COMPOSIX 0123810Recalls & reported problems

Summary

The FDA's MAUDE database contains 63 adverse event reports that list this exact device (DI 00801741031212), received between Aug 16, 2017 and Aug 29, 2025 — classified as 63 injuries.

The most frequently reported specific device problem is “Defective Device” (60 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 63 reports, in the reporter's own words as published by the FDA.

• InjuryAug 29, 2025Migration; Migration

  PER INFORMATION PROVIDED: (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH VENTRAL INCISIONAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF VENTRALIGHT ST USING ECHO PS (DEVICE 1) AND COMPOSIX E/X (DEVICE 2). PER OP NOTES, ¿A LARGE HERNIA SAC WAS IDENTIFIED AND REDUCED. A VENTRALIGHT ST USING ECHO PS (DEVICE 1) AND A COMPOSIX E/X (DEVICE #2) WAS PLACED AND SUTURED USING SORBAFIX ABSORBABLE TACKS.¿ (B)(6) 2020 - PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL INCISIONAL HERNIA WITH ABDOMINAL PAIN THEREBY UNDERWENT ROBOTIC ASSISTED LAPAROSCOPIC REPAIR WITH EXCISION OF VENTRALIGHT ST USING ECHO PS (DEVICE 1), COMPOSIX E/X (DEVICE 2) AND IMPLANT OF VENTRALIGHT ST USING ECHO PS 2 (DEVICE 3). PER OP NOTES, ¿EXTENSIVE ADHESIONS WERE NOTE AND LYSED. THE PRIOR MESH (DEVICE 1 AND 2) IDENTIFIED TO BE RIPPLED AND FOLDED BACK ITSELF AND THE SUPERIOR EDGE OF MESH HAD COME LOOSE. THE ENTIRE MESH (DEVICE 1 AND 2) WAS EXCISED AND REMOVED. THE HERNIA DEFECT WAS IDENTIFIED AND REDUCED. A VENTRALIGHT ST USING ECHO PS 2 (DEVICE 3) WAS PLACED AND SUTURED.¿

  Patient problems: Abdominal Pain; Adhesion(s); Hernia

  MAUDE report 22920813 ↗
• InjuryJul 9, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2004 - PATIENT WAS DIAGNOSED WITH INCARCERATED RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE EXPLANT OF UNKNOWN MARLEX MESH AND IMPLANT OF THREE COMPOSIX E/X MESH (DEVICE #1, DEVICE #2 AND DEVICE #3). PER OPERATIVE NOTES, ¿OLD UNKNOWN MARLEX MESH WAS REMOVED. THREE BARD COMPOSIX E/X MESH (DEVICE #1, DEVICE #2 AND DEVICE #3) WAS PLACED AND SUTURED.¿ (NOTE: THERE WAS NO INFORMATION MENTIONED OF THE PREVIOUSLY PLACED MARLEX MESH, LOT AND CATALOG NO. ARE UNKNOWN.) ON (B)(6) 2009 - PATIENT WAS DIAGNOSED WITH INCARCERATED RECURRENT INCISIONAL HERNIA, PAIN, ADHESION THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF THE BARD COMPOSIX KUGEL MESH (DEVICE #4). PER OPERATIVE NOTES, ¿ALL ADHESIONS WERE TAKEN DOWN. BARD COMPOSIX KUGEL MESH (DEVICE #4) WAS PLACED AND SUTURED.¿ ON (B)(6) 2013 - PATIENT WAS DIAGNOSED WITH INCARCERATED VENTRAL HERNIA, ADHESION, PAIN THEREBY UNDERWENT OPEN REPAIR WITH EXPLANT OF COMPOSIX E/X MESH (DEVICE #1, DEVICE #2 AND DEVICE #3) AND BARD COMPOSIX KUGEL MESH (DEVICE #4) AND IMPLANT OF BARD COMPOSIX MESH (DEVICE #5). PER OPERATIVE NOTES, ¿ALL ADHESIONS WERE TAKEN DOWN. ALL OLD MESHES COMPOSIX E/X MESH

  Patient problems: Adhesion(s); Hernia; Pain

  MAUDE report 22456023 ↗
• InjuryMay 7, 2025Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  PER INFORMATION PROVIDED: ON (B)(6) 2002: PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF BARD FLAT MESH (DEVICE#1). PER OPERATIVE NOTES, ¿THE OLD SYNTHETIC MESH (GORETEX) AND ADHESIONS WERE REMOVED. A BARD FLAT MESH (DEVICE#1) WAS PLACED AND SECURED BY SUTURES.¿ ON (B)(6) 2007: PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH PARTIAL EXPLANT OF BARD FLAT MESH (DEVICE #1) AND IMPLANT OF COMPOSIX EX MESH (DEVICE#2). PER OPERATIVE NOTES, ¿LOOPS OF BOWEL ADHERED INTO THE PREVIOUS MESH (DEVICE#1) WERE EXCISED. ADHESIONS REMOVED. A COMPOSIX EX MESH (DEVICE#2) PLACED INTRA-ABDOMINALLY AND TACKED.¿ ON (B)(6) 2007: PATIENT WAS DIAGNOSED WITH SMALL PERFORATION IN MID-TRANSVERSE COLON THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH EXPLANT OF COMPOSIX EX MESH (DEVICE#2). PER OPERATIVE NOTES, ¿THE TRANSVERSE COLON WAS DENSELY ADHERED TO THE PREVIOUS (DEVICE#1). INFECTED-SMELLING OPAQUE FLUID AND ADHESIONS NOTED. THEN (DEVICE#2) REMOVED ALONG WITH STAPLES.¿ ON (B)(6) 2009: PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH EXPLANT OF MESH (DEVICE#1 & #2) & IMPLANT O

  Patient problems: Adhesion(s); Bowel Perforation; Hernia; Unspecified Infection

  MAUDE report 21975211 ↗
• InjuryApr 29, 2024Patient-Device Incompatibility; Material Deformation; Patient-Device Incompatibility; Material Deformation

  ATTORNEY ALLEGES MULTIPLE PATIENTS HE REPRESENTS HAVE EXPERIENCE UNSPECIFIED INJURY AND ALLEGE THEY MAY HAVE REQUIRED ADDITIONAL MEDICAL/SURGICAL TREATMENT. ATTORNEY ALLEGES THIS PATIENT WAS TREATED WITH A BARD FLAT MESH. CASE-SPECIFIC DETAILS NOT PROVIDED.

  Patient problems: Adhesion(s); Bacterial Infection; Fistula; Hematoma; Hernia; Insufficient Information; Obstruction/Occlusion; Seroma

  MAUDE report 19200955 ↗
• InjuryNov 10, 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 MESH ON (B)(6) 2010. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE COMPOSIX MESH. ATTORNEY ALLEGES THAT THE PATIENT HAD SUBSEQUENT SURGICAL INTERVENTION DUE TO THE HERNIA MESH DEVICE. IT IS ALLEGED THAT THE PATIENT SUSTAINED PERSONAL INJURY, EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Abscess; Hematoma; Insufficient Information; Unspecified Infection

  MAUDE report 12785285 ↗
• InjuryOct 13, 2021Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT ON OR ABOUT (B)(6) 2004, THE PATIENT UNDERWENT SURGERY FOR REPAIR OF AN INCARCERATED UMBILICAL AND EPIGASTRIC HERNIA AND A BARD/DAVOL COMPOSIX E/X MESH WAS IMPLANTED TO REPAIR THE HERNIA DEFECT. IT IS ALLEGED THAT ON OR ABOUT (B)(6) 2005, THE PATIENT UNDERWENT AN ADDITIONAL SURGERY DUE TO A HERNIA RECURRENCE AND A BARD/DAVOL COMPOSIX E/X MESH WAS IMPLANTED TO REPAIR THE HERNIA DEFECT. IT IS ALLEGED THAT THE PATIENT UNDERWENT AN ADDITIONAL SURGERY ON OR ABOUT (B)(6) 2017 DUE TO NECROTIZING INFECTION OF THE ANTERIOR ABDOMINAL WALL FROM A SMALL BOWEL ERODING INTO THE MESH AND PERFORATING INTO THE ABDOMINAL WALL. REMOVAL OF THE INFECTED MESH, BOWEL RESECTION, DEBRIDEMENT OF ANTERIOR WALL, LYSIS OF ADHESIONS AND REPAIR OF SMALL BOWEL PERFORATION WAS PERFORMED. IT IS ALLEGED THAT ON OR ABOUT (B)(6) 2017, THE PATIENT UNDERWENT AN ADDITIONAL SURGERY DUE TO NECROTIZING INFECTION OF THE ANTERIOR ABDOMINAL WALL WITH INVOLVEMENT OF THE SMALL BOWEL. A WOUND VAC WAS PLACED TO HELP WITH TREATMENT. ATTORNEY ALSO ALLEGES THAT THE PATIENT UNDERWENT ADDITIONAL SURGERIES ON OR ABOUT (B)(6) 2017 DURING WHICH DEBRIDEMENT OF ABDOMINAL WALL WOUND AND VACUUM-ASSISTED CLOSURE DEVICE CH

  Patient problems: Bowel Perforation; Erosion; Unspecified Infection

  MAUDE report 12627987 ↗
• InjuryOct 13, 2021Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT ON OR ABOUT (B)(6) 2004, THE PATIENT UNDERWENT SURGERY FOR REPAIR OF AN INCARCERATED UMBILICAL AND EPIGASTRIC HERNIA AND A BARD/DAVOL COMPOSIX E/X MESH WAS IMPLANTED TO REPAIR THE HERNIA DEFECT. IT IS ALLEGED THAT ON OR ABOUT (B)(6) 2005, THE PATIENT UNDERWENT AN ADDITIONAL SURGERY DUE TO A HERNIA RECURRENCE AND A BARD/DAVOL COMPOSIX E/X MESH WAS IMPLANTED TO REPAIR THE HERNIA DEFECT. IT IS ALLEGED THAT THE PATIENT UNDERWENT AN ADDITIONAL SURGERY ON OR ABOUT (B)(6) 2017 DUE TO NECROTIZING INFECTION OF THE ANTERIOR ABDOMINAL WALL FROM A SMALL BOWEL ERODING INTO THE MESH AND PERFORATING INTO THE ABDOMINAL WALL. REMOVAL OF THE INFECTED MESH, BOWEL RESECTION, DEBRIDEMENT OF ANTERIOR WALL, LYSIS OF ADHESIONS AND REPAIR OF SMALL BOWEL PERFORATION WAS PERFORMED. IT IS ALLEGED THAT ON OR ABOUT (B)(6) 2017, THE PATIENT UNDERWENT AN ADDITIONAL SURGERY DUE TO NECROTIZING INFECTION OF THE ANTERIOR ABDOMINAL WALL WITH INVOLVEMENT OF THE SMALL BOWEL. A WOUND VAC WAS PLACED TO HELP WITH TREATMENT. ATTORNEY ALSO ALLEGES THAT THE PATIENT UNDERWENT ADDITIONAL SURGERIES ON OR ABOUT (B)(6) 2017 DURING WHICH DEBRIDEMENT OF ABDOMINAL WALL WOUND AND VACUUM-ASSISTED CLOSURE DEVICE CH

  Patient problems: Bowel Perforation; Erosion; Unspecified Infection

  MAUDE report 12627601 ↗
• InjuryJul 4, 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) 2004. 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 UNDERWENT REVISION SURGERY ON (B)(6) 2010. 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 12114198 ↗
• InjuryJul 1, 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) 2007. 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 UNDERWENT REVISION SURGERY ON (B)(6) 2012. IT IS ALSO ALLEGED THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE. ADDENDUM PER ADDITIONAL INFORMATION PROVIDED: (B)(6) 2007 ¿ PATIENT WAS DIAGNOSED WITH INCARCERATED VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF COMPOSIX E/X MESH (DEVICE #1). PER OP NOTES, ¿THERE WAS A BRIDGE OF MESH PREVIOUSLY PLACED BETWEEN THE TWO FASCIAL DEFECTS. THE INCARCERATED OMENTUM WHICH WAS ADHERENT TO THE HERNIA SAC WAS EXCISED. A BARD COMPOSIX E/X MESH (DEVICE #1) WAS PLACED IN THE PERITONEUM AND SECURED SUBLAY USING SUTURES.¿ (B)(6) 2012 - PATIENT WAS DIAGNOSED WITH SMALL BOWEL OBSTRUCTION SECONDARY TO ADHESIONS THEREBY UNDERWENT OPEN REPAIR. PE

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

  MAUDE report 12101421 ↗
• InjuryMay 23, 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 UNSPECIFIED BARD/DAVOL COMPOSIX E/X AND VENTRALEX ON (B)(6) 2011 AND/OR (B)(6) 2013. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST BOTH DEVICES. ATTORNEY ALLEGES THAT THE PATIENT SUSTAINED UNSPECIFIED INJURIES ON (B)(6) 2011. 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; Obstruction/Occlusion; Pain

  MAUDE report 11868990 ↗
• InjuryOct 21, 2020Defective Device; Detachment of Device or Device Component; Insufficient Device Problem Information; Defective Device; Detachment of Device or Device Component; Insufficient Device Problem Information

  ATTORNEY ALLEGES THAT, ON OR ABOUT (B)(6) 2011, THE PATIENT UNDERWENT SURGERY FOR REPAIR OF AN INCISIONAL HERNIA AND A COMPOSIX E/X MESH WAS IMPLANTED TO REPAIR THE HERNIA DEFECT. ON OR ABOUT (B)(6) 2011, THE PATIENT UNDERWENT AN ADDITIONAL SURGERY TO REMOVE THE INFECTED MESH. THERE WAS EVIDENCE OF FLOATING MESH FOUND. THE MESH WAS COMPLETELY REMOVED. 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 TREATMENTS AND OTHER FORMS OF CARE. ATTORNEY ALSO ALLEGES THAT THE DEVICE WAS DEFECTIVE.

  Patient problems: Disability; Pain; Unspecified Infection

  MAUDE report 10714467 ↗
• InjuryOct 18, 2020Defective Device; Insufficient Device Problem Information; Defective Device; Insufficient Device Problem Information

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR REPAIR OF AN INCISIONAL LEFT VENTRAL HERNIA ON OR ABOUT (B)(6) 2007, A COMPOSIX E/X WAS IMPLANTED TO REPAIR THE HERNIA DEFECT. THE PATIENT UNDERWENT AN ADDITIONAL OPERATION ON OR ABOUT (B)(6) 2014 TO REMOVE THE INFECTED MESH. IT IS ALLEGED THAT THE PATIENT UNDERWENT A FURTHER OPERATION ON OR ABOUT (B)(6) 2015 TO REMOVE THE REMAINING COMPOSIX E/X MESH AND DEAL WITH ADHESION THAT HAD OCCURRED DUE TO THE MESH. IT IS ALLEGED THAT THE PATIENT EXPERIENCED SIGNIFICANT PHYSICAL, PSYCHOLOGICAL AND EMOTIONAL PAIN AND SUFFERING, UNDERGONE SURGERIES AND HOSPITALIZATIONS, AND HAS SUSTAINED PERMANENT AND DEBILITATING INJURIES, DISABILITY AND PAIN. THE PATIENT HAS SUFFERED AND CONTINUES TO SUFFER FROM CHRONIC ABDOMINAL PAIN, AS WELL AS SIGNIFICANT PSYCHOLOGICAL STRESS AND DEPRESSION. THE PATIENT HAS UNDERGONE AND WILL LIKELY REQUIRE IN THE FURTHER OTHER FORMS OF CARE AND MEDICAL TREATMENTS. ATTORNEY ALLEGES THAT THE DEVICE WAS DEFECTIVE.

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

  MAUDE report 10694757 ↗
• InjuryOct 16, 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 IMPLANT OF AN UNSPECIFIED BARD/DAVOL COMPOSIX E/X ON (B)(6) 2007. 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: Adhesion(s); Disability; Injury; Obstruction/Occlusion; Pain

  MAUDE report 10693365 ↗
• 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. IT IS ALLEGED THAT THE PATIENT HAS SUFFERED AND WILL CONTINUE TO SUFFER PHYSICAL PAIN, MENTAL ANGUISH, CHRONIC PAIN, PSYCHOLOGICAL STRESS AND DEPRESSION. 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; Injury; Pain

  MAUDE report 10680659 ↗
• InjurySep 30, 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 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 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; Scar Tissue; Unspecified Infection

  MAUDE report 10604457 ↗
• InjurySep 28, 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 IMPLANT OF AN UNSPECIFIED BARD/DAVOL COMPOSIX E/X ON (B)(6) 2008. 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: Disability; Injury; Pain; Scar Tissue; Unspecified Infection

  MAUDE report 10591718 ↗
• InjuryJun 25, 2020Device Appears to Trigger Rejection; Defective Device; Material Deformation; Insufficient Device Problem Information; Device Appears to Trigger Rejection; 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) 2006 AND VENTRALIGHT ST ON (B)(6) 2014. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE COMPOSIX E/X. IT IS ALLEGED THAT THE PATIENT HAD REVISION SURGERY ON (B)(6) 2014. 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; Scar Tissue

  MAUDE report 10193936 ↗
• InjuryJun 5, 2020Defective Device; Material Deformation; Insufficient Device Problem Information; Defective Device; Material Deformation; 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) 2006. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST COMPOSIX E/X. IT IS ALLEGED 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: Abdominal Pain; Adhesion(s); Hernia; Injury

  MAUDE report 10122032 ↗
• InjuryApr 28, 2020Defective Device; Insufficient Device Problem Information; Defective Device; Insufficient Device Problem Information

  ATTORNEY ALLEGES THAT THE PATIENT WAS IMPLANTED WITH A BARD/DAVOL MARLEX MESH (BARD FLAT MESH) ON OR ABOUT (B)(6) 2004, FOR THE REPAIR OF AN ABDOMINAL HERNIA. ON OR ABOUT (B)(6)2006, THE PATIENT WAS IMPLANTED WITH A NON-BARD/DAVOL SURGICAL MESH IN THE ABDOMEN TO REPAIR AN ABDOMINAL HERNIA. ON OR ABOUT (B)(6) 2007, THE PATIENT UNDERWENT REVISION OF THE BARD/DAVOL MARLEX MESH (BARD FLAT MESH) AND NON-BARD/DAVOL SURGICAL MESH TO REPAIR THE ABDOMINAL HERNIA. DURING REPAIR, THE PATIENT WAS IMPLANTED WITH A BARD/DAVOL COMPOSIX E/X. ON OR ABOUT (B)(6) 2009, THE PATIENT UNDERWENT REMOVAL OF THE MES H PRODUCTS. IT IS ALLEGED THAT THE PATIENT EXPERIENCES AND/OR CONTINUES TO EXPERIENCE CHRONIC AND SEVERE PAIN, CHRONIC INFLAMMATION, GIANT CELL REACTION, INFECTION, ADHESIONS, AND NECROSIS. IT IS ALSO ALLEGED THAT THE PATIENT HAS SUFFERED AND WILL CONTINUE TO SUFFER PHYSICAL PAIN AND SUFFERING, AS WELL AS MENTAL ANGUISH AND EMOTIONAL DISTRESS. IT IS ALSO ALLEGED THAT THE PATIENT SUSTAINED INJURY, SEVERE AND PERMANENT PAIN, SUFFERING, ANXIETY, DEPRESSION, DISABILITY, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, LOSS OF CARE, COMFORT, AND ECONOMIC DAMAGES. IT IS ALSO ALLEGED THAT THE DEVICE IS DEFECTIVE

  Patient problems: Disability; Necrosis; Unspecified Infection

  MAUDE report 10007881 ↗
• InjuryApr 22, 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 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 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

  MAUDE report 9984834 ↗
• InjuryApr 2, 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 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 ALLEGED THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

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

  MAUDE report 9917668 ↗
• InjuryMar 19, 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 AN UNSPECIFIED BARD/DAVOL COMPOSIX E/X ON (B)(6) 2009. 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; Adhesion(s); Disability; Injury; Pain; Unspecified Infection

  MAUDE report 9851846 ↗
• InjuryFeb 28, 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 IMPLANT OF UNSPECIFIED BARD/DAVOL COMPOSIX AND MARLEX (BARD FLAT MESH) ON 1998 AND/OR (B)(6) 2007. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE COMPOSIX. 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: Abscess; Adhesion(s); Cellulitis; Injury; Unspecified Infection

  MAUDE report 9768863 ↗
• InjuryDec 19, 2019Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information; Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information

  ATTORNEY ALLEGES THAT ON (B)(6) 2006 OR (B)(6) 2010, THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL COMPOSIX E/X (DEVICE #1) OR AN UNSPECIFIED BARD/DAVOL COMPOSIX KUGEL HERNIA PATCH (DEVICE #2). IT IS ALLEGED THAT THE PATIENT HAD SUBSEQUENT SURGICAL INTERVENTION DUE TO THE HERNIA MESH DEVICE. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE COMPOSIX E/X (DEVICE #1) AND COMPOSIX KUGEL HERNIA PATCH (DEVICE #2). AS REPORTED, THE ATTORNEY ALLEGES PRODUCT IS DEFECTIVE AND THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS.

  Patient problems: Injury; Pain

  MAUDE report 9496943 ↗
• InjuryNov 21, 2019Defective Device; Insufficient Device Problem Information; Defective Device; Insufficient Device Problem Information

  IT IS ALLEGED BY PATIENT'S ATTORNEY THAT ON OR ABOUT (B)(6) 2012, PATIENT UNDERWENT SURGERY FOR REPAIR OF AN INCISIONAL HERNIA. AS ALLEGED A BARD/DAVOL COMPOSIX E/X, WAS IMPLANTED TO REPAIR THE HERNIA DEFECT. IT IS ALSO ALLEGED BY THE PATIENT'S ATTORNEY THAT ON OR ABOUT (B)(6) 2016, PATIENT UNDERWENT AN ADDITIONAL OPERATION TO REPAIR AND/OR REMOVE THE DEFECTED MESH. THE PATIENT WAS INJURED SEVERELY AND PERMANENTLY. AS ALLEGED, PATIENT HAS SUFFERED AND WILL CONTINUE TO SUFFER PHYSICAL PAIN AND MENTAL ANGUISH. AS REPORTED, PATIENT HAS SUFFERED AND CONTINUES TO SUFFER FROM CHRONIC PAIN, AS WELL AS PSYCHOLOGICAL STRESS AND DEPRESSION. PATIENT HAS UNDERGONE AND WILL LIKELY REQUIRE IN THE FURTHER OTHER FORMS OF CARE AND MEDICAL TREATMENTS DUE TO THE ALLEGED DEFECTIVE COMPOSIX E/X HERNIA PATCH MESH.

  Patient problems: Disability; Injury; Pain

  MAUDE report 9355642 ↗