MAUDE Adverse Event Report: BEAVER-VISITEC INTERNATIONAL, INC. WET-FIELD; ACCU-TEMP® CAUTERY, HIGH TEMP, 0.5'' LOOP TIP,

Model Number	8442000
Medical Device Problem Code	Fire (1245)
Health Effect - Clinical Code	Eye Burn (2523)
Date of Event	03/31/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A customer reported "using the cautery, a flame was created that burned the patient's eyelashes." no medical intervention was reported.

• Brand Name: WET-FIELD
• Common Device Name: ACCU-TEMP® CAUTERY, HIGH TEMP, 0.5'' LOOP TIP,
• 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
• MDR Report Key: 16840373
• Report Number: 1211998-2023-00017
• Device Sequence Number: 7546953
• Product Code: HQP
• UDI-Device Identifier: 30886158010266
• UDI-Public: 30886158010266
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/28/2023

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 Model Number: 8442000
• Device Catalogue Number: 8442000
• Device Lot Number: 6031066
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/31/2023
• Initial Report FDA Received Date: 04/28/2023
• Patient Sequence Number: 1
• Patient Sex: Unknown