MAUDE Adverse Event Report: MALEM MEDICAL MALEM BED-WETTING ENURESIS ALARM

Model Number M04

Device Problems Burst Container or Vessel (1074); Leak/Splash (1354); Melted (1385); Temperature Problem (3022)

Patient Problem Burn, Thermal (2530)

Event Date 12/01/2017

Event Type  malfunction  

Event Description

As soon as i put batteries into the alarm, within 20 minutes or so, the alarm exploded.The batteries leaked out and back blue cover melted from the heat.The alarm was so hot that i burnt my finger touching it.This was going to be placed on my son's neck! very dangerous.

• Brand Name: MALEM BED-WETTING ENURESIS ALARM
• Type of Device: MALEM BED-WETTING ENURESIS ALARM
• Manufacturer (Section D): MALEM MEDICAL
• MDR Report Key: 7112035
• MDR Text Key: 94806188
• Report Number: MW5073923
• 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
• Type of Report: Initial
• Report Date: 12/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M04
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/12/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 6 YR
• Patient Weight: 22