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

Model Number M04SC

Device Problems Break (1069); Overheating of Device (1437)

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

Event Date 07/24/2018

Event Type  malfunction  

Event Description

This alarm is not working like the other device we had.This is an erratic system which goes off for no reason and gets very hot in an hour of battery insertion.I have put in 4 different set of aaa batteries in the malem alarm and each one is making the alarm hot.This cannot be the battery problem.It is a defect in the device.Our previous alarm did so much thing but broke when we were using it.This alarm gets hot and fortunately to me, my daughter was not wearing it at the time she was sleeping or it most certainly would have burnt her.The alarm was purchased from (b)(6) and returned back to them.

• Brand Name: MALEM ULTIMATE BEDWETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL
• MDR Report Key: 7725545
• MDR Text Key: 115357763
• Report Number: MW5078625
• Device Sequence Number: 1
• Product Code: KPN
• Combination Product (y/n): N
• 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: 07/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: M04SC
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 4 YR