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

Model Number PRO

Device Problem Overheating of Device (1437)

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

Event Date 12/27/2019

Event Type  Injury  

Event Description

The complaint is related to the malem enuresis alarm which i have tried to unsuccessfully use on my daughter.I purchased the enuresis alarm from the manufacture¿s website at the recommendation of a pediatrician.The alarm has a defect wherein it's heating up whenever my daughter wets the bed.The first night she used the alarm and she slept, she wet and woke up.She complained the alarm was warm.I reset the alarm by removing the batteries and reinserted.Seemed to work fine, but when she slept and wet again, the alarm got hot once again.The heating up of the device is not normal.The temperature is over 150f and for that reason i discontinued use.I believe the alarm can get hotter if unchecked and can cause skin damage.Fda safety report id # (b)(4).

• Brand Name: MALEM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD; GB
• MDR Report Key: 9538709
• MDR Text Key: 173502919
• Report Number: MW5091950
• 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: 12/30/2019

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: Health Professional
• Device Model Number: PRO
• Device Catalogue Number: SINGLE TONE
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/31/2019
• 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: 6 YR