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

Model Number MO48TEC

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Shock (2072); Skin Discoloration (2074)

Event Date 09/19/2019

Event Type  Injury  

Event Description

When my (b)(6) daughter told me about her second night's most horrified experience of using the malem bedwetting alarm; i was stunned.It gave her 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 cram 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 on choosing such a dangerous product for her which is so unsafe.This product should not be used by other parents for their children.Fda safety report id# (b)(4).

• Brand Name: MALEM ULTIMATE BEDWETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 9129347
• MDR Text Key: 160531844
• Report Number: MW5090082
• 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: 09/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MO48TEC
• Device Catalogue Number: MO48TEC
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 10 YR