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

Model Number M044S

Device Problem Overheating of Device (1437)

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

Event Date 04/20/2020

Event Type  Injury  

Event Description

I followed instructions that were in the user manual and inserted batteries.Then inserted sensor.But alarm just got too hot in my hands.I was setting up the buttons and understanding how to use and alarm got hot in my hands.I got afraid and removed batteries.Then changed batteries and same thing is happening every time i am inserting batteries.Like there is a serious defect.It is getting not hot, but very hot.Will burn my daughter if she is sleeping with this alarm.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: 9995026
• MDR Text Key: 188986055
• Report Number: MW5094244
• 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: 04/21/2020

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: M044S
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/23/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 8 YR