Biodesign G46600Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00827002466005), received between Apr 11, 2016 and Apr 18, 2024 — classified as 1 death, 2 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 reports).

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 3 most recent of 3 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

  COMPLAINANT: CBI EMPLOYEE ¿ THROUGHOUT THE (B)(6) 2024 VIDEO CALLS, THE COMPLAINANT REFERRED/DEFERRED TO THEIR SIBLING FOR CLARITY/VERIFICATION OF THE DETAILS TO ENSURE ACCURACY. CBI¿S PRODUCT SURVEILLANCE ANALYST SPOKE ONLY TO THE COMPLAINANT DURING THE VIDEO CALLS. THE COMPLAINANT AND THEIR SIBLING COMMUNICATED VIA MESSAGING AS NEEDED. 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 T

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19136586 ↗
• InjuryJun 10, 2016Insufficient Device Problem Information

  THE PATIENT PRESENTED TO THE HOSPITAL FOR ELECTIVE TAKEDOWN OF BROOKE'S ILEOSTOMY AND FORMATION OF A NEW KOCK POUCH. IN EARLY MARCH THE PATIENT UNDERWENT EXPLORATORY LAPAROTOMY, LYSIS OF ADHESIONS, CONVERSION OF BROOKE END ILEOSTOMY TO KOCK POUCH, MIDLINE INCISIONAL HERNIA REPAIR WITH BIODESIGN HERNIA GRAFT AND BILATERAL STENT PLACEMENT. THE DEFECT SIZE WAS 5 CM BY 15 CM. FOUR DAYS POST-OP THE JP DRAIN IN HIS RIGHT LOWER QUADRANT WAS REMOVED. ON (B)(6) 2016 THE PATIENT HAD A FEVER TO 38.5 DEGREES CELSIUS (101.3 DEGREES FAHRENHEIT) . DESPITE THIS HE FELT WELL. A CT SCAN WAS DONE WHICH SHOWED A FISTULA BETWEEN KOCK POUCH AND MIDLINE INCISION. TEN DAYS POST-OP THE PATIENT UNDERWENT A FLUOROSCOPY DRAIN STUDY TO FURTHER CHARACTERIZE THE FISTULA. HE WAS SUBSEQUENTLY PREPPED FOR THE OR. ELEVEN DAYS POST-OP THE PATIENT WAS TAKEN BACK TO THE OPERATING ROOM AND UNDERWENT EXPLORATORY LAPAROTOMY WITH EXCISION OF THE PARTIALLY DISSOLVED AND FRAGMENTED BIODESIGN HERNIA GRAFT AND CREATION OF A DIVERTING LOOP ILEOSTOMY. UPDATE: ON 06/30/2016, A REPRESENTATIVE AT THE STUDY SITE REPORTED THAT THE SURGEON DID NOT BELIEVE THAT THE BIODESIGN HERNIA GRAFT CONTRIBUTED TO OR CAUSED THE FORMATION OF THE FI

  Patient problems: Fever; Fistula

  MAUDE report 5718402 ↗
• InjuryApr 11, 2016Difficult to Insert; Mechanical Jam

  DR. ISABELLA MOR PERFORMED A LAPAROSCOPIC SUGARBAKER PROCEDURE, ON (B)(6) 2016, AND PLACED A BIODESIGN HERNIA GRAFT C-SLH-8H-13X22 TO TREAT A PARASTOMAL HERNIA IN AN (B)(6) FEMALE PATIENT. THE SURGEON HAD ATTENDED A COOK PARASTOMAL HERNIA REPAIR WORKSHOP THE DAY PRIOR TO THIS CASE AND WAS REPORTEDLY FAMILIAR WITH THE PROCEDURE. APPROXIMATELY FIVE (5) 0 PDS FULL THICKNESS TRANSFACIAL SUTURES WERE PLACED USING A NOVAPASS SUTURE PASSER. APPROXIMATELY EIGHT (8) PROTACK STAINLESS STEEL SPIRAL TACKS WERE ALSO USED TO AFFIX THE HERNIA GRAFT TO THE PERITONEUM. DURING THE PROCEDURE, THE SURGEON HAD SIGNIFICANT DIFFICULTY INTRODUCING THE HERNIA GRAFT THROUGH THE LAPAROSCOPIC PORT AND INTO THE PATIENT'S ABDOMEN. THE GRAFT WAS SOAKED IN SALINE, AS PER RECOMMENDATIONS, THEN ROLLED AND INSERTED INTO THE 12 MM LAPAROSCOPIC PORT. THE HERNIA GRAFT BECAME STUCK IN THIS PORT A FEW TIMES AND A SIGNIFICANT AMOUNT OF FORCE WAS APPLIED WITH THE GRASPER TO PUSH THE HERNIA GRAFT THROUGH THE PORT. THE HERNIA GRAFT EVENTUALLY HAD TO BE INSERTED BY REMOVING THE PORT AND PLACING THE HERNIA GRAFT DIRECTLY THROUGH THE SKIN INCISION. THE PATIENT WAS NOTED TO HAVE HAD FOUR (4) HOSPITAL ADMISSIONS DURING THE MONTH

  Patient problems: Adhesion(s); Discomfort; Nausea; Obstruction/Occlusion

  MAUDE report 5567479 ↗