MAUDE Adverse Event Report: GEBAUER CO. GEBAUER'S MEDIUM JET STREAM SPRAY, 103.5 ML; REFRIGERANT

Lot Number 2156

Device Problems Fire (1245); Device Markings/Labelling Problem (2911)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/29/2017

Event Type  Other  

Event Description

Patient presented with right finger swelling from jamming finger.Subungual hematoma, provider used ethyl chloride, or "freezy spray" before the procedure.The spray was flammable, and the cautery ignited the chux underneath.Provider extinguished the flames, no harm to patient.The product is not clearly labeled and identifiable for risk of flammability.The product is gebauer's ethyl chloride, by the gebauer company.Dose or amount: 103.5 ml.Frequency: prn.Route: topical.Dates of use: (b)(6) 2017.Diagnosis or reason for use: subungual hematoma of nailbed.Is the product compounded: no.Is the product over-the-counter: no.Event abated after use stopped or dose reduced: yes.

• Brand Name: GEBAUER'S MEDIUM JET STREAM SPRAY, 103.5 ML
• Type of Device: REFRIGERANT
• Manufacturer (Section D): GEBAUER CO.; cleveland OH 44128
• MDR Report Key: 7369578
• MDR Text Key: 103433354
• Report Number: MW5076102
• Device Sequence Number: 0
• 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: Nurse
• Type of Report: Initial
• Report Date: 03/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2018
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2019
• Device Lot Number: 2156
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 10 YR