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
• MDR Text Key: 131052588
• 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: Other
• Type of Report: Initial
• Report Date: 12/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Device Operator: No Information
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/20/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1