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

Model Number 04

Device Problems Overheating of Device (1437); Defective Component (2292)

Patient Problem Burn, Thermal (2530)

Event Date 03/18/2019

Event Type  Injury  

Event Description

The bedwetting alarm has malfunction and burnt my son.He was sleeping and i connected the alarm on him.The instructions required that i connect the alarm on his neck but he was uncomfortable, so i connected it on his waist on his pant.But he was shouting in about an hour of use.He said the alarm was hot and burning his body.I checked and it was the case.The alarm was super hot and i could not hold it in my hand either.My poor son has small red burn marks on his waist and he is scared to use this alarm.

• Brand Name: ULTIMATE BEDWETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 8452838
• MDR Text Key: 140120155
• Report Number: MW5085164
• 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: 03/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 04
• Device Catalogue Number: M
• Was Device Available for Evaluation?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 6 YR