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

Model Number BEDWETTING ALARM

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Difficult to Open or Close (2921); Failure to Shut Off (2939)

Patient Problem Electric Shock (2554)

Event Date 09/21/2019

Event Type  Injury  

Event Description

The first one we received was unusable.The battery compartment could not be opened.We returned it and received another one.Had problems from the very first day.It gave shocks every time it detected urine.Thinking it might be the battery we changed the batteries out, but it started shocking even my hands with no wetness and would not turn off unless we took the battery out.So, it's useless.My daughter got multiple shocks while she was using the alarm at night and we were unaware of it for 4 nights.This is a dangerous product.Fda safety report id# (b)(4).

• Brand Name: MALEM ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 9140377
• MDR Text Key: 160904913
• Report Number: MW5090108
• Device Sequence Number: 2
• 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: 09/26/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: BEDWETTING ALARM
• Device Catalogue Number: ULTIMATE-PINK COLOR
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/30/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 8 YR