MAUDE Adverse Event Report: BOVIE MEDICAL CORP. BOVIE MEDICAL; SUCTION COAGULATOR

Model Number	SCH10
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Burn(s) (1757); Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complaint was unable to be confirmed at this time as the end user remained unresponsive to questions, picture/return of product requests.True root cause is unable to be determined with accuracy at this time.If additional information is obtained that is pertinent to the investigation or provides additional details a follow-up report will be provided.Until such time, this can be seen as the final report.
Event or Problem Description
The complainant alleges, "i am contacting you to notify you of an incident in which a customer was burned using item#sch10.".
Additional Manufacturer Narrative
Awaiting additional information and/or return of the reported device to complete the investigation.
Event or Problem Description
The complainant alleges, "i am contacting you to notify you of an incident in which a customer was burned using item#sch10.".

• Brand Name: BOVIE MEDICAL
• Common Device Name: SUCTION COAGULATOR
• Manufacturer (Section D): BOVIE MEDICAL CORP.; 5115 ulmerton road; clearwater FL 33760
• Manufacturer (Section G): BOVIE MEDICAL CORP.; 5115 ulmerton road; clearwater FL 33760
• Manufacturer Contact: steven fox ; 3034 owen drive; antioch, TN 37013
• MDR Report Key: 20073171
• Report Number: 3007208013-2024-00044
• Device Sequence Number: 2998057
• Product Code: GEI
• UDI-Device Identifier: 00607151006532
• UDI-Public: 00607151006532
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K033003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2024

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?: No
• Device Model Number: SCH10
• Device Lot Number: 230806117
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2024
• Supplement Date Received by Manufacturer: 08/01/2024
• Initial Report FDA Received Date: 08/27/2024
• Supplement Report FDA Received Date: 09/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown