MAUDE Adverse Event Report: MALEM MEDICAL MALEM; ALARM, CONDITIONED RESPONSE ENURESIS

Model Number M05

Device Problems Leak/Splash (1354); Overheating of Device (1437); Material Twisted/Bent (2981)

Patient Problems Burn, Thermal (2530); Partial thickness (Second Degree) Burn (2694)

Event Date 03/19/2019

Event Type  Injury  

Event Description

Alarm has never operated correctly or safely since the day it was purchased.At 9pm, son went to sleep and alarm was attached on him.The sensor was placed outside underwear.At 9:40pm son was crying and complaining of burning feeling on skin.The batteries leaked inside the alarm and bent the door outward from heat.Battery spilled on his neck and clothing.I administered first aid, but a bit late.He has some big blisters on the neck where alarm was touching his neck.Fda safety report id# (b)(4).

• Brand Name: MALEM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL
• MDR Report Key: 8478780
• MDR Text Key: 140871221
• Report Number: MW5085521
• 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: 03/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: M05
• 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): Disability
• Patient Age: 4 YR