MAUDE Adverse Event Report: BEEKLEY CORPORATION O-SPOT; MOLE MARKER

Model Number	791
Health Effect - Clinical Code	No Information (3190)
Date of Event	04/24/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
A mole marker may have caused artifact on a mammogram.As a result, the mammogram was repeated.
Event or Problem Description
A mole marker caused artifact on a mammogram.As a result, the mammogram was repeated.

• Brand Name: O-SPOT
• Common Device Name: MOLE MARKER
• Manufacturer (Section D): BEEKLEY CORPORATION; 1 prestige lane; bristol CT 06010
• MDR Report Key: 7481434
• Report Number: 9021987-2018-00001
• Device Sequence Number: 16570229
• Product Code: JAC
• UDI-Device Identifier: 00815137020551
• UDI-Public: 00815137020551
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 06/14/2018

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: 791
• Device Catalogue Number: 791
• Device Lot Number: 791.04031801
• Initial Date Received by Manufacturer: 04/24/2018
• Supplement Date Received by Manufacturer: 04/24/2018
• Initial Report FDA Received Date: 05/02/2018
• Supplement Report FDA Received Date: 06/14/2018
• 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