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

Model Number ULTIMATE BEDWETTING ALARM SERIES

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

Patient Problem Burn, Thermal (2530)

Event Date 03/16/2019

Event Type  Injury  

Event Description

My son was sleeping with his bedwetting alarm and it has injured him by overheating, the alarm got too hot and burnt him in the neck.Fortunately my son was able to feel the hot alarm by his neck and remove the alarm on time.The device has not been used since and returned back to the manufacturer for analysis.Clearly a defect in the device as the device was new and used as instructions had directed.

• Brand Name: BEDWETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD
• MDR Report Key: 8459992
• MDR Text Key: 140343846
• Report Number: MW5085267
• 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: 03/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ULTIMATE BEDWETTING ALARM SERIES
• Device Catalogue Number: M04
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/27/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 3 YR