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

Model Number ULTIMATE

Device Problems Device Emits Odor (1425); Overheating of Device (1437)

Patient Problem Burn, Thermal (2530)

Event Date 11/19/2019

Event Type  Injury  

Event Description

This is not a safe product.My son was using the wet-stop 3 bedwetting alarm but it was not very effective.The dr told us to discontinue use and start using another alarm.He did not specify a particular brand, but after searching online, i found the malem bedwetting alarm at (b)(6) and ordered it.The results have been devastating for us, my son is (b)(6) y/o and he really wanted to stop bedwetting, but the alarm has ruined his self esteem and scared us into never using a bedwetting alarm again.The malem alarm was received in new condition within a few days of ordering it.I saw online video and read the user manual.After setting it up, i put my son to sleep, 30 mins later, he was screaming in bed.I went to his room and found him tugging on his shirt.He was crying and told me the alarm burnt him.I immediately removed his shirt and the alarm was so very hot.The alarm was hot and it burned his neck.Red scar from the burn on his neck.Not what we were expecting.The alarm gave smell of plastic burning.It likely short circuited during normal use and caused this burn.I had to administer first aid treatment on him and told the dr what happened.We are reporting this to fda on the dr's advice.Fda safety report id# (b)(4).

• Brand Name: BEDWETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 9396728
• MDR Text Key: 168780514
• Report Number: MW5091373
• 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: 11/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: ULTIMATE
• Device Catalogue Number: BLUE
• Was Device Available for Evaluation?: Yes
• 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
• Patient Weight: 22