MAUDE Adverse Event Report: BEDWETTING STORE, MALEM MEDICAL MALEM BEDWETTING ALARM; ENURESIS ALARM

Device Problems Melted (1385); Overheating of Device (1437)

Patient Problem Burn(s) (1757)

Event Date 08/03/2017

Event Type  Injury  

Event Description

The malem bedwetting (enuresis) alarm overheated and burnt my son.The plastic on the back of the alarm melted, went into my son's chest and neck.We had to force pull out the burning hot alarm from him and rush him to the hospital.He is still recovering after weeks of pain.I would have expected the fda to have done their diligence prior to having let any product in the us market, but that doesn't seem to be the case.Someone in your department needs to take a closer look at this product.The sooner the better.

• Brand Name: MALEM BEDWETTING ALARM
• Type of Device: ENURESIS ALARM
• Manufacturer (Section D): BEDWETTING STORE, MALEM MEDICAL
• MDR Report Key: 6830155
• MDR Text Key: 84091054
• Report Number: MW5071819
• Device Sequence Number: 1
• Product Code: KPN
• Combination Product (y/n): N
• 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: 08/27/2017

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?: Yes
• Device Operator: No Information
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/30/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization