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

Catalog Number 8442000

Device Problem Fire (1245)

Patient Problem Burn(s) (1757)

Event Date 06/08/2022

Event Type  Injury  

Event 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
• Type of Device: 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
• MDR Text Key: 320089915
• Report Number: 1211998-2023-00053
• Device Sequence Number: 1
• Product Code: HQP
• UDI-Device Identifier: 30886158010266
• UDI-Public: 30886158010266
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 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
• Initial Date Manufacturer Received: 07/20/2023
• Initial Date FDA Received: 07/31/2023
• Patient Sequence Number: 1
• Patient Outcome(s): Other