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

Model Number ULTIMATE

Device Problem Overheating of Device (1437)

Patient Problems Emotional Changes (1831); Pain (1994); Scarring (2061); Burn, Thermal (2530)

Event Date 04/22/2020

Event Type  Injury  

Event Description

This is the second similar experience i faced with the malem ultimate alarm.It was purchased from website (b)(6) and i received it 4 weeks ago.The alarm was defective and overheated for no reason as soon as batteries were inserted.I then contacted the (b)(6) and they asked me to return it for a new alarm.I did that and a new alarm was shipped to me (that's what they say).This one has the same problem as the old one.It got hot when i put in batteries.These are the batteries that came with the alarm.Unfortunately, my son has the alarm connected on him when the alarm burnt him.He was left with red scars, terrified and crying in pain from the alarm burns.Horrible system.I contacted them several times, but they did not respond.I also reached out to malem, the manufacturer, but they did nor reply either.I have left the alarm with the clinic and administrative facility.They advised me to report this incident to the fda.Fda safety report id# (b)(4).

• Brand Name: BED WETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 10013191
• MDR Text Key: 189598608
• Report Number: MW5094317
• 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: 04/27/2020
• 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: ULTIMATE
• Device Catalogue Number: BLUE COLOR
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/29/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 6 YR