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

Model Number ULTIMATE PRO BEDWETTING ALARM

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

Patient Problems Scarring (2061); Burn, Thermal (2530)

Event Date 09/13/2019

Event Type  Injury  

Event Description

Son was sleeping with malem alarm and it malfunctioned.He was burnt on his neck skin and it left red skin scars.He has blisters from using the alarm.Completely unacceptable.Fda safety report id# (b)(4).

• Brand Name: MALEM MEDICAL BEDWETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 9082090
• MDR Text Key: 159152603
• Report Number: MW5089853
• 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: 09/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: ULTIMATE PRO BEDWETTING ALARM
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 6 YR