MAUDE Adverse Event Report: MERIT MEDICAL - ALISO VIEJO SCOUT; MARKER, RADIOGRAPHIC, IMPLANTABLE

Model Number	SSR75-01
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	07/05/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device was not returned for evaluation.The complaint could not be confirmed.The root cause could not be determined.A review of the device history and complaint database could not be performed since the lot number was not provided.
Event or Problem Description
On april 6, 2021, a merit employee conducted a cer literature search for the scout product family.The study (see citation below) reports adverse events related to the savi scout radar.One event alleges that a patient developed an infection after placement of a scout reflector.Study: srour, marissa k., sungjin kim, farin amersi, armando e.Giuliano, and alice chung."comparison of wire localization, radioactive seed, and savi scout® radar for management of surgical breast disease." the breast journal 26, no.3 (2020): 406-413.

• Brand Name: SCOUT
• Common Device Name: MARKER, RADIOGRAPHIC, IMPLANTABLE
• Manufacturer (Section D): MERIT MEDICAL - ALISO VIEJO; 6 journey unit 125; aliso viejo CA 92656
• MDR Report Key: 12160290
• Report Number: 2032338-2021-00010
• Device Sequence Number: 3490765
• Product Code: NEU
• UDI-Device Identifier: 00852205006024
• UDI-Public: 00852205006024
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K181007
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: literature
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/06/2021

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: SSR75-01
• Device Catalogue Number: SSR75-01
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/06/2021
• Initial Report FDA Received Date: 07/13/2021
• 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: Required Intervention