MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS SCOUT®; Marker, Radiographic, Implantable

Catalog Number	SSR75S-01/Q
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/03/2026
Type of Reportable Event	Malfunction

• Brand Name: SCOUT®
• Common Device Name: Marker, Radiographic, Implantable
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS; 1600 w merit parkway; south jordan UT 84095
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS; 1600 w merit parkway; south jordan UT 84095
• Manufacturer Contact: lisa perz msn, rn, pmp ; 1600 merit parkway; south jordan, UT 84095 ; +1(801)208-4225
• MDR Report Key: 50591816
• Report Number: 2032338-2026-00018
• Device Sequence Number: 15969330
• Product Code: NEU
• UDI-Device Identifier: 00884450719565
• UDI-Public: 00884450719565
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K181007
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: SSR75S-01/Q
• Device Lot Number: H3556290
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 09/04/2026
• Initial Report FDA Received Date: 09/03/2026
• Supplement Report FDA Received Date: 09/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/09/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown