MAUDE Adverse Event Report: MALEM MEDICAL LTD. MALEM BEDWETTING ALARM WITH 1-TONE; ALARM, CONDITIONED RESPONSE ENURESIS

Model Number M04SC

Device Problems Leak/Splash (1354); Deformation Due to Compressive Stress (2889); Electrical Shorting (2926); Temperature Problem (3022)

Patient Problem Burn, Thermal (2530)

Event Date 09/19/2018

Event Type  Injury  

Event Description

In a rather unexpected and surprising event, our dr prescribed bedwetting alarm has malfunctioned and burnt our daughter's neck.She was asleep with the alarm when this happened.We trained her to wear it and remove it in the event that she wet the bed at night.She went to bed at 9:15pm and we set it up correctly.This was the first time that the enuresis alarm was used on her.About an hour later, she came downstairs crying and said that the alarm had burnt her neck and left a small red scar.We noticed that when we sent back to the room that the alarm had indeed burnt her and it had also dissipated so much heat that the plastic structure which contains the batteries had changed shape.It was bulging outwards from heat.The only safe thing to do was to hold it with a towel and remove the batteries.On doing this, i noticed that the batteries had shorted out and leaked into the alarm.This is only possible from an electrical defect in the system in my opinion.My daughter was given a warm water soak followed by ointment and the next day we met with her dr and gave the alarm to him.He advised us to report the matter on the fda's website.

• Brand Name: MALEM BEDWETTING ALARM WITH 1-TONE
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 7909929
• MDR Text Key: 121854541
• Report Number: MW5080091
• Device Sequence Number: 1
• Product Code: KPN
• Combination Product (y/n): N
• Reporter Country Code: GT
• 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: 09/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2018
• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: M04SC
• Was Device Available for Evaluation?: No
• 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