Biodesign G48216Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002482166), received between Jan 24, 2018 and Oct 10, 2022 — classified as 2 injuries.

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

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryOct 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A LAWYER CONTACTED COOK MEDICAL TO INFORM THEM OF A POTENTIAL PRODUCT LIABILITY CLAIM. PATIENT: (B)(6). LOT #: LB504039; CATALOG #: G48216. (B)(6) 2022 - COOK LEGAL INDICATED NO ADDITIONAL DETAILS RECEIVED. (B)(6) 2022 - COOK LEGAL INDICATED STILL NO ADDITIONAL DETAILS RECEIVED. UPDATE: THIS UPDATE WILL REFLECT MEDICAL RECORDS FINDINGS THAT APPEAR PERTINENT TO HERNIA REPAIR AND FACTORS THAT MAY PERTAIN TO THAT. PER MEDICAL RECORDS RECEIVED ON 04/15/2022, THE MOST RECENT RECORDS RECEIVED WERE FROM OCTOBER 2013. AT THAT TIME, THE PATIENT HAD A HISTORY OF EPIGASTRIC HERNIA REPAIR IN 2004, VENTRAL HERNIA REPAIR WITH MESH IN 2008, OPEN VENTRAL HERNIA REPAIR WITH MESH IN 2011, UNILATERAL RIGHT COMPONENT SEPARATION WITH LARGE OPEN VENTRAL HERNIA REPAIR WITH A 20X30 CM BIODESIGN GRAFT IN 2012, LEFT THYROID LOBECTOMY FOR LEFT THYROID GOITER 2012, AND ABDOMINAL WOUND DEBRIDEMENT IN 2013. MEDICAL RECORDS RECEIVED ARE IN THE ATTACHED FILES. IN RELATION TO BIODESIGN, THE PATIENT RECEIVED A BIODESIGN HERNIA GRAFT ON (B)(6) 2012 FOR A RECURRENT VENTRAL HERNIA. THE PATIENT'S HISTORY PRIOR TO THIS DATE WAS NOTED AS 3 PREVIOUS VENTRAL HERNIA REPAIRS THAT HAVE RECURRED ALL 3 TIMES. LAST HERNIA REPAIR

  Patient problems: Hernia

  MAUDE report 15571853 ↗
• InjuryJan 24, 2018Appropriate Device Problem Term/Code Not Available

  ON (B)(6) 2017, DR. (B)(6) PLACED A C-SLH-8H-20X30 IN A (B)(6) MALE PATIENT. THE PATIENT HAD A PRIOR PLACEMENT OF POLYPROPYLENE MESH WHICH BECAME INFECTED. THE INFECTED POLYPROPYLENE WAS REMOVED BY LAPAROSCOPY AND THE BIODESIGN HERNIA GRAFT WAS PLACED IN AN OPEN PROCEDURE. THE BIODESIGN WAS PLACED FOR REPAIR OF A VENTRAL HERNIA. SEROMA FLUID WAS DRAINED FOR APPROXIMATELY 28-30 DAYS. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ONCE THE DRAIN OUTPUT WAS BELOW 20 ML PER DAY. TWO (2) WEEKS LATER, APPROXIMATELY FIFTY (50) DAYS POST BIODESIGN PLACEMENT, THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO FEVER AND SEROMA FORMATION. THE SEROMA WAS UNABLE TO BE DRAINED DUE TO THICKNESS AND THE PATIENT UNDERWENT ADDITIONAL SURGERY TO ASSESS FOR INFECTION AND SEROMA. THE SEROMA WAS DESCRIBED AS THICK, 300 ML FLUID COLLECTION, AND A CAUSE WAS UNABLE TO BE FOUND. A TISSUE SPECIMEN WAS SENT FOR LABORATORY REVIEW.

  Patient problems: Fever; Seroma; Unspecified Infection

  MAUDE report 7214926 ↗