MAUDE Adverse Event Report: MALEM MEDICAL LTD. BEDWETTING DEVICE FOR CHILDREN; ALARM, CONDITIONED RESPONSE ENURESIS

Model Number ULTIMATE ALARM

Device Problems Thermal Decomposition of Device (1071); Melted (1385)

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

Event Date 03/02/2020

Event Type  Injury  

Event Description

It's rather strange that the alarm burnt up in 30 mins of battery being inserted.I inserted batteries and when i checked the alarm after 30 mins, the alarm plastic had melted from head and had fused to my table.Dangerous.Fda safety report id# (b)(4).

• Brand Name: BEDWETTING DEVICE FOR CHILDREN
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 9818057
• MDR Text Key: 183237491
• Report Number: MW5093657
• Device Sequence Number: 1
• Product Code: KPN
• Combination Product (y/n): N
• 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: 03/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: ULTIMATE ALARM
• Device Catalogue Number: BEDWETTING ALARM
• 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: 8 YR