COMPOSIX 0123460Recalls & reported problems

Summary

The FDA's MAUDE database contains 115 adverse event reports that list this exact device (DI 00801741031182), received between Aug 30, 2017 and Jul 3, 2026 — classified as 1 death, 114 injuries.

The most frequently reported specific device problem is “Defective Device” (111 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 115 reports, in the reporter's own words as published by the FDA.

• InjuryJul 3, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2011 - PATIENT WAS DIAGNOSED WITH VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF COMPOSIX E/X MESH (DEVICE 1). PER OP NOTES, ¿THE HERNIA SAC WAS IDENTIFIED IN ABDOMINAL REGION. A COMPOSIX E/X MESH WAS PLACED ON THE INTRAPERITONEAL SURFACE OF THE FASCIA AND SUTURED¿. ON (B)(6) 2019- PATIENT WAS DIAGNOSED WITH VENTRAL INCISIONAL HERNIA REPAIR WITH MESH. ON (B)(6) 2019 - PATIENT WAS DIAGNOSED WITH VENTRAL INCISIONAL HERNIA, EPIGASTRIC HERNIA, THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRALEX ST MESH (DEVICE 2). PER OP NOTES, ¿THE PREVIOUS SCAR WAS EXCISED. THE HERNIA DEFECT WAS REPAIRED BY PLACING A VENTRALEX ST MESH (DEVICE 2) AND SUTURED¿.

  Patient problems: Hernia; Scar Tissue

  MAUDE report 25707240 ↗
• InjuryFeb 25, 2026Material Deformation

  PER INFORMATION PROVIDED: (B)(6) 2010 - PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA WITH PAIN THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF COMPOSIX E/X MESH (DEVICE 1). PER OPERATIVE NOTES, ¿MULTIPLE ANTERIOR ABDOMINAL WALL ADHESIONS WITH A LARGE, HERNIATED DEFECT IN FROM PRIOR PFANNENSTIEL INCISION WAS NOTED. THE ADHESIONS WERE TAKEN DOWN, AND LARGE DEFECT WAS REDUCED AND COMPOSIX E/X MESH (DEVICE 1) WAS PLACED AND OVER THE DEFECT IN THE RIGHT LOWER QUADRANT AND TACKED IN PLACE. THE FASCIA WAS CLOSED AND SECURED WITH SUTURES AND TACKS.¿ (B)(6) 2011 ¿ PATIENT HAD RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF COMPOSIX E/X MESH (DEVICE 2) AND REMOVAL OF TACKS. (NOTE: THERE IS NO OPERATIVE NOTE PROVIDED FOR THIS PROCEDURE IN MEDICAL RECORDS). (B)(6) 2018 ¿ PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA, SMALL BOWEL OBSTRUCTION WITH ABDOMINAL PAIN THEREBY UNDERWENT OPEN REPAIR WITH REMOVAL OF PRIOR MESHES (DEVICE 1 AND 2) AND PRIMARY REPAIR OF RECURRENT HERNIA. PER OPERATIVE NOTES, ¿MINOR OMENTAL ADHESIONS WERE TAKEN DOWN AND WRINKLED MESHES (DEVICE 1 AND 2) IN LOWER ABDOMEN IN MIDLINE WAS NOTED. THE DILATED BOWEL AND DECO

  Patient problems: Abdominal Pain; Adhesion(s); Fibrosis; Hernia; Obstruction/Occlusion; Wrinkling

  MAUDE report 24444449 ↗
• InjuryJan 29, 2026Migration

  PER INFORMATION PROVIDED: (B)(6) 2024 - PATIENT WAS DIAGNOSED WITH INCARCERATED INCISIONAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF COMPOSIX E/X MESH (DEVICE 1 AND 2). PER OP NOTES, ¿THE HERNIA WAS IDENTIFIED IN THE EPIGASTRIC AREA AND THE OMENTUM WAS PARTIALLY REDUCED. ADHESIONS BETWEEN THE SMALL BOWEL AND HERNIA SAC WERE LYSED. SMALL BOWEL ADHERENT TO THE ANTERIOR ABDOMINAL WALL WERE LYSED. A COMPOSIX E/X MESH (DEVICE 1) WAS PLACED ALONG THE ANTERIOR ABDOMINAL WALL AND SECURED WITH TACKER. A COMPOSIX E/X MESH (DEVICE 2) WAS PLACED INTO THE PERITONEAL CAVITY IN THE IDENTICAL CONFIGURATION AND SECURED TO THE ANTERIOR ABDOMINAL WALL WITH TACKER.¿ (B)(6) 2008 - PATIENT WAS DIAGNOSED WITH INFECTED MESH AND RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH EXCISION OF COMPOSIX E/X MESH (DEVICE 1 AND 2) AND IMPLANT OF BIOLOGICAL PATCH. PER OP NOTES, ¿DENSE ADHESIONS AND THE BORDER OF THE MESH WERE IDENTIFIED IN THE LEFT SIDE OF THE ABDOMEN. THE ABSCESS CAVITY BETWEEN THE FASCIA AND THE MESH WAS NOTED. A LARGE AMOUNT OF FECULENT AND FOUL-SMELLING FLUID AS WELL AS BLOOD WAS OBTAINED AND THE AREA WAS IRRIGATED OUT. A LARGE MESH WAS IDENTIFIED ON THE RIGHT S

  Patient problems: Fistula; Hernia; Unspecified Infection

  MAUDE report 24207872 ↗
• InjuryJul 14, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2009 ¿ PATIENT WAS DIAGNOSED WITH TWO INCISIONAL HERNIAS THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT OF COMPOSIX E/X MESH (DEVICE #1) AND VENTRALEX MESHES (DEVICE #2, #3). PER OP NOTES, ¿HERNIA IN THE MIDLINE OF THE ABDOMEN ADJACENT TO UMBILICUS WAS NOTED. A COMPOSIX E/X MESH (DEVICE #1) WAS PLACED THE DEFECT AND SUTURED. THEN, SECOND HERNIA WAS NOTED INFERIORLY WAS REPAIRED USING A VENTRALEX MESH (DEVICE #2) AND TACKED TO INFERIOR ABDOMINAL WALL. A WEAKENED POINT WAS NOTED SUPERIOR TO SECOND HERNIA WAS REPAIRED WITH ANOTHER VENTRALEX MESH (DEVICE #3) AND SUTURED.¿ (B)(6) 2010 ¿ PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT OF SEPRAMESH IP (DEVICE #4). PER OP NOTES, ¿A LARGE AMOUNT OF ADHESIONS WERE NOTED IN THE MIDLINE OF ABDOMEN AND SIGNIFICANT HERNIATION NOTED IN SUPRAUMBILICAL AREA. A LARGE PIECE OF SEPRAMESH IP (DEVICE #4) WAS PLACED INTO THE SUPRAUMBILICAL HERNIA DEFECT AND TACKED USING SORBAFIX.¿ (B)(6) 2016 ¿ PATIENT WAS DIAGNOSED WITH INFECTED MESH AND ENTEROCUTANEOUS FISTULA, ADHESIONS THEREBY UNDERWENT OPEN REPAIR WITH THE REMOVAL OF MESHES (DEVICE #1, #2, #3, #4). PE

  Patient problems: Fistula; Hernia; Unspecified Infection

  MAUDE report 22492559 ↗
• InjuryJan 10, 2025Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  PER INFORMATION PROVIDED BY PATIENT¿S ATTORNEY. (B)(6) 2013 - PATIENT WAS DIAGNOSED WITH LARGE VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF COMPOSIX E/X MESH (DEVICE #1). PER OPERATIVE NOTES, ¿IDENTIFIED THE HERNIA SAC AND WAS DISSECTED FREE. A COMPOSIX E/X MESH (DEVICE #1) WAS TACKED INTO THE ABDOMINAL CAVITY USING SUTURES.¿ (B)(6) 2014 - PATIENT WAS DIAGNOSED WITH INCISIONAL HERNIA RECURRENCE THEREBY UNDERWENT OPEN REPAIR WITH THE REMOVAL OF MESH (DEVICE #1) AND IMPLANT OF COMPOSIX E/X MESH (DEVICE #2). PER OPERATIVE NOTES, ¿HERNIA SAC WAS REMOVED. ADHESIONS OF SMALL BOWEL TO THE ANTERIOR ABDOMEN WALL AND AREA OF SMALL BOWEL ADHESIONS TO THE MESH DIRECTLY WITH THE MESH INCORPORATION INTO THE SEROSA OF THE BOWEL. THIS PIECE OF MESH (DEVICE #1) WAS REMOVED AND THEN DISSECTED OF THE BOWEL. A COMPOSIX E/X MESH (DEVICE #2) WAS SECURED USING SUTURES.¿ (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH ABDOMINAL WALL ABSCESS AND INFECTED VENTRAL HERNIA MESH THEREBY UNDERWENT REPAIR WITH PARTIAL REMOVAL OF MESH (DEVICE #2) AND IMPLANT OF BIOLOGIC MESH. PER OPERATIVE NOTES, ¿THE MESH WAS THEN IDENTIFIED WITH THE ABSCESS OF THE PURULENT FLUID. THE MESH WAS THEN REMOVED (DEVICE #2

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

  MAUDE report 21122245 ↗
• InjuryAug 29, 2023Defective Device; Patient Device Interaction Problem; Migration; Defective Device; Patient Device Interaction Problem; Migration

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF UNSPECIFIED BARD/DAVOL COMPOSIX E/X AND COMPOSIX KUGEL HERNIA PATCH ON (B)(6) 2005 AND/OR (B)(6) 2010. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE BOTH DEVICES. IT IS ALLEGED THAT THE PATIENT HAD REVISION SURGERIES ON (B)(6) 2010 AND (B)(6) 2021. ATTORNEY ALLEGES GENERAL ALLEGATIONS FOR "PAST, PRESENT, AND FUTURE DAMAGES, INCLUDING BUT NOT LIMITED TO, MENTAL AND PHYSICAL PAIN AND SUFFERING FOR SEVERE AND PERMANENT PERSONAL INJURIES SUSTAINED BY THE PATIENT." IT IS ALSO ALLEGED THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Adhesion(s); Hernia; Insufficient Information; Pain

  MAUDE report 17640433 ↗
• InjuryJul 13, 2023Defective Device; Patient-Device Incompatibility; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF UNSPECIFIED BARD/DAVOL VENTRALEX ON (B)(6) 2010, COMPOSIX E/X ON (B)(6) 2010 AND VENTRIO ON (B)(6) 2013. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE VENTRALEX AND COMPOSIX E/X. ATTORNEY ALLEGES GENERAL ALLEGATIONS FOR "PAST, PRESENT, AND FUTURE DAMAGES, INCLUDING BUT NOT LIMITED TO, MENTAL AND PHYSICAL PAIN AND SUFFERING FOR SEVERE AND PERMANENT PERSONAL INJURIES SUSTAINED BY THE PATIENT." IT IS ALSO ALLEGED THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Adhesion(s); Hernia; Insufficient Information; Pain

  MAUDE report 17314500 ↗
• InjuryJun 3, 2022Defective Device; Patient-Device Incompatibility; Patient Device Interaction Problem; Defective Device; Patient-Device Incompatibility; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL COMPOSITE MESH (COMPOSIX) ON (B)(6) 2006. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE COMPOSITE MESH (COMPOSIX). IT IS ALLEGED THAT THE PATIENT HAD INJURY ON (B)(6) 2008 AND ON (B)(6) 2018. ATTORNEY ALLEGES GENERAL ALLEGATIONS FOR "PAST, PRESENT, AND FUTURE DAMAGES, INCLUDING BUT NOT LIMITED TO, MENTAL AND PHYSICAL PAIN AND SUFFERING FOR SEVERE AND PERMANENT PERSONAL INJURIES SUSTAINED BY THE PATIENT¿. IT IS ALSO ALLEGED THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Adhesion(s); Hernia; Insufficient Information; Pain; Scar Tissue

  MAUDE report 14590738 ↗
• InjuryMar 30, 2022Defective Device; Patient Device Interaction Problem; Defective Device; Patient-Device Incompatibility; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF UNSPECIFIED BARD/DAVOL VENTRALIGHT ST ON (B)(6) 2013 AND COMPOSIX E/X ON (B)(6) 2016. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST BOTH DEVICES. ATTORNEY ALLEGES GENERAL ALLEGATIONS FOR "PAST, PRESENT, AND FUTURE DAMAGES, INCLUDING BUT NOT LIMITED TO, MENTAL AND PHYSICAL PAIN AND SUFFERING FOR SEVERE AND PERMANENT PERSONAL INJURIES SUSTAINED BY THE PATIENT." IT IS ALSO ALLEGED THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Adhesion(s); Hernia; Insufficient Information; Pain

  MAUDE report 13951552 ↗
• InjuryMar 29, 2022Defective Device; Patient-Device Incompatibility; Patient Device Interaction Problem; Defective Device; Patient-Device Incompatibility; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL COMPOSIX E/X ON (B)(6) 2016 . AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE COMPOSIX E/X. ATTORNEY ALLEGES THAT THE PATIENT HAD SUBSEQUENT SURGICAL INTERVENTION DUE TO THE HERNIA MESH DEVICE. IT IS ALSO ALLEGED THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Hernia; Insufficient Information

  MAUDE report 13945688 ↗
• InjuryMar 24, 2022Defective Device; Patient-Device Incompatibility; Patient Device Interaction Problem; Defective Device; Patient-Device Incompatibility; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL COMPOSIX E/X ON (B)(6) 2002. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE COMPOSIX E/X. ATTORNEY ALLEGES GENERAL ALLEGATIONS FOR "PAST, PRESENT, AND FUTURE DAMAGES, INCLUDING BUT NOT LIMITED TO, MENTAL AND PHYSICAL PAIN AND SUFFERING FOR SEVERE AND PERMANENT PERSONAL INJURIES SUSTAINED BY THE PATIENT." IT IS ALSO ALLEGED THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Abscess; Insufficient Information; Pain; Scar Tissue; Unspecified Infection

  MAUDE report 13893102 ↗
• InjuryMar 3, 2022Defective Device; Patient-Device Incompatibility; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL COMPOSIX E/X ON (B)(6) 2020. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST COMPOSIX E/X. ATTORNEY ALLEGES THAT THE PATIENT HAD SUBSEQUENT SURGICAL INTERVENTION DUE TO THE HERNIA MESH DEVICE. IT IS ALSO ALLEGED THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Adhesion(s); Hernia; Insufficient Information; Seroma

  MAUDE report 13663790 ↗
• InjuryJul 2, 2021Defective Device; Patient-Device Incompatibility; Patient Device Interaction Problem; Defective Device; Patient-Device Incompatibility; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL COMPOSIX E/X ON (B)(6) 2005. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE COMPOSIX E/X. THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2018. ATTORNEY ALLEGES GENERAL ALLEGATIONS FOR "PAST, PRESENT, AND FUTURE DAMAGES, INCLUDING BUT NOT LIMITED TO, MENTAL AND PHYSICAL PAIN AND SUFFERING FOR SEVERE AND PERMANENT PERSONAL INJURIES SUSTAINED BY THE PATIENT." IT IS ALSO ALLEGED THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Adhesion(s); Hernia; Insufficient Information; Necrosis; Pain; Unspecified Infection

  MAUDE report 12108035 ↗
• InjuryJul 1, 2021Defective Device; Material Deformation; Patient Device Interaction Problem; Migration; Defective Device; Material Deformation; Patient Device Interaction Problem; Migration

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL COMPOSIX E/X ON (B)(6) 2011. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE COMPOSIX E/X. ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2013. ATTORNEY ALLEGES GENERAL ALLEGATIONS FOR "PAST, PRESENT, AND FUTURE DAMAGES, INCLUDING BUT NOT LIMITED TO, MENTAL AND PHYSICAL PAIN AND SUFFERING FOR SEVERE AND PERMANENT PERSONAL INJURIES SUSTAINED BY THE PATIENT." IT IS ALSO ALLEGED THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Adhesion(s); Hernia; Insufficient Information; Pain

  MAUDE report 12101464 ↗
• InjuryJun 3, 2021Defective Device; Patient-Device Incompatibility; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  Attorney alleges that the patient underwent surgery for implant of an unspecified Bard/Davol Composix E/X on (b)(6) 2005. As reported, the patient is making a claim for an adverse patient outcome against the Composix E/X. Attorney alleges that the patient had subsequent surgical intervention due to the Hernia Mesh device. It is also alleged that the patient experienced emotional distress and the device was defective.Addendum per Plaintiff Profile Form and Medical Records:(b)(6) 2005 - Patient was diagnosed with recurrent umbilical/ventral hernia thereby underwent laparoscopic repair with implant of Composix E/X Mesh. Per operative notes, ¿An incision was made into the abdominal cavity. The hernia sac was dissected out. A Composix E/X Mesh was placed into the intra-abdominal cavity and secured it with sutures.¿(b)(6) 2013 - Patient was diagnosed with small bowel obstruction, adhesions thereby underwent open repair with explant of Composix E/X Mesh and primary repair. Per operative notes, ¿An incision was made through previous midline of the umbilicus. There were significant dilated loops of small bowel, some adhesions were bluntly taken down. At the umbilicus the old mesh was identi

  Patient problems: Adhesion(s); Insufficient Information; Obstruction/Occlusion

  MAUDE report 11934956 ↗
• InjuryJan 11, 2021Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information; Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR THE IMPLANT OF AN UNSPECIFIED BARD/DAVOL COMPOSIX E/X ON (B)(6) 2011. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST COMPOSIX E/X. ATTORNEY ALLEGES GENERAL ALLEGATIONS FOR "PAST, PRESENT, AND FUTURE DAMAGES, INCLUDING BUT NOT LIMITED TO, MENTAL AND PHYSICAL PAIN AND SUFFERING FOR SEVERE AND PERMANENT PERSONAL INJURIES SUSTAINED BY THE PATIENT." IT IS ALSO ALLEGED THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Adhesion(s); Disability; Injury; Pain

  MAUDE report 11146904 ↗
• InjuryDec 3, 2020Defective Device; Material Deformation; Insufficient Device Problem Information; Migration; Defective Device; Material Deformation; Insufficient Device Problem Information; Migration

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF UNSPECIFIED BARD/DAVOL COMPOSIX E/X AND VENTRALEX HERNIA PATCH ON (B)(6) 2013. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST BOTH DEVICES. ATTORNEY ALLEGES THAT THE PATIENT HAD SUBSEQUENT SURGICAL INTERVENTION DUE TO THE HERNIA MESH DEVICE. IT IS ALSO ALLEGED THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Adhesion(s); Hernia; Injury; Obstruction/Occlusion; Pain

  MAUDE report 10939591 ↗
• InjuryNov 24, 2020Defective Device; Insufficient Device Problem Information; Migration; Defective Device; Insufficient Device Problem Information; Migration

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR THE IMPLANT OF UNSPECIFIED BARD/DAVOL COMPOSIX E/X (X2) ON (B)(6) 2005 AND (B)(6) 2005. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST BOTH DEVICES. ATTORNEY ALLEGES GENERAL ALLEGATIONS FOR "PAST, PRESENT, AND FUTURE DAMAGES, INCLUDING BUT NOT LIMITED TO, MENTAL AND PHYSICAL PAIN AND SUFFERING FOR SEVERE AND PERMANENT PERSONAL INJURIES SUSTAINED BY THE PATIENT." IT IS ALSO ALLEGED THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Adhesion(s); Disability; Hernia; Injury; Pain

  MAUDE report 10893657 ↗
• InjuryNov 24, 2020Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information; Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR THE IMPLANT OF UNSPECIFIED BARD/DAVOL COMPOSIX E/X (X2) ON (B)(6) 2005 AND (B)(6) 2005. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST BOTH DEVICES. ATTORNEY ALLEGES GENERAL ALLEGATIONS FOR "PAST, PRESENT, AND FUTURE DAMAGES, INCLUDING BUT NOT LIMITED TO, MENTAL AND PHYSICAL PAIN AND SUFFERING FOR SEVERE AND PERMANENT PERSONAL INJURIES SUSTAINED BY THE PATIENT." IT IS ALSO ALLEGED THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Adhesion(s); Disability; Hernia; Injury; Pain

  MAUDE report 10893600 ↗
• InjuryOct 27, 2020Defective Device; Material Deformation; Insufficient Device Problem Information; Defective Device; Material Deformation; Insufficient Device Problem Information

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF UNSPECIFIED BARD/DAVOL COMPOSIX E/X ON (B)(6) 2011 AND VENTRIO ST ON (B)(6) 2013. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST COMPOSIX E/X. IT IS ALLEGED THAT THE PATIENT SUSTAINED INJURIES ON (B)(6) 2013. ATTORNEY ALLEGES GENERAL ALLEGATIONS FOR "PAST, PRESENT, AND FUTURE DAMAGES, INCLUDING BUT NOT LIMITED TO, MENTAL AND PHYSICAL PAIN AND SUFFERING FOR SEVERE AND PERMANENT PERSONAL INJURIES SUSTAINED BY THE PATIENT." IT IS ALSO ALLEGED THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Abdominal Pain; Adhesion(s); Disability; Injury; Pain

  MAUDE report 10739973 ↗
• InjuryOct 24, 2020Defective Device; Insufficient Device Problem Information; Defective Device; Insufficient Device Problem Information

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR REPAIR OF A LEFT INDIRECT INGUINAL HERNIA ON OR ABOUT (B)(6) 2003, A BARD/DAVOL PERFIX PLUG WAS IMPLANTED TO REPAIR THE HERNIA DEFECT. ON OR ABOUT (B)(6) 2003 THE PATIENT UNDERWENT ADDITIONAL SURGERY TO REPAIR THE RECURRENT LEFT INGUINAL HERNIA. IT IS ALLEGED THAT THE PATIENT UNDERWENT ADDITIONAL SURGERY INVOLVING AN EXPLORATION OF WOUND SINUS, RESECTION OF INFECTED MESH AND SUTURE REPAIR OF HERNIA ON OR ABOUT (B)(6) 2004. ON OR ABOUT (B)(6) 2005 THE PATIENT UNDERWENT SURGERY FOR REPAIR OF AN INCISIONAL HERNIA AND A BARD/DAVOL COMPOSIX E/X WAS IMPLANTED TO REPAIR THE HERNIA DEFECT. ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT A REMOVAL OF ABDOMINAL WALL MESH AFTER PRESENTING WITH A SINUS DRAINING AND SEPSIS ON OR ABOUT (B)(6) 2006. ON OR ABOUT (B)(6) 2007 THE PATIENT UNDERWENT ADDITIONAL SURGERY TO REPAIR AN INCISIONAL HERNIA. IT IS ALLEGED THAT THE PATIENT WAS INJURED SEVERELY AND PERMANENTLY. IT IS ALLEGED THAT THE PATIENT SUFFERED PAIN, DISABILITY, HOSPITALIZATIONS AND ADDITIONAL SURGERIES. THE PATIENT HAS SUFFERED AND WILL CONTINUE TO SUFFER PHYSICAL PAIN AND MENTAL ANGUISH, CHRONIC PAIN, PSYCHOLOGICAL STRESS, DEPRESSION AN

  Patient problems: Disability; Sepsis; Unspecified Infection

  MAUDE report 10731803 ↗
• InjuryOct 14, 2020Defective Device; Insufficient Device Problem Information; Defective Device; Insufficient Device Problem Information

  ATTORNEY ALLEGES THAT ON OR ABOUT (B)(6) 2008, THE PATIENT UNDERWENT SURGERY FOR REPAIR OF A MASSIVE INCISIONAL HERNIA. A COMPOSIX E/X, WAS IMPLANTED TO REPAIR THE HERNIA DEFECT. ON OR ABOUT (B)(6) 2008, THE PATIENT UNDERWENT AN ADDITIONAL SURGERY. AN EXCISION OF INFECTED MESH AND REPAIR OF RE-RECURRENT INCISIONAL HERNIA WAS PERFORMED. ON OR ABOUT (B)(6) 2009, THE PATIENT UNDERWENT A REVISION OF WOUND PROCEDURE DUE TO A WOUND HEMATOMA THAT RELEASED THROUGH PREVIOUS INCISION FOLLOWING THE PATIENT'S REPAIR ON (B)(6) 2008. ON OR ABOUT (B)(6) 2015, THE PATIENT UNDERWENT AN ADDITIONAL SURGERY. A LAPAROSCOPIC ABDOMINAL WALL HERNIA REPAIR WITH AN NON-BARD/DAVOL MESH WAS PERFORMED. ON OR ABOUT (B)(6) 2018, THE PATIENT UNDERWENT AN ADDITIONAL SURGERY AND A LAPAROSCOPIC REPAIR OF INCISIONAL HERNIA WITH TWO NON-BARD/DAVOL MESHES WAS PERFORMED. IT IS ALLEGED THAT THE PATIENT WAS INJURED SEVERELY AND PERMANENTLY. THE PATIENT SUFFERED PAIN, DISABILITY, HOSPITALIZATIONS AND ADDITIONAL SURGERIES. IT IS ALSO ALLEGED THAT THE PATIENT HAS SUFFERED AND WILL CONTINUE TO SUFFER PHYSICAL PAIN, CHRONIC PAIN, MENTAL ANGUISH, PSYCHOLOGICAL STRESS, DEPRESSION, HAS UNDERGONE AND WILL LIKELY REQUIRE MEDICAL TR

  Patient problems: Disability; Hernia; Unspecified Infection

  MAUDE report 10680968 ↗
• InjuryOct 14, 2020Defective Device; Insufficient Device Problem Information; Defective Device; Insufficient Device Problem Information

  ATTORNEY ALLEGES THAT ON OR ABOUT (B)(6) 2006, THE PATIENT UNDERWENT SURGERY FOR REPAIR OF AN INCISIONAL VENTRAL HERNIA AND A COMPOSIX E/X WAS IMPLANTED TO REPAIR THE HERNIA DEFECT. ON OR ABOUT (B)(6) 2006, THE PATIENT UNDERWENT A FURTHER SURGERY TO REMOVE THE PREVIOUSLY IMPLANTED MESH AND AN ANOTHER COMPOSIX E/X WAS IMPLANTED TO REPAIR THE HERNIA ISSUE. ON OR ABOUT (B)(6) 2018, THE PATIENT HAD AN OPERATION FOR ABDOMINAL WALL DEBRIDEMENT WITH REMOVAL OF STITCH GRANULOMA DUE TO ISSUES RESULTING FROM THE IMPLANTED COMPOSIX E/X. ON OR ABOUT (B)(6) 2019, THE PATIENT HAD A FURTHER OPERATION DUE TO INFECTED MESH WITH EROSION THROUGH SKIN, WHERE THE MESH WAS REMOVED. THROUGH THIS OPERATION IT WAS FOUND THAT THE PART OF THE BOWEL WAS INCORPORATED INTO AND IN FACT WAS FISTULISED TO THE MESH, CREATING THE NEED FOR BOWEL RESECTION. THE PATIENT HAS SUFFERED AND WILL CONTINUE TO SUFFER PHYSICAL PAIN, MENTAL ANGUISH, CHRONIC PAIN, PSYCHOLOGICAL STRESS AND DEPRESSION. IT IS ALLEGED THAT THE PATIENT HAS UNDERGONE AND WILL LIKELY REQUIRE IN THE FURTHER OTHER FORMS OF CARE AND MEDICAL TREATMENT. IT IS ALLEGED THAT THE PATIENT HAD PAIN, DISABILITY, HOSPITALIZATIONS AND ADDITIONAL SURGERIES. IT IS ALS

  Patient problems: Disability; Fistula; Unspecified Infection

  MAUDE report 10680657 ↗
• InjurySep 20, 2020Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information; Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR THE IMPLANT OF UNSPECIFIED BARD/DAVOL COMPOSIX E/X, VENTRALEX ST AND VENTRIO ST ON (B)(6) 2007 AND/OR (B)(6) 2014 AND/OR (B)(6) 2019. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST ALL DEVICES. ATTORNEY ALLEGES GENERAL ALLEGATIONS FOR "PAST, PRESENT, AND FUTURE DAMAGES, INCLUDING BUT NOT LIMITED TO, MENTAL AND PHYSICAL PAIN AND SUFFERING FOR SEVERE AND PERMANENT PERSONAL INJURIES SUSTAINED BY THE PATIENT." IT IS ALSO ALLEGED THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Adhesion(s); Disability; Hernia; Injury; Obstruction/Occlusion; Pain

  MAUDE report 10557905 ↗
• InjurySep 4, 2020Defective Device; Material Deformation; Insufficient Device Problem Information; Defective Device; Material Deformation; Insufficient Device Problem Information

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL COMPOSIX E/X ON (B)(6) 2011. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE COMPOSIX E/X. ATTORNEY ALLEGES THAT THE PATIENT HAD SUBSEQUENT SURGICAL INTERVENTION DUE TO THE HERNIA MESH DEVICE. IT IS ALSO ALLEGED THAT THE PATIENT SUSTAINED PERSONAL INJURY, EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

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

  MAUDE report 10492795 ↗