MAUDE Adverse Event Report: MALEM MEDICAL MALEM ULTIMATE BEDWETTING ALARM

Model Number M04S

Device Problems Melted (1385); Overheating of Device (1437); Chemical Spillage (2894)

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

Event Date 01/22/2018

Event Type  No Answer Provided  

Event Description

Switched from a dr.(b)(4) brand of bedwetting alarm to the malem ultimate bedwetting alarm.The dr.(b)(4) brand was not working effectively.The malem was recommended by a friend and purchased for a young child (age (b)(6)).The 4 nights the alarm was used, it got extremely hot.So hot that it had to be removed from clothing and powered off by removing batteries.It does not appear to be normal.On the (b)(6), the alarm was getting warm we let it be where it was and did not put it on our son.The alarm got hot and the back melted from the heat generated.Batteries leaked and spilled on the mattress.This is dangerous.

• Brand Name: MALEM ULTIMATE BEDWETTING ALARM
• Type of Device: MALEM ULTIMATE BEDWETTING ALARM
• Manufacturer (Section D): MALEM MEDICAL
• MDR Report Key: 7227863
• MDR Text Key: 98676074
• Report Number: MW5074952
• 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: 01/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: M04S
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 7 YR