MAUDE Adverse Event Report: MALEM MEDICAL MALEM ULTIMATE SELECTABLE BEDWETTING ALARM; ALARM CONDITION RESPONSE ENURESIS

Device Problems Overheating of Device (1437); Loss of Power (1475); Defective Component (2292)

Patient Problem No Information (3190)

Event Date 07/25/2018

Event Type  malfunction  

Event Description

My son has nocturnal enuresis and we were prescribed an enuresis alarm for him by his pediatrician.The alarm we purchased was the malem ultimate selectable bedwetting alarm.It does not work as advertised.The alarm randomly powers on and off and gets hot and then powers off.After a few minutes when it has cooled down a bit, it starts to operate again and gets hot.This is an erratic product operation which is in error and a medical device defect.When hot, the alarm is sufficiently hot to burn skin it is in contact with.

• Brand Name: MALEM ULTIMATE SELECTABLE BEDWETTING ALARM
• Type of Device: ALARM CONDITION RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL; nottingham ; UK
• MDR Report Key: 7738797
• MDR Text Key: 115779026
• Report Number: MW5078711
• 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: Pharmacist
• Type of Report: Initial
• Report Date: 07/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/31/2018
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 6 YR
• Patient Weight: 24