MAUDE Adverse Event Report: MALEM MEDICAL UNITED KINGDOM MALEM ULTIMATE BEDWETTING ALARM; ENURESIS ALARM

Device Problem Temperature Problem (3022)

Patient Problems Pain (1994); Scar Tissue (2060); Burn, Thermal (2530)

Event Date 03/03/2018

Event Type  Injury  

Event Description

Malem bedwetting alarm is a dangerous product for children's use.My son found it turning extremely hot when he put it on his t-shirt while sleeping and had to pull it out and threw it on the ground.This alarm has left minor scars on his neck and lots of pain.This is the first time in my experience that i have found such harmful product for children.Such items need to be inspected by fda.

• Brand Name: MALEM ULTIMATE BEDWETTING ALARM
• Type of Device: ENURESIS ALARM
• Manufacturer (Section D): MALEM MEDICAL UNITED KINGDOM; UK
• MDR Report Key: 7365067
• MDR Text Key: 103347824
• Report Number: MW5075981
• 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: 03/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• 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: 29 MO