MAUDE Adverse Event Report: MALEM MEDICAL MALEM SELECTABLE BEDWETTING ALARM; BED WETTING ALARM

Device Problems Bent (1059); Leak/Splash (1354); Overheating of Device (1437); Device Operates Differently Than Expected (2913)

Patient Problem Caustic/Chemical Burns (2549)

Event Date 02/14/2018

Event Type  Injury  

Event Description

A brand new bedwetting alarm which was prescribed for my (b)(6) -year old daughter has malfunctioned.The alarm had some kind of short circuit in it which caused it to get extremely hot.The plastic housing has bent inward from the heat and the battery has leaked out.This has burnt my daughter on her neck.We administered first aid treatment at home.

• Brand Name: MALEM SELECTABLE BEDWETTING ALARM
• Type of Device: BED WETTING ALARM
• Manufacturer (Section D): MALEM MEDICAL
• MDR Report Key: 7288771
• MDR Text Key: 100783459
• Report Number: MW5075397
• 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: 02/19/2018

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: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/21/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 6 YR