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

Lot Number NONE

Device Problem Overheating of Device (1437)

Patient Problems Burn(s) (1757); Pain (1994)

Event Date 11/19/2017

Event Type  Injury  

Event Description

I bought the malem bedwetting alarm for my son, little did i know that the alarm would overheat and burn him on his neck and shoulder.This product overheated within few hours of first using it, i.E.In the middle of the night it burned my son so badly that he had to receive treatment from his doctor and even after a few days now he is still in pain.I ask, why is this product being sold in the us? i have noticed multiple complaints of this malem alarm on the fda's site, then why hasn't the fda inspected this product yet? i wish i had known about this flaw earlier, so i wouldn't have purchased this product and even better if the fda has recalled this alarm my son wouldn't have gotten hurt.Https://bedwettingstore.Com.

• Brand Name: MALEM BEDWETTING ALARM
• Type of Device: ENURESIS, ALARM
• Manufacturer (Section D): MALEM
• MDR Report Key: 7083132
• MDR Text Key: 93817889
• Report Number: MW5073727
• 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
• Type of Report: Initial
• Report Date: 11/30/2017

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: Lay User/Patient
• Device Lot Number: NONE
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/04/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention