MAUDE Adverse Event Report: BOVIE MEDICAL CORP. BOVIE MEDICAL; GENERATOR

Model Number A1250U

Device Problem Insufficient Information (3190)

Patient Problem Burn(s) (1757)

Event Type  malfunction  

Manufacturer Narrative

We are continuing to reach out to the complainant for additional information.If additional information is obtained that is pertinent to the investigation or provides additional details a follow-up report will be provided.

Event Description

Per the complainant, "patients are receiving burns with operating with the a1250u unit".

• Brand Name: BOVIE MEDICAL
• Type of Device: GENERATOR
• Manufacturer (Section D): BOVIE MEDICAL CORP.; 5115 ulmerton road; clearwater FL 33760
• Manufacturer (Section G): BOVIE MEDICAL CORP.; 5115 ulmerton ave.; clearwater FL 33760
• Manufacturer Contact: steven fox ; 3034 owen drive; antioch, TN 37013
• MDR Report Key: 18699826
• MDR Text Key: 336424753
• Report Number: 3007208013-2024-00004
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K001955
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: A1250U
• Date Manufacturer Received: 01/18/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1