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

Model Number SELECTABLE ALARM

Device Problems Overheating of Device (1437); Defective Component (2292)

Patient Problems Erythema (1840); Burn, Thermal (2530)

Event Date 02/10/2019

Event Type  Injury  

Event Description

We have been using the malem bed wetting alarm with our son with no success.This is a bed wetting alarm whose intended purpose is to detect urine and alert the user.Till date, we have used the product for about 10 nights and all 10 nights, my son has wet the bed, but the alarm has not triggered even once.However we continued to use it with expectation that it may do what it is intended to do.Recently we noticed small red marks on my sons neck area.It was small, but over the last 10 days, got more visible and brighter color.We were not sure what is causing the red marks.Last night, we finally found the root cause.It was the bed wetting alarm.The alarm was cleaned properly prior to use, but it's generating a lot of heat at night.This heat is touching my sons neck and burning him every night.We feel responsible for this and have stopped using the alarm.Unsafe!.

• Brand Name: MALEM BEDWETTING ALARM
• Type of Device: ALARM, CONDITIONAL RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD
• MDR Report Key: 8343769
• MDR Text Key: 136981189
• Report Number: MW5084126
• 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: 02/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: SELECTABLE ALARM
• 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
• Patient Age: 5 YR