GORE DUALMESH PLUS BIOMATERIAL 1DLMCP02Recalls & reported problems

Summary

The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 00733132601097), received between Jun 27, 2018 and Nov 7, 2023 — classified as 38 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (38 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 38 reports, in the reporter's own words as published by the FDA.

• InjuryNov 7, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN INCISIONAL HERNIA REPAIR ON (B)(6), 2012 WHEREBY A GORE® DUALMESH® PLUS BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6), 2014, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: MESH REMOVED DUE TO INFECTION. MESH HAD PULLED AWAY FROM THE MEDIAL ASPECT OF THE HERNIA. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 18083198 ↗
• InjuryJan 24, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT LAPAROSCOPIC PARASTOMAL HERNIA REPAIR ON (B)(6) 2019 WHEREBY A GORE® DUALMESH® PLUS BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2021, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: CHRONIC PAIN, RECURRENCE, SMALL BOWEL OBSTRUCTION. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

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

  MAUDE report 16237116 ↗
• InjuryAug 22, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT LAPAROSCOPIC VENTRAL HERNIA REPAIR ON (B)(6) 2007 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: ADDITIONAL SURGERY, RECURRENCE, ADHESIONS, INFECTION, SEROMA, WOUND VAC (JP DRAIN), WOUND DEBRIDEMENT, NG TUBE, ERYTHEMA PAIN & SUFFERING. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

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

  MAUDE report 15271973 ↗
• InjuryAug 19, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN VENTRAL HERNIA REPAIR ON (B)(6) 2006 WHEREBY A GORE® DUALMESH® PLUS 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: ABSCESS, INFECTED MESH, REMOVAL OF MESH, ABDOMINAL WALL RECONSTRUCTION, ADHESIONS, AND PAIN AND SUFFERING. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Abscess; Unspecified Infection

  MAUDE report 12343660 ↗
• InjuryJul 22, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT LAPAROSCOPIC VENTRAL/INCISIONAL HERNIA REPAIR ON (B)(6) 2008 WHEREBY A GORE® DUALMESH® PLUS 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: INFECTION, REVISION/REMOVAL SURGERY. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Erosion; Tissue Breakdown; Unspecified Infection

  MAUDE report 12212197 ↗
• InjuryMay 3, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN PARAESOPHAGEAL HERNIA REPAIR ON (B)(6) 2013 WHEREBY A GORE® DUALMESH® PLUS 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: "MESH FAILURE", MIGRATION, HERNIA RECURRENCE, MASSIVE ADHESIONS. INFECTION, EXPLANT. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Hernia; Unspecified Infection

  MAUDE report 11766294 ↗
• InjuryMar 2, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN VENTRAL HERNIA REPAIR ON (B)(6) 2015 WHEREBY A GORE® DUALMESH® PLUS 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: REMOVAL OF GORE MESH, MESH WAS NOT INCORPORATED INTO THE FASCIA, MESH WAS ENTANGLED IN VERY DENSE ADHESIONS, STIFF AND UNWIELDY, SMALL BOWEL RESECTION, SMALL BOWEL OBSTRUCTION, INCARCERATED RECURRENT VENTRAL HERNIA REPAIRED WITH SUTURES. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

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

  MAUDE report 11401794 ↗
• InjuryJan 26, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT LAPAROSCOPIC VENTRAL HIATAL HERNIA REPAIR ON (B)(6) 2010, (B)(6) 2017, AND (B)(6) 2017, WHEREBY GORE® DUALMESH® PLUS BIOMATERIAL AND GORE® BIO-A® TISSUE REINFORCEMENT WERE IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2014, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY ONE OF THE GORE DEVICES WERE EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: REMOVAL OF GORE MESH DUE TO DENSE EROSION AND INFECTION, GORE MESH WAS STAINED THROUGHOUT DUE TO EROSION, FOUL SMELL FROM THE INFECTED GORE MESH, LARGE PORTION OF THE STOMACH ERODED TO THE GORE MESH, GASTRECTOMY DUE TO MESH EROSION, PORTION OF GORE MESH APPEARED DARK AND DISCOLORED, DENSE ADHESIONS NOTED ALONG THE UNDERSURFACE OF THE LIVER, PRIMARY REPAIR OF RECURRENT HIATAL HERNIA DEFECT. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

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

  MAUDE report 11231310 ↗
• InjuryDec 18, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN VENTRAL HERNIA REPAIR ON (B)(4)2007 WHEREBY A GORE® DUALMESH® PLUS 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: RECURRENCE, DENSE ADHESIONS, MESH SHRINKAGE, MESH EROSION, PAIN AND SUFFERING. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

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

  MAUDE report 11038618 ↗
• InjuryDec 17, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT LAPAROSCOPIC UMBILICAL HERNIA REPAIR ON (B)(6) 2009 WHEREBY A GORE® DUALMESH® PLUS 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 MIGRATION, DENSE ADHESIONS, RECURRENCE, PAIN AND SUFFERING. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

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

  MAUDE report 11032715 ↗
• InjurySep 25, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT LAPAROSCOPIC VENTRAL HERNIA REPAIR ON (B)(6) 2007 WHEREBY A GORE® DUALMESH® PLUS BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2007, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: HERNIA RECURRENCE, MESH ROLLED UP INSIDE THE ABDOMEN, MESH STUCK SUPERIORLY TO OMENTUM, SEVERE PAIN, DIARRHEA, STOMACH CRAMPS. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

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

  MAUDE report 10590471 ↗
• InjuryAug 11, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN VENTRAL HERNIA REPAIR ON (B)(6) 2007 WHEREBY A GORE® DUALMESH® PLUS BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2007, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: INFECTION AND SEROMA; WOUND EXPLORATION AND DRAINAGE OF SEROMA. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Seroma; Unspecified Infection

  MAUDE report 10393769 ↗
• InjuryJun 2, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN VENTRAL HERNIA REPAIR ON (B)(6) 2010 WHEREBY A GORE-TEX® SOFT TISSUE PATCH WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2011, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY A GORE® DUALMESH® PLUS BIOMATERIAL WAS IMPLANTED. ON (B)(6) 2018 AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE® DUALMESH® PLUS BIOMATERIAL WAS PARTIALLY REMOVED DUE TO INFECTED ABDOMINAL WALL MESH. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: RECURRENT VENTRAL HERNIA DUE TO MESH FAILURE; DENSELY ADHERED TO BOWEL LOOPS; PAIN & SUFFERING.

  Patient problems: Unspecified Infection

  MAUDE report 10109875 ↗
• InjuryNov 26, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT INCISIONAL HERNIA REPAIR ON (B)(6) 2010 WHEREBY A GORE® DUALMESH® PLUS BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2014 AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: MESH REMOVAL, MESH WAS DETACHED AND WADDED UP AND CHRONICALLY INFECTED. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

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

  MAUDE report 9379375 ↗
• InjuryNov 5, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT VENTRAL HERNIA REPAIR ON (B)(6) 2005 WHEREBY A GORE® DUALMESH® PLUS BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2006, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: REMOVAL OF MESH REQUIRING AN ADDITIONAL SURGERY. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: No Information; Unspecified Infection

  MAUDE report 9280410 ↗
• InjuryOct 22, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT LAPAROSCOPIC UMBILICAL HERNIA REPAIR ON (B)(6) 2008 WHEREBY A GORE® DUALMESH® PLUS BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: TO BE SUPPLEMENTED. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Insufficient Information; No Information

  MAUDE report 9220177 ↗
• InjuryOct 2, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT LAPAROSCOPIC VENTRAL HERNIA REPAIR ON (B)(6) 2008 WHEREBY A GORE® DUALMESH® PLUS 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: MESH INFECTION, ABDOMINAL WALL ABSCESS, FISTULA, MESH ADHERENCE TO SMALL BOWEL REQUIRING SMALL BOWEL RESECTION, MESH REMOVAL. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Abscess; Adhesion(s); Unspecified Infection

  MAUDE report 9146147 ↗
• InjurySep 30, 2019Insufficient 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® PLUS 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: INFECTED MESH REQUIRING REMOVAL SURGERY. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Abscess; Unspecified Infection

  MAUDE report 9135359 ↗
• InjurySep 27, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT LAPAROSCOPIC INCISIONAL HERNIA REPAIR ON (B)(6) 2006 WHEREBY TWO GORE® DUALMESH® PLUS BIOMATERIAL WERE IMPLANTED. THE COMPLAINT ALLEGES THAT ON AN UNKNOWN DATE IN (B)(6) 2019, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: MESH REMOVAL REQUIRING AN ADDITIONAL SURGERY. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Insufficient Information; No Information

  MAUDE report 9131860 ↗
• InjurySep 25, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT UMBILICAL HERNIA REPAIR ON (B)(6) 2008 WHEREBY A GORE® DUALMESH® PLUS 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 INFECTED MESH. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 9119132 ↗
• InjurySep 6, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT LAPAROSCOPIC VENTRAL HERNIA REPAIR ON (B)(6) 2008 WHEREBY A GORE® DUALMESH® PLUS 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: MESH CONTRACTED, MESH REMOVAL, ADDITIONAL SURGERY. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Hernia; No Code Available

  MAUDE report 8968703 ↗
• InjuryAug 30, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN INCISIONAL HERNIA REPAIR ON (B)(6) 2008 WHEREBY A GORE® DUALMESH® PLUS BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2018, AN ADDITIONAL REVISION PROCEDURE OCCURRED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: MESH WAS CURLED AT THE EDGES, MESH FAILURE REQUIRING REVISION SURGERY. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Code Available

  MAUDE report 8951681 ↗
• InjuryAug 27, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN INCISIONAL HERNIA REPAIR ON (B)(6) 2009 WHEREBY A GORE® DUALMESH® PLUS 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 AND ADDITIONAL SURGERY. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

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

  MAUDE report 8938031 ↗
• InjuryAug 27, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN INCISIONAL HERNIA REPAIR ON (B)(6) 2005 WHEREBY A GORE® DUALMESH® PLUS 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, REMOVAL OF BOTH MESH PRODUCTS AND SMALL BOWEL OBSTRUCTION. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Adhesion(s); Obstruction/Occlusion

  MAUDE report 8934375 ↗
• InjuryAug 22, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN INCISIONAL HERNIA REPAIR ON (B)(6) 2005 WHEREBY A GORE® DUALMESH® PLUS BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2007, AN ADDITIONAL PROCEDURE OCCURRED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: MESH FAILURE AND ADDITIONAL SURGERY. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: No Code Available; Obstruction/Occlusion

  MAUDE report 8920093 ↗