MAUDE Adverse Event Report: MALEM MEDICAL MALEM BEDWETTING ALARM

Model Number MO4S2

Device Problems Overheating of Device (1437); Fumes or Vapors (2529)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/26/2016

Event Type  malfunction  

Event Description

At night during first night of use, the product overheated and fumes started coming out of the battery door.The product was clipped at my child's neck line and this could have caused a two-fold damage.First it could have hurt my child from overheating, secondly, the fumes could have caused breathing problem.

• Brand Name: MALEM BEDWETTING ALARM
• Type of Device: MALEM BEDWETTING ALARM
• Manufacturer (Section D): MALEM MEDICAL
• MDR Report Key: 6217842
• MDR Text Key: 63817301
• Report Number: MW5066999
• Device Sequence Number: 1
• Product Code: KPN
• 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: 12/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2016
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MO4S2
• Was Device Available for Evaluation?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 8 YR
• Patient Weight: 31