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

Device Problems Leak/Splash (1354); Device Emits Odor (1425); Overheating of Device (1437)

Patient Problems Bruise/Contusion (1754); Pain (1994)

Event Date 04/09/2019

Event Type  Injury  

Event Description

My son is (b)(6) y/o and was diagnosed with nocturnal enuresis.His pediatrician had recommended that we use an alarm to treat the bedwetting.We purchased a malem alarm for the treatment, but the alarm has complicated matters further.Two nights ago, we used the alarm for the very first time and exactly as the user manual stated.I put my son to bed with the alarm connected on him.He came over to my room an hour later crying in pain from the alarm.He was pulling on his t-shirt.I notified that the alarm was too hot to touch.It was smelling bad and was evident that something was burning in the system.I had to pull vigorously, but the alarm would not come out his shirt.Eventually, we had to remove the clothing altogether.He was bruised by the alarm.The bruise was the result of the alarm on his skin for the 1 hour he slept.About 15 mins later, the alarm stopped heating up because the batteries leaked inside it.I was able to provide first aid treatment to my son for the bruise.Fda safety report id# (b)(4).

• Brand Name: MALEM
• Type of Device: ALARM CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD; UK
• MDR Report Key: 8518673
• MDR Text Key: 142193444
• Report Number: MW5085882
• 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: 04/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/15/2019
• 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