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

Model Number PURPLE COLOR

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problem Electric Shock (2554)

Event Date 08/21/2019

Event Type  Injury  

Event Description

Been using the malem alarm for 1 night.Alarm is new and was purchased from malem's website.Alarm is giving electrical shocks on bedwetting.Daughter wet the bed and complained that she sensed a shock where sensor was attached.I dismissed it and connected it back on her.About 3 hours later, when she wet the bed again, she complained that she got a shock and refused to wear again.I have stopped using the alarm.I don't know how to test it further, but my daughter is (b)(6) and she knows what a shock is and how it feels.Have also returned the alarm back to malem.Fda safety report id# (b)(4).

• Brand Name: MALEM ULTIMATE PRO BEDWETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 8939667
• MDR Text Key: 156011075
• Report Number: MW5089379
• 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: 08/25/2019

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: Lay User/Patient
• Device Model Number: PURPLE COLOR
• Device Catalogue Number: ULTIMATE PRO
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/27/2019
• 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