GORE DUALMESH Biomaterial 1DLMC03Recalls & reported problems

Summary

The FDA's MAUDE database contains 85 adverse event reports that list this exact device (DI 00733132600960), received between Jun 27, 2018 and Nov 19, 2024 — classified as 85 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (82 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 85 reports, in the reporter's own words as published by the FDA.

• InjuryNov 19, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN VENTRAL INCISIONAL HERNIA REPAIR ON (B)(6) 2003 WHEREBY A GORE® DUALMESH® BIOMATERIAL WAS IMPLANTED. IT WAS ALSO REPORTED TO GORE THAT THE PATIENT UNDERWENT ADDITIONAL HERNIA REPAIR ON (B)(6) 2004 WHEREBY A GORE® DUALMESH® BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2010, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: MESH REMOVAL; MESH FAILURE TO INCORPORATE; MESH PULLED AWAY FROM TISSUE; DENSE ADHESIONS; RECURRENCE; FIBROSIS; INFLAMMATION; LONG HOSPITALIZATION FOR REMOVAL SURGERY. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Hernia

  MAUDE report 20723536 ↗
• InjuryJul 8, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT SACROCOLPOPEXY HERNIA REPAIR ON (B)(6) 2009 WHEREBY A GORE® DUALMESH® BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2022, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: EROSION, INFECTED MESH, MESH REMOVAL, DEVELOPED COMPLICATIONS INCLUDING BLOOD CLOT POST-REVISION PROCEDURE. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Erosion; No Clinical Signs, Symptoms or Conditions; Unspecified Infection

  MAUDE report 19690634 ↗
• InjurySep 11, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  THE FOLLOWING INFORMATION WAS OBTAINED FROM MEDICAL RECORDS. IMPLANT PROCEDURE: REPAIR OF LARGE VENTRAL HERNIA UTILIZING 15 X 10 CM DUALMESH. LAPAROSCOPIC LIVER BIOPSY. IMPLANT: GORE® DUALMESH® BIOMATERIAL [1DLMC03/(B)(6)] IMPLANT DATE: (B)(6) 2010 . REVISION #1 PROCEDURE: REPAIR WITH MESH MEASURING 15 X 15 CM. [IMPLANT: ULTRAPRO] REVISION #1 DATE: (B)(6) 2011. EXPLANT PROCEDURE: OPEN REPAIR OF RECURRENT VENTRAL INCISIONAL HERNIA. EXCISION OF RIGHT LOWER QUADRANT ABDOMINAL WALL CYST. EXCISION OF VERRUCOUS LESION, RIGHT UPPER LIP (LIP LESION MEASURING 3 MM X 3 MM, CYST MEASURING 4 CM X 3 CM X 2.5 CM). EXPLANT DATE: (B)(6) 2014. IMPLANT #1: (B)(6). IT WAS INITIALLY REPORTED TO GORE THAT THE PATIENT UNDERWENT LAPAROSCOPIC VENTRAL HERNIA REPAIR ON (B)(6) 2010 WHEREBY A GORE® DUALMESH® BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2011 AND (B)(6) 2014, ADDITIONAL PROCEDURES OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: HERNIA RECURRENCE, DENSE/MULTIPLE ADHESIONS, SEVERE AND CHRONIC PAIN/DISCOMFORT. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Hernia

  MAUDE report 17721732 ↗
• InjuryMar 14, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT LAPAROSCOPIC DIAPHRAGMATIC HERNIA REPAIR ON (B)(6) 2010 WHEREBY A GORE® DUALMESH® BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2010 AND (B)(6) 2010, ADDITIONAL PROCEDURES OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: ADDITIONAL SURGERIES, PAIN & SUFFERING, INFECTION, MESH REMOVAL, SEROMA, INFECTED MESH, PAIN & SUFFERING. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Infection

  MAUDE report 16541918 ↗
• InjuryOct 6, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN INCISIONAL VENTRAL HERNIA REPAIR ON (B)(6) 2008 WHEREBY TWO GORE® DUALMESH® BIOMATERIAL WERE IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2013 AND (B)(6) 2013, ADDITIONAL PROCEDURES OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: ADDITIONAL SURGERIES; EMESIS; DISRUPTION OF INTERNAL MESH ON FASCIA/FASCIAL MESH SEPARATION; HEAVY POST-OP BLEEDING; ADHESIONS; BOWEL OBSTRUCTION; MESH REMOVAL; WOUND VAC; PAIN & SUFFERING. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 15556073 ↗
• InjuryJul 7, 2022Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT INCISIONAL HERNIA REPAIR ON (B)(6) 2006 WHEREBY A GORE® DUALMESH® BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2008, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: "REMOVAL OF ALL THREE GORE MESH". ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Obstruction/Occlusion

  MAUDE report 14946390 ↗
• InjuryJul 1, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT LAPAROSCOPIC VENTRAL HERNIA REPAIR ON (B)(6) 2013 WHEREBY A GORE® DUALMESH® BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2013, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: ADDITIONAL SURGERY, PERFORATION, MESH MIGRATION, SEROMA, WOUND VAC (JP DRAIN), RECURRENCE, PAIN & SUFFERING. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Hernia; No Clinical Signs, Symptoms or Conditions; Seroma

  MAUDE report 14892205 ↗
• InjuryMay 27, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN INCISIONAL HERNIA REPAIR ON (B)(6) 2006 WHEREBY A GORE® DUALMESH® BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2010, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: ADHESIONS, MESHOMA, MIGRATION, PAIN. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED. INITIAL REVIEW OF THE MEDICAL RECORDS INDICATE A REPORTABLE HERNIA RECURRENCE.

  Patient problems: Hernia

  MAUDE report 14526806 ↗
• InjuryMay 27, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN INCISIONAL HERNIA REPAIR ON (B)(6) 2015 WHEREBY A GORE® DUALMESH® BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2018, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: ABDOMINAL PAIN, ADHESIONS, HERNIA RECURRENCE, AND MESH EXPLANT. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Obstruction/Occlusion

  MAUDE report 14524033 ↗
• InjuryMay 26, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT LAPAROSCOPIC INCISIONAL HERNIA REPAIR ON (B)(6) 2007 WHEREBY A GORE® DUALMESH® BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2015, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: EXPLANT OF MESH, RECURRENT HERNIA, FOLDED MESH, BOWEL OBSTRUCTION, SCAR TISSUE REMOVAL. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Hernia; No Clinical Signs, Symptoms or Conditions

  MAUDE report 14518569 ↗
• InjuryMay 19, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN VENTRAL HERNIA REPAIR ON (B)(6) 2003 WHEREBY A GORE® DUALMESH® BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2003, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: ABSCESS, BOWEL OBSTRUCTION/PROBLEMS, DEBRIDEMENT, EXPULSION OF MESH, FISTULA, INCISION & DRAINAGE, INFECTION, HERNIA RECURRENCE, SEROMA, WOUND VAC, REMOVAL, REVISIONS, BOWEL RESECTION, AND BOWEL INVOLVEMENT. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Seroma; Tissue Breakdown; Unspecified Infection

  MAUDE report 14434473 ↗
• InjuryJan 19, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN EPIGASTRIC HERNIA REPAIR ON (B)(6) 2005 AND (B)(6) 2008 WHEREBY A GORE® DUALMESH® BIOMATERIAL DEVICES WERE IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6), 2007, (B)(6), 2008 AND (B)(6), 2010, ADDITIONAL PROCEDURES OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: ADHESIONS, MESH REMOVAL, RECURRENCE, FISTULA, NON-HEALING WOUND, PAIN AND SUFFERING. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Adhesion(s); Obstruction/Occlusion

  MAUDE report 13291789 ↗
• InjuryJul 21, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN INCARCERATED INCISIONAL HERNIA REPAIR ON (B)(6) 2018, WHEREBY A GORE® DUALMESH® BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2020, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: ABSCESS, DEBRIDEMENT, FISTULA, INCISION AND DRAINAGE, INFECTION, MESH REMOVAL, PAIN. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Abscess; Fistula; No Clinical Signs, Symptoms or Conditions; Unspecified Infection

  MAUDE report 12206828 ↗
• InjuryJun 10, 2021Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT LAPAROSCOPIC VENTRAL HERNIA REPAIR ON (B)(6) 2009 AND(B)(6) 2010 WHEREBY A GORE® DUALMESH® BIOMATERIAL WAS IMPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: RECURRENT RIGHT SUBCOSTAL VENTRAL INCISIONAL HERNIA, ADDITIONAL SURGICAL PROCEDURE REQUIRED, AND OMENTAL ADHESIONS. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Hematoma; Unspecified Infection

  MAUDE report 11979588 ↗
• InjuryJun 2, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT LAPAROSCOPIC VENTRAL HERNIA REPAIR ON (B)(6) 2009, AND (B)(6) 2010, WHEREBY A GORE® DUALMESH® BIOMATERIAL WAS IMPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: RECURRENT RIGHT SUBCOSTAL VENTRAL INCISIONAL HERNIA, ADDITIONAL SURGICAL PROCEDURE REQUIRED, AND OMENTAL ADHESIONS. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Hematoma; No Clinical Signs, Symptoms or Conditions; Unspecified Infection

  MAUDE report 11925599 ↗
• InjuryApr 20, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT LAPAROSCOPIC VENTRAL HERNIA REPAIR ON (B)(6) 2006 WHEREBY A GORE® DUALMESH® BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2013, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: EXPLORATORY LAPAROTOMY WITH REPAIR OF RECURRENT INCARCERATED VENTRAL INCISIONAL HERNIA WITH REMOVAL OF OLD MESH AND ATTENUATED ABDOMINAL WALL, RELEASE OF PARTIAL SMALL BOWEL OBSTRUCTION CAUSED BY ADHESIVE BANDS. MESH WAS COMPLETELY REMOVED. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Obstruction/Occlusion

  MAUDE report 11697661 ↗
• InjuryJan 6, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN PARASTOMAL HERNIA REPAIR ON (B)(6) 2019 WHEREBY A GORE® DUALMESH® BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2019, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: EXTENSIVE LYSIS OF ADHESIONS, SURGERY TO REMOVE MESH, INFECTION, SINUS TRACT, CHRONIC ABSCESS AROUND THE MESH, MESH WAS ADHERENT TO THE SMALL BOWEL AT THE BASE OF THE TRACT, MESH "CLEARLY SOURCE OF THE SINUS TRACT", ENTEROCUTANEOUS FISTULA, SEVERE AND CHRONIC PAIN/DISCOMFORT. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 11125000 ↗
• InjurySep 4, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN INCISIONAL UMBILICAL, INCISIONAL EPIGASTRIC, HERNIA REPAIR ON (B)(6) 2010, WHEREBY TWO GORE® DUALMESH® BIOMATERIAL'S WERE IMPLANTED. THE PATIENT ALSO UNDERWENT OPEN INCISIONAL RIGHT FLANK, AND INCISIONAL VENTRAL HERNIA REPAIR ON (B)(6) 2011, WHEREBY TWO GORE® DUALMESH® PLUS BIOMATERIAL'S WERE IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2011, (B)(6) 2014, (B)(6) 2015, (B)(6) 2016 AND (B)(6) 2018 ADDITIONAL PROCEDURES OCCURRED WHEREBY THE GORE DEVICES WERE EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: REMOVAL OF GORE MESH DUE TO IT WAS FOUND BRIDGING AND PULLED AWAY FROM EDGES, BOWEL OBSTRUCTION, MULTIPLE SWISS-CHEESE DEFECT, DENSE ADHESIONS, INCARCERATED RECURRENT VENTRAL HERNIA REPAIRED WITH PLACEMENT OF NEW MESH. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Hernia; No Code Available; Obstruction/Occlusion

  MAUDE report 10496067 ↗
• InjurySep 4, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN INCISIONAL UMBILICAL, INCISIONAL EPIGASTRIC, HERNIA REPAIR ON (B)(6) 2010, WHEREBY TWO GORE® DUALMESH® BIOMATERIAL'S WERE IMPLANTED. THE PATIENT ALSO UNDERWENT OPEN INCISIONAL RIGHT FLANK, AND INCISIONAL VENTRAL HERNIA REPAIR ON (B)(6) 2011, WHEREBY TWO GORE® DUALMESH® PLUS BIOMATERIAL'S WERE IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2011, (B)(6) 2014, (B)(6) 2015, (B)(6) 2016 AND (B)(6) 2018 ADDITIONAL PROCEDURES OCCURRED WHEREBY THE GORE DEVICES WERE EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: REMOVAL OF GORE MESH DUE TO IT WAS FOUND BRIDGING AND PULLED AWAY FROM EDGES, BOWEL OBSTRUCTION, MULTIPLE SWISS-CHEESE DEFECT, DENSE ADHESIONS, INCARCERATED RECURRENT VENTRAL HERNIA REPAIRED WITH PLACEMENT OF NEW MESH. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Hernia; No Clinical Signs, Symptoms or Conditions; No Code Available; Obstruction/Occlusion

  MAUDE report 10495478 ↗
• InjurySep 1, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT MULTIPLE OPEN INCISIONAL HERNIA REPAIRS ON (B)(6) 1999 AND (B)(6) 2001 WHEREBY A GORE-TEX® SOFT TISSUE PATCH AND GORE® DUALMESH® BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2000 AND (B)(6) 2016, ADDITIONAL PROCEDURES OCCURRED WHEREBY THE GORE DEVICES WERE EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: REMOVAL OF PREVIOUS GORE MESH, REMOVAL OF SMALL BOWEL FISTULA, RESECTION OF SMALL BOWEL DUE TO FISTULA, RECURRENT VENTRAL INCISIONAL HERNIA DEFECT REPAIRED WITH PLACEMENT OF NEW MESH, ABDOMINAL WOUND DRAINAGE, SEVERE PAIN, DEBRIDEMENT OF NON-HEALING OPEN WOUND. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Fistula; No Clinical Signs, Symptoms or Conditions

  MAUDE report 10480157 ↗
• InjuryAug 25, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT LAPAROSCOPIC UMBILLICAL HERNIA REPAIR ON (B)(6) 2009 WHEREBY A GORE® DUALMESH® BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2017, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: SMALL BOWEL OBSTRUCTION, ADHESIONS, RECURRENCE, PAIN/DISCOMFORT. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Obstruction/Occlusion

  MAUDE report 10447025 ↗
• InjuryMay 11, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT VENTRAL HERNIA REPAIR ON (B)(6) 2009, WHEREBY A GORE® DUALMESH® BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2013, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: REMOVAL, STAPHYLOCOCUS AUREUS IAND E-COLI INFECTION, WOUND VAC, SINUS TRACT, ADHESIONS, FOREIGN BODY GRANULOMATOUS INFLAMMATION, ORGANIZING FAT NECROSIS, AND EXTENSIVE DENSE FIBROSIS, ADHERENT ACUTELY AND CHRONICALLY INFLAMED GRANULATION TISSUE, AND PAIN. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Adhesion(s); No Clinical Signs, Symptoms or Conditions; Pain; Unspecified Infection

  MAUDE report 10043252 ↗
• InjuryMay 6, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT LAPAROSCOPIC VENTRAL HERNIA REPAIR ON (B)(6) 2006 WHEREBY A GORE® DUALMESH® PLUS BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2006 AND (B)(6) 2006 ADDITIONAL PROCEDURES OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: DISLODGED MESH, RECURRENT HERNIA, SMALL BOWEL OBSTRUCTION, PARTIAL EXCISION OF MESH, UNINCORPORATED MESH, INFECTION, SEROMA, MESH REMOVAL. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Hernia; No Clinical Signs, Symptoms or Conditions; Seroma; Unspecified Infection

  MAUDE report 10029472 ↗
• InjuryMay 4, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN INTERCOSTAL HERNIA REPAIR ON (B)(6) 2011 WHEREBY A GORE® DUALMESH® BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2015, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY A SECOND GORE® DUALMESH® BIOMATERIAL WAS IMPLANTED. BOTH OF THE DEVICES REMAIN IN THE PATIENT. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: RECURRENCE AND MORE MESH IMPLANTED. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Hernia; No Clinical Signs, Symptoms or Conditions

  MAUDE report 10022511 ↗
• InjuryMay 4, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN VENTRAL HERNIA REPAIR ON (B)(6) 2009 WHEREBY A GORE® DUALMESH® PLUS BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2009, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: WADDING OF MESH, FORMATION OF 8X6CM MASS, SWISS CHEESE DEFECT FORMATION, RECURRENT HERNIA, REMOVAL AND NEW IMPLANT. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Hernia; No Code Available

  MAUDE report 10020932 ↗