MAUDE Adverse Event Report: MALEM MEDICAL UK MALEM BEDWETTING ALARM

Model Number NONE

Device Problem Overheating of Device (1437)

Patient Problem Pain (1994)

Event Date 09/01/2017

Event Type  Injury  

Event Description

My son was using the malem ultimate bedwetting alarm which i bought from the (b)(6) store (link: (b)(6)), the alarm got hot and burnt my son on his neck and shoulder.This problem occurred on the very first day of using the alarm, which makes it nothing but a manufacturing defect with the product.Unfortunately, since this incident occurred in the middle of the night, my family physician was not available then.So we applied ice water to his burns several times a night and took him to the doctor first thing in the morning.I tell you, the pain was excruciating and my son had to bear it all.There is a problem with the product and i request the fda to look into this at the earliest.

• Brand Name: MALEM BEDWETTING ALARM
• Type of Device: MALEM BEDWETTING ALARM
• Manufacturer (Section D): MALEM MEDICAL UK
• MDR Report Key: 6851350
• MDR Text Key: 85593149
• Report Number: MW5072021
• 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: 09/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2017
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Model 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): Required Intervention
• Patient Age: 33 YR