MAUDE Adverse Event Report: MALEM MEDICAL MALEM BEDWETTING ALARM; ALARM, CONDITIONED RESPONSE ENURESIS

Model Number M04S

Device Problems Leak/Splash (1354); Melted (1385); Temperature Problem (3022)

Patient Problems Scarring (2061); Depression (2361); Burn, Thermal (2530)

Event Date 12/12/2017

Event Type  Injury  

Event Description

The malem bedwetting alarm which my son was using exploded just 30 minutes into the night.The alarm was hot and caused the batteries to leak on my son's body.The back plastic also melted from the heat.I took my son to the hospital next morning for treatment.The alarm burnt my son and he is depressed.The burn scars have not gone and they tell us it will take several weeks to heal.This was a brand new alarm purchased from the mfr.

• Brand Name: MALEM BEDWETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL
• MDR Report Key: 7128132
• MDR Text Key: 95325100
• Report Number: MW5074075
• 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: 12/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: M04S
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/19/2017
• 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: 20