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

Model Number MO48TEC

Device Problems Overheating of Device (1437); Chemical Spillage (2894)

Patient Problems Burn(s) (1757); Irritation (1941); Rash (2033)

Event Date 02/25/2018

Event Type  malfunction  

Event Description

My son was using a wet-stop3 alarm but it did not work as we thought, so we replaced it with a malem alarm.This alarm was used tonight for the first time.It has some serious problem.The batteries were inserted into the alarm unit as directed, however the alarm unit got very hot within minutes of use.This made me worry what might happen over a night use.Thinking that the problem may be in the batteries, i replaced the batteries as well, but that did not help.Same thing happened.I burnt the tip of my finger when i picked up the alarm and some battery spills on my hands.Minor skin rash and irritation, but at least no harm done to my son.

• Brand Name: ALARM, CONDITIONED RESPONSE ENURESIS
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD
• MDR Report Key: 7302240
• MDR Text Key: 101254059
• Report Number: MW5075547
• 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: 02/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MO48TEC
• 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): Other
• Patient Age: 5 YR
• Patient Weight: 19