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O-SPOT 791Recalls & reported problems

Beekley Corporation · Mole Markers, 1mm uniform ultra-sheer see-through ring, pinch-free material · Class 1

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00815137020551), received between May 2, 2018 and May 2, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Signal Artifact/Noise” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Signal Artifact/Noise1

Patient problems

  • No Information1

Recent adverse event reports

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

  • InjuryMay 2, 2018Signal Artifact/Noise

    A MOLE MARKER MAY HAVE CAUSED ARTIFACT ON A MAMMOGRAM. AS A RESULT, THE MAMMOGRAM WAS REPEATED.

    Patient problems: No Information

    MAUDE report 7481434 ↗

Other System, X-Ray, Film Marking, Radiographic devices

All System, X-Ray, Film Marking, Radiographic devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.