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

Model Number ULTIMATE BEDWETTING ALARM

Device Problems Fluid/Blood Leak (1250); Material Deformation (2976)

Patient Problems Pain (1994); Chemical Exposure (2570)

Event Date 06/26/2018

Event Type  Injury  

Event Description

A rather strange issue took place on the night of the (b)(6).My daughter wore the malem alarm and went to sleep but an hour or two later, she complained that the alarm hurt her.On investigation, i saw that the alarm batteries leaked on her neck and the alarm had deformed from excessive heat.This is a new device which was recently purchased and this was the first night it was used.

• Brand Name: MALEM ALARM CONDITIONED RESPONSE ENURESIS
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL
• MDR Report Key: 7658186
• MDR Text Key: 113169211
• Report Number: MW5078194
• 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: 06/29/2018

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?: No
• Device Operator: Lay User/Patient
• Device Model Number: ULTIMATE BEDWETTING ALARM
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/02/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 5 YR