MAUDE Adverse Event Report: BEAVER-VISITEC INTERNATIONAL, INC.; ACCU-TEMP® CAUTERY

Device Problem Fire (1245)

Patient Problem Burn(s) (1757)

Event Date 04/08/2021

Event Type  Injury  

Event Description

Bvi received a complaint alleging first and/or second degree burns to face, neck, upper chest and right shoulder, in addition to episodes of increased blood pressure.The complaint did not disclose the catalog or lot number of the device associated.

Manufacturer Narrative

This complaint was received with out the part number and lot number and for that reason does not have an associated udi number.

• Type of Device: ACCU-TEMP® CAUTERY
• 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: 17194809
• MDR Text Key: 317785725
• Report Number: 1211998-2023-00050
• Device Sequence Number: 1
• Product Code: HQP
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/23/2023

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
• Initial Date Manufacturer Received: 06/13/2023
• Initial Date FDA Received: 06/23/2023
• Patient Sequence Number: 1
• Patient Outcome(s): Other