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

Model Number M04

Device Problems Overheating of Device (1437); Noise, Audible (3273)

Patient Problem Burn, Thermal (2530)

Event Date 10/11/2018

Event Type  Injury  

Event Description

The malem ultimate bedwetting alarm has a serious problem.We set it up correctly just like instructions say, but the alarm is not operating properly.It is getting hot.With batteries in, the alarm is making click sounds and then with the sensor inserted, it's getting hot.Not normal operation for an alarm.The heat is enough to burn my hand.The batteries have been removed and the alarm is ready to be returned to the mfr from where i purchased it.

• Brand Name: MALEM ULTIMATE BEDWETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD
• MDR Report Key: 7968856
• MDR Text Key: 123947321
• Report Number: MW5080559
• Device Sequence Number: 0
• Product Code: KPN
• Reporter Country Code: CA
• 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: 10/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2018
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: M04
• 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: 4 YR
• Patient Weight: 14