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

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).

• Brand Name: ETHYL CHLORIDE
• Type of Device: REFRIGERANT, TOPICAL (VAPOCOOLANT)
• Manufacturer (Section D): GEBAUER COMPANY
• MDR Report Key: 8185477
• Report Number: MW5082319
• Device Sequence Number: 1
• Product Code: MLY
• Combination Product (y/n): N
• Number of Events Reported: 1
• 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

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2018

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