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PDS PDP452GRecalls & reported problems

Ethicon, LLC · Antibacterial Violet Monofilament (Polydioxanone), Absorbable Surgical Suture · Class 2 · Implant

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705031218734), received between Sep 8, 2023 and Sep 8, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Separation” (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

  • Material Separation1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

  • MalfunctionSep 8, 2023Material Separation; Material Separation

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2023 AND SUTURE WAS USED. BEFORE USE ON THE PATIENT OR DURING THE PROCEDURE, IT WAS REPORTED BY THE CUSTOMER THE SUTURES ARE NOT COMING OUT OF THE PACKAGE CORRECTLY, THE NEEDLE KEEPS FALLING OR BREAKING OFF. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17711170 ↗

Other SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE devices

All SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE devices →

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