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

Model Number BEDWETTING ALARM

Device Problems Device Emits Odor (1425); Overheating of Device (1437)

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

Event Date 09/14/2019

Event Type  Injury  

Event Description

First night the malem alarm is being used and it's behaving abnormally.Too hot, i thought we did something wrong.I replaced the batteries, but it did not help either.Alarm is just inoperable the way it is.Way too hot.I worry that it will catch fire, it's so hot.I removed the batteries and it's now useless.Not to mention the bad burning smell that comes from the alarm once it heats up.Fda safety report id# (b)(4).

• Brand Name: MALEM ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 9082314
• MDR Text Key: 159152408
• Report Number: MW5089859
• 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?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 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: 5 YR