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

Model Number M04S

Device Problems Bent (1059); Overheating of Device (1437)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/09/2018

Event Type  Injury  

Event Description

Saturday night was the second time i tried to use a malem alarm.The first alarm malfunctioned.Within minutes of inserting batteries, the alarm made a clicking sound and started getting warm.As time went by, it started getting warmer and warmer and i removed batteries.The previous malem alarm was purchased a week earlier and it also exhibited similar characteristics.Within minutes of inserting batteries, the alarm got warm and then very hot.If my son were wearing this alarm, it surely would have burnt him.The back casing of the alarm had bent from the heat generated.The alarm appears to be dangerous for children.

• Brand Name: ENURESIS ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 7605099
• MDR Text Key: 111363815
• Report Number: MW5077864
• 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: 06/13/2018
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: M04S
• 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: 6 YR