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

Model Number ULTIMATE 1 TONE

Device Problems Thermal Decomposition of Device (1071); Overheating of Device (1437); Noise, Audible (3273)

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

Event Date 12/29/2019

Event Type  malfunction  

Event Description

This complaint is regarding the malem bedwetting alarm (1 tone) which i am attempting to use for the first time.I followed the instructions and put in batteries.Then i lifted the sensor lever and inserted the sensor inside the alarm but as soon as i do that, the alarm makes a strange sound like something is stuck and within a few mins, the alarm gets hot.Also, there is a bad smell of burning from the alarm.I gave it 20 mins and the alarm was hot.I could have burned my hand.I then removed the batteries and replaced them, but same thing happened.How can this device be safely used if it is getting so hot.It's unsafe for my (b)(6) year old daughter.Fda safety report id# (b)(4).

• Brand Name: ENURESIS ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 9540208
• MDR Text Key: 173574108
• Report Number: MW5091997
• 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: 12/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: ULTIMATE 1 TONE
• Device Catalogue Number: ULTIMATE 1 TONE
• Device Lot Number: LIGHT BLUE
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 4 YR