MAUDE Adverse Event Report: MALEM MEDICAL MALEM ULTIMATE BEDWETTING ALARM; ENURESIS ALARM

Device Problems Leak/Splash (1354); Overheating of Device (1437); Chemical Spillage (2894)

Patient Problem Chemical Exposure (2570)

Event Date 09/23/2017

Event Type  Injury  

Event Description

My son went to bed about an hour ago with his bedwetting alarm.The alarm has over heated and the batteries have leaked out of the alarm.The alarm is very hot and the battery door that houses the batteries has curved inwards from the heat.The dark black and gray battery acid has spilled on his clothing and his neck.I happened to check on him when that happened and i am fortunate that it didn't cause any more damage.This could have been extremely harmful if not detected early.Pink color.

• Brand Name: MALEM ULTIMATE BEDWETTING ALARM
• Type of Device: ENURESIS ALARM
• Manufacturer (Section D): MALEM MEDICAL
• MDR Report Key: 6893728
• MDR Text Key: 87461857
• Report Number: MW5072413
• 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: 09/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• 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: 5 YR