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

Model Number RED COLOR

Device Problems Overheating of Device (1437); Defective Device (2588)

Patient Problems Skin Irritation (2076); Burn, Thermal (2530)

Event Date 10/16/2018

Event Type  Injury  

Event Description

A medical device we were using to stop night time bedwetting has malfunctioned after just 2 nights of use.The alarm has overheated and short the batteries inside the case.This has caused the back to heat up and burn my son's neck.The batteries leaked on his clothes and the combination has caused severe skin irritation.He has been receiving medical treatment for this.The alarm was new and used exactly as explained in the user manual.Defective and dangerous.

• Brand Name: MALEM ULTIMATE SELECTABLE BEDWETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 8014186
• MDR Text Key: 125439870
• Report Number: MW5080866
• 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: 10/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: RED COLOR
• 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: 5 YR
• Patient Weight: 18