MAUDE Adverse Event Report: MALEM MALEM BEDWETTING ALARM

Model Number NONE ON PRODUCT BOX

Device Problems Melted (1385); Overheating of Device (1437); Temperature Problem (3022)

Patient Problem Burn, Thermal (2530)

Event Date 12/04/2016

Event Type  Injury  

Event Description

I bought the malem bedwetting alarm from the bedwetting store.(b)(6).At night my son yelled loudly and i ran to his room.We noticed that the malem alarm was scorching hot and it had created a burn mark on my son's neck.It was similar to a hot iron.I removed the alarm and threw it on the bed, later placed the alarm in an oven mitt till it cooled down as i didn't want to burn my bed sheet.Applied a burn ointment on my son's neck.I think it will take several weeks or even months for the burn mark to heal.These kind of cheap products should be removed permanently.Please take strictest action.

• Brand Name: MALEM BEDWETTING ALARM
• Type of Device: MALEM BEDWETTING ALARM
• Manufacturer (Section D): MALEM; maryland
• MDR Report Key: 6150912
• MDR Text Key: 61622353
• Report Number: MW5066569
• Device Sequence Number: 1
• Product Code: KPN
• 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: 12/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: NONE ON PRODUCT BOX
• Device Catalogue Number: NONE ON PRODUCT BOX
• Device Lot Number: NONE ON PRODUCT BOX
• Was Device Available for Evaluation?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: OTC MEDS: NONE.; RX MEDS: NONE.
• Patient Outcome(s): Other
• Patient Age: 3 YR