MAUDE Adverse Event Report: MALEM MALEM ENURESIS ALARM

Device Problems Fluid/Blood Leak (1250); Material Deformation (2976)

Patient Problem Superficial (First Degree) Burn (2685)

Event Date 09/18/2017

Event Type  Injury  

Event Description

This is the first adverse event in our clinic.A patient came in with her (b)(6) son who had used a bedwetting alarm at night.The child had been burnt from hot battery leaks on neck, chest and hands.The battery door that houses the alarm had deformed from heat.The child was treated for burns and discharged.The child has suffered first degree burns.

• Brand Name: MALEM ENURESIS ALARM
• Type of Device: ENURESIS ALARM
• Manufacturer (Section D): MALEM
• MDR Report Key: 6910666
• MDR Text Key: 88127847
• Report Number: MW5072558
• 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: Nurse
• Type of Report: Initial
• Report Date: 09/29/2017

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: No Information
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/03/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 7 YR
• Patient Weight: 27