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

Model Number ULTIMATE BEDWETTING DEVICE

Device Problem Overheating of Device (1437)

Patient Problems Pain (1994); Swelling (2091); Injury (2348)

Event Date 02/18/2019

Event Type  Injury  

Event Description

A young (b)(6) years old girl has been injured from normal use of a bedwetting device.Parents noticed blisters around the patient's neck area after using the alarm for 6 days.They thought that it was from food allergy (peanut), but later determined that the cause was heat coming out of the bedwetting device.The backside of the device was getting hot when it detected urine and woke up the child.When not detecting urine, the alarm worked normally.This erratic action has caused the patient pain.We have treated the patient and advised family to discontinue using the bedwetting device.

• Brand Name: MALEM
• Type of Device: ALARM CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD
• MDR Report Key: 8371206
• MDR Text Key: 137358616
• Report Number: MW5084362
• Device Sequence Number: 1
• Product Code: KPN
• Combination Product (y/n): N
• Reporter Country Code: MY
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: ULTIMATE BEDWETTING DEVICE
• Device Catalogue Number: M04
• Was Device Available for Evaluation?: No
• 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): Other; Required Intervention
• Patient Age: 6 YR
• Patient Weight: 28