MAUDE Adverse Event Report: MALEM MEDICAL / BEDWETTING STORE MALEM BEDWETTING ALARM

Device Problem Overheating of Device (1437)

Patient Problem Burn(s) (1757)

Event Date 09/01/2017

Event Type  Injury  

Event Description

This substandard malem bedwetting alarm was connected to my son to monitor his nighttime bedwetting.In the middle of the night the product overheated and burnt him, so we had to rush him to the hospital for treatment.My son has suffered severe burns.The product when hot was worse than a pot of boiling water.My son shouldn't have had to go through this nonsense.I'd like to know if the fda done their due-diligence on this product.I would like the fda remove this product from all households that currently use it for their children.This inferior piece of junk can get super hot at anytime.Fyi, i bought this product from (b)(6).

• Brand Name: MALEM BEDWETTING ALARM
• Type of Device: MALEM BEDWETTING ALARM
• Manufacturer (Section D): MALEM MEDICAL / BEDWETTING STORE
• MDR Report Key: 6864454
• MDR Text Key: 86267911
• Report Number: MW5072125
• 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: 09/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 3 YR