MAUDE Adverse Event Report: MALEM MEDICAL UK BEDWETTING ALARM

Model Number M04

Device Problems Burst Container or Vessel (1074); Fluid/Blood Leak (1250); Overheating of Device (1437)

Patient Problem Burn(s) (1757)

Event Date 11/14/2017

Event Type  Injury  

Event Description

Batteries in our bedwetting alarm leaked out at night when child was sleeping.The bedwetting alarm was brand new and just arrived 1 day prior to use.All we did was put batteries in the alarm unit and put our daughter to bed.It took about 30 minutes for the alarm to get hot and batteries inside to explode and leak.The battery leak was a dark black slimy substance which burnt my child's neck.We have used the batteries that came with the product and used exactly as instructed.This is a product defect and a dangerous one.

• Brand Name: BEDWETTING ALARM
• Type of Device: BEDWETTING ALARM
• Manufacturer (Section D): MALEM MEDICAL UK
• MDR Report Key: 7063311
• MDR Text Key: 93180197
• Report Number: MW5073573
• 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: 11/22/2017

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
• Device Model Number: M04
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/28/2017
• 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
• Patient Weight: 24