MAUDE Adverse Event Report: BEEKLEY CORPORATION TOMOSPOT; PALPABLE MASS MARKER

Model Number	784
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/29/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Tomospot lot 784.05231801 was part of recall 9021987-6/14/18-001-r.
Event or Problem Description
A palpable mass marker caused artifact on a mammogram.As a result, the mammogram was repeated.

• Brand Name: TOMOSPOT
• Common Device Name: PALPABLE MASS MARKER
• Manufacturer (Section D): BEEKLEY CORPORATION; 1 prestige lane; bristol CT 06010
• MDR Report Key: 9330391
• Report Number: 9021987-2019-00004
• Device Sequence Number: 2498282
• Product Code: JAC
• UDI-Device Identifier: 00815137020513
• UDI-Public: 00815137020513
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 11/15/2019

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: 784
• Device Catalogue Number: 784
• Device Lot Number: 784.05231801
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2019
• Initial Report FDA Received Date: 11/15/2019
• 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