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PDS PDP397HRecalls & reported problems

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

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 10705031048218), received between Jul 26, 2022 and Jul 26, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Material Integrity Problem” (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 Integrity Problem1

Patient problems

  • Purulent Discharge1
  • Unspecified Infection1

Recent adverse event reports

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

  • InjuryJul 26, 2022Material Integrity Problem; Material Integrity Problem

    IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST RECONSTRUCTION PROCEDURE IN (B)(6) 2022 AND SUTURE WAS USED. IT WAS STATED THAT THE PRODUCT WAS USED AND STILL REMAINED IN THE BODY. THERE WERE DEFORMATIONS AND PUS IN THE FORM, SO SEVERAL REMOVAL OPERATIONS WERE PERFORMED. IT WAS ALSO REPORTED THAT THE PATIENT HAD AN INFECTION. ADDITIONAL INFORMATION WAS REQUESTED.

    Patient problems: Purulent Discharge; Unspecified Infection

    MAUDE report 15103396 ↗

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.