FDA Adverse Event
Injury
Summary report: N
SCHOLL FREEZE VERRUCA AND WART REMOVER
MDR report key: 7929562
·
Received October 3, 2018
Report
- Report Number
- 3004142665-2018-00001
- Event Type
- Injury
- Date Received
- October 3, 2018
- Report Date
- April 20, 2023
- Manufacturer
- ORASURE TECHNOLOGIES, INC.
- Product Code
- GEH
- PMA / PMN Number
- K023487
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
4/20/2023- THIS REPORT WAS INITIALLY SENT TO THE FDA ON 12SEPT2018, HOWEVER THE FDA DID NOT RECEIVE THE SUBMISSION, THEREFORE THIS REPORT IS BEING SUBMITTED RETROSPECTIVELY PER FDA REQUEST.
Description of Event or Problem · 0
A CONSUMER REPORTED THAT ON AN UNKNOWN DATE, A FEMALE PATIENT OF AN UNKNOWN AGE PURCHASED SCHOLL WART AND VERRUCA FREEZE FROM AN UNKNOWN INDICATION. CONSUMER STATED THAT SHE CAREFULLY FOLLOWED THE INSTRUCTIONS STEP BY STEP AS STATED. HOWEVER, ONCE SHE PRESSED DOWN ON THE CAN FOR 5 SECONDS AS INSTRUCTED, THE WHOLE CAN BURST INTO FLAMES CAUSING A FIRE BALL WHICH HIT THE CONSUMER'S FACE AND IGNITED HER HAND. CONSUMER IS NOW LEFT WITH BURNS TO HER HAND AND FACE WHICH REQUIRED HOSPITAL ATTENTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 773798 | SCHOLL FREEZE VERRUCA AND WART REMOVER | SCHOLL FREEZE VERRUCA AND WART REMOVER | GEH | ORASURE TECHNOLOGIES, INC. | 1001-0166 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Hospitalization |