Biodesign G36032Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002360327), received between Oct 11, 2022 and Apr 18, 2024 — classified as 1 death, 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

Recent adverse event reports

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

• DeathApr 18, 2024Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  PATIENT: MOTHER OF COMPLAINANT. ON (B)(6) 2024, THE COMPLAINANT REPORTED (VIA TEAMS) AWARENESS OF A BIODESIGN DEVICE IMPLANTED IN A PATIENT WHO LATER SUCCUMBED TO COMPLICATIONS. ON (B)(6) 2024, CBI¿S PRODUCT SURVEILLANCE ANALYST, WHO WAS ON PTO FROM 03/25/2024 THROUGH 03/28/2024, VIEWED THE COMPLAINANT¿S MESSAGE AND RESPONDED. THE COMPLAINANT WOULD ARRANGE A VIDEO CALL FOR DISCUSSION OF THE FEEDBACK. ON (B)(6) 2024, THE COMPLAINANT AND CBI¿S PRODUCT SURVEILLANCE ANALYST SPOKE VIA VIDEO CALL. THE COMPLAINANT EXPLAINED THE DETAILS OF THE PATIENT¿S COURSE OF EVENTS AS THE PRODUCT SURVEILLANCE ANALYST TOOK NOTES. DURING THIS CALL, THE COMPLAINANT WAS TEARFUL AS THEY RECALLED THE PATIENT¿S COURSE OF EVENTS. THE COMPLAINANT EXPRESSED FEELING THERE SHOULD HAVE BEEN MORE DONE, BY THE HOSPITAL STAFF AND SURGEON, TO INTERVENE AND NOT RESULT IN THE DEATH OF THE PATIENT. ON (B)(6) 2024, THE COMPLAINANT AND CBI¿S PRODUCT SURVEILLANCE ANALYST SPOKE AGAIN VIA VIDEO CALL. THE POINT OF THIS DISCUSSION WAS TO REVIEW THE PRIOR DAY¿S NOTES AND EDIT AS NEEDED TO ENSURE ACCURACY IN THE TIMELINE OF EVENTS. ON (B)(6) 2024, CBI¿S QUALITY SYSTEMS MANAGER REVIEWED THE COMPLAINT DETAILS AND REQUESTED CLARITY

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19135484 ↗
• InjuryOct 11, 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 # - LB562350. (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. MEDICAL RECORDS REVIEWED ARE IN THE ATTACHED FILES. PER MEDICAL RECORDS RECEIVED ON (B)(6) 2022: ON (B)(6) 2012, THE PATIENT UNDERWENT AN INCISIONAL HERNIA REPAIR WITH PARIETEX MESH. ON (B)(6) 2012, THE PATIENT UNDERWENT REPLACEMENT OF INFECTED AND REJECTED MESH AND SURGISIS HERNIA GRAFT WAS PLACED. ON (B)(6) 2013, THE PATIENT UNDERWENT ABDOMINAL WOUND EXPLORATION WITH DRAINAGE OF ABDOMINAL WALL ABSCESSES AND REMOVAL OF INFECTED MESH (PARTIAL). THE PATIENT WAS NOTED TO HAVE A RECURRENT HERNIA AND CHRONIC DISCHARGE FROM THE ABDOMINAL WOUND SINCE THE FIRST HERNIA REPAIR. SUTURES AND POLYPROPYLENE TYPE MESH WAS FOUND WITHIN THE ABSCESS. ON (B)(6) 2014, THE PATIENT UNDERWENT EXPLORATORY LAPAROTOMY, LYSIS OF ADHESIONS, RESECTION OF A LARGE HERNIA SAC, REPAIR OF VENTRAL HERNIA WITH COMPONENT SEPARAT

  Patient problems: Hernia

  MAUDE report 15575967 ↗