WELCH ALLEN 71050 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-05-27 for WELCH ALLEN 71050 * manufactured by Welch Allen Inc..

Event Text Entries

[16405323] After an employee was washing her hands she reached for a paper towel. There were two otoscope chargers hanging over the paper towels. The employee brushed her left hand onto the charger. She experienced a strong electrical shock, this caused her to jump back. She became short of breath, dizzy, weak, and sweaty. Her vs were stable. She was taken to the emergency room for evaluation. The numbness and tingling in her arm worsened. She was admitted to the hospital for observation. Upon device evaluation by the bio-medical department. It was noted that the casing of the battery charger was producing 116v.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 94879
• MDR Report Key: 94879
• Date Received: 1997-05-27
• Date of Report: 1997-05-23
• Date of Event: 1997-05-16
• Date Facility Aware: 1997-05-17
• Report Date: 1997-05-23
• Date Reported to FDA: 1997-05-27
• Date Added to Maude: 1997-06-03
• 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: 0
• 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 Details

• Brand Name: WELCH ALLEN
• Generic Name: BATTERY CHARGER FOR OTOSCOPE
• Product Code: ERA
• Date Received: 1997-05-27
• Model Number: 71050
• Catalog Number: *
• Lot Number: *
• ID Number: 120V 60HZ 9-10 MA
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: 10 YR
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 93682
• Manufacturer: WELCH ALLEN INC.
• Manufacturer Address: STATE STREET ROAD SKANEATELES FALLS NY 13153 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization	1997-05-27