MAUDE Adverse Event Report: MALEM MEDICAL UK MALEM ENURESIS BED WETTING ALARM

Model Number M04

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

Patient Problem Caustic/Chemical Burns (2549)

Event Date 02/02/2018

Event Type  Injury  

Event Description

Purchased this alarm brand new from (b)(6).It arrived in new/boxed condition and started use on my (b)(6) boy.Watched how to use videos and read the user manual.The alarm has a problem wherein it starts getting hot as soon as batteries are inserted.The alarm will not stop getting hot.At first, i thought that it perhaps was normal as the alarm unit kept warming up and put it on my boy.But an hour later, the alarm heated up like a furnace and he pulled it off.Unfortunately for us, he was burnt in the neck where the alarm was connected.The two aaa batteries that are in the alarm also leaked out and burnt him.

• Brand Name: MALEM ENURESIS BED WETTING ALARM
• Type of Device: MALEM ENURESIS BED WETTING ALARM
• Manufacturer (Section D): MALEM MEDICAL UK
• MDR Report Key: 7276086
• MDR Text Key: 100413649
• Report Number: MW5075280
• 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: 02/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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): Hospitalization
• Patient Age: 5 YR