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

Model Number NONE

Device Problem Insufficient Information (3190)

Patient Problem Burn(s) (1757)

Event Date 11/15/2017

Event Type  Injury  

Event Description

My (b)(6) year old son got burnt while using the malem bedwetting alarm.This is the first night that we had connected any sort of device to my son.The burns on his neck are similar to a hot iron coming in contact with the body.We had to rush him to the nearest hospital for treatment.This product is totally ridiculous and unacceptable.When i tried to reach the company, no one has ever bothered to respond.Who is going to pay the medical bills? why isn't anyone owning to the responsibility of this product? my son is now in a state of shock.This product needs to be removed from sales here in the us.I bought the malem alarm online from: (b)(6).

• Brand Name: MALEM BEDWETTING ALARM
• Type of Device: ENURESIS ALARM
• Manufacturer (Section D): BEDWETTING STORE
• MDR Report Key: 7071412
• MDR Text Key: 93442389
• Report Number: MW5073635
• 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: 11/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: NONE
• Device Catalogue Number: NONE
• Device Lot Number: NONE
• 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: 8 YR