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

Model Number ULTIMATE ALARM (M024)

Device Problem Defective Device (2588)

Patient Problem Electric Shock (2554)

Event Date 06/25/2019

Event Type  Injury  

Event Description

When my (b)(6) year-old daughter told me about her second night's most horrified experience of using the malem bedwetting alarm; i was stunned.It gave her a big shock when she wet the bed.It was like a strong electrical shock.She was shivering and frightened when she loudly called me in the night.I had to check on her and tried to make her calm and rubbed cream on the big red patch.Right in the morning i had to show her to the dr who was also surprised to know how it happened.I am very upset that this alarm is so unsafe and dangerous.She is scared and so am i.Fda safety report id# (b)(4).

• Brand Name: ULTIMATE ALARM TO STOP BEDWETTING BY MALEM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 8776954
• MDR Text Key: 150743945
• Report Number: MW5087990
• 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: 07/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: ULTIMATE ALARM (M024)
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/09/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 10 YR