FDA Adverse Event
Injury
Summary report: N
LASER - INDIGO OPTIMA LASER SYSTEM
MDR report key: 698495
·
Received April 11, 2006
Report
- Report Number
- 2210968-2006-00270
- Event Type
- Injury
- Date Received
- April 11, 2006
- Date of Event
- December 21, 2005
- Report Date
- March 16, 2006
- Manufacturer
- ETHICON, INC.
- Product Code
- HQF
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT UNDERWENT A UROLOGICAL PROCEDURE IN 11/2006. ON 12/21/2005 THE PATIENT REPORTED TO THE SURGEON THAT HE WAS EXPERIENCING IMPOTENCE. THE PHYSICIAN PRESRIBED VIAGRA WHICH THE PATIENT WA MODERATELY RESPONSIVE TO. THE SURGEON STATED THAT NO FURTHER THERAPY IS EXPECTED AND THAT HE BELIEVES THE IMPOTENCE WILL RESOLVE WITH TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LASER - INDIGO OPTIMA LASER SYSTEM | LASER INSTRUMENT SURGICAL, POWERED | HQF | ETHICON, INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Required Intervention |