MAUDE Adverse Event Report: BEAVER-VISITEC INTERNATIONAL, INC. WET-FIELD; BVI, ACCU-TEMP HIGH TEMPERATURE CAUTERY BX/10

Catalog Number	8442000
Medical Device Problem Code	Fire (1245)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	06/08/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
A customer alleged that a fire was ignited by the cautery.While oxygen was being used and the drape appears to have caught on fire burning the patienst face.

• Brand Name: WET-FIELD
• Common Device Name: BVI, ACCU-TEMP HIGH TEMPERATURE CAUTERY BX/10
• Manufacturer (Section D): BEAVER-VISITEC INTERNATIONAL, INC.; 500 totten pond rd; 10 citypoint; waltham MA 02451
• Manufacturer (Section G): BEAVER-VISITEC INTERNATIONAL, INC.; 500 totten pond rd; 10 citypoint; waltham MA 02451
• Manufacturer Contact: aminah crawford ; 500 totten pond rd; 10 citypoint; waltham, MA 02451 ; 7815306377
• MDR Report Key: 17430485
• Report Number: 1211998-2023-00053
• Device Sequence Number: 2709664
• Product Code: HQP
• UDI-Device Identifier: 30886158010266
• UDI-Public: 30886158010266
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/28/2023

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 Catalogue Number: 8442000
• Device Lot Number: 6031864
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/20/2023
• Initial Report FDA Received Date: 07/31/2023
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown