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

Model Number M042

Device Problem Temperature Problem (3022)

Patient Problem No Information (3190)

Event Date 04/13/2019

Event Type  malfunction  

Event Description

We ordered and received a new malem ultimate bedwetting alarm for the treatment of nightmare bedwetting for my son.The alarm is not functioning as expected.I have tried several times with different batteries, but the alarm is getting too hot to hold in the hand within 15 mins of inserting to sensor.When sensor is removed, the alarm is starting to cool down.But it needs to be used with the sensor.So it will be hot.The temperature is easily over 170f and that is too hot for skin contact.Fda safety report id# (b)(4).

• Brand Name: ULTIMATE ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD
• MDR Report Key: 8522740
• MDR Text Key: 142265097
• Report Number: MW5085913
• 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: 04/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: M042
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 6 YR