FDA Adverse Event
Injury
Summary report: N
NONE
MDR report key: 3022336
·
Received March 20, 2013
Report
- Report Number
- 2937094-2013-00342
- Event Type
- Injury
- Date Received
- March 20, 2013
- Date of Event
- July 26, 2012
- Report Date
- March 7, 2013
- Manufacturer
- AMERICAN MEDICAL SYSTEMS
- Product Code
- GEX
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED IN A LETTER PT RECEIVED "PERSONAL INJURIES ARISING FROM GREENLIGHT LASER". REPORTEDLY, A DOCTOR PERFORMED THIS PROCEDURE ON (B)(6) 2012.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 116655 | NONE | GEX | AMERICAN MEDICAL SYSTEMS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |