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

Model Number M041

Device Problem Temperature Problem (3022)

Patient Problem No Patient Involvement (2645)

Event Date 04/08/2019

Event Type  Injury  

Event Description

Malem bedwetting alarm has a severe defect.It's getting hot within mins of being powered on.I inserted batteries and got ready to place on my daughter.By the time i set up the sensor and got ready to connect it on her, the alarm was already warm to hold.I was not sure if it was supposed to do this.I let the alarm sit for a few mins and as it got hotter.I just had to remove the batteries for fear of the device blowing up.I have replaced the original batteries with new ones but the same thing keeps happening over and over again.This is a device defect which renders it unusable and dangerous to my daughter, especially if she is sleeping at night with the device.I have returned the device.Fda safety report id# (b)(4).

• Brand Name: ULTIMATE BEDWETTING ALARM
• Type of Device: ALARM CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD
• MDR Report Key: 8518711
• MDR Text Key: 142194167
• Report Number: MW5085884
• 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: 04/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: M041
• Device Catalogue Number: PINK COLOR
• 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: 8 YR