MAUDE Adverse Event Report: BEEKLEY CORPORATION A-SPOT; PALPABLE MASS MARKER

Model Number	651
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/12/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The customer notified beekley of the product issue on (b)(6) 2018.However, the customer confirmed that a patient had their mammogram repeated due to the product issue on (b)(6) 2018.
Event or Problem Description
The imaging component of the a-spot palpable mass marker separated from the adhesive component and therefore did not show up on the mammogram image.As a result, the mammogram was repeated.

• Brand Name: A-SPOT
• Common Device Name: PALPABLE MASS MARKER
• Manufacturer (Section D): BEEKLEY CORPORATION; 1 prestige lane; bristol CT 06010
• MDR Report Key: 7992331
• Report Number: 9021987-2018-00005
• Device Sequence Number: 13835638
• Product Code: JAC
• UDI-Device Identifier: 00815137020384
• UDI-Public: 00815137020384
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 10/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 651
• Device Catalogue Number: 651
• Device Lot Number: 651.06151601
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/08/2018
• Initial Report FDA Received Date: 10/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 0
• Outcome Attributed to Adverse Event: Other