Halyard SAMM053-03_0012Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10809160325049), received between Sep 21, 2021 and Sep 21, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Sharp Edges” (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 18, 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.

• InjurySep 21, 2021Sharp Edges; Sharp Edges

  AN AVID COMPLAINT WAS RECEIVED WITH COMPLAINT NUMBER (B)(4) FOR SHARP FORCEPS LACERATION. IT WAS REPORTED BY THE NURSE THAT A SHARP EDGE ON THE FORCEPS CAUSED A SMALL LACERATION ON THE INFANT DURING THE PROCEDURE. THE PATIENT WAS UNDERGOING A CIRCUMCISION PROCEDURE, THE PHYSICIAN NOTICED A SMALL AMOUNT OF BLOOD. HE NOTED ONE PRONG OF THE CURVED FORCEP WAS ABNORMALLY SHARP AND WITHDREW THE DEFECTIVE INSTRUMENT FOR ONE THAT WAS NOT DEFECTIVE. AT THE END OF THE PROCEDURE, THE INFANT HAD A SMALL LACERATION ON THE GLANS FROM THE SHARP INSTRUMENT. NO OTHER TREATMENT WAS NOTED.

  Patient problems: Laceration(s)

  MAUDE report 12510588 ↗