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

Model Number M034

Device Problems Defective Device (2588); Temperature Problem (3022); Noise, Audible (3273)

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

Event Date 04/10/2019

Event Type  malfunction  

Event Description

I have just received a malem bedwetting alarm by mail but the device is seriously defective.It is not working at all.All it does is make a click-click sound when i insert batteries and then gets hot.Also, it smells as if it's burning on the inside.I am worried that the alarm can burn my daughter if she is sleeping.I had it on for 30 mins and it was very hot.Then i placed batteries and same thing.It is not the batteries, but something within this device that is causing it to get dangerously hot.(b)(4).

• Brand Name: MALEM ORIGINAL BEDWETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD
• MDR Report Key: 8514471
• MDR Text Key: 142218663
• Report Number: MW5085833
• 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: 04/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M034
• Device Catalogue Number: YELLOW 8 RANDOM TONES
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/12/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 5 YR