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

Model Number SINGLE TONE

Device Problem Overheating of Device (1437)

Patient Problem No Patient Involvement (2645)

Event Date 09/13/2018

Event Type  malfunction  

Event Description

Just received a malem bedwetting alarm in mail.The alarm is not operating normally.Upon inserting batteries, the alarm is getting hot.If it comes in contact with a child's body, it will quite easily cause skin burn.There is no way that this device can be safely used on a child.This is the first attempt to use it and we are extremely worried about the safety of the alarm.A thermometer shows that the alarm temperature is reaching 175f which is too dangerous for skin contact.This device is faulty and dangerous.

• Brand Name: MALEM BEDWETTING ALARM ULTIMATE MODEL
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD
• MDR Report Key: 7880534
• MDR Text Key: 120524484
• Report Number: MW5079816
• Device Sequence Number: 1
• Product Code: KPN
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 09/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: SINGLE TONE
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/14/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 3 MO