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

Model Number M04

Device Problems Overheating of Device (1437); Gas/Air Leak (2946); Material Deformation (2976)

Patient Problem Injury (2348)

Event Date 06/28/2018

Event Type  malfunction  

Event Description

Our son's malem alarm overheated at night and burnt him in the neck.The batteries have also leaked and the alarm was bent from heat.

• Brand Name: MALEM ALARM, CONDITIONED RESPONSE ENURESIS
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL; nottingham ; UK
• MDR Report Key: 7663410
• MDR Text Key: 113293619
• Report Number: MW5078232
• 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: Nurse
• Type of Report: Initial
• Report Date: 07/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M04
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 6 YR
• Patient Weight: 23