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Biodesign G36033Recalls & reported problems

Cook Biotech Incorporated · Biodesign Hernia Graft · 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 00827002360334), received between Jul 5, 2018 and Jul 5, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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

  • Insufficient Device Problem Information1

Patient problems

  • Adhesion(s)1
  • Pain1

Recent adverse event reports

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

  • InjuryJul 5, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

    IN (B)(6) 2015, DR. (B)(6) PLACED A BIODESIGN HERNIA GRAFT FOR REPAIR OF AN INCISIONAL HERNIA. IN 2018, THE PATIENT WAS SEEN FOR COMPLAINTS OF PAIN. DR. (B)(6) REOPERATED AND FOUND THE DEVICE ADHERED TO THE SMALL BOWEL, NOT INCORPORATED, AND CRUMPLED. THE DEVICE WAS REPORTEDLY EXPLANTED.

    Patient problems: Adhesion(s); Pain

    MAUDE report 7664320 ↗

Other Mesh, surgical, collagen, large abdominal wall defects devices

All Mesh, surgical, collagen, large abdominal wall defects devices →

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