COMPOSIX 0134460Recalls & reported problems

Summary

The FDA's MAUDE database contains 49 adverse event reports that list this exact device (DI 00801741031274), received between Mar 21, 2017 and Apr 7, 2026 — classified as 49 injuries.

The most frequently reported specific device problem is “Defective Device” (41 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 49 reports, in the reporter's own words as published by the FDA.

• InjuryApr 7, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2011 - PATIENT WAS DIAGNOSED WITH LEFT LUMBAR HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF VENTRALEX MESH (DEVICE 1). PER OP NOTES, "A VENTRALEX MESH (DEVICE 1) WAS PLACED TO THE ABDOMINAL WALL USING PROLENE SUTURES." (B)(6) 2012 - PATIENT WAS DIAGNOSED WITH RECURRENT LEFT FLANK HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE REMOVAL OF PREVIOUS MESH (DEVICE 1) AND IMPLANT OF COMPOSIX L/P MESH (DEVICE 2). PER OP NOTES, "THERE WAS A HERNIA SAC AND THE MESH (DEVICE 1) WAS PULLED AWAY FROM THE INFERIOR ATTACHMENTS AND JUST WAS A LITTLE POSTERIOR, THE MESH WAS EXCISED. A COMPOSIX L/P MESH (DEVICE 2) WAS PLACED TO THE FASCIA USING PROLENE SUTURES." (B)(6) 2013 - PATIENT WAS DIAGNOSED WITH RECURRENT LEFT FLANK HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE REMOVAL OF PREVIOUS MESH (DEVICE 2) AND IMPLANT OF VENTRIO MESH (DEVICE 3). PER OP NOTES, "THERE WAS A HERNIA AND PART OF THIS WENT THROUGH THE MESH AND PULLED OUT SUPERIORLY AND FOLDED IN ON ITSELF, THEREFORE EXCISED THE OLD MESH (DEVICE 2). A VENTRIO MESH (DEVICE 3) WAS SECURED USING PROLENE SUTURES THROUGH MID FASCIA AROUND THE EDGES."

  Patient problems: Hernia

  MAUDE report 24801215 ↗
• InjuryMar 26, 2026Device Appears to Trigger Rejection; Migration

  PER INFORMATION PROVIDED: (B)(6) 2019- PATIENT WAS DIAGNOSED WITH INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF COMPOSIX L/P MESH (DEVICE 1). PER OP NOTES, ¿THE HERNIA SAC WAS IDENTIFIED IN THE UMBILICAL REGION AND DISSECTED. A COMPOSIX L/P MESH (DEVICE 1) WAS PLACED AND SUTURED¿. (B)(6) 2019 - PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA, THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH ADHESIOLYSIS, EXPLANT OF COMPOSIX L/P MESH (DEVICE 1), IMPLANT OF COMPOSIX L/P MESH (DEVICE 2). PER OP NOTES, ¿RECURRENT HERNIA WAS IDENTIFIED IN UMBILICAL REGION AND THE PRIOR MESH (DEVICE 1) WAS EXCISED. A NEW COMPOSIX L/P MESH (DEVICE 2) WAS PLACED AND SUTURED CIRCUMFERENTIALLY¿. (B)(6) 2020- PATIENT WAS DIAGNOSED WITH INCISIONAL HERNIA WITH DENSE INTRA-ABDOMINAL ADHESIONS, THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF SYNTHETIC MESH. PER OP NOTES,¿ DENSE ADHESIONS WERE TAKEN DOWN. THE PRIOR MESH (DEVICE 2) WAS FOUND TO BE PULLED AWAY FROM LEFT SIDE. EVENTRATION OF MESH WAS NOTED. A SYNTHETIC MESH WAS PLACED IN THE ABDOMINAL CAVITY AND TACKED.¿

  Patient problems: Adhesion(s); Hernia

  MAUDE report 24698699 ↗
• InjuryJan 12, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2009: PATIENT WAS DIAGNOSED WITH VENTRAL INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF BARD FLAT MESH (DEVICE 1). PER OP NOTES, "A PREVIOUS SCAR WAS NOTED JUST BELOW THE UMBILICUS. A BARD FLAT MESH (DEVICE 1) WAS PLACED USING SUTURES." ON (B)(6) 2011: PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL INCISIONAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT OF COMPOSIX L/P MESH (DEVICE 2). PER OP NOTES, "ADHESIONS WERE TAKEN DOWN. A COMPOSIX L/P MESH (DEVICE 2) WAS PLACED TO THE ABDOMINAL CAVITY USING TACKS." ON (B)(6) 2011: PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL INCISIONAL HERNIA AND SMALL BOWEL OBSTRUCTION THEREBY UNDERWENT REPAIR WITH REMOVAL OF MESH (DEVICE 1 AND 2). PER OP NOTES, "THE PREVIOUSLY PLACED MESH (DEVICE 1 AND 2) WERE REMOVED. NOTED THE SMALL BOWEL OBSTRUCTION."

  Patient problems: Hernia; Obstruction/Occlusion

  MAUDE report 24033308 ↗
• InjuryOct 30, 2025Material Deformation; Migration; Material Deformation; Migration

  PER ADDITIONAL INFORMATION PROVIDED: ON (B)(6) 2014 ¿ PATIENT WAS DIAGNOSED WITH VENTRAL INCISIONAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF COMPOSIX LP MESH (DEVICE 1) AND VENTRIO MESH (DEVICE 2). PER OPERATIVE NOTES, ¿THE DEFECT WAS MEASURED, AND AN OVAL COMPOSIX LP MESH (DEVICE 1) WAS PLACED AND SUTURED INTO THE ABDOMINAL CAVITY. A VENTRIO MESH (DEVICE 2) WAS PLACED FOR ADDITIONAL COVERAGE TO COVER THE LOWER EDGE OF THE DEFECT.¿ ON (B)(6) 2016 ¿ PATIENT HAD MESH MIGRATION, HERNIA RECURRENCE THEREBY UNDERWENT OPEN REPAIR WITH REMOVAL OF MESHES (DEVICE 1 AND DEVICE 2). PER OPERATIVE NOTES, ¿THE HERNIA SAC WHICH CONTAINED A WADDED UP MATTED LARGE MESH (DEVICE 1 AND DEVICE 2) ADHERENT TO BOWEL WALLS AND OMENTUM. ADHESIONS WERE LYSED. THE MESHES (DEVICE 1 AND DEVICE 2) WERE EXCISED. THE HERNIA DEFECT WAS MEASURED AND REPAIRED USING SUTURES.¿

  Patient problems: Adhesion(s); Hernia

  MAUDE report 23422927 ↗
• InjuryAug 28, 2025Migration; Migration

  PER INFORMATION PROVIDED: ON (B)(6) 2017 ¿ PATIENT WAS DIAGNOSED WITH INCARCERATED UMBILICAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT OF COMPOSIX L/P MESH (DEVICE #1). PER OPERATIVE NOTES, ¿A PIECE OF COMPOSIX L/P MESH (DEVICE #1) WAS PLACED ON THE SKIN OF THE ANTERIOR ABDOMINAL WALL USING SORBAFIX TACKERS.¿ ON (B)(6) 2017 ¿ PATIENT WAS RECURRENT INCARCERATED VENTRAL INCISIONAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT OF VENTRALIGHT ST MESH (DEVICE #2). PER OPERATIVE NOTES, ¿THE ADHESIONS TO ANTERIOR ABDOMINAL WALL NEAR THE HERNIA DEFECT AND MESH (DEVICE #1). THE ADHESIONS WERE LYSED. A VENTRALIGHT ST MESH (DEVICE #2) WAS PLACED IN THE MIDDLE AND CENTERED OVER THE HERNIA DEFECT USING TACKER.¿ ON (B)(6) 2017 ¿ PATIENT WAS DIAGNOSED WITH REDUCIBLE VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR. PER OPERATIVE NOTES, ¿THE HERNIA WAS IN SUBXIPHOID REGION. THE PREVIOUSLY PLACED MESH (DEVICE #1, #2) WAS ENCOUNTERED. THE OVERLYING MESH (DEVICE #1) HAD MOVED APART SOMEWHAT.¿ ON (B)(6) 2018 ¿ PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF VENTRALIGHT ST MESH (DEVICE #3). PER OPERATIVE NOTES, ¿ADHES

  Patient problems: Adhesion(s); Hernia

  MAUDE report 22911097 ↗
• InjuryJul 15, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2009 - PATIENT WAS DIAGNOSED WITH SYMPTOMATIC ABDOMINAL INCISIONAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH COMPOSIX LP MESH (DEVICE #1). PER OPERATIVE NOTES, ¿THE HERNIA DEFECT WAS NOTED IN THE ANTERIOR ABDOMINAL WALL AND COMPOSIX LP MESH (DEVICE #1) WAS PLACED AND SUTURED AND TACKED.¿ ON (B)(6) 2010 - PATIENT WAS DIAGNOSED WITH RECURRENT ABDOMINAL INCISIONAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF COMPOSIX LP MESH (DEVICE #2). PER OPERATIVE NOTES, ¿ADHESIOLYSIS WAS PERFORMED. THE HERNIA DEFECT WAS PLACED WITH COMPOSIX LP MESH (DEVICE #2) AND SUTURED. THE PREVIOUSLY PLACED MESH (DEVICE #1) WAS SEEN ROLLED UNDER THE HERNIA DEFECT. THE MESH (DEVICE #1) WAS UNFURLED AND SUTURED AND TACKED.¿ ON (B)(6) 2011 - PATIENT WAS DIAGNOSED WITH MULTIPLE RECURRENT LOWER ABDOMINAL WALL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRIO MESH (DEVICE #3). PER OPERATIVE NOTES, ¿THE ADHESIONS OF THE PERITONEUM AND INTESTINE AND OLD BIOLOGICAL MESH WAS REMOVED. THE DOME OF THE BLADDER WAS CLEARLY INVOLVED IN HERNIA DEFECT. A VENTRIO MESH (DEVICE #3) WAS PLACED AND SUTURED.¿ ON (B)(6) 2012 - PATIENT WAS DIAGNOSED WITH RECURRENT

  Patient problems: Abscess; Hernia; Unspecified Infection

  MAUDE report 22505410 ↗
• InjuryMar 5, 2024Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  PER INFORMATION PROVIDED BY THE PATIENT'S ATTORNEY: (B)(6) 2009 - PATIENT WAS DIAGNOSED WITH INCISIONAL VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF COMPOSIX L/P MESH (DEVICE #1). PER OPERATIVE NOTES, ¿THE HERNIA DEFECT WAS NOTED ABOVE THE UMBILICUS AND ADHESIONS WERE TAKEN DOWN SHARPLY. A COMPOSIX L/P MESH (DEVICE #1) WAS PLACED AS AN UNDERLAY AND SUTURED.¿ (B)(6) 2009 - PATIENT UNDERWENT HERNIA REPAIR WITH IMPLANT OF VENTRIO MESH (DEVICE #2). (NOTE: THERE WAS NO OPERATIVE NOTES PROVIDED). (B)(6) 2010 - PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF VENTRIO MESH (DEVICE #3) AND REMOVAL OF MESH (DEVICE #2). PER OPERATIVE NOTES, ¿TWO HERNIA DEFECTS WERE NOTED, 1 SUPERIOR TO UMBILICUS AND TO THE RIGHT LATERAL PREVIOUS HERNIA REPAIR WHEREAS THE OTHER ONE INFERIOR TO THE UMBILICUS AND TO THE LEFT LATERAL PREVIOUS HERNIA REPAIR. THE LOWER ROUND MESH WAS TAKEN DOWN LEAVING THE UPPER MESH INTACT. THIS MESH (DEVICE #2) AND HERNIA SAC WERE REMOVED. ALL THE ADHESIONS FROM EITHER OF THE MESH OR HERNIA SITES WERE CLEARED. A SHEET OF VENTRIO MESH (DEVICE #3) WAS PLACED AS AN UNDERLAY AND SUTURED.¿ (B)(6) 2011 - PATIEN

  Patient problems: Adhesion(s); Hernia; Inflammation

  MAUDE report 18835061 ↗
• InjuryMay 16, 2023Defective 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 L/P ON (B)(6) 2022. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE COMPOSIX L/P. 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

  MAUDE report 16939333 ↗
• InjuryApr 19, 2023Defective 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 L/P ON (B)(6) 2009. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE COMPOSIX L/P. 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; Obstruction/Occlusion; Post Operative Wound Infection

  MAUDE report 16768432 ↗
• InjuryJan 20, 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 UNSPECIFIED BARD/DAVOL COMPOSIX L/P ON (B)(6) 2014 AND VENTRIO ST ON (B)(6) 2020. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE 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: Abscess; Hernia; Insufficient Information; Pain; Unspecified Infection

  MAUDE report 13306931 ↗
• InjuryDec 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 UNSPECIFIED BARD/DAVOL COMPOSIX L/P AND VENTRIO PATCH ON (B)(6) 2007. 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 SUSTAINED PERSONAL INJURY, EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

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

  MAUDE report 12914933 ↗
• InjuryJul 9, 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 ON (B)(6) 2013. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST 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: Hernia; Insufficient Information

  MAUDE report 12141262 ↗
• InjuryJul 8, 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 THE IMPLANT OF AN UNSPECIFIED BARD/DAVOL COMPOSIX L/P ON (B)(6) 2009. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST COMPOSIX L/P. 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; Insufficient Information; Unspecified Infection

  MAUDE report 12135138 ↗
• InjuryFeb 25, 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 IMPLANT OF UNSPECIFIED BARD/DAVOL COMPOSIX L/P AND VENTRALEX HERNIA PATCH ON (B)(6) 2019 AND/OR (B)(6) 2017. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST BOTH THE 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: Injury; Pain

  MAUDE report 11379150 ↗
• InjuryJan 4, 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 IMPLANT OF AN UNSPECIFIED BARD/DAVOL COMPOSIX L/P ON 2014. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST COMPOSIX L/P. 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; Injury

  MAUDE report 11106627 ↗
• InjuryNov 24, 2020Defective Device; Insufficient Device Problem Information; Migration; Defective Device; Insufficient Device Problem Information; Migration

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF UNSPECIFIED BARD/DAVOL COMPOSIX L/P AND VENTRALIGHT ST ON (B)(6) 2010 AND/OR (B)(6) 2017. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE COMPOSIX L/P. 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 10894378 ↗
• InjuryOct 29, 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 L/P ON (B)(6) 2009. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE COMPOSIX L/P. 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: Abdominal Pain; Hernia; Injury

  MAUDE report 10754036 ↗
• InjuryAug 14, 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 L/P ON (B)(6) 2009. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE COMPOSIX L/P. 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: Abdominal Pain; Adhesion(s); Injury

  MAUDE report 10406064 ↗
• InjuryAug 6, 2020Defective Device; Patient-Device Incompatibility; Material Deformation; Insufficient Device Problem Information; Migration; Defective Device; Patient-Device Incompatibility; Material Deformation; Insufficient Device Problem Information; Migration

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF UNSPECIFIED BARD/DAVOL COMPOSIX L/P AND XENMATRIX SURGICAL GRAFT ON (B)(6) 2011 AND/OR (B)(6) 2013. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE COMPOSIX L/P. 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; Granuloma; Hernia; Injury; Obstruction/Occlusion; Pain; Scar Tissue

  MAUDE report 10372777 ↗
• InjuryJun 9, 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 COMPOSITE MESH (COMPOSIX) ON (B)(6) 2011. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE COMPOSITE MESH (COMPOSIX). 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 10132456 ↗
• InjuryMay 22, 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 L/P ON (B)(6) 2012. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE COMPOSIX L/P. 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: Adhesion(s); Hernia; Injury

  MAUDE report 10081585 ↗
• InjuryApr 9, 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 L/P ON (B)(6) 2012. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE COMPOSIX L/P. 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: Injury; Pain

  MAUDE report 9944705 ↗
• InjuryMar 10, 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 L/P AND VENTRALEX HERNIA PATCH ON (B)(6) 2008 AND/OR (B)(6) 2008. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST BOTH DEVICES. 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: Adhesion(s); Hernia; Injury; Scar Tissue

  MAUDE report 9810579 ↗
• InjuryMar 5, 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 L/P, PHASIX AND TWO VENTRALEX DEVICES. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE TWO VENTRALEX DEVICES IMPLANTED ON (B)(6) 2007 AND COMPOSIX L/P IMPLANTED ON (B)(6) 2016. IT IS ALLEGED THAT THE PATIENT SUSTAINED UNSPECIFIED INJURIES ON (B)(6) 2016 AND (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 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; Hernia; Injury; Pain

  MAUDE report 9792401 ↗
• InjuryFeb 11, 2020Patient-Device Incompatibility; Patient Device Interaction Problem; Patient-Device Incompatibility; Patient Device Interaction Problem

  AS REPORTED, ON (B)(6) 2007, THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF TWO (2) BARD/DAVOL COMPOSIX L/P MESH. IT WAS REPORTED THAT THE PATIENT BEGAN TO EXPERIENCE ABDOMINAL PAIN TOWARD THE END OF 2018 AND UNDERWENT ADDITIONAL SURGERY ON (B)(6) 2019 FOR PARTIAL EXPLANT OF BOTH DEVICES. IT IS ALLEGED THAT THE MESH HAD CAUSED A (B)(6) INFECTION AND LYSIS OF ADHESIONS FROM HER APPENDIX AND INTESTINES.

  Patient problems: Abscess; Adhesion(s); Fistula; Staphylococcus Aureus; Unspecified Infection

  MAUDE report 9694872 ↗