COMPOSIX 0123114Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00801741031175), received between Mar 20, 2018 and Dec 28, 2021 — classified as 11 injuries.

The most frequently reported specific device problem is “Defective Device” (10 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryDec 28, 2021Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED, DURING A VENTRAL INCISIONAL HERNIA REPAIR PROCEDURE ON (B)(6) 2014, A BARD/DAVOL COMPOSIX E/X MESH WAS IMPLANTED. IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT ANOTHER SURGERY FOR COLORECTAL CANCER, DURING WHICH IT WAS NOTED THAT THE MESH (EPTFE SIDE) HAD FIBROUS ADHESIONS WITH THE INTESTINAL TRACT. AS REPORTED, THERE WAS NO EXTREME BENDING OF THE MESH, THE POLYPROPYLENE SIDE WAS NOT EXPOSED TO THE INTESTINAL TRACT SIDE AND LYSIS OF ADHESIONS WAS PERFORMED FOR ABOUT 2 HOURS. AS REPORTED, AFTER MAKING A MIDLINE INCISION IN THE MESH AND TREATING COLORECTAL CANCER, THE MESH WAS BROUGHT CLOSE TOGETHER AND CLOSED WITH A NON-ABSORBENT THREAD, AND A NON-BARD/DAVOL ADHESION-PREVENTING MATERIAL WAS ATTACHED TO COMPLETE THE PROCEDURE. THE PATIENT DID NOT EXPERIENCE ANY PAIN OR OTHER SYMPTOMS DUE TO THE ADHESIONS. POSTOPERATIVELY THE PATIENT IS DOING GOOD WITHOUT ANY HEALTH DAMAGE.

  Patient problems: Adhesion(s)

  MAUDE report 13097122 ↗
• InjurySep 1, 2021Defective Device; Patient Device Interaction Problem; Defective Device; Material Deformation; 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, SUSTAINED PERSONAL INJURY AND THE DEVICE WAS DEFECTIVE.

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

  MAUDE report 12406218 ↗
• InjurySep 10, 2020Defective Device; Insufficient Device Problem Information; Patient Device Interaction Problem; Defective Device; Insufficient Device Problem Information; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL COMPOSIX E/X ON (B)(6) 2006. 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. ADDENDUM PER ADDITIONAL INFORMATION PROVIDED: (B)(6) 2006 - PATIENT WAS DIAGNOSED WITH INCISIONAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT OF COMPOSIX E/X MESH. PER OPERATIVE NOTES, ¿LARGE COLOSTOMY SITE HERNIA SAC, SMALL BOWEL AND COLON WERE DISSECTED. A COMPOSIX E/X MESH WAS PLACED AND SECURE IT WITH SUTURE.¿ (B)(6) 2006 - PATIENT WAS DIAGNOSED WITH REMOVAL OF INFECTED MESH AND REPAIR OF COMPLEX INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE EXPLANT OF COMPOSIX E/X MESH AND IMPLANT OF BIOLOGICAL MESH. PER OPERATIVE NOTES, ¿INFECTED MESH WAS REMOVED. BIOLOGICAL MESH WAS PLACED AND SECURE IT WITH SUTURE.¿ ATTORNEY ALLEGES THAT

  Patient problems: Disability; Injury; Pain; Unspecified Infection

  MAUDE report 10512787 ↗
• InjuryNov 8, 2019Defective Device; Insufficient Device Problem Information; Patient Device Interaction Problem; Defective Device; Insufficient Device Problem Information; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL COMPOSIX E/X (DEVICE #1) ON (B)(6) 2008 AND UNSPECIFIED BARD/DAVOL VENTRIO ST (DEVICE #2) ON (B)(6) 2012. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE COMPOSIX E/X (DEVICE #1) AND THE VENTRIO ST (DEVICE #2). AS REPORTED, THE 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."

  Patient problems: Abscess; Adhesion(s); Bacterial Infection; Cellulitis; Disability; Fistula; Hernia; Injury; Pain; Scar Tissue

  MAUDE report 9298467 ↗
• InjurySep 23, 2019Defective Device; Insufficient Device Problem Information; Patient Device Interaction Problem; Defective Device; Insufficient Device Problem Information; Patient Device Interaction Problem

  ATTORNEY ALLEGES THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL COMPOSIX E/X ON (B)(6) 2007. IT IS ALSO ALLEGED BY PATIENT'S ATTORNEY THAT ON (B)(6) 2009, THE PATIENT HAD UNSPECIFIED INJURIES RELATED TO A DEFECT IN THE COMPOSIX E/X, AND UNDERWENT REVISION SURGERY. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE COMPOSIX E/X. AS REPORTED, THE 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."

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

  MAUDE report 9105885 ↗
• InjurySep 19, 2019Defective Device; Insufficient Device Problem Information; Patient Device Interaction Problem; Migration; Defective Device; Insufficient Device Problem Information; Patient Device Interaction Problem; Migration

  ATTORNEY ALLEGES THAT ON (B)(6) 2002, THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL COMPOSIX E/X. IT IS ALLEGED THAT ON (B)(6) 2002, THE PATIENT HAD UNSPECIFIED INJURIES RELATED TO A DEFECT IN THE COMPOSIX E/X, AND UNDERWENT REVISION SURGERY. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE COMPOSIX E/X. AS REPORTED, THE 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."

  Patient problems: Abscess; Adhesion(s); Disability; Injury; Pain; Unspecified Infection

  MAUDE report 9087750 ↗
• InjuryDec 18, 2018Defective Device; Material Deformation; Insufficient Device Problem Information; Patient Device Interaction Problem; Defective Device; Material Deformation; Insufficient Device Problem Information; Patient Device Interaction Problem

  THE FOLLOWING WAS ALLEGED BY THE PATIENT'S ATTORNEY: (B)(6) 2006: THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL COMPOSIX E/X. (B)(6) 2008:THE PATIENT HAD UNSPECIFIED INJURIES AND UNDERWENT REVISION SURGERY. THE PATIENT IS ONLY MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE COMPOSIX E/X. THE 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.¿

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

  MAUDE report 8177428 ↗
• InjurySep 14, 2018Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information; Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information

  THE FOLLOWING WAS ALLEGED BY THE PATIENT'S ATTORNEY: ON (B)(6) 2005: THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL COMPOSIX E/X( DEVICE #1). ON (B)(6) 2005: THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL PERFIX PLUG (DEVICE #2). THE PATENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE COMPOSIX E/X (DEVICE #1) AND THE PERFIX PLUG (DEVICE #2). THE 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."

  Patient problems: Abscess; Bowel Perforation; Disability; Fistula; Injury; Pain; Unspecified Infection

  MAUDE report 7879550 ↗
• InjuryJul 25, 2018Defective Device; Insufficient Device Problem Information; Patient Device Interaction Problem; Defective Device; Insufficient Device Problem Information; Patient Device Interaction Problem

  THE FOLLOWING WAS ALLEGED BY THE PATIENT'S ATTORNEY: ON (B)(6) 2013: THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL COMPOSIX E/X(DEVICE#1). ON (B)(6) 2016, THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL VENTRIO ST. THE PATIENT IS ONLY MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE COMPOSIX E/X (DEVICE #1). THE 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.¿ .

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

  MAUDE report 7718572 ↗
• InjuryJul 10, 2018Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information; Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information

  THE FOLLOWING WAS ALLEGED BY THE PATIENT'S ATTORNEY: ON (B)(6) 2007: THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL COMPOSIX E/X. AS REPORTED, THE PATIENT IS MAKING CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE BARD/DAVOL COMPOSIX E/X. AS REPORTED, THE 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."

  Patient problems: Adhesion(s); Disability; Fistula; Injury; Pain; Unspecified Infection

  MAUDE report 7673992 ↗
• InjuryMar 20, 2018Defective Device; Insufficient Device Problem Information; Patient Device Interaction Problem; Defective Device; Insufficient Device Problem Information; Patient Device Interaction Problem

  THE FOLLOWING WAS ALLEGED BY THE PATIENT'S ATTORNEY: ON (B)(6) 2009: THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL COMPOSIX E/X MESH. AS REPORTED, THE ATTORNEY ALLEGES A GENERAL CLAIM "FOR PAST, PRESENT, AND FUTURE DAMAGES, INCLUDING BUT NOT LIMITED TO, MENTAL AND PHYSICAL PAIN AND SUFFERING FOR SEVERE AND PERMANENT PERSONAL INJURIES SUSTAINED".

  Patient problems: Abscess; Adhesion(s); Disability; Fistula; Pain; Scar Tissue; Unspecified Infection

  MAUDE report 7355571 ↗