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

Model Number M04

Device Problem Temperature Problem (3022)

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

Event Date 03/06/2019

Event Type  malfunction  

Event Description

Alarm is just getting too hot to use even when placed on bed.The purpose is to detect urine and alert my son, but this is not during that.When i insert batteries and then connect sensor, its getting hot.The fault is not in the batteries as they have been changed many times with other brands, same things happens.Possible that there is a defective part or a defective component in there that is making the alarm hot when it is to be used.The temperature is too high to be used safely and hance we can not use this on our son.

• Brand Name: BEDWETTING ALARM ULTIMATE
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 8413981
• MDR Text Key: 138769874
• Report Number: MW5084823
• 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: 03/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M04
• Was Device Available for Evaluation?: No
• Type of Device Usage: N
• Patient Sequence Number: 1