MAUDE Adverse Event Report: MALEM MEDICAL, LTD. MALEM; ENURESIS ALARM

Model Number MO4SECB

Device Problems Fluid/Blood Leak (1250); Temperature Problem (3022); Noise, Audible (3273)

Patient Problem Burn, Thermal (2530)

Event Date 04/02/2018

Event Type  Injury  

Event Description

Son is (b)(6) and was prescribed an "enuresis alarm." i purchased it at (b)(6) and a brand new one was determined in sealed condition.Per the instructions, the alarm portion is put close to child's neck and sensor is to be put outside the underwear.This seemed straightforward and simple, but upon inserting batteries, the alarm portion makes a hissing noise like something was stuck inside the alarm.My son was wearing it and awake when he complained of heat and wetness from the alarm portion.On inspection, the alarm had malfunctioned and the two batteries that are inside the alarm had leaked out.I removed the alarm and realized that the alarm was extremely hot and could not be handled by hand.The battery leak was substantial and had spread on his clothing.Heat from the alarm and battery leak had burnt him and he has small red blisters where the alarm was connected.The alarm has been returned to (b)(6).

• Brand Name: MALEM
• Type of Device: ENURESIS ALARM
• Manufacturer (Section D): MALEM MEDICAL, LTD. ; lowdham, nottingham NG14 7EJ; UK NG14 7EJ
• MDR Report Key: 7471882
• MDR Text Key: 106896534
• Report Number: MW5076817
• 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: 04/10/2018

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?: Yes
• Device Operator: Health Professional
• Device Model Number: MO4SECB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/27/2018
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 6 YR
• Patient Weight: 25