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

Model Number M043

Device Problems Overheating of Device (1437); Battery Problem (2885)

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

Event Date 05/05/2019

Event Type  malfunction  

Event Description

Brand new bedwetting alarm is exhibiting erratic and dangerous characteristics.The device, when powered up touches a temperature of over 175f within 45 mins making is potentially dangerous and unusable.There is absolutely no way this is to be used on my daughter who turned (b)(6) last week.The device was purchased new and has issues with shorting batteries as well.When left to operate without intervention, the device leaked batteries and is now useless.Fda safety report id# (b)(4).

• Brand Name: MALEM ULTIMATE BEDWETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 8599607
• MDR Text Key: 144798588
• Report Number: MW5086516
• 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: 05/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: M043
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 5 YR