MAUDE Adverse Event Report: MALEM BEDWETTING ALARM COMPANY MALEM

Model Number M04S

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

Patient Problems Bruise/Contusion (1754); Burn, Thermal (2530); Chemical Exposure (2570)

Event Date 11/03/2017

Event Type  malfunction  

Event Description

A few weeks ago, our enuresis alarm malfunctioned in the middle of the night.The alarm got extremely hot from normal use.The alarm was brand new and purchased.Within a few minutes of inserting batteries in the alarm unit, the batteries got so hot that the back battery door melted and the batteries leaked out of the alarm.Battery acid spilled on my son's neck and hands.He has minor bruises from the battery leak which have caused scarring on skin.The product was returned for a refund.

• Brand Name: MALEM
• Type of Device: MALEM
• Manufacturer (Section D): MALEM BEDWETTING ALARM COMPANY
• MDR Report Key: 7052183
• MDR Text Key: 92845841
• Report Number: MW5073502
• 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: 11/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: M04S
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 6 YR
• Patient Weight: 24