GORE DUALMESH Biomaterial 1DLMC200Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00733132601035), received between Jun 27, 2018 and May 3, 2021 — classified as 11 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (11 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryMay 3, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN UMBILICAL HERNIA REPAIR ON (B)(6) 2014 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: INFECTION, EXPLANT. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 11763235 ↗
• InjuryApr 30, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT UMBILICAL HERNIA REPAIR ON (B)(6) 2010 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: RECURRENCE. MIGRATION. EXPLANT. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Hernia

  MAUDE report 11754295 ↗
• InjuryMar 24, 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) 2015, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: RECURRENCE, INFECTED MESH, DRAINING SINUS. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

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

  MAUDE report 11566037 ↗
• InjuryAug 26, 2020Insufficient 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) 2007, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: ADHESIONS, BOWEL OBSTRUCTION/PROBLEMS, HERNIA RECURRENCE, REMOVAL, REVISION, BOWEL RESECTION, BOWEL INVOLVEMENT. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

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

  MAUDE report 10457158 ↗
• InjuryAug 29, 2019Insufficient 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® BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2013, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS REVISED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: MESH FAILURE REQUIRING AN ADDITIONAL REVISION SURGERY. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

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

  MAUDE report 8944465 ↗
• InjuryAug 21, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT LAPAROSCOPIC/OPEN INCISIONAL HERNIA REPAIR ON (B)(6) 2012 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: INFECTED MESH & WOUND VAC PLACEMENT, MESH REMOVAL, ADDITIONAL SURGERY. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8915490 ↗
• InjuryAug 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) 2002 AND (B)(6) 2002 WHEREBY GORE® DUALMESH® BIOMATERIALS WERE IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2002, AN ADDITIONAL PROCEDURE FOR SEROMA DRAIN PLACEMENT OCCURRED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: SEROMA, ADDITIONAL PROCEDURE. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

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

  MAUDE report 8914879 ↗
• InjuryAug 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) 2002 AND (B)(6) 2002 WHEREBY GORE® DUALMESH® BIOMATERIALS WERE IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2002, AN ADDITIONAL PROCEDURE FOR SEROMA DRAIN PLACEMENT OCCURRED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: SEROMA, ADDITIONAL PROCEDURE. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

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

  MAUDE report 8914874 ↗
• InjuryAug 21, 2019Insufficient 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® 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: RETRACTION OF MESH (B)(6) 2017, INFECTED MESH, REMOVAL OF MESH, ADDITIONAL SURGERIES. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

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

  MAUDE report 8914444 ↗
• InjuryJun 27, 2018No Apparent Adverse Event; Insufficient Device Problem Information; No Apparent Adverse Event; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN CHEST WALL RECONSTRUCTION ON (B)(6) 2010 AND (B)(6) 2010 WHEREBY GORE DUALMESH® PLUS BIOMATERIAL DEVICES WERE IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2010, THE GORE DEVICES WERE EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: PAIN, OPEN DRAINING WOUND, INFECTION, AND MESH REMOVAL. ADDITIONAL EVENT SPECIFIC INFORMATION AND MEDICAL RECORDS HAVE BEEN REQUESTED.

  Patient problems: Discharge; Not Applicable; Pain; Unspecified Infection

  MAUDE report 7640951 ↗
• InjuryJun 27, 2018No Apparent Adverse Event; Insufficient Device Problem Information; No Apparent Adverse Event; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN CHEST WALL RECONSTRUCTION ON (B)(6) 2010 AND (B)(6) 2010 WHEREBY GORE DUALMESH® PLUS BIOMATERIAL DEVICES WERE IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2010, THE GORE DEVICES WERE EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: PAIN, OPEN DRAINING WOUND, INFECTION, AND MESH REMOVAL. ADDITIONAL EVENT SPECIFIC INFORMATION AND MEDICAL RECORDS HAVE BEEN REQUESTED.

  Patient problems: Discharge; Not Applicable; Pain; Unspecified Infection

  MAUDE report 7640944 ↗