MAUDE Adverse Event Report: MALEM MALEM BEDWETTING ALARM

Model Number M04

Device Problems Burst Container or Vessel (1074); Fluid/Blood Leak (1250); Melted (1385); Overheating of Device (1437)

Patient Problem Burn, Thermal (2530)

Event Date 01/24/2018

Event Type  Injury  

Event Description

Daughter's bedwetting alarm overheated and got very hot.The heat made the alarm case melt and batteries to explode inside the alarm.The batteries leaked on to her neck and she has been burnt.

• Brand Name: MALEM BEDWETTING ALARM
• Type of Device: MALEM BEDWETTING ALARM
• Manufacturer (Section D): MALEM
• MDR Report Key: 7227649
• MDR Text Key: 98637839
• Report Number: MW5074932
• 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: 01/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2018
• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: M04
• 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
• Patient Weight: 16