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

Model Number M SERIES

Device Problems Thermal Decomposition of Device (1071); Leak/Splash (1354); Overheating of Device (1437); Electrical Shorting (2926)

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

Event Date 06/18/2019

Event Type  Injury  

Event Description

It took less than 30 mins for the bedwetting alarm to overheat and leak out batteries.The device has a short circuit.I placed batteries and it turned on.I then inserted the cable and that was it.Checking back 10 mins later, it felt warm.About 15 mins later, it was warmer; 20 mins later, it was hot and there was bad smell.I was unable to pick it up to remove batteries.I was frightened that it may catch fire, but 30 mins into batteries inserted, it just stopped.I opened the battery part and the batteries leaked out.I have tried using it with different batteries, but the alarm is not working anymore.It's burnt from inside and overheat.The bottom part has deformed from excess heat as well.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: 8730895
• MDR Text Key: 149240277
• Report Number: MW5087577
• 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: 06/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: M SERIES
• Device Catalogue Number: BLUE COLOR
• Device Lot Number: 42
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 4 YR