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

Model Number	118
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	07/11/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
A ct-spot may have caused artifact on a patient's ct scan.As a result, the ct scan was repeated.

• Brand Name: CT-SPOT
• Common Device Name: CT SIMULATION SKIN MARKERS
• Manufacturer (Section D): BEEKLEY CORPORATION; 1 prestige lane; bristol CT 06010
• MDR Report Key: 8808172
• Report Number: 9021987-2019-00002
• Device Sequence Number: 16224887
• Product Code: JAC
• UDI-Device Identifier: 00815137020070
• UDI-Public: 00815137020070
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (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): 07/19/2019

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 Model Number: 118
• Device Catalogue Number: 118
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2019
• Initial Report FDA Received Date: 07/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other