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

Catalog Number 8442000

Device Problem Insufficient Information (3190)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/17/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Customer alleged that small flames came from the accu-temp cautery device.There were no reports of patient or user injury for this event.

• Brand Name: ACCU-TEMP
• 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: 13848104
• MDR Text Key: 287906745
• Report Number: 1211998-2022-00027
• Device Sequence Number: 1
• Product Code: HQP
• Combination Product (y/n): Y
• Reporter Country Code: BE
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 8442000
• Device Lot Number: 6031066
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1