COMPOSIX 0123113Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00801741031168), received between Nov 2, 2017 and Jul 30, 2026 — classified as 22 injuries.

The most frequently reported specific device problem is “Defective Device” (16 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• InjuryJul 30, 2026Patient-Device Incompatibility

  Per information provided:26-Nov-2001 - Patient was diagnosed with recurrent ventral hernia thereby underwent open repair with the implant of Composix Mesh (Device 1). Per op notes, "The underlying hernia defect was dissected free. A piece of Composix Mesh (Device 1) was placed into defect and secured to fascia using sutures."11-Apr-2002 - Patient was diagnosed with recurrent ventral hernia, adhesion thereby underwent laparoscopic repair with the implant of Composix E/X Mesh. Per op notes, "There were massive adhesions up into the old hernia area and stuck to previously placed mesh. The defect was noted. An Composix E/X Mesh was placed as marlex portion up against the abdominal wall and secured circumferentially using tacks."10-Mar-2004 - Patient was diagnosed with recurrent ventral hernia thereby underwent open repair. Per op notes, "An infraumbilical cutdown was made in the middle where the hernia was noted. There were some adhesions. A mesh was sutured peripherally." (Note: The mesh implanted in this procedure was unknown)

  Patient problems: Adhesion(s); Hernia

  MAUDE report 50089799 ↗
• InjuryMar 30, 2026Material Deformation; Migration

  PER INFORMATION PROVIDED: (B)(6) 2003 - PATIENT WAS DIAGNOSED WITH VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF COMPOSIX E/X MESH (DEVICE 2 AND 3). PER OP NOTES, ¿AN INCISION WAS MADE OVER THE UPPER ABDOMEN PREVIOUS INCISION SITE. ADHESIONS TO THE ABDOMINAL WALL WERE TAKEN DOWN. TWO COMPOSIX E/X MESH (DEVICE 2 AND 3) WERE PLACED INTO THE ABDOMEN AND SECURED WITH SUTURES TIED ON EACH OF THE OVAL ENDS TO THE ANTERIOR ABDOMINAL WALL AND TACKED INTO POSITION.¿ (B)(6) 2004 - PATIENT WAS DIAGNOSED WITH UPPER ABDOMEN VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF COMPOSIX E/X MESH (DEVICE 4 AND 5). PER OP NOTES, ¿AN INCISION WAS MADE THROUGH THE OLD CHEVRON INCISION. THE HERNIA WAS IDENTIFIED UNDER THE OLD SCAR. THE HERNIA SAC WAS NOTED TO BE VERY THIN. DISSECTION WAS MADE DOWN TO THE FLANK SIDE ON LEFT LATERAL SIDE AND THEN ANTERIORLY TO ABOVE THE UMBILICUS. TWO COMPOSIX E/X MESH (DEVICE 4 AND 5) WERE PLACED ON TOP OF EACH OTHER AND SECURED TOGETHER WITH SUTURES. THE OVERLAP WAS THEN EXCISED AND THE MESH WAS PLACED UNDER THE ABDOMEN AND SECURED WITH SUTURES AND TACKED TO ANTERIOR ABDOMINAL WALL.¿ (B)(6) 2007 ¿ PATIENT WAS DIAGNOSED WITH ABSCESS ABDOMINAL WAL

  Patient problems: Abscess; Fistula; Hernia; Necrosis; Unspecified Infection

  MAUDE report 24714032 ↗
• InjuryMar 26, 2026Migration

  PER INFORMATION PROVIDED: (B)(6) 2003 - PATIENT WAS DIAGNOSED WITH VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF COMPOSIX E/X MESH (DEVICE 2 AND 3). PER OP NOTES, ¿AN INCISION WAS MADE OVER THE UPPER ABDOMEN PREVIOUS INCISION SITE. ADHESIONS TO THE ABDOMINAL WALL WERE TAKEN DOWN. TWO COMPOSIX E/X MESH (DEVICE 2 AND 3) WERE PLACED INTO THE ABDOMEN AND SECURED WITH SUTURES TIED ON EACH OF THE OVAL ENDS TO THE ANTERIOR ABDOMINAL WALL AND TACKED INTO POSITION.¿ (B)(6) 2004 - PATIENT WAS DIAGNOSED WITH UPPER ABDOMEN VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF COMPOSIX E/X MESH (DEVICE 4 AND 5). PER OP NOTES, ¿AN INCISION WAS MADE THROUGH THE OLD CHEVRON INCISION. THE HERNIA WAS IDENTIFIED UNDER THE OLD SCAR. THE HERNIA SAC WAS NOTED TO BE VERY THIN. DISSECTION WAS MADE DOWN TO THE FLANK SIDE ON LEFT LATERAL SIDE AND THEN ANTERIORLY TO ABOVE THE UMBILICUS. TWO COMPOSIX E/X MESH (DEVICE 4 AND 5) WERE PLACED ON TOP OF EACH OTHER AND SECURED TOGETHER WITH SUTURES. THE OVERLAP WAS THEN EXCISED AND THE MESH WAS PLACED UNDER THE ABDOMEN AND SECURED WITH SUTURES AND TACKED TO ANTERIOR ABDOMINAL WALL.¿ (B)(6) 2007 ¿ PATIENT WAS DIAGNOSED WITH ABSCESS ABDOMINAL WAL

  Patient problems: Abscess; Fistula; Necrosis; Unspecified Infection

  MAUDE report 24700338 ↗
• InjuryJul 14, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2009 - PATIENT WAS DIAGNOSED WITH MULTIPLE INCARCERATED INCISIONAL HERNIAS THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF COMPOSIX E/X (DEVICE #1 & #2). PER OP NOTES, ¿THE DENSE ADHESIONS OF ABDOMINAL WALL TO HERNIA SAC WERE LYSED. AFTER LYSED ALL ADHESIONS, THE INTESTINE INCARCERATED IN SAC WAS FREED. TWO COMPOSIX E/X (DEVICE #1 & #2) WERE PLACED AND TACKED. ¿ (B)(6) 2009 - PATIENT WAS DIAGNOSED WITH INTESTINAL PERFORATION AND RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH EXCISION OF COMPOSIX (DEVICE #1 & #2) AND RESECTION OF SMALL BOWEL. PER OP NOTES, ¿THE PRIOR MESH (DEVICE #1 & #2) WAS IDENTIFIED AND REMOVED. EXTENSIVE LYSIS OF ADHESIONS WAS PERFORMED. A SMALL PINHOLE PERFORATION OF THE INTESTINE WAS IDENTIFIED IN MID JEJUNUM. THAT PART OF INTESTINE WAS RESECTED. THE HERNIA DEFECT WAS REPAIRED WITH SUTURES. ¿ (B)(6) 2009 - PATIENT WAS DIAGNOSED WITH VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF COMPOSIX MESH (DEVICE #3). PER OP NOTES, ¿THE HERNIA SAC WAS IDENTIFIED AND EXCISED. THE ADHESIONS WERE LYSED. A COMPOSIX MESH (DEVICE #3) WAS PLACED USING PROLENE SUTURES. ¿ (B)(6) 2010 - PATIENT WAS DIAGNOSED WITH

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

  MAUDE report 22496243 ↗
• InjuryJul 14, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2009 - PATIENT WAS DIAGNOSED WITH MULTIPLE INCARCERATED INCISIONAL HERNIAS THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF COMPOSIX E/X (DEVICE #1 & #2). PER OP NOTES, ¿THE DENSE ADHESIONS OF ABDOMINAL WALL TO HERNIA SAC WERE LYSED. AFTER LYSED ALL ADHESIONS, THE INTESTINE INCARCERATED IN SAC WAS FREED. TWO COMPOSIX E/X (DEVICE #1 & #2) WERE PLACED AND TACKED. ¿ (B)(6) 2009 - PATIENT WAS DIAGNOSED WITH INTESTINAL PERFORATION AND RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH EXCISION OF COMPOSIX (DEVICE #1 & #2) AND RESECTION OF SMALL BOWEL. PER OP NOTES, ¿THE PRIOR MESH (DEVICE #1 & #2) WAS IDENTIFIED AND REMOVED. EXTENSIVE LYSIS OF ADHESIONS WAS PERFORMED. A SMALL PINHOLE PERFORATION OF THE INTESTINE WAS IDENTIFIED IN MID JEJUNUM. THAT PART OF INTESTINE WAS RESECTED. THE HERNIA DEFECT WAS REPAIRED WITH SUTURES. ¿ (B)(6) 2009 - PATIENT WAS DIAGNOSED WITH VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF COMPOSIX MESH (DEVICE #3). PER OP NOTES, ¿THE HERNIA SAC WAS IDENTIFIED AND EXCISED. THE ADHESIONS WERE LYSED. A COMPOSIX MESH (DEVICE #3) WAS PLACED USING PROLENE SUTURES. ¿ (B)(6) 2010 - PATIENT WAS DIAGNOSED WITH

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

  MAUDE report 22495676 ↗
• InjuryJul 14, 2025Migration; Migration

  PER INFORMATION PROVIDED: ON (B)(6) 2009 - PATIENT WAS DIAGNOSED WITH MULTIPLE INCARCERATED INCISIONAL HERNIAS THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF COMPOSIX E/X (DEVICE #1 & #2). PER OP NOTES, ¿THE DENSE ADHESIONS OF ABDOMINAL WALL TO HERNIA SAC WERE LYSED. AFTER LYSED ALL ADHESIONS, THE INTESTINE INCARCERATED IN SAC WAS FREED. TWO COMPOSIX E/X (DEVICE #1 & #2) WERE PLACED AND TACKED. ¿ ON (B)(6) 2009 - PATIENT WAS DIAGNOSED WITH INTESTINAL PERFORATION AND RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH EXCISION OF COMPOSIX (DEVICE #1 & #2) AND RESECTION OF SMALL BOWEL. PER OP NOTES, ¿THE PRIOR MESH (DEVICE #1 & #2) WAS IDENTIFIED AND REMOVED. EXTENSIVE LYSIS OF ADHESIONS WAS PERFORMED. A SMALL PINHOLE PERFORATION OF THE INTESTINE WAS IDENTIFIED IN MID JEJUNUM. THAT PART OF INTESTINE WAS RESECTED. THE HERNIA DEFECT WAS REPAIRED WITH SUTURES. ¿ ON (B)(6) 2009 - PATIENT WAS DIAGNOSED WITH VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF COMPOSIX MESH (DEVICE #3). PER OP NOTES, ¿THE HERNIA SAC WAS IDENTIFIED AND EXCISED. THE ADHESIONS WERE LYSED. A COMPOSIX MESH (DEVICE #3) WAS PLACED USING PROLENE SUTURES. ¿ ON (B)(6) 2010 - PATIENT WAS DIA

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

  MAUDE report 22493108 ↗
• InjuryFeb 18, 2025Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  PER INFORMATION PROVIDED: (B)(6)2017 - PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF COMPOSIX E/X MESH (DEVICE #1). PER OPERATIVE NOTES, ¿THE HERNIA SAC WAS IDENTIFIED AND DISSECTED. A COMPOSIX OVAL MESH (DEVICE #1) WAS THEN PLACED INTO THE ABDOMINAL CAVITY AND SECURED.¿ (B)(6)2017 - PATIENT WAS DIAGNOSED WITH LARGE INCISIONAL HERNIA WITH CONTAMINATED MESH AND ADHESIONS THEREBY UNDERWENT REPAIR WITH IMPLANT OF PHASIX ST MESH (DEVICE #2) AND REMOVAL OF MESH (DEVICE #1). PER OPERATIVE NOTES, ¿THE MESH (DEVICE #1) AND IDENTIFIED AND DISSECTED FROM SURROUNDING AREA WHICH REVEALED ADHESIONS. A PHASIX ST MESH (DEVICE #2) WAS PLACED INTRAABDOMINALLY AND SUTURED.¿ (B)(6)2018 - PATIENT WAS DIAGNOSED WITH RECURRENT LARGE INCISIONAL ABDOMINAL WALL HERNIA AND ADHESIONS THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF COMPOSIX E/X MESH (DEVICE #3) AND COMPOSIX L/P MESH (DEVICE #4) AND LYSIS OF ADHESIONS. PER OPERATIVE NOTES, ¿THE PREVIOUSLY PLACED ONLAY PATCH (DEVICE #2) WAS NOTED TO BE INTACT AND THERE WERE ADHESIONS TO THE ANTERIOR ABDOMINAL CAVITY. A COMPOSIX MESHES (DEVICE #3 & #4) WAS PLACED IN THE AREA OF ABDOMINAL CAVITY AND SECURED

  Patient problems: Abscess; Bacterial Infection; Scar Tissue

  MAUDE report 21394265 ↗
• InjuryJun 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 E/X ON (B)(6) 2003. 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 SUSTAINED PERSONAL INJURY, EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Abdominal Pain; Fistula; Hernia; Insufficient Information; Unspecified Infection

  MAUDE report 11958428 ↗
• InjuryFeb 7, 2021Defective 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 E/X AND ALLOMAX ON (B)(6) 2010 AND/OR (B)(6) 2012. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE COMPOSIX E/X. ATTORNEY ALLEGES THAT THE PATIENT SUSTAINED INJURIES ON (B)(6) 2014 AND (B)(6) 2017. 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; Unspecified Infection

  MAUDE report 11290431 ↗
• InjuryNov 24, 2020Defective Device; Insufficient Device Problem Information; Defective Device; Insufficient Device Problem Information

  ATTORNEY ALLEGES THAT ON OR ABOUT (B)(6) 2011, THE PATIENT UNDERWENT SURGERY FOR AN INCARCERATED SMALL AND LARGE BOWEL AND INTERMITTENT SMALL BOWEL OBSTRUCTION. A BARD/DAVOL COMPOSIX E/X, WAS IMPLANTED TO REPAIR THE HERNIA DEFECT. ON OR ABOUT (B)(6) 2015, THE PATIENT UNDERWENT AN ADDITIONAL OPERATION TO REPAIR THE DEFECTIVE MESH. 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; Injury; Pain

  MAUDE report 10898427 ↗
• InjurySep 28, 2020Defective Device; Insufficient Device Problem Information; Defective Device; Insufficient Device Problem Information

  ATTORNEY ALLEGES THAT ON OR ABOUT (B)(6) 2012 THAT THE PATIENT UNDERWENT A SURGERY FOR THE IMPLANT OF A BARD/DAVOL COMPOSIX E/X FOR THE REPAIR OF VENTRAL HERNIA AND WERE IMPLANTED TO REPAIR THE HERNIA DEFECT. IT IS ALSO ALLEGED THAT ON OR ABOUT (B)(6) 2018, THE PATIENT UNDERWENT AN ADDITIONAL SURGERY TO REMOVE THE DEFECTIVE AND INFECTED MESH. THE PATIENT WAS INJURED SEVERELY AND PERMANENTLY. THE PATIENT HAS SUFFERED AND WILL CONTINUE TO SUFFER PHYSICAL PAIN AND MENTAL ANGUISH. IT IS ALLEGED THAT THE PATIENT SUFFERED PAIN, DISABILITY, HOSPITALIZATIONS AND ADDITIONAL SURGERIES. IT IS ALSO ALLEGED THAT THE PATIENT HAS SUFFERED AND CONTINUES TO SUFFER FROM CHRONIC PAIN, PSYCHOLOGICAL STRESS, DEPRESSION AND HAS UNDERGONE AND WILL LIKELY REQUIRE IN THE FURTHER OTHER FORMS OF CARE AND MEDICAL TREATMENTS. IT IS FURTHER ALLEGED THAT THE DEVICE WAS DEFECTIVE.

  Patient problems: Disability; Injury; Unspecified Infection

  MAUDE report 10597071 ↗
• InjuryApr 22, 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) 2007. 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: Injury; Pain

  MAUDE report 9985530 ↗
• InjuryMar 4, 2020Defective Device; Insufficient Device Problem Information; Migration; Defective Device; Insufficient Device Problem Information; Migration

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF TWO UNSPECIFIED BARD/DAVOL COMPOSITE MESHES (COMPOSIX MESH) ON (B)(6) 2008 AND (B)(6) 2009. 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 9785357 ↗
• InjuryDec 3, 2019Defective Device; Insufficient Device Problem Information; Migration; Defective Device; Insufficient Device Problem Information; Migration

  ATTORNEY ALLEGES THAT ON (B)(6) 2015, THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL COMPOSIX E/X. 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. AS REPORTED, THE ATTORNEY ALLEGES PRODUCT IS DEFECTIVE AND THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS.

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

  MAUDE report 9402367 ↗
• InjuryOct 23, 2019Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information; Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information

  ATTORNEY ALLEGES THAT ON (B)(6) 2005, THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL COMPOSIX E/X. 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: Abdominal Pain; Disability; Hematoma; Injury; Pain; Unspecified Infection

  MAUDE report 9226926 ↗
• InjurySep 3, 2019Defective Device; Material Deformation; Insufficient Device Problem Information; Defective Device; Material Deformation; Insufficient Device Problem Information

  ATTORNEY ALLEGES 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. 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; Obstruction/Occlusion; Pain

  MAUDE report 8957537 ↗
• InjuryAug 7, 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 ON (B)(6) 2011. 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." ATTORNEY ALLEGES UNSPECIFIED INJURIES ON (B)(6) 2011.

  Patient problems: Bacterial Infection; Disability; Fibrosis; Fluid Discharge; Hematoma; Injury; Pain; Seroma

  MAUDE report 8871289 ↗
• InjuryJun 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) 2008: THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL COMPOSIX E/X. NI/NI/NI: THE PATIENT HAD UNSPECIFIED INJURIES. AS REPORTED, THE PATIENT IS ONLY MAKING A 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; Hernia; Inflammation; Injury; Pain; Purulent Discharge; Unspecified Infection

  MAUDE report 7634592 ↗
• InjuryMay 11, 2018Defective Device; Material Deformation; Defective Device; Material Deformation

  THE FOLLOWING WAS ALLEGED BY THE PATIENT'S ATTORNEY: ON (B)(6) 2006: THE PATIENT UNDERWENT REPAIR OF MULTIPLE VENTRAL HERNIAS. AS REPORTED, A COMPOSIX E/X 10" X 13", REF NO. 0123113, LOT NO. 43CPD488 WAS IMPLANTED IN THE PATIENT DURING THIS REPAIR. ON (B)(6) 2013: THE PATIENT UNDERWENT SURGERY TO EXPLANT A FAILED COMPOSIX E/X. AS REPORTED, DURING THE SURGERY, THE SURGEON NOTED THAT "APPROXIMATELY 80% OF PREVIOUS COMPOSIX MESH WAS ADHERENT OMENTUM, SMALL BOWEL. THERE WERE RECURRENT HERNIA SUPERIORLY, INFERIORLY, AND TO THE RIGHT LATERAL ASPECT OF THE PREVIOUS REPAIR. THE MESH HAD CURLED, AND THERE WAS EXPOSED POLYPROPYLENE MESH, WITH ADDITIONAL ADHESIONS OF SMALL BOWEL AND COLON TO THE AREA." IT IS ALLEGED THAT THE PATIENT CONTINUES TO EXPERIENCE COMPLICATIONS RELATED TO THE EPTFE BARD MESH (COMPOSIX EX) AND WILL LIKELY REQUIRE ADDITIONAL SURGERIES TO REPAIR THE DAMAGE FROM THE ALLEGEDLY "DEFECTIVE" COMPOSIX EX MESH.

  Patient problems: Adhesion(s); Disability; Hernia

  MAUDE report 7506190 ↗
• InjuryFeb 16, 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: (B)(6) 2004: THE PATIENT UNDERWENT SURGERY FOR REPAIR OF AN INCISIONAL HERNIA. A BARD/DAVOL COMPOSIX E/X HERNIA PATCH MESH, (B)(4), LOT NUMBER 43 AND 150 WAS IMPLANTED TO REPAIR THE HERNIA DEFECT. (B)(6) 2014: THE PATIENT UNDERWENT AN ADDITIONAL SURGERY TO REPAIR THE HERNIA DEFECT. (B)(6) 2014: THE PATIENT UNDERWENT AN ADDITIONAL SURGERY TO REMOVE THE MESH. AS ALLEGED, THE PATIENT WAS INJURED SEVERELY AND PERMANENTLY AND HAS SUFFERED AND WILL CONTINUE TO SUFFER PHYSICAL PAIN DUE TO THE ALLEGED DEFECTIVE COMPOSIX E/X HERNIA PATCH.

  Patient problems: Abdominal Pain; Abscess; Adhesion(s); Bacterial Infection; Disability; Fibrosis; Fistula; Hernia; Obstruction/Occlusion; Pain

  MAUDE report 7277562 ↗
• InjuryDec 4, 2017Defective Device; Material Deformation; Insufficient Device Problem Information; Patient Device Interaction Problem; Defective Device; Material Deformation; Insufficient Device Problem Information; Patient Device Interaction Problem

  IT IS ALLEGED BY THE PATIENTS ATTORNEY THAT ON (B)(6) 2008, THE PATIENT UNDERWENT SURGERY FOR REPAIR OF AN INCISIONAL HERNIA. AS REPORTED, A BARD/DAVOL COMPOSIX E/X HERNIA PATCH MESH, REFERENCE NUMBER 0123113, LOT NUMBER 43BPD262 WAS IMPLANTED TO REPAIR THE HERNIA DEFECT. IT IS ALLEGED THAT SEVERAL YEARS LATER ON (B)(6) 2011, THE PATIENT UNDERWENT AN ADDITIONAL SURGERY TO REMOVE THE COMPOSIX E/X, WHICH HAD FAILED, AND TO REPAIR THE RECURRENT INCISIONAL HERNIA. AS ALLEGED, THE PATIENT WAS INJURED SEVERELY AND PERMANENTLY AND HAS SUFFERED AND WILL CONTINUE TO SUFFER PHYSICAL PAIN.

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

  MAUDE report 7080903 ↗
• InjuryNov 2, 2017Defective Device; Insufficient Device Problem Information; Patient Device Interaction Problem; Defective Device; Insufficient Device Problem Information; Patient Device Interaction Problem

  THE FOLLOWING WAS REPORTED TO DAVOL BY THE PATIENT'S ATTORNEY. ON (B)(6) 2006 THE PATIENT UNDERWENT SURGERY FOR REPAIR OF AN INCISIONAL HERNIA. A COMPOSIX E/X HERNIA PATCH MESH WAS IMPLANTED TO REPAIR THE HERNIA DEFECT. ON (B)(6) 2015 THE PATIENT UNDERWENT AN "ADDITIONAL SURGERY TO REPAIR THE HERNIA DEFECT AND REMOVE IT". IT IS ALLEGED BY THE PATIENT'S ATTORNEY THAT SUBSEQUENTLY THE PATIENT ENDURED ADDITIONAL SURGERIES TO TREAT MESH-RELATED COMPLICATIONS DUE TO THE HERNIA REPAIR SURGERY FAILING. RESULTING IN PAIN AND SUFFERING AND WAS INJURED SEVERELY AND PERMANENTLY.

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

  MAUDE report 6995750 ↗