GORE DUALMESH PLUS BIOMATERIAL 1DLMCP07Recalls & reported problems

Summary

The FDA's MAUDE database contains 87 adverse event reports that list this exact device (DI 00733132601141), received between Jun 27, 2018 and May 22, 2026 — classified as 1 death, 86 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (85 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 87 reports, in the reporter's own words as published by the FDA.

• InjuryMay 22, 2026Insufficient 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, AND (B)(6) 2019, ADDITIONAL PROCEDURES OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: HERNIA RECURRENCE, INFECTION, ABSCESS, DENSE ADHESIONS, WOUND VAC. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Abscess; Unspecified Infection

  MAUDE report 25259826 ↗
• InjuryJun 5, 2024Insufficient 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) 2022, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: (B)(6) 2022 - EXPLANTATION OF ABDOMINAL WALL HERNIOPLASTY MESH FOR INFECTION. PLACEMENT OF WOUND VAC. ¿AS EXPECTED, THE MESH WAS NOT INCORPORATED AND COULD EASILY BE PULLED OFF OF THE ABDOMINAL WALL. SUPERFICIAL TO THE MESH WAS A CHRONIC ABSCESS CAVITY WITH INFECTED APPEARING FLUID¿. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Abscess; Unspecified Infection

  MAUDE report 19468151 ↗
• InjuryFeb 2, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN VENTRAL HERNIA REPAIR ON (B)(6) 2002 WHEREBY TWO GORE® DUALMESH® PLUS BIOMATERIAL WERE IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2016, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: ADHESIONS TO BOWEL, HERNIA RECURRENCE, MESH DISRUPTION, SMALL BOWEL OBSTRUCTION, ADHESIONS, OPEN DRAINING WOUND, SURGERY TO REMOVE PARTIAL MESH, EXPOSED MESH, INFECTION, FISTULA, BOWEL RESECTION, SCARRING, SURGERY TO REMOVE MESH, ABDOMINAL WALL RECONSTRUCTION, GROSS PURULENCE ON MESH, ABSCESS, MESH DETACHMENT, SUCCUS STAINING ON MESH, SMALL BOWEL FISTULA TO MESH, ADHESIONS TO SMALL INTESTINE, CHRONIC INFLAMMATION, INFLAMMATION. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Hernia

  MAUDE report 18630160 ↗
• InjurySep 13, 2023Migration; Migration

  THE FOLLOWING INFORMATION WAS OBTAINED FROM THE MEDICAL RECORDS. IMPLANT PROCEDURE: EXPLORATORY LAPAROTOMY. TAKEDOWN OF THE BOWEL FROM THE ADHESIONS TO THE PREVIOUS MESH. PLACEMENT OF 20 X 30 GORE-TEX MESH. APPENDECTOMY. [IMPLANT: GORE® DUALMESH® PLUS BIOMATERIAL, 1DLMCP07/9651014, 20CM X 30CM X 1MM THICK] IMPLANT DATE: (B)(6) 2012. (HOSPITALIZATION (B)(6) 2012). PARTIAL EXPLANT PROCEDURE: EXPLORATORY ABDOMINAL SURGERY WITH REMOVAL OF MOST OF THE GORE-TEX MESH, ESPECIALLY DISTALLY WHERE THE WORST MASS AND PAIN WAS. PRIMARY REPAIR OF THE ANTERIOR ABDOMINAL WALL. PARTIAL EXPLANT DATE:(B)(6) 2020 (HOSPITALIZATION DATES UNKNOWN). A PORTION OF THE DEVICE REMAINS IMPLANTED. IT WAS INITIALLY REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN VENTRAL INCISIONAL HERNIA REPAIR ON (B)(6) 2012 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: MESH ROLLED OVER AND KINKED, ESPECIALLY IN THE INFERIOR AND INTO THE RIGHT OF THE MIDLINE, MESH DETA HMENT, SURGERY TO REMOVE MESH, MOST OF MESH WAS REMOVED, SEVERE AND CHRONI

  Patient problems: Hernia

  MAUDE report 17736005 ↗
• InjuryApr 17, 2023Insufficient 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) 2009 AND (B)(6) 2013, ADDITIONAL PROCEDURES OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: HERNIA RECURRENCE, REVISION SURGERY, CHRONIC ABDOMINAL PAIN, SURGERY TO REMOVE MESH, ADHESIONS, COMPONENT SEPARATION. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Hernia

  MAUDE report 16754718 ↗
• InjuryApr 5, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN INCISIONAL HERNIA REPAIR ON (B)(6)2017, 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: INFECTED MESH, MESH EXPOSURE, HERNIA RECURRENCE. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Abscess; Tissue Breakdown; Unspecified Infection

  MAUDE report 16685579 ↗
• InjuryMay 19, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT LAPAROSCOPIC INCISIONAL HERNIA REPAIR ON (B)(6) 2013 WHEREBY A GORE® DUALMESH® PLUS BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2013 AND (B)(6) 2014, ADDITIONAL PROCEDURES OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: ADHESIONS, DEBRIDEMENT, INFECTION, WOUND VAC, AND REMOVAL. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

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

  MAUDE report 14438888 ↗
• InjuryJan 25, 2022Insufficient 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® 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, INFECTION, SEROMA, ABSCESS, PAIN AND SUFFERING. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

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

  MAUDE report 13345446 ↗
• InjuryJan 6, 2022Insufficient 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) 2019, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: ADHESIVE DISEASE, ABDOMINAL PAIN, DENSE ADHESIONS, HERNIA RECURRENCE, MESH CONTRACTION, AND THE NEED FOR ADDITIONAL SURGICAL INTERVENTION. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Seroma

  MAUDE report 13181719 ↗
• InjuryOct 29, 2021Adverse Event Without Identified Device or Use Problem

  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 WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: "MESH INFECTION", "MESH REMOVAL", "ADDITIONAL SURGERY". ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Tissue Breakdown

  MAUDE report 12718198 ↗
• InjuryOct 15, 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) 2011 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: REMOVAL OF GORE MESH DUE TO HIGH GRADE BOWEL OBSTRUCTION; EXTENSIVE LYSIS OF ADHESIONS TO FREE SMALL BOWEL FROM GORE MESH; MULTIPLE LOOPS OF SEVERELY DILATED SMALL BOWEL DENSELY ADHERENT TO GORE MESH; ABDOMINAL PAIN; FLUID IN PELVIS. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Obstruction/Occlusion

  MAUDE report 12641421 ↗
• InjurySep 21, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN INCISIONAL HERNIA REPAIR ON (B)(6) 2010 WHEREBY A GORE® DUALMESH® PLUS BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2010, (B)(6) 2010 AND (B)(6) 2011 ADDITIONAL PROCEDURES OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: ADDITIONAL SURGERIES, INCISION AND DRAINAGE, PAIN, SEROMA, WOUND VAC, MESH REMOVAL. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Seroma; Unspecified Infection

  MAUDE report 12510500 ↗
• InjuryJul 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) 2012 WHEREBY A GORE® DUALMESH® PLUS 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: OPEN DRAINING WOUND, SURGERY TO REMOVE MESH, INFECTION, SCARRING, ADHESIONS, SEVERE AND CHRONIC PAIN/DISCOMFORT. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

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

  MAUDE report 12200367 ↗
• InjuryJul 8, 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® PLUS 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: ADHESIONS, ABDOMINAL PAIN. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 12139725 ↗
• InjuryJul 8, 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® PLUS 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: ADHESIONS, ABDOMINAL PAIN. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 12139687 ↗
• InjuryJun 21, 2021Insufficient 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) 2017, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: ADHESIONS TO SMALL INTESTINE, ADHESIONS, BOWEL RESECTION, SURGERY TO REMOVE MESH, FISTULA, INFLAMMATION, CHRONIC ABDOMINAL PAIN, INFECTION, HERNIA RECURRENCE. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

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

  MAUDE report 12037714 ↗
• InjuryApr 29, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN INCISIONAL HERNIA REPAIR ON (B)(6) 2002 WHEREBY A GORE® DUALMESH® PLUS BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2018 AND (B)(6) 2019, ADDITIONAL PROCEDURES OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: OPEN DRAINING WOUND, RIGHT UPPER ABDOMINAL WOUND ABSCESS, EXPLANT DUE TO INFECTION. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Abscess; Unspecified Infection

  MAUDE report 11749308 ↗
• InjuryApr 29, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT LAPAROSCOPIC INCARCERATED DIAPHRAGMATIC & INCARCERATED VENTRAL HERNIA REPAIR ON (B)(6) 2016 WHEREBY A GORE® DUALMESH® PLUS BIOMATERIAL WAS IMPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: INFECTION. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

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

  MAUDE report 11749250 ↗
• InjuryApr 12, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT LAPAROSCOPIC ABDOMINAL INCISIONAL HERNIA REPAIR ON (B)(6) 2015 WHEREBY A GORE® DUALMESH® PLUS 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: SMALL BOWEL OBSTRUCTION, RECURRENT HERNIA, DEHISCENCE OF PREVIOUS REAPPROXIMATED GORETEX MESH, RECTUS DIASTASIS SECONDARY TO BRIDGED HERNIA MESH, ADHESIONS. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

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

  MAUDE report 11650259 ↗
• InjuryMar 25, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN VENTRAL/INCISIONAL HERNIA REPAIR ON (B)(6) 2002 WHEREBY A GORE® DUALMESH® PLUS 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: CHRONIC INFECTION OF "GORE-TEX MESH; EXPLANT: DENSE SEROMA CAPSULE LOCATED UNDERNEATH DUALMESH WHICH WAS ITSELF DENSELY ADHERENT TO OMENTUM AND SMALL-BOWEL IN ALL FOUR QUADRANTS ADHESIOLYSIS OF ADHESIONS PERFORMED. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Seroma; Unspecified Infection

  MAUDE report 11569192 ↗
• InjuryNov 24, 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) 2009, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: REMOVAL OF GORE MESH, MESH FOUND BROKEN DOWN AND RETRACTED WITH MULTIPLE SEGMENTS OF SMALL BOWEL INCORPORATED IN, GORE MESH EROSION TO BOWEL CAUSING OBSTRUCTION, RECURRENT VENTRAL HERNIA REPAIRED WITH PLACEMENT OF NEW MESH, EXTENSIVE ADHESIONS. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Hernia; Obstruction/Occlusion

  MAUDE report 10892578 ↗
• InjurySep 28, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT UPPER, MIDLINE, AND LOWER ABDOMEN HERNIA REPAIR ON (B)(6) 2003 WHEREBY TWO GORE® DUALMESH® PLUS BIOMATERIAL WERE 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: ADHESIONS, HERNIA RECURRENCE, SEROMA, SCARRING, INFECTION, NECROSIS, SURGERY TO REMOVE MESH, ADHESIONS TO SMALL INTESTINE, ADHESIONS TO BOWEL, BOWEL OBSTRUCTION, PRIOR MESH HAD SEPARATED FROM THE FASCI, CHRONIC ABDOMINAL PAIN, FOREIGN BODY REACTION. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

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

  MAUDE report 10596811 ↗
• InjurySep 28, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT UPPER, MIDLINE, AND LOWER ABDOMEN HERNIA REPAIR ON (B)(6) 2003 WHEREBY TWO GORE® DUALMESH® PLUS BIOMATERIAL WERE 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: ADHESIONS, HERNIA RECURRENCE, SEROMA, SCARRING, INFECTION, NECROSIS, SURGERY TO REMOVE MESH, ADHESIONS TO SMALL INTESTINE, ADHESIONS TO BOWEL, BOWEL OBSTRUCTION, PRIOR MESH HAD SEPARATED FROM THE FASCI, CHRONIC ABDOMINAL PAIN, FOREIGN BODY REACTION. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

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

  MAUDE report 10596784 ↗
• InjurySep 21, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT LAPAROSCOPIC INCISIONAL HERNIA REPAIR ON (B)(6) 2001 WHEREBY A GORE® DUALMESH® PLUS BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2001, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: INFECTION, ADHESIONS, FISTULA, ABSCESS. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Fistula; Unspecified Infection

  MAUDE report 10564461 ↗
• InjuryAug 13, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  HOLD KV 8/16/23

  Patient problems: Unspecified Infection

  MAUDE report 10402707 ↗