MAUDE Adverse Event Report: GEBAUER COMPANY GEBAUER'S ETHYL CHLORIDE MIST SPRAY

Device Problem Fire (1245)

Patient Problem Superficial (First Degree) Burn (2685)

Event Date 12/30/2017

Event Type  No Answer Provided  

Event Description

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.

• Brand Name: GEBAUER'S ETHYL CHLORIDE MIST SPRAY
• Type of Device: GEBAUER'S ETHYL CHLORIDE MIST SPRAY
• Manufacturer (Section D): GEBAUER COMPANY
• MDR Report Key: 7251596
• MDR Text Key: 99362968
• Report Number: MW5075134
• Device Sequence Number: 1
• Product Code: MLY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 01/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: P/N 0386-0001-02
• Patient Outcome(s): Other
• Patient Age: 15 YR
• Patient Weight: 57