MAUDE Adverse Event Report: MALEM MEDICAL LTD. MALEM ULTIMATE ALARM FOR BEDWETTING CHILDREN; ALARM, CONDITIONED RESPONSE ENURESIS

Model Number M042

Device Problem Overheating of Device (1437)

Patient Problem Burn, Thermal (2530)

Event Date 05/15/2019

Event Type  Injury  

Event Description

Twenty mins into using the bedwetting alarm, the device got hot and injured my son.It was his first night of sleeping with the device and i set it up correctly.I saw online videos and instructions.The alarm malfunctioned and overheated.Likely from a defect in mfg or a short circuit.Either way, it overheated and scarred his neckline near the shoulder.I treated him with neosporin and have returned the device to the mfr.Fda safety report id# (b)(4).

• Brand Name: MALEM ULTIMATE ALARM FOR BEDWETTING CHILDREN
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 8627917
• MDR Text Key: 145840387
• Report Number: MW5086791
• 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: 05/16/2019

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: M042
• Device Catalogue Number: ULTIMATE SERIES
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/20/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 3 YR
• Patient Weight: 14