MAUDE Adverse Event Report: MALEM BEDWETTING ALARMS; ALARM, RESPONSE ENURESIS

Model Number M04

Device Problems Burst Container or Vessel (1074); Corroded (1131); Leak/Splash (1354); Overheating of Device (1437); Device Displays Incorrect Message (2591)

Patient Problem Chemical Exposure (2570)

Event Date 03/09/2018

Event Type  Injury  

Event Description

Son's malem bedwetting alarm has suddenly malfunctioned.The batteries burst within the alarm unit and leaked on to my son's clothing.This is extremely dangerous.Fortunately, we were all with him when it happened.I noticed a black battery substance leaking out of the alarm when this happened and pulled out the alarm.It was not warm, but very hot to touch.I also removed the batteries which had corroded.

• Brand Name: BEDWETTING ALARMS
• Type of Device: ALARM, RESPONSE ENURESIS
• Manufacturer (Section D): MALEM
• MDR Report Key: 7334097
• MDR Text Key: 102319986
• Report Number: MW5075807
• 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: 03/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: M04
• Device Catalogue Number: BLUE COLOR
• 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: 6 YR