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

Model Number M04

Device Problems Overheating of Device (1437); Defective Device (2588)

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

Event Date 10/06/2018

Event Type  malfunction  

Event Description

The alarm is getting very hot within mins of putting batteries.I take batteries out and it cools down.Then again, when i put in batteries, it gets hot.Can so easily burn my hands, let alone put in on my son.Defective device and dangerous for a child.All i did was put in batteries that came with the device and the heating starts.I think the heat is as much as boiling water.

• Brand Name: MALEM
• Type of Device: ALARM, CONDITIONED, RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD
• MDR Report Key: 7956099
• MDR Text Key: 123571556
• Report Number: MW5080454
• 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: Other
• Type of Report: Initial
• Report Date: 10/06/2018

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: No Information
• Device Model Number: M04
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/10/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 9 YR