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

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Shock (2072); Burn, Thermal (2530)

Event Date 06/04/2019

Event Type  Injury  

Event Description

We used the malem alarm on (b)(6) on our (b)(6) year-old son for his bedwetting problems.As we connected the alarm he went to sleep within a few minutes.I was there with him then and within no time at all started to urinate.He yelled as he received shocks from the alarm and i pulled out the alarm immediately and threw it on the floor.We noticed a big red patch and had to rush him to the hospital at night.This is totally not called for.Before, i logged this complaint, i noticed hundred of other complaints with the same/similar problem.This product needs to be banned for sale without excuse.Malem bedwettings alarm are risky.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: 8767992
• MDR Text Key: 150406640
• Report Number: MW5087915
• 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: 07/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 3 YR