MAUDE Adverse Event Report: MALEM MEDICAL MALEM ENURESIS ALARM

Device Problems Fire (1245); Overheating of Device (1437)

Patient Problem Burn(s) (1757)

Event Date 08/29/2016

Event Type  Injury  

Event Description

Product overheated and caught fire.Burnt my child's neck.Had to be rushed to the hospital.

• Brand Name: MALEM ENURESIS ALARM
• Type of Device: MALEM ENURESIS ALARM
• Manufacturer (Section D): MALEM MEDICAL
• MDR Report Key: 5935363
• MDR Text Key: 54154345
• Report Number: MW5064582
• Device Sequence Number: 1
• Product Code: KPN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 09/03/2016

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: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/03/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 3 YR