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

Model Number ULTIMATE ALARM

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

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

Event Type  Injury  

Event Description

From the moment i put the batteries in the unit started screeching.Nothing i could do to make it stop or reset it somehow so that we could possibly even give it a try.I also noticed that the alarm is getting very hot within mins of putting batteries inside it.This makes it too dangerous.At first i thought that it's just another electronic device warming up, but then, you realize that it's not warm but hot.My wife panicked and we removed the batteries.We retested with a fresh set of batteries and the same thing kept going on.The temperature on the alarm is over 170f.This will cause serious injuries.Fda safety report id# (b)(4).

• Brand Name: BEDWETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 8822157
• MDR Text Key: 152180729
• Report Number: MW5088321
• 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: 07/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: ULTIMATE ALARM
• Device Catalogue 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 Outcome(s): Other; Required Intervention
• Patient Age: 3 YR