILE PROSTHESIS | FAE | AMERICAN MEDICAL SYSTEMS, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR | Hospitalization| R |