PTFE Polymer Pledgets 88868682-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521104648), received between Aug 14, 2019 and Aug 14, 2019 — classified as 2 injuries.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (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 16, 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.

• InjuryAug 14, 2019Migration or Expulsion of Device; Migration or Expulsion of Device

  ACCORDING TO THE SURVEY PERFORMED WHICH COVERS THE LAST 12 MONTHS FOR THE ADVERSE EVENT REACTION USING THE SUTURE, ONE MILD INFECTION OR ABSCESS FORMATION, ONE PLEDGET MIGRATION, AND ONE MILD ACUTE INFLAMMATORY REACTION WERE EXPERIENCED.

  Patient problems: Inflammation; Unspecified Infection

  MAUDE report 8895736 ↗
• InjuryAug 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO A WOUND CLOSURE SURVEY SOURCE CONDUCTED, PATIENTS EXPERIENCED MINIMAL LOCAL INFLAMMATION.

  Patient problems: Inflammation

  MAUDE report 8893762 ↗