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

Model Number M048TEC

Device Problems Overheating of Device (1437); Device Inoperable (1663); Noise, Audible (3273)

Patient Problem No Information (3190)

Event Date 04/07/2018

Event Type  Injury  

Event Description

Another day has gone by and the device has malfunctioned.This is only the second time it was used.The first time the device was used.It got extremely hot and it was no too dangerous to use on my son.I called the mfr and they exchanged it for a new one.The new device is exhibiting the exact same behavior.Batteries go into the device and it makes a rattling noise and gets warm and then hot.Fortunately after the first experience, i was careful to monitor the device on my son.I discontinued use after 20 mins.It is so hot i can't even hold it in my hand.

• Brand Name: MALEM BEDWETTING ALARM FOR CHILDREN
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 7471906
• MDR Text Key: 106910805
• Report Number: MW5076823
• 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: 04/07/2018

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: Lay User/Patient
• Device Model Number: M048TEC
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/27/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 5 YR
• Patient Weight: 20