MAUDE Adverse Event Report: MALEM MEDICAL MALEM MEDICAL BEDWETTING ALARM

Model Number BLUE ONE TONE

Device Problems Burst Container or Vessel (1074); Leak/Splash (1354); Electrical Shorting (2926)

Patient Problems Burn, Thermal (2530); Chemical Exposure (2570)

Event Date 10/28/2017

Event Type  Injury  

Event Description

I would like to report that the malem medical bedwetting alarm has malfunctioned.The alarm was used by my (b)(6) son and the alarm somehow shorted out at night and exploded.The batteries leaked from the alarm unit on to my son's skin - neck and chest.This report was done at the request of the pediatrician who is treating my son.The alarm was given to the pediatrician who will also report to the fda.

• Brand Name: MALEM MEDICAL BEDWETTING ALARM
• Type of Device: BEDWETTING ALARM
• Manufacturer (Section D): MALEM MEDICAL
• MDR Report Key: 6993386
• MDR Text Key: 90851962
• Report Number: MW5073059
• 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: 10/29/2017

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: BLUE ONE TONE
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/01/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 6 YR