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

Model Number ULTIMATE ALARM

Device Problems Fluid/Blood Leak (1250); Overheating of Device (1437)

Patient Problem Burn, Thermal (2530)

Event Date 05/19/2020

Event Type  Injury  

Event Description

First night of use, the alarm overheated and caused injury to my son while he was sleeping.He has sustained burns on skin from hot alarm.When i checked, the alarm had leaked batteries and did not work after that.Just too dangerous to cause burns on child in their sleep.Fda safety report id #: (b)(4).

• Brand Name: BED WETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 10104928
• MDR Text Key: 194025988
• Report Number: MW5094758
• 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: 05/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: ULTIMATE 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