GORE DUALMESH PLUS BIOMATERIAL 1DLMCP04Recalls & reported problems

Summary

The FDA's MAUDE database contains 210 adverse event reports that list this exact device (DI 00733132601110), received between Jun 26, 2018 and Apr 15, 2024 — classified as 210 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (203 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 210 reports, in the reporter's own words as published by the FDA.

• InjuryApr 15, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN VENTRAL HERNIA REPAIR ON (B)(6) 2011 WHEREBY A GORE® DUALMESH® PLUS BIOMATERIAL WITH HOLES WAS IMPLANTED AND ON (B)(6)2014 WHEREBY A GORE® DUALMESH® PLUS BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2023, ADDITIONAL PROCEDURES OCCURRED WHEREBY THE GORE DEVICE WERE EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: HERNIA RECURRENCE, REMOVAL, BOWEL INVOLVEMENT, ADHESIONS. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Hernia

  MAUDE report 19106363 ↗
• InjuryApr 8, 2024Insufficient 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), 2023, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: FISTULA, BOWEL ADHESION TO MESH, ADHESIONS, BOWEL RESECTION, FIBROSIS, INFLAMMATION, PAIN. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Fistula; Obstruction/Occlusion; Unspecified Infection

  MAUDE report 19058797 ↗
• InjuryNov 13, 2023Insufficient 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® PLUS BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2006 AND (B)(6) 2007, ADDITIONAL PROCEDURES OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. THE COMPLAINT ALSO ALLEGES THAT ON (B)(6) 2007 AND (B)(6) 2008, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: MULTIPLE REMOVAL SURGERIES DUE TO MESH INFECTION. INSTANCES OF FREE FLOATING MESH AND ADHESIONS TO THE MESH. TWO SINUS TRACTS REMOVED. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

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

  MAUDE report 18127720 ↗
• 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 18085247 ↗
• InjuryOct 25, 2023Insufficient 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® PLUS 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 REVISED DUE TO RECURRENT HERNIA WITH SMALL BOWEL OBSTRUCTION AND LARGE CHRONIC SEROMA. MESH REMOVED DUE TO INFECTION AND ABSCESS. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Seroma; Unspecified Infection

  MAUDE report 18003476 ↗
• InjuryAug 29, 2023Insufficient 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) 2010, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: HERNIA RECURRENCE, SEVERE AND CHRONIC PAIN/DISCOMFORT. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED. INFORMATION FROM OUTSIDE OF GORE RECEIVED ON OCTOBER 13, 2022 CHANGED THE ALLEGATIONS TO: ¿HERNIA RECURRENCE, SEVERE AND CHRONIC PAIN/DISCOMFORT, INFECTED MESH, FAILURE TO INCORPORATE.¿ INFORMATION FROM OUTSIDE OF GORE RECEIVED ON OCTOBER 13, 2022 CONTAINED THE FOLLOWING: EXPLANT DATE CHANGED FROM ¿(B)(6) 2010-REVISION NOT EXPLANT¿ ; EXPLANT DATE #2: (B)(6) 2010.

  Patient problems: Unspecified Infection

  MAUDE report 17643862 ↗
• InjuryJul 31, 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) 2013, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: INFECTION, DEBRIDEMENT, PAIN. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 17425468 ↗
• InjuryJul 24, 2023Microbial Contamination of Device; Microbial Contamination of Device

  THE FOLLOWING INFORMATION WAS OBTAINED FROM MEDICAL RECORDS. IMPLANT PROCEDURE: EXPLORATORY LAPAROTOMY, LYSIS OF DENSE ADHESION, REPAIR OF MULTIPLE INCARCERATED RECURRENT INCISIONAL HERNIA X6 WITH DUALMESH. PARTIAL OMENTECTOMY. IMPLANT: GORE® DUALMESH® PLUS BIOMATERIAL [1DLMCP04/11263274]. IMPLANT DATE: (B)(6) 2013 EXPLANT PROCEDURE: DEBRIDEMENT OF ANTERIOR ABDOMINAL WOUND. EXCISION OF FISTULA. EXCISION OF INFECTED GORE-TEX MESH. EXPLANT DATE: (B)(6) 2014 IMPLANT #1: 3730-1. IT WAS INITIALLY REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN INCISIONAL HERNIA REPAIR ON (B)(6) 2013 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: INFECTION, EXPLANT AND FISTULA. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Abscess; Unspecified Infection

  MAUDE report 17380064 ↗
• InjuryMay 22, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT LAPAROSCOPIC EPIGASTRIC HERNIA REPAIR ON (B)(6) 2004 WHEREBY A GORE® DUALMESH® PLUS BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2004, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: PAIN, HERNIA RECURRENCE DUE TO FAILURE OF MESH. FAILURE MODE IS MIGRATION OF MESH. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 16974940 ↗
• InjuryMay 2, 2023Insufficient 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) 2020, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: ADDITIONAL SURGERY, PAIN, REMOVAL, ADHESIONS, EXPULSION OF MESH. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

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

  MAUDE report 16856288 ↗
• InjuryApr 6, 2023Migration; Migration

  HOLD NBII 4/6THE FOLLOWING INFORMATION WAS OBTAINED FROM MEDICAL RECORDS IMPLANT PROCEDURE: VENTRAL HERNIORRHAPHY, LAPAROSCOPIC REPAIR WITH DUAL MESH USED BY GORE. [IMPLANT: GORE® DUALMESH® PLUS BIOMATERIAL, 1DLMCP06/8634130, 18CM X 24CM X 1 MM THICK] IMPLANT #1 DATE: (B)(6) 2011 (HOSPITALIZATION DATES UNKNOWN). IMPLANT #2 PROCEDURE: LAPAROSCOPIC VENTRAL HERNIA REPAIR. IMPLANT: GORE® DUALMESH® BIOMATERIAL, 1DLMCP04/(B)(4), 15CM X 19CM X 1MM THICK, OVAL) IMPLANT #2 DATE: (B)(6) 2013 (HOSPITALIZATION (B)(6) 2013). EXPLANT #1 AND #2 PROCEDURE: EXPLORATORY LAPAROTOMY. LYSIS OF ADHESIONS. REDUCTION OF RECURRENT, INCARCERATED VENTRAL INCISIONAL HERNIA CONTENTS. EXPLANATION OF ABDOMINAL WALL MESH. EXPLANT #1 AND #2 DATE: (B)(6) 2017 (HOSPITALIZATION (B)(6) 2017) IMPLANT #1: 3245-1 IMPLANT #2: 3245-2 . IT WAS INITIALLY REPORTED TO GORE THAT THE PATIENT UNDERWENT LAPAROSCOPIC VENTRAL HERNIA REPAIR ON (B)(6) 2011 AND 2013 WHEREBY GORE® DUALMESH® PLUS BIOMATERIAL WERE IMPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: MESH FAILURE RESULTING IN PAIN, LIMITED RANGE OF MOTION. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Hernia

  MAUDE report 16689737 ↗
• InjuryApr 6, 2023Material Deformation; Material Deformation

  THE FOLLOWING INFORMATION WAS OBTAINED FROM THE MEDICAL RECORDS. IMPLANT PROCEDURE: LAPAROSCOPIC EXPLORATION WITH TAKEDOWN OF ADHESIONS, AND REPAIR OF INCISIONAL HERNIA. [IMPLANT: GORE® DUALMESH® PLUS BIOMATERIAL, 1DLMCP04/8706163, 15 CM X 19 CM X 1MM THICK, OVAL] IMPLANT DATE: (B)(6) 2012 (HOSPITALIZATION (B)(6) 2012) EXPLANT PROCEDURE: DIAGNOSTIC LAPAROSCOPY WITH REDUCTION OF SUPERIOR AND INFERIOR HERNIAS AROUND CONTRACTED MESH. LAPAROSCOPIC MESH REMOVAL. EXPLANT DATE: (B)(6) 2020 [HOSPITALIZATION DATES UNKNOWN] IT WAS INITIALLY REPORTED TO GORE THAT THE PATIENT UNDERWENT LAPAROSCOPIC INCISIONAL HERNIA REPAIR ON (B)(6) 2012 WHEREBY A GORE® DUALMESH® PLUS BIOMATERIAL WAS IMPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: MESH FAILURE RESULTING IN PAIN, LIMITED RANGE OF MOTION, NEED FOR EXCISION. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Hernia

  MAUDE report 16689411 ↗
• InjuryApr 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS OBTAINED FROM THE MEDICAL RECORDS. IMPLANT #1 PROCEDURE: REPAIR OF PARASTOMAL HERNIA. [IMPLANT: GORE® BIO-A® TISSUE REINFORCEMENT, FS0915/(B)(4), 9CM X 15 CM]. IMPLANT #1 DATE: (B)(6) 2014 (HOSPITALIZATION (B)(6) 2014). IMPLANT #2 PROCEDURE: LAPAROSCOPIC PARASTOMAL HERNIA REPAIR WITH MESH. [IMPLANT: GORE® DUALMESH® PLUS BIOMATERIAL, 1DLMCP04/(B)(4), 15CM X 19CM X 1 MM THICK, OVAL]. IMPLANT #2 DATE: (B)(6) 2018 (HOSPITALIZATION (B)(6) 2018) . EXPLANT PROCEDURE: DIAGNOSTIC LAPAROSCOPY. REMOVAL OF PREVIOUSLY PLACED MESH. REDUCTION OF INCARCERATED SMALL BOWEL FROM PARASTOMAL HERNIA WITH LAPAROSCOPIC SMALL BOWEL RESECTION AND ANASTOMOSIS. PARASTOMAL HERNIA REPAIR WITH STRATTICE MESH. EXPLANT DATE: (B)(6) 2019 (HOSPITALIZATION (B)(6) 2019). IMPLANT #1: 1375-1. IMPLANT #2: 1375-2. NO EVIDENCE THAT EXPLANT OF THE DEVICE #1 [BIO-A] OCCURRED. IT WAS INITIALLY REPORTED TO GORE THAT THE PATIENT UNDERWENT LAPAROSCOPIC PARASTOMAL HERNIA REPAIR ON (B)(6) 2014 AND (B)(6) 2018 WHEREBY A GORE® BIO-A® TISSUE REINFORCEMENT AND GORE® DUALMESH® PLUS BIOMATERIAL WERE IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2018 AND (B)(6) 2019, ADDITIONAL PROCEDURES OCCURRED WHEREBY

  Patient problems: Obstruction/Occlusion

  MAUDE report 16689216 ↗
• InjuryMar 27, 2023Migration; Migration

  THE FOLLOWING INFORMATION WAS OBTAINED FROM MEDICAL RECORDS. IMPLANT PROCEDURE: LAPAROSCOPIC REDUCTION OF SIGMOID VOLVULUS AND SOME PARTIAL REDUCTION. ATTEMPTED PARASTOMAL HERNIA REPAIR CONVERTED TO OPEN PARASTOMAL HERNIA REPAIR WITH GORE-TEX DUALMESH 15 X 19 CM¿MODIFIED KEYHOLE REPAIR. [IMPLANT: GORE® DUALMESH® PLUS BIOMATERIAL, 1DLMCP04/(B)(4), 15CM X 19CM X 1MM THICK, OVAL]. IMPLANT DATE: (B)(6) 2013 (HOSPITALIZATION APRIL (B)(6) 2013). EXPLANT PROCEDURE: SPY PHI INDOCYANINE FLUORESCENT ANGIOGRAPHY TO ASSESS BOWEL PERFUSION. END ILEOSTOMY REVERSAL WITH ANASTOMOSIS TO RECTAL STUMP. EXPLANATION OF GORE DUALMESH AT PARASTOMAL HERNIA SITE. BILATERAL RETRORECTUS MYOFASCIAL RELEASE. RIGHT SIDED TRANSVERSE ABDOMINIS RELEASE. REPAIR OF INCISIONAL MIDLINE HERNIA AND PARASTOMAL HERNIA. IMPLANTATION OF MESH. EXPLANT DATE: (B)(6) 2020 (HOSPITALIZATION (B)(6) 2020). IMPLANT #1: 2806-1. IT WAS INITIALLY REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN PARASTOMAL HERNIA REPAIR ON (B)(6) 2013 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 ALLE

  Patient problems: Hernia

  MAUDE report 16617830 ↗
• InjuryFeb 21, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT AN UNKNOWN LAPAROSCOPIC/ROBOTIC HERNIA REPAIR ON (B)(6), 2011 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: MESH EXPLANT, SEROMA, INFECTION, PAIN. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Seroma

  MAUDE report 16409163 ↗
• InjuryFeb 10, 2023Insufficient 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® PLUS BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2017 AND (B)(6) 2017, ADDITIONAL PROCEDURES OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: HERNIA RECURRENCE, INFECTIONS, DRAINAGE, ADHESIONS, MESH MIGRATION AND SEVERE PAIN, AND LOSS OF DOMAIN. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Abscess; Unspecified Infection

  MAUDE report 16355141 ↗
• InjuryJan 31, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT LAPAROSCOPIC INCISIONAL HERNIA REPAIR ON (B)(6) 2010 WHEREBY A GORE® DUALMESH® PLUS BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2016, (B)(6) 2016 AND (B)(6) 2017 , ADDITIONAL PROCEDURES OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: ADDITIONAL SURGERIES; ADHESIONS; SMALL BOWEL OBSTRUCTION; RECURRENCE; MESH REMOVAL; NECROSIS & FIBROSIS; WOUND VAC; JP DRAIN; PAIN & SUFFERING. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Obstruction/Occlusion

  MAUDE report 16273403 ↗
• InjuryJan 31, 2023Insufficient 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 WITH HOLES WAS IMPLANTED AND ON (B)(6) 2012 WHEREBY A GORE® DUALMESH® PLUS BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2008 AND (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; MULTIPLE RECURRENCES; MESH REMOVAL; INFECTED MESH; SEROMA; SEROSAL TEAR; WOUND VAC PAIN & SUFFERING. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

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

  MAUDE report 16271705 ↗
• InjuryOct 21, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT LAPAROSCOPIC VENTRAL HERNIA REPAIR ON (B)(6) 2018 WHEREBY A GORE® DUALMESH® PLUS BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2020 AND (B)(6) 2020, ADDITIONAL PROCEDURES OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: MESH REMOVAL, RECURRENCE, SEROMA, ADHESIONS, PAIN AND SUFFERING. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Seroma

  MAUDE report 15653582 ↗
• InjuryAug 17, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN VENTRAL 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: ADDITIONAL SURGERY, CHRONIC INFLAMMATION, MESH REMOVAL, WOUND DEBRIDEMENT, WOUND VAC, INFECTION, ADHESIONS, RECURRENCE, SEROMA, PAIN & SUFFERING. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Insufficient Information; Unspecified Infection

  MAUDE report 15242768 ↗
• InjuryJul 6, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT LAPAROSCOPIC INCISIONAL HERNIA REPAIR ON (B)(6) 2004, (B)(6) 2007, AND (B)(6) 2011 WHEREBY GORE® DUALMESH® PLUS BIOMATERIAL DEVICES WERE IMPLANTED. THE COMPLAINT ALLEGES THAT ON (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: RECURRENCE. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

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

  MAUDE report 14936217 ↗
• InjuryJul 6, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT LAPAROSCOPIC INCISIONAL HERNIA REPAIR ON (B)(6) 2004, (B)(6) 2007, AND (B)(6) 2011 WHEREBY GORE® DUALMESH® PLUS BIOMATERIAL DEVICES WERE IMPLANTED. THE COMPLAINT ALLEGES THAT ON (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: RECURRENCE. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

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

  MAUDE report 14935466 ↗
• InjuryJun 30, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT LAPAROSCOPIC VENTRAL HERNIA REPAIR ON (B)(6) 2002 WHEREBY A GORE® DUALMESH® PLUS BIOMATERIAL WAS 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: ADDITIONAL SURGERY, RECURRENCE, DIARRHEA, INFECTION, LEUKOCYTOSIS, NAUSEA, PAIN & SUFFERING. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

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

  MAUDE report 14881120 ↗
• InjuryJun 29, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT LAPAROSCOPIC VENTRAL HERNIA REPAIR ON (B)(6) 2005 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: ADDITIONAL SURGERY, PAIN & SUFFERING, INFECTION, MESH REMOVAL, SEROMA, INFECTED MESH. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Seroma; Unspecified Infection

  MAUDE report 14860152 ↗
• InjuryJun 15, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT LAPAROSCOPIC INCISIONAL 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: ADHESIONS, DENSE ADHESIONS, MESH DEFORMATION/MIGRATION, MESH REMOVAL, RECURRENCE, REVISION, SEROMA, PAIN AND SUFFERING. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

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

  MAUDE report 14705825 ↗