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

Model Number ULTIMATE

Device Problem Electrical Shorting (2926)

Patient Problem Electric Shock (2554)

Event Date 06/04/2019

Event Type  Injury  

Event Description

This alarm is unsafe for kids.This item is no good at all.We used it less than a day and i was so excited about, it developed a short circuit in the alarm unit which attached to the t-shirt.This is where the sensor is inserted for operation.The second night my daughter slept, she wet the bed and got an electric shock on her genitals.The alarm should wake her up, not shock her.The shock was big enough to wake her up shaken scared in her sleep.Horrible.No thank you.I am not asking for my child to get electrocuted.I am so disappointed this did not work.Was this device serviced by a third party servicer? no.Fda safety report id# (b)(4).

• Brand Name: MALEM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD. ; UK
• MDR Report Key: 8712420
• MDR Text Key: 148621975
• Report Number: MW5087455
• 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: 06/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ULTIMATE
• Device Catalogue Number: M042
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 5 YR