PDM D497Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00812444029291), received between Sep 17, 2021 and Sep 17, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

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

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2021Break; Break

  ACCORDING TO THE REPORTER, "WE HAVE BEEN HAVING A PROBLEM WITH THE 3-0 PDM SUTURE ON PS-2 NEEDLE. WE HAVE ONE BOX WITH 2 LEFT, AND A FULL UNOPENED BOX. OF THE 8 WE'VE USED, DR. " " AND I CAN THINK OF 4 OF THE NEEDLES FALLING OFF, TWO OF WHICH WERE TODAY DURING SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12488346 ↗
• MalfunctionSep 17, 2021Break; Break

  ACCORDING TO THE REPORTER, "WE HAVE BEEN HAVING A PROBLEM WITH THE 3-0 PDM SUTURE ON PS-2 NEEDLE. WE HAVE ONE BOX WITH 2 LEFT, AND A FULL UNOPENED BOX. OF THE 8 WE'VE USED DR ." "AND I CAN THINK OF 4 OF THE NEEDLES FALLING OFF, TWO OF WHICH WERE TODAY DURING SURGERY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12488237 ↗