MAUDE Adverse Event Report: MALEM MEDICAL MALEM ULTIMATE BED WETTING ALARM; ALARM CONDITION RESPONSE ENURESIS

Model Number M04SC

Device Problems Overheating of Device (1437); Failure to Read Input Signal (1581)

Patient Problem Burn, Thermal (2530)

Event Type  Injury  

Event Description

My son has a big red patch where the bedwetting alarm was connected on his neck.For some strange reason, the alarm got very hot under normal use at night when he was asleep.He was crying frantically and i noticed that the alarm had just burnt him.The only way to shut it off was to remove the batteries from the alarm.The heat that this alarm generated was extremely high and burnt a child's skin.

• Brand Name: MALEM ULTIMATE BED WETTING ALARM
• Type of Device: ALARM CONDITION RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL
• MDR Report Key: 7663409
• MDR Text Key: 113289495
• Report Number: MW5078231
• 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: 07/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Model Number: M04SC
• Device Catalogue Number: CAMOUFLAGE
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/03/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 6 YR
• Patient Weight: 24