MAUDE Adverse Event Report: BEEKLEY CORPORATION TOMOSPOT; SCAR MARKER

Model Number	783
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/18/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
A scar marker fell off a patient during a mammogram.As a result, the mammogram was repeated.

• Brand Name: TOMOSPOT
• Common Device Name: SCAR MARKER
• Manufacturer (Section D): BEEKLEY CORPORATION; 1 prestige lane; bristol CT 06010
• MDR Report Key: 8582000
• Report Number: 9021987-2019-00001
• Device Sequence Number: 19286635
• Product Code: JAC
• UDI-Device Identifier: 00815137020506
• UDI-Public: 00815137020506
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 05/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 783
• Device Catalogue Number: 783
• Device Lot Number: 783.03221901
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2019
• Initial Report FDA Received Date: 05/06/2019
• 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