O-SPOT 791

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2018-05-02 for O-SPOT 791 manufactured by Beekley Corporation.

Event Text Entries

[107185617] A mole marker may have caused artifact on a mammogram. As a result, the mammogram was repeated.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 9021987-2018-00001
• MDR Report Key: 7481434
• Report Source: DISTRIBUTOR,FOREIGN
• Date Received: 2018-05-02
• Date of Report: 2018-06-14
• Date of Event: 2018-04-24
• Date Mfgr Received: 2018-04-24
• Device Manufacturer Date: 2018-04-03
• Date Added to Maude: 2018-05-02
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: KATE CHASE
• Manufacturer Street: 1 PRESTIGE LANE
• Manufacturer City: BRISTOL CT 06010
• Manufacturer Country: US
• Manufacturer Postal: 06010
• Manufacturer Phone: 8605834700
• Manufacturer G1: BEEKLEY CORPORATION
• Manufacturer Street: 1 PRESTIGE LANE
• Manufacturer City: BRISTOL CT 06010
• Manufacturer Country: US
• Manufacturer Postal Code: 06010
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: O-SPOT
• Generic Name: MOLE MARKER
• Product Code: JAC
• Date Received: 2018-05-02
• Model Number: 791
• Catalog Number: 791
• Lot Number: 791.04031801
• Operator: RADIOLOGIC TECHNOLOGIST
• Device Availability: *
• Device Age: DA
• Device Eval'ed by Mfgr: N
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: BEEKLEY CORPORATION
• Manufacturer Address: 1 PRESTIGE LANE BRISTOL CT 06010 US 06010

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2018-05-02