MAUDE Adverse Event Report: WELCH ALLYN, INC. WELCH ALLYN RECHARGEABLE HANDLE; OTOSCOPE

Device Problems Melted (1385); Overheating of Device (1437); Smoking (1585); Battery Problem (2885)

Patient Problem Blister (4537)

Event Date 02/01/2021

Event Type  Injury  

Event Description

[welch allyn otoscope] treatment under emergency use authorization(eua): otoscope overheated and started smoking.Nurse removed battery, sustained tiny blister to thumb, refused medical care.Battery started to melt, biomed contacted.Otoscope was removed by biomed for replacement.Otoscope was removed from service.Discovered a faulty battery and otoscope will be replaced with a new battery.Welch allyn rechargeable handle #71670 battery #72200.Fda safety report id # (b)(4).

• Brand Name: WELCH ALLYN RECHARGEABLE HANDLE
• Type of Device: OTOSCOPE
• Manufacturer (Section D): WELCH ALLYN, INC.
• MDR Report Key: 11581085
• MDR Text Key: 242970612
• Report Number: MW5100308
• Device Sequence Number: 1
• Product Code: ERA
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 03/24/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: No
• 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 Outcome(s): Required Intervention