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

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

Patient Problem Emotional Changes (1831)

Event Date 08/10/2019

Event Type  Injury  

Event Description

Although used for only 3 nights, the alarm has been nothing more than a problem.It is faulty, defective and outright dangerous.The first night, my son (who has the bedwetting problem) used it with anticipation of helping him overcome bedwetting.The morning he was soaking in urine, but the alarm did not alert us.He said that 30 mins into using it, he felt it as hot as an iron rod against his neck, so he removed it.I tested it but that did not happen.I barely tested it for 2 mins by inserting sensor and putting water on sensor.The retried the next night and he complained of the same issue.So, i retried the next night, same result.Finally, i slept with him on the third night and made sure the alarm was pinned correctly.It was a complete disaster for us.The alarm started to smell bad at night and i woke up.My son was crying and said the alarm injured him.The alarm was hot, i immediately pulled it off and placed it outside the door afraid it would burst from heat.My son was luckily not hurt, but scared, traumatized and so am i.This little alarm is so dangerous.I can't use another such device again for bedwetting treatment.Fda safety report id# (b)(4).

• Brand Name: MALEM
• Type of Device: ENURESIS ALARM
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 8907414
• MDR Text Key: 155041478
• Report Number: MW5089149
• 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: 08/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2019
• 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): Other; Required Intervention
• Patient Age: 7 YR