FDA Adverse Event
Injury
Summary report: N
AMS SPECTRA CONCEALABLE PENILE PROSTHESIS
MDR report key: 4090139
·
Received September 15, 2014
Report
- Report Number
- 2183959-2014-00401
- Event Type
- Injury
- Date Received
- September 15, 2014
- Date of Event
- August 21, 2014
- Report Date
- August 28, 2014
- Manufacturer
- AMERICAN MEDICAL SYSTEMS (MN)
- Product Code
- FAE
- PMA / PMN Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- EG
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
TWO EXPLANTED SPECTRA MALLEABLE CYLINDERS WERE RETURNED. BOTH PERFORMED WITHIN SPECIFICATIONS, THEREFORE THE REPORTED EVENT COULD NOT BE CONFIRMED.
Description of Event or Problem · 1
IT WAS REPORTED THE PATIENT'S SPECTRA PENILE PROSTHESIS REVISION OCCURRED. THE REASON FOR THE REVISION WAS NOT PROVIDED. ADDITIONAL INFORMATION WAS REQUESTED AND NOT OBTAINED. NO PATIENT COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 569833 | AMS SPECTRA CONCEALABLE PENILE PROSTHESIS | PROSTHESIS, PENILE | FAE | AMERICAN MEDICAL SYSTEMS (MN) |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 35 YR | Hospitalization| R |