MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS INC SCOUT 7.5cm Delivery Needle and Reflector, Single-Hand; MARKER, RADIOGRAPHIC, IMPLANTABLE

Catalog Number	SSR75S-01
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	05/04/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient underwent a lumpectomy using the device where a reflector was placed and removed 9 days later.Four weeks post procedure, the patient developed a skin rash that persisted and moved for the past two months.The patient has a reported nickel allergy.
Additional Manufacturer Narrative
the investigation is ongoing.If additional reportable information becomes available, it will be submitted in a supplemental report.

• Brand Name: SCOUT 7.5cm Delivery Needle and Reflector, Single-Hand
• Common Device Name: MARKER, RADIOGRAPHIC, IMPLANTABLE
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC; 6 journey unit 125; aliso viejo CA 92656
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS, INC; 6 journey unit 125; aliso viejo CA 92656
• Manufacturer Contact: nimisha pathak ; 6 journey unit 125; aliso viejo, CA 92656 ; +1(949)360-0059
• MDR Report Key: 50842364
• Report Number: 2032338-2026-00020
• Device Sequence Number: 18629330
• Product Code: NEU
• UDI-Device Identifier: 00884450719527
• UDI-Public: 00884450719527
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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
• Report Date (Section B): 09/21/2026

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
• Device Catalogue Number: SSR75S-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/24/2026
• Initial Report FDA Received Date: 09/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown