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

Model Number ULTIMATE ALARM

Device Problems Vibration (1674); Temperature Problem (3022)

Patient Problem Burn, Thermal (2530)

Event Date 04/24/2019

Event Type  Injury  

Event Description

Last night, we received a new malem alarm for bedwetting.It is defective.The alarm will start vibrating for no reason at all as soon as the sensor is placed inside the alarm, even without any urine.The problem is that it starts getting very hot once it vibrates.I am not sure about the safety of this alarm because so much heat is just not normal.It was on my son's bed and then i picked it up; it was extremely hot.I burnt my finger tips from the alarm, only thing i could do was to remove the batteries and left it cool down.It is not safe for my son.Fda safety report id # (b)(4).

• Brand Name: MALEM ALARM FOR BEDWETTING
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD
• MDR Report Key: 8560591
• MDR Text Key: 143552678
• Report Number: MW5086237
• 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: 04/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ULTIMATE ALARM
• Device Catalogue Number: M042
• 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: 6 YR