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

Device Problems Thermal Decomposition of Device (1071); Device Emits Odor (1425); Smoking (1585)

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

Event Date 12/02/2019

Event Type  Injury  

Event Description

We used the dry easy bedwetting alarm to cure our sons nightmare bedwetting problem.The results were not achieved in even 4 months.We purchased malem ultimate pro bedwetting alarm from (b)(6) website.Alarm has electrical issues.All we did was insert batteries and connect sensor and there was smoke coming from the top of the device.It was like the electronics were on fire, you could see fumes and smell plastic burning.Afraid for safety.I removed the batteries.No, the batteries were inserted correctly.The issue is with the new device.What is scary is that it is a new device i reached out to (b)(6) and malem 3 times but no response from them.Fda safety report id# (b)(4).

• Brand Name: ULTIMATE PRO BEDWETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 9451556
• MDR Text Key: 170452429
• Report Number: MW5091577
• 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: 12/07/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2019
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 5 YR