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

Model Number ULTIMATE BEDWETTING ALARM

Device Problems Defective Alarm (1014); Leak/Splash (1354); Melted (1385); Moisture Damage (1405); Battery Problem (2885)

Patient Problem No Patient Involvement (2645)

Event Date 05/01/2020

Event Type  malfunction  

Event Description

The new alarm was not working as expected.When the sensor got wet, there was no beeping or vibration.I tested it many times, but the product did nothing.I left it on the table.When i checked it an hour later, the alarm plastic (housing) had melted from excess heat.The batteries leaked from backside and battery door was bent inside.This is a device malfunction and short circuit.Good, my son was not wearing it when this incident happened.Fda safety report id# (b)(4).

• Brand Name: BED WETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 10028477
• MDR Text Key: 190155890
• Report Number: MW5094389
• 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: 05/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: ULTIMATE BEDWETTING ALARM
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 5 YR