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

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

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

Event Date 08/10/2019

Event Type  Injury  

Event Description

I was demonstrating to my daughter how to set up and use the bedwetting alarm.Her dr prescribed it for her.During the demonstration, the alarm part got very hot and i had to remove the batteries.I tried again several times, but the same thing happened over and over gain.It's too hot and cannot be operated safely.I have not used it since.I worry that it's dangerous.Also, the top has smell coming out like burning plastic.Fda safety report id# (b)(4).

• Brand Name: ULTIMATE ALARM FOR BEDWETTING
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 8894125
• MDR Text Key: 154538994
• Report Number: MW5089024
• 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: 08/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/13/2019
• 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