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

Model Number M

Device Problems Device Emits Odor (1425); Overheating of Device (1437)

Patient Problems Burn, Thermal (2530); Partial thickness (Second Degree) Burn (2694)

Event Date 03/12/2019

Event Type  Injury  

Event Description

In a rather strange incident, my son was hurt at night when he was sleeping.The root cause was his bedwetting alarm.He is a deep sleeper and did not wake up in time to the alarm.But when i entered his room, i noticed a smell of something burning.I noticed that his shirt had a hole from the burns and his skin was red and burn marks and blisters.The alarm had somehow burnt him at night when he was sleeping.This is the first night we used the alarm on him, and we were scared and worried how this happened.

• Brand Name: ULTIMATE BEDWETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD
• MDR Report Key: 8436455
• MDR Text Key: 139417884
• Report Number: MW5085032
• 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: 03/15/2019

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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: M
• Device Catalogue Number: 04
• Device Lot Number: BLUE
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/19/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 5 YR