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PDS PDP451GRecalls & 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 10705031218710), received between Dec 4, 2018 and Dec 4, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (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

  • Break1

Patient problems

  • Wound Dehiscence1

Recent adverse event reports

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

  • MalfunctionDec 4, 2018Break; Break

    IT WAS REPORTED AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2018 AND SUTURE WAS USED. THE SUTURE IS BREAKING DOWN CAUSING THE SURGICAL SITE TO DEHISCENCE. IT IS UNKNOWN IF ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE.

    Patient problems: Wound Dehiscence

    MAUDE report 8130515 ↗

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.