MAUDE Adverse Event Report: MALEM MEDICAL LTD ENURESIS ALARM BY MALEM ULTIMATE WITH 8 TONES; ALARM, CONDITIONED RESPONSE ENURESIS

Device Problems Overheating of Device (1437); Defective Device (2588)

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

Event Date 10/22/2019

Event Type  malfunction  

Event Description

I purchased a malem bedwetting alarm and it was defective from the very first day.I placed batteries and it got super hot.I thought it was something wrong, so i contacted the company.They promptly told me to ship the alarm back to them and they would send me a new one.Now i received the new alarm and it is doing exactly the same thing.I have reached out to the company and they have not responded over the last 4 days.I have used (b)(6) batteries.(b)(6) batteries and others, but the alarm outer body is hot and dangerous to even hold in hands.There is something wrong with the device itself.This cannot happen twice with the same brand.If i am not able to hold it, how can my son sleep with it? just too risky to use.It was so hot that i had to use a wet towel to pull out the batteries or i would burn my hand.Fda safety report id# (b)(4).

• Brand Name: ENURESIS ALARM BY MALEM ULTIMATE WITH 8 TONES
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD
• MDR Report Key: 9255422
• MDR Text Key: 164625909
• Report Number: MW5090769
• Device Sequence Number: 2
• 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: 10/27/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2019
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 5 YR