MAUDE Adverse Event Report: BEEKLEY CORPORATION CT-SPOT; CT SIMULATION SKIN MARKER

Catalog Number	118
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/15/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A ct simulation skin marker was used under a bolus for a ct-scan resulting in an air gap artifact.As a result, the ct-scan was repeated.

• Brand Name: CT-SPOT
• Common Device Name: CT SIMULATION SKIN MARKER
• Manufacturer (Section D): BEEKLEY CORPORATION; 1 prestige lane; bristol CT 06010
• Manufacturer (Section G): BEEKLEY CORPORATION; 1 prestige lane; bristol CT 06010
• Manufacturer Contact: kate chase ; 1 prestige lane; bristol, CT 06010 ; 8605834700
• MDR Report Key: 22939672
• Report Number: 9021987-2025-00001
• Device Sequence Number: 9893620
• Product Code: JAC
• UDI-Device Identifier: 00815137020070
• UDI-Public: 00815137020070
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/02/2025

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
• Operator of Device: Health Professional
• Device Catalogue Number: 118
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2025
• Initial Report FDA Received Date: 09/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown