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

Device Problems Overheating of Device (1437); Difficult to Remove (1528)

Patient Problems Emotional Changes (1831); Burning Sensation (2146)

Event Date 07/02/2019

Event Type  Injury  

Event Description

First night gave my child a massive scare which took a long time to calm him down, and then he was afraid of it.The alarm was overheating at night when it detected urine and he couldn't turn it off.When i arrived to the room, it was buzzing and even i had a very hard time to remove the cable to finally get it to stop.It was extremely hot and i could swear i burnt my fingers pulling it from his body and clothing.I cannot possibly try this alarm on him again.In fact, we can't even imagine using another alarm for his problem.This is a scare and worrisome issue for us.Defective alarm could have caused serious injuries.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: 8793525
• MDR Text Key: 151308708
• Report Number: MW5088135
• Device Sequence Number: 0
• 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
• Type of Report: Initial
• Report Date: 07/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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 Age: 5 YR