MAUDE Adverse Event Report: MALEM MEDICAL (BEDWETTING STORE) MALEM ENURESIS ALARM; MALEM BEDWETING ALARM

Model Number MO4S2

Device Problems Thermal Decomposition of Device (1071); Melted (1385); Overheating of Device (1437); Expulsion (2933)

Patient Problem Superficial (First Degree) Burn (2685)

Event Date 12/15/2016

Event Type  Injury  

Event Description

I prescribed a nocturnal enuresis alarm for a (b)(6) female pt 3 weeks ago.The parent purchased and used the same.On the second night, i was informed that the child has to be admitted to the emergency room.The nocturnal enuresis alarm had exploded and damaged the subjects skin.The alarm had over heated, malfunctioned and melted on the child's chest causing first degree burns and permanent scarring.

• Brand Name: MALEM ENURESIS ALARM
• Type of Device: MALEM BEDWETING ALARM
• Manufacturer (Section D): MALEM MEDICAL (BEDWETTING STORE) ; fulton MD 20759
• MDR Report Key: 6185982
• MDR Text Key: 62745547
• Report Number: MW5066779
• Device Sequence Number: 1
• Product Code: KPN
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/16/2016

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
• Device Model Number: MO4S2
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/16/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 6 YR