MAUDE Adverse Event Report: MALEM MEDICAL LTD. MALEM ; ALARM, CONDITIONED RESPONSE ENURESIS

Model Number ULTIMATE PRO BEDWETTING ALARM

Device Problems Overheating of Device (1437); Defective Device (2588)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/08/2019

Event Type  Injury  

Event Description

As a nurse, i am familiar with how bedwetting alarms work.This enuresis alarm was purchased for my daughter, but it is defective.It only takes a few mins after i insert batteries for the alarm to overheat making if unstable and dangerous.This is not normal.The outer casing of the alarm reaches high temperature making is unusable and too hot for skin contact.Batteries need to be removed for normal operation.Tried and tested with different batteries and same response.Unusable as is.Fda safety report id# (b)(4).

• Brand Name: MALEM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 9459547
• MDR Text Key: 170665834
• Report Number: MW5091618
• 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: 12/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ULTIMATE PRO BEDWETTING ALARM
• Device Catalogue Number: BLUE WITH 8 TONES
• Device Lot Number: MISSING
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• 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 Outcome(s): Required Intervention
• Patient Weight: 22