FDA Adverse Event
Summary report: N
GEBAUER'S ETHYL CHLORIDE MIST SPRAY
MDR report key: 7251596
·
Received February 8, 2018
Report
- Report Number
- MW5075134
- Date Received
- February 8, 2018
- Date of Event
- December 30, 2017
- Report Date
- January 29, 2018
- Manufacturer
- GEBAUER COMPANY
- Product Code
- MLY
- Report Source
- Voluntary report
- Reporter Location
- WA, US
- Reporter Occupation
- PHARMACIST
Narratives
Description of Event or Problem · 1
GEBAUER'S ETHYL CHLORIDE SPRAY APPLIED TO PATIENT'S BIG TOE TO REDUCE PAIN WITH MINOR PROCEDURE. ELECTRICAL CAUTERY THEN USED, CAUSING IGNITION OF THE PRODUCT. PATIENT SUFFERED FIRST DEGREE BURN TO TOE. GEBAUER'S ETHYL CHLORIDE SPRAY DOES HAVE SMALL FLAME AND STATEMENT OF FLAMMABILITY ON THE LABEL, ALTHOUGH THIS WAS NOT NOTICED OR KNOWN BY THE PROVIDER USING THE PRODUCT. THERAPY DURATION: 1 DAY. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED: YES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 97125 | GEBAUER'S ETHYL CHLORIDE MIST SPRAY | GEBAUER'S ETHYL CHLORIDE MIST SPRAY | MLY | GEBAUER COMPANY |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 15 YR | Other | P/N 0386-0001-02 |