MAUDE Adverse Event Report: MALEM MALEM BEDWETTING ALARM

Model Number IS

Device Problem Chemical Spillage (2894)

Patient Problem Caustic/Chemical Burns (2549)

Event Date 01/04/2018

Event Type  Injury  

Event Description

Malem alarm got very hot and short circuited under normal use.The batteries leaked out and burnt my son.He has big red blisters on his neck as an adverse reaction to the hot battery leak.

• Brand Name: MALEM BEDWETTING ALARM
• Type of Device: BEDWETTING ALARM
• Manufacturer (Section D): MALEM
• MDR Report Key: 7178714
• MDR Text Key: 96946753
• Report Number: MW5074473
• Device Sequence Number: 1
• Product Code: KPN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 01/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: IS
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 4 YR