FDA Adverse Event
Other
Summary report: N
COMPOUND W FREEZE OFF
MDR report key: 534880
·
Received July 15, 2004
Report
- Report Number
- 2528909-2004-00016
- Event Type
- Other
- Date Received
- July 15, 2004
- Date of Event
- June 10, 2004
- Report Date
- July 15, 2004
- Manufacturer
- ORASURE TECHNOLOGIES, INC.
- Product Code
- GEH
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
A PT WAS TREATED WITH ONE APPLICATION OF FREEZE OFF ON A PLANTAR WART LOCATED ON THE BOTTOM OF FOOT. TREATED AREA SWELLED AND HAD RED STREAKS (UNKNOWN TIME INTERVAL). FAMILY MEMBER TOOK PT TO HOSP WHERE ER PHYSICIAN CUT THE TREATED AREA OPEN AND REPORTED AN INFECTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COMPOUND W FREEZE OFF | CRYOSURGICAL WART TREATMENT SYSTEM | GEH | ORASURE TECHNOLOGIES, INC. | * | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 11 YR | Other |