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

Model Number ULTIMATE ALARM

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

Patient Problem Burn, Thermal (2530)

Event Date 08/09/2019

Event Type  Injury  

Event Description

The complaint is regarding an enuresis alarm which has injured my son.It was the 2nd night my son was sleeping with his alarm and somehow, the device got too hot and burnt him.I am not able to replicate it as the device is non-operational.The internal electronics seem to have burnt out from the overheating, my son was exposed to heat and battery leaks.This is not normal for a device which is to be issued by children.Fortunately the burns are minor and i was able to quickly treat him.He should recover in a few days.But we are startled about the reliability of enuresis alarms and their safety.Fda safety report id # (b)(4).

• Brand Name: MALEM ENURESIS ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.; GB
• MDR Report Key: 8894391
• MDR Text Key: 154421627
• Report Number: MW5089035
• 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: Physician Assistant
• Type of Report: Initial
• Report Date: 08/11/2019

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?: No
• Device Operator: Health Professional
• Device Model Number: ULTIMATE ALARM
• Device Catalogue Number: NONE
• Device Lot Number: NONE
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/13/2019
• 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 Outcome(s): Required Intervention
• Patient Age: 4 YR