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

Model Number ULTIMATE M042

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problem Electric Shock (2554)

Event Date 07/16/2019

Event Type  malfunction  

Event Description

I thought the malem alarm was going to be the solution for our daughter who has had issues with bedwetting.Unfortunately, the alarm has scared us completely at night.It would go off in the middle of the night when my daughter wasn't even wet and give her shocks.She didn't urinate at all.It would only shock her at night, she would get up cranky for the full day.There is no way for it to be user error.It is a defect in the alarm.Now she does not want to wear it anymore because this essentially keeps her awake all night as she's now afraid of the shocks she gets.We were unaware this was happening till asked her after a week what the problem was.She explained it to me.At first i thought she was avoiding it, but then, when i tested it myself, i got a shock too.The malem alarm has made my daughter give up on bedwetting and she refuses to use any other alarm.An absolutely useless, poorly built and flawed product.Fda safety report id# (b)(4).

• Brand Name: MALEM BEDWETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 8822092
• MDR Text Key: 152221770
• Report Number: MW5088318
• 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: 07/20/2019

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: ULTIMATE M042
• Device Lot Number: BLUE
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/23/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 4 YR