MAUDE Adverse Event Report: MALEM MEDICAL MALEM; INCONTINENCE ALARM

Model Number ULTIMATE ALARM

Device Problem Melted (1385)

Patient Problem Burn, Thermal (2530)

Event Type  Injury  

Event Description

My son was sleeping with a bedwetting alarm and just an hour ago, the alarm malfunctioned and the back battery door housing melted.The burning plastic melted and burned his neck.It is 2:40 am now.The accident took place at about 1:30 tonight.Dangerous product.

• Brand Name: MALEM
• Type of Device: INCONTINENCE ALARM
• Manufacturer (Section D): MALEM MEDICAL
• MDR Report Key: 6642819
• MDR Text Key: 77719799
• Report Number: MW5070402
• Device Sequence Number: 1
• Product Code: KPN
• 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: 06/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: ULTIMATE ALARM
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/13/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 7 YR