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

Model Number M42

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Electric Shock (2554)

Event Date 07/01/2019

Event Type  Injury  

Event Description

I thought the malem alarm was going to be the solution for our son who has had issues with bedwetting.Unfortunately, the sound gave him multiple shocks at night.The alarm kept going off and giving him shocks as soon as he wet the bed.Now, even when you lift the clip the alarm still goes off non-stop and gives shocks.Now he does not want to wear it anymore because he is afraid that other bedwetting treatments will also shock him.The malem alarm has made my son give up on bedwetting and he refuses to use any other alarm.An absolutely useless, poorly built and flawed product.Gives shocks when child is sleeping and urinating.Just terrible.Fda safety report id# (b)(4).

• Brand Name: ULTIMATE ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 8776813
• MDR Text Key: 150739241
• Report Number: MW5087984
• 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: 07/05/2019

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: M42
• 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): Required Intervention