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

Model Number MO4

Device Problems Leak/Splash (1354); Temperature Problem (3022)

Patient Problem Chemical Exposure (2570)

Event Date 11/13/2017

Event Type  Injury  

Event Description

This was the first attempt to use our bedwetting alarm.It was placed correctly with batteries, and the sensor was clipped outside my son's underwear.The alarm unit got very hot.So hot that was could feel the heat and could not even touch it.The batteries were also hot.I smelt a burning smell coming from the alarm and that is when i opened the battery door to remove the batteries since this product has no on/off switch.The batteries were leaking inside the alarm and as soon as i opened the battery door, the battery acid spilled out on to my hands.This could have burnt my son if he were asleep at night.I am fortunate that this happened within 5 minutes of setting it up or he would be in the hospital tonight.

• Brand Name: BEDWETTING ALARM
• Type of Device: ENURESIS ALARM
• Manufacturer (Section D): MALEM MEDICAL
• MDR Report Key: 7037435
• MDR Text Key: 92290870
• Report Number: MW5073340
• 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: 11/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MO4
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/16/2017
• 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