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

Model Number ULTIMATE ALARM

Device Problems Device Emits Odor (1425); Overheating of Device (1437); Battery Problem (2885)

Patient Problem Alteration In Body Temperature (2682)

Event Date 12/21/2019

Event Type  Injury  

Event Description

Malem alarm came with batteries pre-installed and a white tab which had to be pulled out to activate the alarm.I pulled the tab and started to use the alarm when i felt excess heat in my hands.Within a few mins, the alarm was too hot to hold and there a bad smell (like something was burning) from the alarm.I immediately removed the batteries and that cooled it down.Thinking the issue is with the batteries, i replaced the batteries, but the same thing happened.The issue is not with batteries but with the alarm.It's too hot for safe operation and will cause burns i think if my daughter is sleeping with it.Fda safety report id# (b)(4).

• Brand Name: BEDWETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 9525102
• MDR Text Key: 173067902
• Report Number: MW5091902
• 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: 12/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: ULTIMATE ALARM
• Device Catalogue Number: 1 TONE
• Device Lot Number: BLUE
• 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: 7 YR