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

Model Number 8442000

Device Problem Fire (1245)

Patient Problem Eye Burn (2523)

Event Date 03/31/2023

Event Type  Injury  

Event 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
• Type of Device: 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
• MDR Text Key: 314259606
• Report Number: 1211998-2023-00017
• Device Sequence Number: 1
• Product Code: HQP
• UDI-Device Identifier: 30886158010266
• UDI-Public: 30886158010266
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: 04/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2023
• 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
• Date Manufacturer Received: 03/31/2023
• Patient Sequence Number: 1