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

Model Number M043

Device Problems Leak/Splash (1354); Overheating of Device (1437); Material Deformation (2976)

Patient Problems Shock (2072); Skin Discoloration (2074); Burn, Thermal (2530)

Event Date 05/15/2019

Event Type  Injury  

Event Description

Son is (b)(6) and has some medical conditions which prevent him from sleeping alone.He has also been diagnosed with incontinence and we started using the malem alarm on may 15.However, the alarm has only caused more pain than benefit.The night it was used, the alarm has hurt him.He was wearing the alarm as the instructions said, but the alarm had heated up and somehow scalped his skin.Removing the alarm was extremely difficult and pain for me as well.In the process; i have burnt the tip of my fingers.This device has deformed plastic from heat.My son also complained that it was giving him a shock when he was sleeping.We are not able to test that as the alarm is no longer working.The batteries have leaked inside the alarm rendering it useless.My son did not get seriously burnt, but was injured and has a pinkish red patch on his skin from contact with the alarm.Shocks on skin.Fda safety report id# (b)(4).

• Brand Name: MALEM ULTIMATE BEDWETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 8646776
• MDR Text Key: 146263427
• Report Number: MW5086934
• 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: 05/23/2019

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: M043
• Device Catalogue Number: M SERIES
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/28/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 5 YR