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

Model Number PRO

Device Problem Overheating of Device (1437)

Patient Problems Burn(s) (1757); Pain (1994)

Event Date 07/25/2019

Event Type  Injury  

Event Description

The dr in our clinic prescribed an electronic enuresis alarm for pt who suffers from chronic incontinence.Pt is immobile and needs medical attention.The pt's purchased malem enuresis alarm (pro) model to detect urine leaks.Child was wearing alarm and awake when incident occurred.It was the first use case of the device.Within less than an hour, system developed a flaw which caused the temperature to rise significantly, causing child's skin to burn.She was awake and in pain from burns.Pt was brought back to clinic.The injuries are the result of extreme heat and hot plastic touching pt's skin.Burns have been treated and pt has returned home.Fda safety report id# (b)(4).

• Brand Name: MALEM ENURESIS ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 8915497
• MDR Text Key: 155195602
• Report Number: MW5089207
• 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: Nurse Practitioner
• Type of Report: Initial
• Report Date: 08/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: PRO
• 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): Other
• Patient Age: 4 YR