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

Model Number ULTIMATE PRO BEDWETTING ALARM

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

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

Event Date 09/10/2019

Event Type  malfunction  

Event Description

I am not sure if i should even use this alarm.It clearly appears dangerous and unreliable.It arrived in the mail now and i want to use it on my son who is (b)(6).I inserted batteries and then plugged in the sensor and to my surprise, the alarm is making a clicking sound.It's clear that there is something stuck in the device.Then when i hold it after about 10 mins, it's significantly warmer and only getting hotter as time passes by.I changed batteries and redid this 3 times and each time, the device is going hot to hotter to really very very hot.I can't possibly use this alarm on my son.It can so easily burn him at night when he's sleeping.Very defective and dangerous.Fda safety report id# (b)(4).

• Brand Name: BEDWETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 9027478
• MDR Text Key: 158849157
• Report Number: MW5089752
• 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: 09/10/2019

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: Other
• Device Model Number: ULTIMATE PRO BEDWETTING ALARM
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/12/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 5 YR
• Patient Weight: 25