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

Model Number ULTIMATE BEDWETTING ALARM

Device Problems Thermal Decomposition of Device (1071); Overheating of Device (1437); Material Twisted/Bent (2981)

Patient Problem Burning Sensation (2146)

Event Date 06/11/2019

Event Type  Injury  

Event Description

My son was asleep with his bedwetting alarm.This was the first night he slept with it and the alarm has acted strange, overheated and injured him in his sleep.This is surprising because i did not expect the alarm to become so hot, considering that it uses 2 batteries, but it did.He's older and he removed the alarm on time as soon as he felt his skin burning.The alarm was burning as the plastic case is bent from heat.Fda safety report id# (b)(4).

• Brand Name: MALEM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD. ; UK
• MDR Report Key: 8707728
• MDR Text Key: 148455327
• Report Number: MW5087417
• 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: 06/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ULTIMATE BEDWETTING ALARM
• Device Catalogue Number: M04SB - ROYAL BLUE
• Was Device Available for Evaluation?: Yes
• 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