MAUDE Adverse Event Report: MALEM MEDICAL MALEM BEDWETTING ALARM

Lot Number NONE

Device Problem Overheating of Device (1437)

Patient Problem Burn(s) (1757)

Event Date 09/13/2017

Event Type  Injury  

Event Description

I bought a bedwetting alarm called the malem alarm from (b)(6) to stop my sons pee problem.I used the alarm as per instructions, but never did it mention that after a couple of hours of use the alarm would get hot and it needs to be removed.My son has suffered burns because of this faulty alarm.He was treated for 15 - 20 days with constant visits to the doctor in order to recover completely.Such products need to be removed permanently from the market.

• Brand Name: MALEM BEDWETTING ALARM
• Type of Device: ALARM
• Manufacturer (Section D): MALEM MEDICAL
• MDR Report Key: 6993395
• MDR Text Key: 90853973
• Report Number: MW5073061
• 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: 10/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• 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): Life Threatening; Required Intervention
• Patient Age: 6 YR