GORE DUALMESH Biomaterial 1DLMC02Recalls & reported problems

Summary

The FDA's MAUDE database contains 47 adverse event reports that list this exact device (DI 00733132600953), received between Jun 26, 2018 and Jun 20, 2024 — classified as 47 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (46 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 47 reports, in the reporter's own words as published by the FDA.

• InjuryJun 20, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT LAPAROSCOPIC INCISIONAL HERNIA REPAIR ON (B)(6) 2014 WHEREBY A GORE® DUALMESH® BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2019 AND (B)(6) 2019, ADDITIONAL PROCEDURES OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: BOWEL, COLON, OR OMENTUM ADHESIONS TO MESH, SEROMA/ABSCESS, BOWELL OR COLON RESECTION, BOWEL, COLON OR OTHER ORGAN PERFORATION, WOUND TREATMENT/WOUND VAC FOR 90+ DAYS ON (B)(6)2 014 - INCISIONAL HERNIA REPAIRED WITH GORE DUAL MESH. ON (B)(6) 2019 - TAKEN TO EMERGENCY SURGERY FOR COLONIC PERFORATION, OLD MESH AND PORTIONS OF COLON REMOVED. MESH WAS DENSELY ADHERENT TO THE UNDERLYING VISCERA. DURING THE LYSIS OF ADHESIONS A RIGHT RETROPERITONEAL ABSCESS WAS NOTED BEHIND THE TERMINAL ILEUM. ON (B)(6) 2019 - END COLOSTOMY CREATION AND PARTIAL SKIN CLOSURE WITH PACKING.. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Abscess; Tissue Breakdown; Unspecified Infection

  MAUDE report 19578309 ↗
• InjuryNov 7, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT LAPAROSCOPIC INCISIONAL, VENTRAL SUPRAUMBILICAL HERNIA REPAIR ON (B)(6) 2001 WHEREBY A GORE® DUALMESH® PLUS BIOMATERIAL WAS IMPLANTED. IF APPLICABLE: THE COMPLAINT ALLEGES THAT ON (B)(6) 2011, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: RECURRENT HERNIA WITH ADHESIONS. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Hernia

  MAUDE report 18085714 ↗
• InjuryNov 7, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT LAPAROSCOPIC INCISIONAL, VENTRAL SUPRAUMBILICAL HERNIA REPAIR ON (B)(6) 2001 WHEREBY A GORE® DUALMESH® PLUS BIOMATERIAL WAS IMPLANTED. IF APPLICABLE: THE COMPLAINT ALLEGES THAT ON (B)(6) 2011, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: RECURRENT HERNIA WITH ADHESIONS. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Hernia

  MAUDE report 18085700 ↗
• InjuryNov 1, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN INCISIONAL HERNIA REPAIR ON (B)(6) 2007 WHEREBY A GORE® DUALMESH® BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON APRIL 28, 2015, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: MESH REMOVED DUE TO RECURRENT HERNIA WITH INFECTED MESH. MESH WAS UNINCORPORATED AND FLOATING IN THE LOWER CHRONIC SINUS TRACT. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 18048040 ↗
• InjurySep 18, 2023Migration; Migration

  THE FOLLOWING INFORMATION WAS OBTAINED FROM THE MEDICAL RECORDS. IMPLANT PROCEDURE: LYSIS OF ADHESIONS. REMOVAL OF EXISTING HERNIA MESH. RECURRENT VENTRAL INCISIONAL HERNIA REPAIR WITH MESH. [IMPLANT: GORE® DUALMESH® BIOMATERIAL, 1DLMC02/ (B)(6), 8CM X 12CM X 1MM THICK] IMPLANT DATE: (B)(6), 2009 [HOSPITALIZATION DATES UNKNOWN]. EXPLANT PROCEDURE: 1. EXTERNAL LYSIS OF ADHESIONS. 2. LEFT-SIDED POSTERIOR COMPONENT SEPARATION. 3. VENTRAL INCISIONAL HERNIA REPAIR WITH A PIECE OF 28X36 CM RETROMUSCULAR HEAVYWEIGHT POLYPROPYLENE MESH. 4. REMOVAL OF EXISTING MESH. [IMPLANT: CR BARD MESH MARLEX POLYPROPYLENE 14IN X 10IN [36 X 28 CM] EXPLANT DATE: (B)(6) 2015 [HOSPITALIZATION DATES UNKNOWN]. IT WAS INITIALLY REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN INCISIONAL HERNIA REPAIR ON (B)(6) 2009 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: RECURRENT VENTRAL INCISIONAL HERNIA REPAIR WITH MESH, REMOVAL OF EXISTING MESH, LYSIS OF ADHESIONS, ADHESIONS BETWEEN THE COLON AND THE MESH WERE TAKEN DOWN. INFERIOR ASPECT

  Patient problems: Hernia

  MAUDE report 17765606 ↗
• InjuryAug 21, 2023Insufficient 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® BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2009 AND (B)(6) 2012, ADDITIONAL PROCEDURES OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: MESH REMOVED DUE TO INFECTED MESH. SECOND MESH REMOVED DUE TO INFECTED MESH WITH RECURRENT HERNIA. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 17590190 ↗
• InjuryAug 21, 2023Insufficient 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® BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6), 2009 AND (B)(6), 2012, ADDITIONAL PROCEDURES OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: MESH REMOVED DUE TO INFECTED MESH. SECOND MESH REMOVED DUE TO INFECTED MESH WITH RECURRENT HERNIA. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 17590186 ↗
• InjuryFeb 26, 2022Insufficient 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® 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: OPEN DRAINING WOUND, INFECTION, FISTULA, ABSCESS, AND CHRONIC PAIN/DISCOMFORT. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

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

  MAUDE report 13609097 ↗
• InjuryJun 22, 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) 2001 WHEREBY A GORE® DUALMESH® 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, SURGERY TO REMOVE MESH, HERNIA RECURRENCE, SEVERE AND CHRONIC PAIN/DISCOMFORT. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Hernia; Unspecified Infection

  MAUDE report 12046021 ↗
• InjuryMay 4, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT LAPAROSCOPIC INGUINAL HERNIA REPAIR ON (B)(6) 2019 WHEREBY TWO GORE® DUALMESH® BIOMATERIAL DEVICES WERE 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: HERNIA RECURRENCE, MESH MIGRATION, INFLAMMATION-2 DM+ DEVICES, 1 IN RIGHT INGUINAL AND 1 IN LEFT INGUINAL. RIGHT SIDED DEVICE "MIGRATED FAR ANTERIOR TO THE INGUINAL ORIFICE" AND WAS EXPLANTED. NO ALLEGATIONS AGAINST LEFT INGUINAL GORE DEVICE. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

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

  MAUDE report 11767955 ↗
• InjuryApr 30, 2021Insufficient 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) 2007, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. 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 11754252 ↗
• InjuryApr 30, 2021Insufficient 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® BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2011, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: ADHESIONS, "CURLING OF THE MESH AND NON-ADHERENCE" MIGRATION, EXPLANT, HERNIA RECURRENCE. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

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

  MAUDE report 11754228 ↗
• InjuryAug 6, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT LAPAROSCOPIC OPEN INCISIONAL HERNIA REPAIR ON (B)(6) 2007 AND (B)(6) 2007 WHEREBY MULTIPLE GORE® DUALMESH® BIOMATERIAL WERE IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2007, (B)(6) 2007, AND (B)(6) 2007 ADDITIONAL PROCEDURES OCCURRED WHEREBY THE GORE DEVICES WERE EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: INFECTION, PAIN, ADDITIONAL SURGICAL PROCEDURES, MESH REMOVAL, ABSCESS AND EXCISION OF NECROTIC SKIN AND HERNIA SAC. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

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

  MAUDE report 10374117 ↗
• InjuryMay 6, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT LAPAROSCOPIC MORGAGNI HERNIA REPAIR ON (B)(6) 2010 WHEREBY A GORE® DUALMESH® BIOMATERIAL WAS IMPLANTED. AND AN INCISIONAL LAPAROSCOPIC HERNIA REPAIR ON (B)(6) 2010 AND (B)(6) 2014, WHEREBY A GORE® DUALMESH® BIOMATERIAL WAS ALSO IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2010 AND (B)(6) 2014, ADDITIONAL PROCEDURES OCCURRED WHEREBY THE GORE DEVICES WERE EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: RECURRENCE OF HERNIA, MESH REMOVED, NEW MESH PLACED, AND RECURRENCE OF HERNIA, SMALL BOWEL OBSTRUCTION, MESH PULLED AWAY. MORE MESH IMPLANTED. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

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

  MAUDE report 10029555 ↗
• InjuryMay 5, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT LAPAROSCOPIC VENTRAL INCISIONAL HERNIA REPAIR ON (B)(6) 2010 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: REMOVAL OF INFECTED MESH; LYSIS OF ADHESIONS, FISTULA, SMALL BOWEL OBSTRUCTION, UMBILICAL DRAINAGE; INFLAMMATION; SMALL BOWEL PERFORATION; PAIN AND SUFFERING. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

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

  MAUDE report 10024178 ↗
• InjuryMar 13, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT LAPAROSCOPIC PARAESOPHAGEAL HIATAL HERNIA REPAIR ON (B)(6) 2003 WHEREBY A GORE® DUALMESH® BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2006, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2006 AND (B)(6) 2007, ADDITIONAL PROCEDURES OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: ADHESIONS, HERNIA RECURRENCE, MESH EROSION, MESH MIGRATION, MESH DETACHMENT, SURGERY TO REMOVE MESH, PARTIAL EXPLANT X2, SEVERE AND CHRONIC PAIN. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Adhesion(s); Dysphagia/ Odynophagia; Erosion; Hernia; Pain

  MAUDE report 9830174 ↗
• InjuryDec 6, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT LAPAROSCOPIC INCISIONAL HERNIA REPAIR ON (B)(6) 2002 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: REMOVAL OF INFECTED MESH. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

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

  MAUDE report 9428900 ↗
• InjuryOct 21, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT LAPAROSCOPIC VENTRAL HERNIA REPAIR ON (B)(6) 2012 AND (B)(6) 2015 WHEREBY A "ALLEGED GORE DEVICE" AND A GORE® DUALMESH® BIOMATERIAL WERE IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2017, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE AND "ALLEGED GORE DEVICE" WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: MESH INFECTION REQUIRING REMOVAL. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

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

  MAUDE report 9216026 ↗
• InjuryOct 21, 2019Insufficient 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® 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: INFECTED MESH REQUIRING REMOVAL SURGERY. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 9213621 ↗
• InjuryOct 14, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN VENTRAL HERNIA REPAIR ON (B)(6) 2001 WHEREBY A GORE® DUALMESH® 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: INFECTED MESH REQUIRING REMOVAL SURGERY. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

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

  MAUDE report 9186383 ↗
• InjuryOct 4, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT LAPAROSCOPIC VENTRAL HERNIA REPAIR ON (B)(6) 2004 WHEREBY A GORE® DUALMESH® BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2015, AN ADDITIONAL PROCEDURE OCCURRED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: SMALL BOWEL OBSTRUCTION ON (B)(6) 2015 REQUIRING AN ADDITIONAL SURGERY. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Obstruction/Occlusion

  MAUDE report 9158203 ↗
• 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) 2008 WHEREBY TWO GORE® DUALMESH® BIOMATERIAL WERE IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2009, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICES WERE 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: No Information; Obstruction/Occlusion

  MAUDE report 9134352 ↗
• 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) 2008 WHEREBY TWO GORE® DUALMESH® BIOMATERIAL WERE IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2009, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICES WERE 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: No Clinical Signs, Symptoms or Conditions; No Information

  MAUDE report 9134345 ↗
• InjurySep 28, 2019Insufficient 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® BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2005, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: MESH WADDED UP, MESH REMOVAL. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

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

  MAUDE report 9132464 ↗
• InjurySep 24, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT PERIUMBILICAL INCISIONAL HERNIA REPAIR ON (B)(6) 2007 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: MESH WADDED UP AND PROTRUDED THROUGH, MESH REMOVAL REQUIRING AN ADDITIONAL SURGERY. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

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

  MAUDE report 9112639 ↗