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

Device Problems Bent (1059); Leak/Splash (1354); Overheating of Device (1437); Material Deformation (2976)

Patient Problem No Information (3190)

Event Date 06/13/2018

Event Type  Injury  

Event Description

New bedwetting alarm has malfunctioned first night of use.The alarm overheated within an hour of being powered on and leaked hot battery acid.I was lucky that my son was not wearing it at the time or he would have been burnt very badly on his neck.The battery acid has spilled all over the countertop where it was placed and heat caused the alarm to bend inwards and deform.A dangerous product for children.

• Brand Name: MALEM BEDWETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD; UK
• MDR Report Key: 7619013
• MDR Text Key: 111847631
• Report Number: MW5077937
• 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: 06/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• 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 Outcome(s): Required Intervention
• Patient Age: 4 YR