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

Model Number M04

Device Problems Leak/Splash (1354); Temperature Problem (3022)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/25/2018

Event Type  Injury  

Event Description

Our daughter's enuresis alarm was a defect.It was operating as expected till about an hour earlier.When i checked on her, i noticed that the alarm seemed very hot.My daughter was asleep.Fortunately there was a thick blanket her and the alarm.I immediately removed it from her neck and put it on the side of the bed.Within a few minutes, it seemed to be fine.On inspection i saw that the enuresis alarm has become very hot and the batteries leaked out from the intense heat generated.This could have been dangerous for my daughter had i not checked on her.The alarm was new and ordered only a week ago.

• Brand Name: MALEM ONE TONE ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD
• MDR Report Key: 7918577
• MDR Text Key: 122160078
• Report Number: MW5080182
• 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: 09/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2018
• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: M04
• 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: 7 YR
• Patient Weight: 24