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

Model Number M043

Device Problems Vibration (1674); Physical Resistance/Sticking (4012); Excessive Heating (4030)

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

Event Type  Injury  

Event Description

As soon as batteries and sensor is inserted into the alarm part of the malem device, the device shakes a bit.It is clear that the moving part is stuck and short inside the electrical components.It takes about 15 minutes for the device to go from room temperature to hot.I can't use it.I touched a thermometer on it and it read red and over 150f.I don't intend to injure my daughter when she is sleeping or awake.Unsafe.It is not the batteries as i replaced them and it¿s the same thing all over again.Hot hot hot.Fda safety report id # (b)(4).

• Brand Name: BEDWETTING ALARM
• Type of Device: ALARM, CONDTIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD
• MDR Report Key: 8759678
• MDR Text Key: 150143669
• Report Number: MW5087833
• 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: 06/28/2019

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: Health Professional
• Device Model Number: M043
• Device Catalogue Number: ULTIMATE BEDWETTING ALARM
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/02/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 9 YR