MAUDE Adverse Event Report: MALEM MEDICAL UK MALEM ENURESIS ALARM; BED-WETTING ALARM

Model Number M04

Device Problems Melted (1385); Overheating of Device (1437)

Patient Problem Burn(s) (1757)

Event Date 11/24/2015

Event Type  Injury  

Event Description

The enuresis alarm overheated and the plastic housing at the back of the alarm which houses the electronics melted.The alarm is connected at patients neckline and left burn marks on patients neck.Dates of use: (b)(6) 2015.Diagnosis or reason for use: patient suffers from primary nocturnal enuresis.(b)(6).

• Brand Name: MALEM ENURESIS ALARM
• Type of Device: BED-WETTING ALARM
• Manufacturer (Section D): MALEM MEDICAL UK; nottingham, gb
• MDR Report Key: 5263950
• MDR Text Key: 32666596
• Report Number: MW5058261
• Device Sequence Number: 1
• Product Code: KPN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: M04
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 6 YR
• Patient Weight: 20