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

Model Number ULTIMATE ALARM

Device Problems Melted (1385); Overheating of Device (1437); Smoking (1585)

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

Event Date 08/02/2020

Event Type  Injury  

Event Description

The report is concerning a malem bedwetting alarm.This alarm was purchased in new condition from the manufacturer.Once i inserted batteries, it started vibrating without sensor and there was no way to turn it off.I removed the batteries and reinserted them in.But that did not help.After 5 minutes of vibration, smoke started coming out of the alarm, and it was super hot.The plastic housing was bending from heat.This is so scary and dangerous.I had to use oven mitts to open the alarm and remove the batteries.If my son was sleeping with this alarm, it would have been very dangerous and easily burnt him.Fda safety report id# (b)(4).

• Brand Name: BEDWETTING ALARM DEVICE
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL, LTD.
• MDR Report Key: 10379042
• MDR Text Key: 202211477
• Report Number: MW5095948
• 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: 08/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: ULTIMATE 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): Required Intervention
• Patient Age: 7 YR