MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. SCOUT®; MARKER, RADIOGRAPHIC, IMPLANTABLE

Catalog Number	SG-01/D
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device was acting up and getting very warm during use on a patient.No patient injury or medical intervention was reported.No additional information is available.
Additional Manufacturer Narrative
The suspected device is expected to be returned for evaluation.A follow up report will be submitted once product history review and investigation are complete.

• Brand Name: SCOUT®
• Common Device Name: MARKER, RADIOGRAPHIC, IMPLANTABLE
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; 1600 merit parkway; south jordan UT 84095
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS, INC.; 1600 merit parkway; south jordan UT 84095
• Manufacturer Contact: nimisha pathak ; 6 journey unit 125; aliso viejo, CA 92656 ; 9493600059
• MDR Report Key: 25246122
• Report Number: 2032338-2026-00004
• Device Sequence Number: 10547601
• Product Code: NEU
• UDI-Device Identifier: 00884450530139
• UDI-Public: 00884450530139
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2026

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: SG-01/D
• Device Lot Number: SF00600
• 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: 04/23/2026
• Supplement Date Received by Manufacturer: 06/02/2026
• Initial Report FDA Received Date: 05/21/2026
• Supplement Report FDA Received Date: 06/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/08/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown