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

Model Number	651
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/09/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A palpable mass marker fell off during a mammogram.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
• Manufacturer (Section G): BEEKLEY CORPORATION; 1 prestige lane; bristol CT 06010
• Manufacturer Contact: kate chase ; 1 prestige lane; bristol, CT 06010 ; 8605834700
• MDR Report Key: 25596309
• Report Number: 9021987-2026-00003
• Device Sequence Number: 5442985
• Product Code: JAC
• UDI-Device Identifier: 00815137020384
• UDI-Public: (01)00815137020384(10)651.26000113
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/23/2026

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: 651
• Device Catalogue Number: 651
• Device Lot Number: 651.26000113
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/09/2026
• Initial Report FDA Received Date: 06/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/07/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown