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

Model Number ULTIMATE PRO BEDWETTING ALARM

Device Problems Thermal Decomposition of Device (1071); Device Emits Odor (1425); Overheating of Device (1437); Defective Device (2588)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/11/2019

Event Type  Injury  

Event Description

I am using the malem bedwetting alarm on my daughter and this is the first night i am using it.I have recommended these alarms to pts and i got this particular alarm from (b)(6).It is defective.I put it on my daughter and 10 mins later she called me to her room.She said that there was bad smell and alarm was hot.I promptly removed the alarm and noticed that she was right.The alarm has a pungent burning plastic stench and it was actually warm to touch.I left it sit in my hands and 5 mins later, the smell got worse and the heat that came from the device got hotter and hotter.I removed the batteries.From my experience as someone who works with medical devices, i know that this is a device malfunction.I tried the only thing that could help - replacing batteries.It didn't help.The problem continued, so it's not a battery fault.This device can pose a serious condition if a child is sleeping with the device.Clearly a failure of the electronics part.The alarm is new and was never used before.Fda safety report id# (b)(4).

• Brand Name: MALEM BEDWETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD. ; UK
• MDR Report Key: 9069920
• MDR Text Key: 158795496
• Report Number: MW5089787
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date: 09/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ULTIMATE PRO BEDWETTING ALARM
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 6 YR
• Patient Weight: 24