MAUDE Adverse Event Report: BEEKLEY CORPORATION TOMOSPOT; MOLE MARKER

Model Number	782
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	06/26/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
A mole marker caused artifact on a mammogram.As a result, the mammogram was repeated.

• Brand Name: TOMOSPOT
• Common Device Name: MOLE MARKER
• Manufacturer (Section D): BEEKLEY CORPORATION; 1 prestige lane; bristol CT 06010
• MDR Report Key: 7660244
• Report Number: 9021987-2018-00003
• Device Sequence Number: 16189039
• Product Code: JAC
• UDI-Device Identifier: 00815137020490
• UDI-Public: 00815137020490
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Health Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 07/03/2018

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: Radiologic Technologist
• Device Model Number: 782
• Device Catalogue Number: 782
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2018
• Initial Report FDA Received Date: 07/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 9021987-6/14/18-001-R
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other