FDA Adverse Event
Other
Summary report: N
COMPOUND W FREEZE OFF
MDR report key: 500792
·
Received December 11, 2003
Report
- Report Number
- 2528909-2003-00005
- Event Type
- Other
- Date Received
- December 11, 2003
- Date of Event
- November 28, 2003
- Report Date
- December 10, 2003
- Manufacturer
- ORASURE TECHNOLOGIES, INC.
- Product Code
- GEH
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
PT USED FREEZE OFF ON A BUMP (NOT A WART) LOCATED ABOUT THE BIKINI AREA. CLIENT SELF ADMINISTERED TREATMENT AND CONTINUED TO DEPRESS THE VALVE FOR FORTY SECONDS, ALLOWING LIQUID CRYOGEN TO RUN DOWN THEIR LEG. WENT TO HOSP IN 2003, DR DIAGNOSED SECOND DEGREE BURNS BUT TREATMENT IS UNKNOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COMPOUND W FREEZE OFF | CRYOSURGICAL WART TREATMENT SYSTEM | GEH | ORASURE TECHNOLOGIES, INC. | * | 0803 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 49 YR | Required Intervention |