SecurMark SMARK-E13-SS3Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05420045503932), received between Apr 11, 2023 and Apr 11, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryApr 11, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED ON (B)(6) 2023 THAT A PATIENT RECEIVED A SMARK MARKER IN HER BREAST IN A STEREOTACTIC BIOPSY. AT THE TIME OF THE IMPLANTATION THE PATIENT REFERRED THAT THE TECHNOLOGIST REFERRED TO HER THAT THE MATERIAL OF THE MARKER WAS TITANIUM BUT LATER THE PATIENT READ THAT SOME OF THE MATERIALS FROM THE MARKERS COULD BE STAINLESS STEEL. THE PATIENT LATER REPORTED THAT SHE WAS ALLERGIC TO STAINLESS STEEL AND NICKEL AND NOW IT IS EXPERIENCING FREQUENT RASHES IN THE AREA. THE PATIENT HAS NOT REPORTED ADDITIONAL MEDICAL INTERVENTION OR TREATMENT. NO OTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 16712675 ↗