COMPOSIX 0123790Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 00801741031205), received between Apr 28, 2016 and Dec 26, 2025 — classified as 30 injuries.

The most frequently reported specific device problem is “Defective Device” (28 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 30 reports, in the reporter's own words as published by the FDA.

• InjuryDec 26, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2016- PATIENT WAS DIAGNOSED WITH INCARCERATED INCISIONAL HERNIA, THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRALEX MESH (DEVICE 1). PER OP NOTES, ¿THE HERNIA SAC WITH OMENTUM WAS IDENTIFIED IN THE ABDOMINAL REGION AND THE OMENTUM WAS REDUCED. A LARGE VENTRALEX MESH WAS PLACED INTO THE DEFECT AND SUTURED¿. ON (B)(6) 2016- PATIENT WAS DIAGNOSED WITH INCARCERATED RECURRENT INCISIONAL HERNIA, THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH EXPLANT OF VENTRALEX (DEVICE 1) AND IMPLANT OF COMPOSIX E/X MESH (DEVICE 2). PER OP NOTES, ¿MIDLINE SCAR WAS REINCISED. THE PRIOR MESH WAS FOUND TO BE PULLED AWAY. THE LOOPS OF SMALL BOWEL FOUND ADHERENT TO THE VENTRALEX MESH (DEVICE 1) WITH PARTIAL BOWEL OBSTRUCTION. THE VENTRALEX MESH WAS REMOVED AND A COMPOSIX E/X MESH (DEVICE 2) WAS PLACED IN THE ABDOMINAL REGION AND SUTURED¿. ON (B)(6) 2016- PATIENT WAS DIAGNOSED WITH RIGHT LOWER QUADRANT PAIN, THEREBY HAD A CT SCAN WHICH SHOWS LARGE FLUID COLLECTION WHICH IS LIKELY TO BE SEROMA.

  Patient problems: Pain; Seroma

  MAUDE report 23896051 ↗
• InjuryJul 9, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (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.) (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.¿ (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 (DEVICE

  Patient problems: Adhesion(s); Hernia; Pain

  MAUDE report 22456434 ↗
• InjuryNov 29, 2024Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  PER INFORMATION PROVIDED: ON (B)(6) 2008 - PATIENT WAS DIAGNOSED WITH INCARCERATED INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF COMPOSIX KUGEL MESH (DEVICE #1). PER OPERATIVE NOTES, ¿ENTIRE HERNIA SAC WAS OPENED UP AND SMALL BOWEL WAS STUCK INTO SAC, LOOKS LIKE ISCHEMIC AND DUSKY WAS FREED UP FROM SAC. THE SAC WAS FREED UP ALL AROUND THE EDGE AND PLACED A PIECE OF SEPRAFILM UNDERNEATH AND THEN PLACED THE COMPOSIX KUGEL MESH (DEVICE #1) WAS SEWN CIRCUMFERENTIALLY WITH INTERRUPTED SUTURES.¿ ON (B)(6) 2016 - PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL HERNIA, ADHESION AND BOWEL OBSTRUCTION THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF COMPOSIX E/X MESH (DEVICE #2) AND REMOVAL OF COMPOSIX KUGEL MESH (DEVICE #1). PER OPERATIVE NOTES, ¿THE HERNIA SAC WAS IDENTIFIED AND CLEARED FROM SUBCUTANEOUS ATTACHMENTS. PARTIALLY REDUCIBLE INCARCERATED SMALL BOWEL WAS NOTED IN HERNIA SAC AND OBSTRUCTION AND ADHESION CAUSING MESH WAS NOTED. THE OLD COMPOSIX KUGEL MESH (DEVICE #1) WAS REMOVED FROM THE FASCIAL ATTACHMENTS. THE SMALL BOWEL WAS DENSELY ADHERED TO MESH (DEVICE #1) WAS RESECTED. ADDITIONAL VENTRAL HERNIA SAC IN THE SUBCUTANEOUS AREA WAS IDENTIFIED AND REMOVED. TH

  Patient problems: Adhesion(s); Hernia; Scar Tissue

  MAUDE report 20810337 ↗
• InjuryFeb 23, 2022Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT THE PATIENT WAS IMPLANTED WITH A BARD/DAVOL COMPOSIX E/X (PRODUCT). IS ALLEGED THAT ON (B)(6) 2006, THE PATIENT WAS IMPLANTED WITH THE PRODUCT IN THE COURSE OF AN INCISIONAL VENTRAL HERNIA REPAIR SURGERY. IT IS ALLEGED THAT FURTHER TO THE PATIENT'S IMPLANTATION WITH THE PRODUCT, THE PATIENT SUFFERED THE DEVELOPMENT OF CHRONIC PAIN, INFLAMMATION, SWELLING, BOWEL OBSTRUCTION, GASTROINTESTINAL MALFUNCTION, AND HERNIA RECURRENCE, NECESSITATING FURTHER REPARATIVE SURGERY ON (B)(6) 2008. IS ALLEGED THAT SUBSEQUENT TO THE LATTER SURGERY, THE PLAINTIFF HAS CONTINUED TO SUFFER FROM CHRONIC PAIN, INFLAMMATION, SWELLING, BOWEL OBSTRUCTION, GASTROINTESTINAL MALFUNCTION, AND HERNIA RECURRENCE. IT IS ALLEGED THAT SUBSEQUENT TO THE LATTER SURGERY, THE PATIENT HAS CONTINUED TO SUFFER FROM CHRONIC PAIN, INFLAMMATION, SWELLING, BOWEL OBSTRUCTION, GASTROINTESTINAL MALFUNCTION, AND HERNIA RECURRENCE. ATTORNEY ALLEGES THAT THE PATIENT SUFFERED INJURIES, LOSSES, AND DAMAGES RESULTING FROM NUMEROUS DEFECTS IN THE PRODUCT THAT CREATE AN UNREASONABLY HIGH RISK OF INJURY WITH SEVERE PERMANENT ADVERSE HEALTH CONSEQUENCES. IT IS ALSO ALLEGED THAT THE PATIENT EXPERIENCED SEVERE PAIN AND S

  Patient problems: Hernia; Inflammation; Obstruction/Occlusion; Pain

  MAUDE report 13587875 ↗
• InjuryOct 13, 2021Defective Device; Material Deformation; Patient Device Interaction Problem; Defective Device; Material Deformation; Patient Device Interaction Problem

  ATTORNEY ALLEGES THE PATIENT UNDERWENT SURGERY TO REPAIR A MIDLINE HERNIA AND IMPLANTED WITH A NON-BARD/DAVOL PRODUCT ON OR ABOUT (B)(6) 2012. IT IS ALLEGED THAT THE PATIENT UNDERWENT REVISION SURGERY OF THE NON-BARD/DAVOL PRODUCT FOR A RECURRENT MIDLINE HERNIA AND A BARD/DAVOL COMPOSIX E/X WAS IMPLANTED ON OR ABOUT (B)(6) 2017. IT IS ALSO ALLEGED THAT THE PATIENT UNDERWENT REMOVAL SURGERY ON OR ABOUT (B)(6) 2019. ATTORNEY ALLEGES THAT THE PATIENT EXPERIENCED AND/OR CONTINUES TO EXPERIENCE SEVERE AND CHRONIC PAIN/DISCOMFORT, DENSE ADHESIONS, ADHESIONS TO THE SMALL INTESTINE, MESH CONTRACTION, MESH WAS ATTACHED TO A SEVERE FIBROTIC PLATE, NECROSIS, FIBROSIS, RECURRENCE, AND SURGERY TO REMOVE MESH. IT IS ALLEGED THAT THE PATIENT IS AT A HIGHER RISK OF SEVERE COMPLICATIONS DURING AN ABDOMINAL SURGERY, TO THE EXTENT THAT FUTURE ABDOMINAL OPERATIONS MIGHT NOT BE FEASIBLE. ATTORNEY ALLEGES PAST, PRESENT, AND FUTURE DAMAGES, INCLUDING BUT NOT LIMITED TO, PAIN AND SUFFERING FOR SEVERE AND PERMANENT PERSONAL INJURIES SUSTAINED BY THE PATIENT. IT IS ALSO ALLEGED THAT THE DEVICE WAS DEFECTIVE.

  Patient problems: Adhesion(s); Hernia; Necrosis

  MAUDE report 12628139 ↗
• InjuryFeb 2, 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 VENTRIO ST ON (B)(6) 2010 AND/OR (B)(6) 2012. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST BOTH DEVICES. ATTORNEY ALLEGES THAT THE PATIENT SUSTAINED INJURIES ON (B)(6) 2012 AND (B)(6) 2019. 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; Erosion; Hernia; Injury; Obstruction/Occlusion; Pain; Unspecified Infection

  MAUDE report 11264802 ↗
• 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 IMPLANT OF AN UNSPECIFIED BARD/DAVOL COMPOSIX ON (B)(6) 2002. 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: Adhesion(s); Fistula; Injury; Unspecified Infection

  MAUDE report 9987184 ↗
• InjuryMar 11, 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) 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; Disability; Injury; Pain; Unspecified Infection

  MAUDE report 9817598 ↗
• InjuryFeb 25, 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: Disability; Hernia; Injury; Pain; Scar Tissue

  MAUDE report 9748811 ↗
• InjuryNov 22, 2019Defective Device; Material Deformation; Insufficient Device Problem Information; Patient Device Interaction Problem; Defective Device; Material Deformation; Insufficient Device Problem Information; Patient Device Interaction Problem

  ATTORNEY ALLEGES THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL BARD MESH (DEVICE #1) OR OR AN UNSPECIFIED BARD/DAVOL COMPOSIX E/X (DEVICE #2) OR AN UNSPECIFIED BARD/DAVOL COMPOSIX KUGEL HERNIA PATCH (DEVICE #3) ON (B)(6) 2003 OR (B)(6) 2004 OR (B)(6) 2007. IT IS ALLEGED THAT THE PATIENT HAD SUBSEQUENT SURGICAL INTERVENTION DUE TO THE HERNIA MESH DEVICE(S). AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE BARD/DAVOL BARD MESH (DEVICE #1), THE COMPOSIX E/X (DEVICE #2) AND THE COMPOSIX KUGEL HERNIA PATCH (DEVICE #3). AS REPORTED, THE ATTORNEY ALLEGES PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Abscess; Adhesion(s); Bacterial Infection; Hematoma; Hernia; Injury; Necrosis; Seroma

  MAUDE report 9364078 ↗
• InjuryNov 6, 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 THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL FLAT MESH (DEVICE #1) ON (B)(6) 2006, AND AN UNSPECIFIED BARD/DAVOL COMPOSIX E/X (DEVICE #2 AND DEVICE #3) ON (B)(6) 2007 AND ON (B)(6) 2008. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE FLAT MESH(DEVICE #1) AND THE TWO (2) COMPOSIX E/X (DEVICES #2 AND #3). 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; Abscess; Adhesion(s); Bacterial Infection; Disability; Fistula; Injury; Obstruction/Occlusion; Pain

  MAUDE report 9287584 ↗
• InjurySep 19, 2019Defective Device; Insufficient Device Problem Information; Defective Device; Insufficient Device Problem Information

  IT IS ALLEGED BY THE PATIENT'S ATTORNEY THAT ON OR ABOUT (B)(6) 2011, 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 ALLEGED BY THE PATIENT'S ATTORNEY THAT ON OR ABOUT (B)(6) 2011, PATIENT UNDERWENT AN ADDITIONAL SURGERY FOR THE REMOVAL OF IMPLANTED MESH AND DRAINAGE OF INTRAPERITONEAL ABSCESS AND ABDOMINAL WALL DEBRIDEMENT. THE PATIENT WAS INJURED SEVERELY AND PERMANENTLY. AS REPORTED, PATIENT HAS EXPERIENCED SIGNIFICANT PHYSICAL, PSYCHOLOGICAL AND EMOTIONAL PAIN AND SUFFERING, AND HAS SUSTAINED PERMANENT AND DEBILITATING INJURIES. FURTHERMORE, DESPITE HAVING PROCEDURE, THE PATIENT CONTINUES TO EXPERIENCE PROBLEMS WITH HERNIA DEFECT. AS ALLEGED, PATIENT HAS SUFFERED AND CONTINUES TO SUFFER FROM CHRONIC DEBILITATING PAIN, AS WELL AS SIGNIFICANT PSYCHOLOGICAL STRESS AND DEPRESSION. AS REPORTED, 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.

  Patient problems: Abscess; Disability; Hernia

  MAUDE report 9089087 ↗
• InjurySep 19, 2019Defective Device; Insufficient Device Problem Information; Migration; Defective Device; 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) 2005. IT IS ALSO ALLEGED BY PATIENT'S ATTORNEY THAT THE PATIENT HAD UNSPECIFIED INJURIES RELATED TO A DEFECT IN THE COMPOSIX E/X, AND UNDERWENT REVISION SURGERY ON (B)(6) 2010. 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; Scar Tissue; Unspecified Infection

  MAUDE report 9089079 ↗
• InjuryAug 21, 2019Defective Device; Insufficient Device Problem Information; Defective Device; Insufficient Device Problem Information

  IT IS ALLEGED BY PATIENT'S ATTORNEY: ON (B)(6) 2005: PATIENT UNDERWENT SURGERY FOR REPAIR OF A VENTRAL HERNIA. A COMPOSIX E/X WAS IMPLANTED TO REPAIR THE HERNIA DEFECT. ON (B)(6) 2008: PATIENT UNDERWENT AN ADDITIONAL LAPAROSCOPIC SURGERY TO REPAIR AND/OR REMOVE THE DEFECTED MESH. THE PATIENT WAS INJURED SEVERELY AND PERMANENTLY. PATIENT HAS SUFFERED AND WILL CONTINUE TO SUFFER PHYSICAL PAIN AND MENTAL ANGUISH. 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. THE COMPOSIX E/X IS DEFECTIVE.

  Patient problems: Disability; Injury; Pain

  MAUDE report 8915605 ↗
• InjuryJul 16, 2019Defective 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 (DEVICE #1) ON (B)(6) 2006 AND SEPRAMESH IP (DEVICE #2) ON (B)(6) 2011. IT IS ALLEGED THAT THE PATIENT HAD SUBSEQUENT SURGICAL INTERVENTION DUE TO THE HERNIA MESH DEVICE(S). AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE BARD/DAVOL COMPOSIX E/X (DEVICE #1) AND SEPRAMESH IP (DEVICE #2). AS REPORTED, THE ATTORNEY ALLEGES PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Adhesion(s); Hernia; Injury

  MAUDE report 8795947 ↗
• InjuryMay 13, 2019Defective Device; Insufficient Device Problem Information; Patient Device Interaction Problem; Defective Device; Insufficient Device Problem Information; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT ON (B)(6) 2008, THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL COMPOSIX E/X. IT IS ALLEGED THAT ON (B)(6) 2018, 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; Fibrosis; Fistula; Injury; Pain; Unspecified Infection

  MAUDE report 8603633 ↗
• InjuryApr 2, 2019Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information; Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information

  ATTORNEY ALLEGES THAT ON (B)(6) 2016 OR (B)(6) 2018, THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL COMPOSIX E/X (DEVICE #1) OR AN UNSPECIFIED BARD/DAVOL VENTRIO 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 VENTRIO PATCH (DEVICE #2). AS REPORTED, THE ATTORNEY ALLEGES PRODUCT IS DEFECTIVE AND THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS.

  Patient problems: Injury; Pain

  MAUDE report 8473402 ↗
• InjuryMar 29, 2019Defective Device; Insufficient Device Problem Information; Patient Device Interaction Problem; Defective Device; Insufficient Device Problem Information; Patient Device Interaction Problem

  PER LEGAL COMPLAINT: (B)(6) 2012 - PATIENT UNDERWENT SURGERY DURING WHICH THE PATIENT WAS IMPLANTED WITH AN UNSPECIFIED BARD/DAVOL COMPOSIX E/X (DEVICE 1) AND VENTRALIGHT ST. THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE COMPOSIX E/X (DEVICE 1). 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; Fibrosis; Inflammation; Injury; Pain

  MAUDE report 8465831 ↗
• InjuryFeb 20, 2019Defective 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) 2012 OR (B)(6) 2013:THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL COMPOSIX E/X (DEVICE #1) OR AN UNSPECIFIED BARD/DAVOL COMPOSIX KUGEL (DEVICE#2). ON NI/NI/NI:THE PATIENT HAD SUBSEQUENT SURGICAL INTERVENTION DUE TO THE HERNIA MESH DEVICE(S) THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE BARD/DAVOL COMPOSIX E/X (DEVICE #1) AND THE COMPOSIX KUGEL (DEVICE#2). THE ATTORNEY ALLEGES PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Abdominal Pain; Injury; Obstruction/Occlusion

  MAUDE report 8355514 ↗
• InjuryFeb 19, 2019Defective 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: (B)(6) 2007: THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL COMPOSIX E/X. ON NI/NI/NI: THE PATIENT HAD SUBSEQUENT SURGICAL INTERVENTION DUE TO THE HERNIA MESH DEVICE(S). THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE BARD/DAVOL COMPOSIX E/X. THE ATTORNEY ALLEGES PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

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

  MAUDE report 8351451 ↗
• InjuryNov 28, 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) 2008: THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL COMPOSIX E/X. THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE COMPOSIX E/X. THE PATIENT'S 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 8110488 ↗
• InjuryNov 21, 2018Defective Device; Detachment of Device or Device Component; Defective Device; Detachment of Device or Device Component

  THE FOLLOWING WAS ALLEGED BY THE PATIENT'S ATTORNEY: ON (B)(6) 2006: THE PATIENT UNDERWENT REPAIR OF AN SURGICAL HERNIA. A BARD/DAVOL COMPOSIX EX (DEVICE #1) WAS IMPLANTED IN THE PATIENT DURING THIS REPAIR. ON (B)(6) 2012: THE PATIENT UNDERWENT REVISION SURGERY TO REPAIR HER RECURRENT HERNIA. DURING THE SURGERY THE PHYSICIAN NOTED ¿THE MESH HAD PULLED AWAY FROM THE RIGHT ABDOMINAL WALL.¿ IN THE COURSE OF THE AFORESAID REVISION PROCEDURE, THE PATIENT WAS IMPLANTED WITH A BARD/DAVOL VENTRIO (DEVICE #2). (B)(6) 2013: THE PATIENT UNDERWENT REPAIR OF AN RECURRENT HERNIA. A BARD/DAVOL VENTRIO (DEVICE #3) WAS IMPLANTED IN THE PATIENT DURING THIS REPAIR ON (B)(6) 2013: THE PATIENT UNDERWENT REVISION AND REMOVAL SURGERY TO REPAIR RECURRENT HERNIA AND SMALL BOWEL OBSTRUCTION. DURING THE SURGERY THE PHYSICIAN NOTED ¿SMALL BOWEL WAS DENSELY ADHERENT TO THE RECENTLY PLACED MESH. THERE WAS A SEGMENT OF MESH THAT WAS FOLDED AND THE NON-PTFE SIDE WAS EXPOSED.¿ AND ¿I REALIZED THE MESH HAD DISLODGED FROM THE SITE OF ANCHORING AND THE MESH WILL BE A PROBLEM IN THE FUTURE GIVEN ITS EXPOSED NON-PTFE SIDE.¿ THE PATIENT CONTINUES TO EXPERIENCE COMPLICATIONS RELATED TO THE MESH AND WILL LIKELY REQUIRE AD

  Patient problems: Disability; Hernia; Injury

  MAUDE report 8097639 ↗
• InjuryOct 2, 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) 2004: THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL COMPOSIX E/X. NI/NI/NI: THE PATIENT HAD UNSPECIFIED INJURIES. THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE COMPOSIX E/X. THE PATIENT'S 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; Disability; Fistula; Injury; Pain; Unspecified Infection

  MAUDE report 7928032 ↗
• InjuryMar 16, 2018Break; Degraded; Defective Device; Material Deformation; Patient Device Interaction Problem; Break; Degraded; Defective Device; Material Deformation; Patient Device Interaction Problem

  THE FOLLOWING WAS ALLEGED BY THE PATIENT'S ATTORNEY: ON (B)(6) 2006: THE PATIENT UNDERWENT REPAIR OF AN INCARCERATED VENTRAL HERNIA WITH A BARD/DAVOL HERNIA MESH LABELS AS A 17.8CM X 22.9CM BARD/DAVOL COMPOSIX E/X MESH, REFERENCE NUMBER 0123790, LOT NUMBER 43AQD784. AS REPORTED, THE PATIENT ALLEGES THAT THE HERNIA MESH DEVICE IMPLANTED IN HER IN (B)(6) 2006 WAS ACTUALLY A BARD/DAVOL COMPOSIX KUGEL PATCH, OR THAT SHE WAS SUBSEQUENTLY IMPLANTED WITH A BARD/DAVOL COMPOSIX KUGEL PATCH. AS ALLEGED, THE COMPOSIX KUGEL AND/OR COMPOSIX E/X MESH SUBSEQUENTLY MALFUNCTIONED AND CEASED TO SERVE ANY MEDICAL PURPOSE. ION (B)(6) 2013: THE PATIENT WAS ADMITTED TO THE HOSPITAL AND REQUIRED SURGERY TO REMOVE THE BARD/DAVOL COMPOSIX KUGEL AND/OR COMPOSIX E/X DEVICE, TO REMOVE PART OF HER BOWEL AND TO TAKE DOWN AN ENTEROCUTANEOUS FISTULA. AS REPORTED, THE COMPOSIX KUGEL AND/OR COMPOSIX E/X MESH HAD CONTRACTED, DEGRADED, PERFORATED HER BOWEL AND CAUSED SEVERE PAIN AND SUFFERING AND THE SURGEON DESCRIBED THE EXPLANTED DEVICE AS A "KUGEL TYPE MESH" AND NOTED IN THE RECORDS THAT IT "DID HAVE THE RING DISRUPTED." AS ALLEGED, SOMETIME AFTER PLACEMENT THE DEVICE MALFUNCTIONED BY, INTER ALIA, CONTRACTING, SUF

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

  MAUDE report 7345562 ↗
• InjuryFeb 21, 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) 2011: THE PATIENT UNDERWENT SURGERY FOR REPAIR OF A VENTRAL HERNIA. A BARD/DAVOL COMPOSIX E/X HERNIA PATCH MESH, (B)(4), LOT NUMBER HUUD1833 WAS IMPLANTED TO REPAIR THE HERNIA DEFECT. (B)(6) 2012: THE PATIENT UNDERWENT AN ADDITIONAL SURGERY TO REMOVE MESH AND RECURRENCE REPAIR. 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: Disability; Hernia; Pain

  MAUDE report 7285122 ↗