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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GEBAUER COMPANY ETHYL CHLORIDE REFRIGERANT, TOPICAL (VAPOCOOLANT)

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GEBAUER COMPANY ETHYL CHLORIDE REFRIGERANT, TOPICAL (VAPOCOOLANT) Back to Search Results
Device Problem Fire (1245)
Patient Problem Superficial (First Degree) Burn (2685)
Event Type  No Answer Provided  
Event Description
Gebauer's ethyl chloride spray was applied to pt's great toe. Electrical cautery was subsequently used, causing ignition. The provider was able to quickly smother flame, although pt suffered first degree burn on his toe and is now undergoing wound care for this. The product label does have a small flame and warning of not using electrical cautery, however, the provider did not notice these warnings and or know about this risk. Date received 01/29/2018. Dosage form: spray. (b)(6). Access number: (b)(4).
 
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Brand NameETHYL CHLORIDE
Type of DeviceREFRIGERANT, TOPICAL (VAPOCOOLANT)
Manufacturer (Section D)
GEBAUER COMPANY
MDR Report Key8185477
MDR Text Key131052588
Report NumberMW5082319
Device Sequence Number1
Product Code MLY
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 12/20/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/20/2018
Device Operator
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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