COMPOSIX 0134810Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00801741031311), received between Dec 21, 2017 and Apr 23, 2025 — classified as 18 injuries.

The most frequently reported specific device problem is “Defective Device” (17 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjuryApr 23, 2025Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  PER INFORMATION PROVIDED: (B)(6) 2004 - PATIENT WAS DIAGNOSED WITH VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF COMPOSIX KUGEL MESH (DEVICE #1). PER OPERATIVE NOTES, "THE HERNIA WAS IDENTIFIED AND DISSECTED FREE DOWN TO THE LEVEL OF FASCIA. THE DEFECT WAS NOTED AND A COMPOSIX KUGEL MESH (DEVICE #1) WAS SEWN WITH SUTURES." (B)(6) 2007 - PATIENT WAS DIAGNOSED WITH DRAINING UMBILICAL GRANULATION WOUND THEREBY UNDERWENT EXCISION OF GRANULATION TISSUE AND CLOSURE OF UMBILICAL HERNIA. PER OPERATIVE NOTES, "THE GRANULATION AND NECROTIC TISSUES WERE COMPLETELY EXCISED ALONG WITH A SUTURE. THE FASCIAL EDGES WERE ADHERENT TO THE UNDERLYING MESH (DEVICE #1)." (B)(6) 2008 - PATIENT WAS DIAGNOSED WITH CHRONICALLY INFECTED HERNIA MESH THEREBY UNDERWENT OPEN REPAIR WITH REMOVAL OF MESH (DEVICE #1) AND IMPLANT OF BIOLOGIC MESH. PER OPERATIVE NOTES, "THE INFECTED MESH (DEVICE #1) WAS REMOVED COMPLETELY. A SMALL PORTION OF OMENTUM ADHERENT TO THE MESH WAS ALSO EXCISED. A PIECE OF BIOLOGIC MESH WAS SUTURED." (B)(6) 2009 - PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA (X4) THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT OF COMPOSIX L/P MESH (DEVICE #2). PER OPERATIV

  Patient problems: Abscess; Adhesion(s); Fluid Discharge; Necrosis

  MAUDE report 21889887 ↗
• InjuryFeb 13, 2025Defective Device; Patient Device Interaction Problem; Migration; Defective Device; Patient Device Interaction Problem; Migration

  PER INFORMATION PROVIDED: (B)(6) 2012 - PATIENT WAS DIAGNOSED WITH INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF VENTRALEX (DEVICE #1). PER OPERATIVE NOTES, ¿IDENTIFIED THE HERNIA SAC AND WAS DISSECTED DOWN. A VENTRALEX MESH (DEVICE #1) WAS THEN PLACED INTO THE DEFECT USING PROLENE SUTURES.¿ (B)(6) 2012 - PATIENT WAS DIAGNOSED WITH ACUTE ABDOMINAL PAIN WITH CHRONIC ABDOMINAL WALL HERNIAS. (B)(6) 2013 - PATIENT WAS DIAGNOSED WITH LARGE INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF COMPOSIX L/P MESH (DEVICE #2). PER OPERATIVE NOTES, ¿THERE WERE NUMEROUS ADHESIONS IN THE HERNIA SAC, AND THESE WERE TAKEN DOWN. A COMPOSIX L/P MESH (DEVICE #2) WAS THEN PLACED AND SECURED USING PROLENE SUTURES.¿ (NOTE: THERE WAS NO MENTION/VISUALIZATION OF THE PREVIOUSLY PLACED VENTRALEX MESH (DEVICE #1) DURING THIS PROCEDURE.) (B)(6) 2013 - PATIENT VISITED HOSPITAL FOR ABDOMINAL ABSCESS. (B)(6) 2013 - PATIENT WAS DIAGNOSED WITH INFECTED ABDOMINAL WALL MESH THEREBY UNDERWENT REPAIR WITH REMOVAL OF MESHES (DEVICE #1 & #2). PER OPERATIVE NOTES, ¿THE INCISION WAS CARRIED DOWN ALONG THE FISTULA TRACT. THE MESH WAS ADHERENT TO THE ABDOMINAL WALL, AND THIS WAS TAKEN D

  Patient problems: Abscess; Adhesion(s); Bacterial Infection; Fistula

  MAUDE report 21372607 ↗
• InjurySep 2, 2021Defective Device; Material Deformation; Patient Device Interaction Problem; Defective Device; Material Deformation; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF UNSPECIFIED BARD/DAVOL COMPOSIX ON (B)(6) 2009. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST COMPOSIX. IT IS ALLEGED THAT THE PATIENT HAD SUBSEQUENT SURGICAL INTERVENTION DUE TO THE HERNIA MESH DEVICE. ATTORNEY ALLEGES THAT THE PATIENT SUSTAINED PERSONAL INJURY, EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Adhesion(s); Bowel Perforation; Insufficient Information

  MAUDE report 12419132 ↗
• InjuryJun 2, 2021Defective Device; 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 (X2) ON (B)(6) 2007 AND VENTRALEX HERNIA PATCH ON (B)(6) 2011. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST ALL 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. ADDENDUM PER ADDITIONAL INFORMATION PROVIDED: (B)(6) 2007 - PATIENT WAS DIAGNOSED WITH INCISIONAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT OF TWO COMPOSIX L/P (DEVICE #1 & #2). PER OP NOTES, ¿TWO COMPOSIX L/P MESH (DEVICE #1 & #2) WERE PLACED WITHIN THE ABDOMEN AND TACKED TO THE LEFT ASPECT OF THE HERNIA USING SUTURES.¿ (B)(6) 2009 - PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT OF DULEX MESH (DEVICE #3). PER OP NOTES, ¿OMENTAL ADHESIONS WERE TAKEN DOWN. A DULEX MESH (DEVICE #3) WAS PLACED IN THE ABDOMEN AND TACKED TO THE OVERLYING PERITONEUM USING SUTURES.¿ (NOTE: THERE IS NO MENTION/VISUALIZATION OF PREVIOUSLY PLACED COMPOSIX L/P (DEVICE #1 & #2

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

  MAUDE report 11920958 ↗
• InjuryOct 29, 2020Defective Device; Insufficient Device Problem Information; Migration; Defective Device; Insufficient Device Problem Information; Migration

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR THE IMPLANT OF UNSPECIFIED BARD/DAVOL COMPOSIX L/P ON (B)(6) 2009 AND COMPOSIX KUGEL HERNIA PATCH ON (B)(6) 2010. 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

  MAUDE report 10754296 ↗
• InjuryAug 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 UNSPECIFIED BARD/DAVOL COMPOSIX KUGEL HERNIA PATCH AND COMPOSITE MESH (COMPOSIX) ON (B)(6) 2007 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) 2010. 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. THE DATE OF IMPLANT FOR COMPOSITE MESH WILL BE CONSIDERED AS (B)(6) 2012, SINCE THE INITIAL LEGAL CLAIM IDENTIFIED THE IMPLANT DATE FOR THE COMPOSIX KUGEL HERNIA PATCH AS (B)(6) 2007.

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

  MAUDE report 10391508 ↗
• InjuryJun 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 L/P MESH ON (B)(6) 2017. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE COMPOSIX L/P MESH. 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; Injury; Obstruction/Occlusion

  MAUDE report 10108250 ↗
• InjuryApr 15, 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 KUGEL HERNIA PATCH AND COMPOSIX L/P ON (B)(6) 2010. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST BOTH THE DEVICES. IT IS ALLEGED THAT THE PATIENT SUSTAINED INJURIES ON (B)(6) 2010 DUE TO THE HERNIA MESH DEVICE. 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: Abdominal Pain; Adhesion(s); Disability; Injury; Pain; Purulent Discharge; Unspecified Infection

  MAUDE report 9966065 ↗
• 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 STAPH INFECTION AND LYSIS OF ADHESIONS FROM HER APPENDIX AND INTESTINES.

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

  MAUDE report 9694868 ↗
• InjurySep 24, 2019Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information; Defective Device; 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 BARD/DAVOL COMPOSIX L/P. IT IS ALLEGED THAT THE PATIENT HAD SUBSEQUENT SURGICAL INTERVENTION DUE TO THE HERNIA MESH DEVICE. AS REPORTED, THE ATTORNEY ALLEGES PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Abdominal Pain; Adhesion(s); Hernia; Injury; Scar Tissue

  MAUDE report 9111990 ↗
• InjurySep 6, 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 ON (B)(6) 2016. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE COMPOSIX. 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

  MAUDE report 8971900 ↗
• InjuryJul 16, 2019Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information; Defective Device; Insufficient Device Problem Information

  ATTORNEY ALLEGES THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL COMPOSIX L/P ON (B)(6) 2009. 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 L/P. AS REPORTED, THE ATTORNEY ALLEGES PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

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

  MAUDE report 8795874 ↗
• InjuryJul 9, 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 PERFIX PLUG ON (B)(6) 2010. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE BARD/DAVOL PERFIX PLUG. IT IS ALLEGED THAT THE PATIENT HAD SUBSEQUENT SURGICAL INTERVENTION DUE TO THE HERNIA MESH DEVICE. AS REPORTED, THE ATTORNEY ALLEGES PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

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

  MAUDE report 8773263 ↗
• InjuryApr 17, 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 WITH IMPLANT OF AN UNSPECIFIED BARD/DAVOL COMPOSIX L/P ON (B)(6) 2010. 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 L/P. AS REPORTED, THE ATTORNEY ALLEGES PRODUCT IS DEFECTIVE AND THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS.

  Patient problems: Adhesion(s); Hernia; Injury; Necrosis; Obstruction/Occlusion; Pain; Purulent Discharge

  MAUDE report 8525065 ↗
• InjuryJan 10, 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) 2010: THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF A BARD/DAVOL COMPOSIX MESH. NI/NI/NI: THE PATIENT UNDERWENT ADDITIONAL SURGICAL INTERVENTION. THE PATIENT'S ATTORNEY ALLEGES PATIENT EXPERIENCED EMOTIONAL DISTRESS DUE TO THE DEFECTIVE DEVICE.

  Patient problems: Hernia; Injury; Ischemia; Obstruction/Occlusion; Strangulation

  MAUDE report 8237470 ↗
• InjuryNov 13, 2018Defective Device; Insufficient Device Problem Information; Defective Device; Insufficient Device Problem Information

  THE FOLLOWING WAS ALLEGED BY THE PATIENT'S ATTORNEY: (B)(6) 2013: THE PATIENT UNDERWENT REPAIR OF A VENTRAL INCISIONAL HERNIA. A BARD/DAVOL COMPOSIX L/P WAS IMPLANTED IN THE PATIENT DURING THIS REPAIR. (B)(6) 2014: THE PATIENT UNDERWENT SURGERY TO REPAIR A CHRONICALLY DRAINING FISTULA. DURING THE SURGERY, THE SURGEON NOTED THAT THE MESH WAS INFECTED AND DENSELY ADHERENT TO THE SMALL BOWEL. THE MESH HAD TO BE REMOVED. THE PATIENT CONTINUES TO EXPERIENCE COMPLICATIONS RELATED TO THE BARD/DAVOL COMPOSIX L/P. THE PATIENT WILL LIKELY REQUIRE ADDITIONAL SURGERIES TO REPAIR THE DAMAGE FROM THE MESH. THE MESH IMPLANTED IN THE PATIENT FAILED TO REASONABLY PERFORM AS INTENDED. THE PRODUCT THEREFORE HAD TO BE SURGICALLY REMOVED, NECESSITATING FURTHER INVASIVE SURGERY TO REPAIR THE VERY ISSUE THAT THE MESH WAS INTENDED TO REPAIR. THE PATIENT HAS BEEN INJURED, SUSTAINED SEVERE AND PERMANENT PAIN, SUFFERING, ANXIETY, DEPRESSION, DISABILITY AND IMPAIRMENT.

  Patient problems: Disability; Fistula; Unspecified Infection

  MAUDE report 8066535 ↗
• InjuryMay 31, 2018Defective Device; Insufficient Device Problem Information; Defective Device; Insufficient Device Problem Information

  THE FOLLOWING WAS ALLEGED BY THE PATIENT'S ATTORNEY: ON (B)(6) 2007 - THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF A BARD/DAVOL COMPOSIX KUGEL (DEVICE 1). ON (B)(6) 2010 - THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF A BARD/DAVOL COMPOSIX LP (DEVICE 2). ON (B)(6) 2015 - THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL COMPOSIX KUGEL (DEVICE 3). THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST TWO COMPOSIX KUGEL MESH (DEVICE 1 AND 3) AND THE COMPOSIX LP (DEVICE 2). AS REPORTED, THE PATIENT'S ATTORNEY ALLEGES A GENERAL CLAIM RELATED TO THE COMPOSIX KUGEL (DEVICES 1 AND 3) AND THE COMPOSIX LP (DEVICE 2) "FOR PAST, PRESENT, AND FUTURE DAMAGES, INCLUDING BUT NOT LIMITED TO, MENTAL AND PHYSICAL PAIN AND SUFFERING FOR SEVERE AND PERMANENT PERSONAL INJURIES SUSTAINED."

  Patient problems: Disability; Injury; Pain

  MAUDE report 7557107 ↗
• InjuryDec 21, 2017Defective Device; Material Deformation; Patient Device Interaction Problem; Defective Device; Material Deformation; Patient Device Interaction Problem

  THE FOLLOWING WAS REPORTED TO DAVOL BY THE PATIENT'S ATTORNEY: (B)(6) 2010 - THE PATIENT UNDERWENT IMPLANT OF A COMPOSIX L/P MESH. (B)(6) 2016 - THE PATIENT BECAME ILL, WHICH INCLUDED AN OBSTRUCTED BOWEL. (B)(6) 2016 - THE PATIENT UNDERWENT SURGERY WHICH REVEALED AN ALLEGED DEFORMED MESH. PRESENT WAS A BOWEL PERFORATION AND EXTENSIVE ADHESIONS, AMONG OTHER ALLEGED FINDINGS. THE PATIENT HAD AN APPROXIMATELY SIX WEEK HOSPITALIZATION, NINETEEN DAYS OF WHICH WERE IN INTENSIVE CARE FOR A COMA. TO THIS DAY IT IS ALLEGED THE PATIENT SUFFERED FROM SEVERE, PERMANENT AND DISABLING INJURIES. THIS INCLUDES, BUT IS NOT LIMITED TO, THE INABILITY FOR FURTHER HERNIA REPAIR SURGERIES. IT IS ALLEGED THAT THE PATIENT NOW SUFFERS FROM A LARGE DEFECT AND PROTRUDING HERNIA WHICH PREVENTS HIM FROM DOING HIS NORMAL DAILY AND EMPLOYMENT ACTIVITIES, AS WELL AS BEING AT RISK FOR FURTHER INJURY. ADDENDUM PER ADDITIONAL INFORMATION RECEIVED: (B)(6) 2010 - PATIENT WAS DIAGNOSED WITH INCISIONAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF COMPOSIX L/P MESH. PER OPERATIVE NOTES, ¿THERE WERE 4 SEPARATE HERNIA DEFECTS IDENTIFIED. AT THE SUPERIOR ASPECT OF THE HERNIA DEFECTS, THE COLON WAS STUCK TO T

  Patient problems: Adhesion(s); Bowel Perforation; Coma; Obstruction/Occlusion

  MAUDE report 7140380 ↗