MAUDE Adverse Event Report: MALEM MEDICAL MALEM BEDWETTING ALARM

Model Number M04

Device Problems Leak/Splash (1354); Overheating of Device (1437); Battery Problem (2885)

Patient Problems Caustic/Chemical Burns (2549); Partial thickness (Second Degree) Burn (2694)

Event Date 01/03/2018

Event Type  Injury  

Event Description

A few nights ago, on the advice of a pediatrician, i purchased a bedwetting alarm for my step daughter.She is a chronic bedwetter and the alarm was for her to stop wetting at night.The alarm came packed and sealed in a box directly from an online website in brand new condition.As per the instructions, batteries were installed and the product was powered on.The sensor was attached to the alarm part and almost immediately, the product started to rattle like something was stuck in the alarm unit.Gradually the alarm started to get a little warm.At first i thought this was normal as it was operating.So i placed it over my daughter's t-shirt and went downstairs.About 30-45 minutes later, my daughter was crying loudly.I found that the alarm was super hot.So hot that i could not even touch it.The back casing has melted from excessive heat and fused to her clothing.The batteries (aaa) had exploded within the unit and leaked on to her body.Warm battery leaks were all over her skin and burnt her.She was unable to move from fear of burns.Immediately we gave her first aid by rinsing with warm water and saline.Then rushed her to the closest er where she was treated for minor chemical burns.The alarm has since been left at the er and daughter is recovering.Burns have resulted in blisters and bright red scars on neck area.

• Brand Name: MALEM BEDWETTING ALARM
• Type of Device: MALEM BEDWETTING ALARM
• Manufacturer (Section D): MALEM MEDICAL; nottingham ; UK
• MDR Report Key: 7178699
• MDR Text Key: 96961033
• Report Number: MW5074472
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/08/2018

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?: Yes
• Device Operator: Health Professional
• Device Model Number: M04
• Device Catalogue Number: ULTIMATE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/09/2018
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 4 YR