FLURO-ETHYL SKIN REFRIGERENTGEBAUER'S ETHYL CHLORIDE *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-05-11 for FLURO-ETHYL SKIN REFRIGERENTGEBAUER'S ETHYL CHLORIDE * manufactured by Gebauer Co.

Event Text Entries

[15189947] A md (medical doctor) applied ethyl chloride (local anesthesia) spray to pt's forehead. Once the area dried, the physician turned on an electric cautery device to i&d (incision and drainage) a boil-like abscess. The pt's synthetic hair caught on fire. The fire was doused by a blanket and normal saline was used to saturate the pt's head. A first degree burn was sustained on the top of the pt's ear.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 527984
• MDR Report Key: 527984
• Date Received: 2004-05-11
• Date of Report: 2004-04-01
• Date of Event: 2004-04-01
• Date Added to Maude: 2004-06-04
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: RISK MANAGER
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: FLURO-ETHYL SKIN REFRIGERENTGEBAUER'S ETHYL CHLORIDE
• Generic Name: TOPICAL ANESTHETIC SKIN REFRIGERANT
• Product Code: MLY
• Date Received: 2004-05-11
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: *
• Device Age: UNKNOWN
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 517172
• Manufacturer: GEBAUER CO
• Manufacturer Address: 9410 SAINT CATHERINE AVE CLEVELAND OH 44104 US

Device Sequence Number: 2

• Brand Name: BATTERY OPERATED CAUTERIES
• Generic Name: CAUTERY
• Product Code: HQP
• Date Received: 2004-05-11
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: UNK
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 2
• Device Event Key: 517174
• Manufacturer: ABCO DEALERS, INC
• Manufacturer Address: * NASHVILLE TN 372172124 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2004-05-11