COMPOSIX 0134680Recalls & reported problems

Summary

The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 00801741031298), received between Apr 12, 2017 and Jan 14, 2026 — classified as 37 injuries.

The most frequently reported specific device problem is “Defective Device” (29 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 37 reports, in the reporter's own words as published by the FDA.

• InjuryJan 14, 2026Patient-Device Incompatibility

  PER ADDITIONAL INFORMATION PROVIDED: (B)(6) 2012 ¿ PATIENT WAS DIAGNOSED WITH RECURRENT INCARCERATED INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF COMPOSIX KUGEL PATCH (DEVICE 1). PER OP NOTES, ¿THE PREVIOUS MESH BELOW THE UMBILICUS WAS NOTED. THE HERNIA WAS RECURRED ABOVE THE UMBILICUS. A PIECE OF COMPOSIX KUGEL MESH (DEVICE 1) WAS POSITIONED ON INNER ASPECT OF ABDOMINAL WALL WITH THE ROUGH AGAINST ABDOMINAL WALL AND SMOOTH EDGE TOWARDS PERITONEAL CAVITY USING SUTURES.¿ (B)(6) 2012 ¿ PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE REMOVAL OF MESH (DEVICE 1) AND IMPLANT OF COMPOSIX L/P MESH (DEVICE 2). PER OP NOTES, ¿A LARGE SAC WAS ENCOUNTERED WHICH CONTAINED MULTIPLE LOOPS. A WAD OF OLD MESH WAS NOTED TO BE FREE FLOATING AND HAD CONTRACTED SIGNIFICANTLY. THE PTFE SIDE WAS INDEED AGAINST THE OMENTUM AND BOWEL AND THE POLYPROPYLENE SIDE WAS NOT INCORPORATED ITSELF TO ANY ADEQUATE FASCIA. THE MESH (DEVICE 1) WAS REMOVED. THERE WAS A SMALL RENT IN FASCIA. A LARGE COMPOSIX L/P MESH (DEVICE 2) WAS PLACED IN CAVITY AND LAID DOWN WITH PTFE SIDE AGAINST BOWEL AND OMENTUM AND POLYPROPYLENE SIDE FACING ABDOMINAL CAVITY USIN

  Patient problems: Adhesion(s); Hematoma; Hernia

  MAUDE report 24066324 ↗
• InjuryJan 8, 2026Migration

  PER INFORMATION PROVIDED: (B)(6) 2009 - PATIENT WAS DIAGNOSED WITH INCARCERATED INCISIONAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF COMPOSIX L/P (DEVICE 1). PER OP NOTES, ¿INCISION WAS MADE ON LEFT SIDE OF ABDOMEN. DENSE ADHESIONS WERE NOTED AND LYSED. THE HERNIA SAC WITH INCARCERATED OMENTUM WAS REDUCED. A COMPOSIX L/P (DEVICE 1) WAS PLACED AND SECURED USING SUTURES.¿ (B)(6) 2009 - PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA AT LAPAROSCOPIC SITE THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF COMPOSIX KUGEL (DEVICE 2). PER OP NOTES, ¿A LARGE PIECE OF PRIOR MESH (DEVICE 1) WAS NOTED. THIS REVEALED THE HERNIATED KNUCKLE OF OMENTUM AND COLON WAS NOTED AND THE OMENTUM AND COLON WERE REDUCED. A COMPOSIX KUGEL (DEVICE 2) WAS PLACED IN THE PERITONEAL CAVITY AND TACKED.¿ (B)(6) 2010 - PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA LLQ THEREBY UNDERWENT OPEN REPAIR MESH REVISION. PER OP NOTES, ¿THE OLD SCAR IN LLQ WAS EXCISED. THERE WAS NOTED TO BE THE OLD MESH (DEVICE 1 AND 2) LATERAL TO THIS NEW HERNIA DEFECT WITH INCARCERATED OMENTUM AND PERITONEAL FAT WERE REDUCED. THE LATERAL EDGE OF THE OLD MESH (DEVICE 1 AND 2) HAD PULLED FREE FROM THE FASCIA. A

  Patient problems: Hernia; Scar Tissue

  MAUDE report 24001823 ↗
• InjuryDec 13, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2009 - PATIENT WAS DIAGNOSED WITH SYMPTOMATIC ABDOMINAL INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF COMPOSIX KUGEL PATCH (DEVICE 1). PER OPERATIVE NOTES, ¿A MIDLINE SKIN INCISION WAS MADE OVER THE SCAR TISSUE WHERE THE SUBCUTANEOUS TISSUE WAS SHARPLY DIVIDED. A LARGE HERNIA SAC WAS NOTED, WHICH WAS DISSECTED OUT. A COMPOSIX KUGEL PATCH (DEVICE 1) WAS PLACED INTO THE FASCIA AND SECURE IT WITH SUTURES.¿ ON (B)(6) 2010 - PATIENT WAS DIAGNOSED WITH ABDOMINAL INCISIONAL HERNIA, ADHESION THEREBY UNDERWENT OPEN REPAIR WITH EXPLANT OF COMPOSIX KUGEL PATCH (DEVICE 1) AND IMPLANT OF COMPOSIX KUGEL PATCH (DEVICE 2). PER OPERATIVE NOTES, ¿A MIDLINE SKIN INCISION WAS MADE IN THE OLD SCAR TISSUE. PREVIOUSLY PLACED COMPOSIX KUGEL PATCH (DEVICE 1) HAD DISRUPTED, WHICH WAS REMOVED. THE HERNIA SAC WAS DISSECTED OUT. LYSIS OF ADHESION WAS PERFORMED. A COMPOSIX KUGEL PATCH (DEVICE 2) WAS PLACED INTO THE FASCIA AND SECURE IT WITH SUTURES.¿ ON (B)(6) 2011 ¿ PATIENT WAS DIAGNOSED WITH ABDOMINAL INCISIONAL HERNIA; ADHESION THEREBY UNDERWENT OPEN REPAIR WITH EXPLANT OF COMPOSIX KUGEL PATCH (DEVICE 2) AND IMPLANT OF COMPOSIX L/P MESH (DEVICE 3). PER OP

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

  MAUDE report 23797154 ↗
• InjuryJul 15, 2025Material Deformation; Material Deformation

  PER INFORMATION PROVIDED: (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.¿ (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.¿ (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.¿ (B)(6) 2012 - PATIENT WAS DIAGNOSED WITH RECURRENT INCARCERATE

  Patient problems: Abscess; Hernia; Unspecified Infection

  MAUDE report 22505578 ↗
• InjuryOct 4, 2023Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  PER INFORMATION PROVIDED BY THE PATIENT'S ATTORNEY: ON (B)(6) 2008, PATIENT WAS DIAGNOSED WITH INCISIONAL HERNIA AND UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF COMPOSIX L/P MESH (DEVICE #1). PER OPERATIVE NOTES, ¿INCISIONAL HERNIA REINFORCED USING A PIECE OF COMPOSIX L/P MESH (DEVICE #1) AND WAS SECURED ALL AROUND THE EDGE USING TACKER.¿ (B)(6) 2009 - PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF COMPOSIX KUGEL MESH (DEVICE #2) AND EXPLANT OF COMPOSIX L/P MESH (DEVICE #1). PER OPERATIVE NOTES, ¿NUMEROUS ADHESIONS ALONG THE MESH WERE DISSECTED. THE MESH WAS DISSECTED OFF OF THE MUSCLE LAYER ON BOTH SIDES OF THE DIVIDED MESH AND THEN THE MESH WAS DISCARDED (DEVICE #1). THERE WAS A HERNIA SAC BELOW THE MESH THAT WAS DISSECTED. A PIECE OF COMPOSIX KUGEL PATCH (DEVICE #2) WAS PLACED INTO THE ABDOMINAL WALL WITH PROPYLENE SIDE ORIENTED TOWARD THE FASCIA AND WAS TACKED.¿ (B)(6) 2014 - PATIENT WAS DIAGNOSED WITH PAIN, ERYTHEMA, INFECTED ABDOMINAL MESH WITH SMALL BOWEL FISTULA THEREBY UNDERWENT REMOVAL OF COMPOSIX KUGEL MESH (DEVICE #2). PER OPERATIVE NOTES, "THERE WERE NUMEROUS ADHESIONS TO THE MESH WHICH WERE TAKEN DOWN CAREFULLY.

  Patient problems: Adhesion(s); Hernia

  MAUDE report 17867414 ↗
• InjurySep 20, 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. IT IS ALLEGED THAT THE PATIENT HAD REVISION SURGERY ON (B)(6) 2022. 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; Post Operative Wound Infection

  MAUDE report 17783855 ↗
• InjuryAug 18, 2023Defective Device; Patient-Device Incompatibility; Defective Device; Patient-Device Incompatibility

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT HERNIA REPAIR SURGERY AND WAS IMPLANTED WITH COMPOSIX L/P MESH ON OR AROUND (B)(6) 2017. ON OR AROUND (B)(6) 2020, THE PATIENT UNDERWENT REVISION SURGERY DUE TO THE DEFECTIVE QUALITIES OF THE MESH. IT IS ALLEGED THAT BETWEEN (B)(6) 2017 AND THE PRESENT, PATIENT SUFFERED FROM RECURRENT HERNIA REQUIRING MULTIPLE VISITS, SUBSEQUENT HOSPITALIZATION AND SURGERY TO REPAIR THE RECURRENT HERNIA. IT IS ALSO ALLEGED THAT THE PATIENT SUFFERED AND WILL CONTINUE TO SUFFER SEVERE AND PERMANENT PERSONAL INJURIES INCLUDING BUT NOT LIMITED TO PAIN, SUFFERING AND DISABILITY.

  Patient problems: Hernia; Pain

  MAUDE report 17570966 ↗
• InjuryAug 4, 2023Device Appears to Trigger Rejection; Defective Device; Patient Device Interaction Problem; Device Appears to Trigger Rejection; Defective Device; Patient Device Interaction Problem

  PER INFORMATION PROVIDED BY THE PATIENT'S ATTORNEY: (B)(6) 2008 - PATIENT WAS DIAGNOSED WITH INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH PERFIX PLUG (DEVICE #1). PER THE OPERATIVE NOTES, "INCISIONAL HERNIA WAS NOTED AND WAS DISSECTED FREE. AN EXTRA-LARGE PERFIX PLUG (DEVICE #1) WAS INSERTED AND SUTURED." (B)(6) 2011 - PATIENT DEVELOPED ABDOMINAL PAIN THEREBY UNDERWENT LAPAROSCOPIC LYSIS OF ADHESIONS, REMOVAL OF POSSIBLY INFECTED MESH AND PARTIAL OMENTECTOMY. PER THE OPERATIVE NOTES, "ADHESIONS WERE ACTUALLY ADHERED TO A PIECE OF MESH (DEVICE #1) WHICH SEEMED TO HAVE BEEN BUNCHED UP AND DISPLACED TO THE LATERAL RIGHT SIDE. PERFORMED PARTIAL OMENTECTOMY TO FREE THE ADHESIONS FROM THE MESH. THERE WAS A POSSIBLE INFECTION OF THE MESH. THE MESH ITSELF WAS BUNCHED UP AND WAS DISSECTED OUT." (B)(6) 2011 - PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL INCISIONAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH COMPOSIX L/P MESH (DEVICE #2). PER THE OPERATIVE NOTES, "ENTEROLYSIS OF THE OMENTUM AND OMENTAL ATTACHMENTS TO THE ANTERIOR ABDOMINAL WALL AS WELL AS AROUND THE VENTRAL HERNIA WAS PERFORMED. A COMPOSIX L/P MESH (DEVICE #2) WAS TACKED TO THE ANTERIOR ABDOMINAL WALL." (B)(6) 2

  Patient problems: Abdominal Pain; Hernia

  MAUDE report 17461067 ↗
• InjuryJun 8, 2022Defective 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 MESH (BARD FLAT MESH) AND BARD/DAVOL COMPOSITE MESH (COMPOSIX) 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 ALSO ALLEGES THAT THE PATIENT SUSTAINED INJURIES ON (B)(6) 2012, (B)(6) 2016, (B)(6) 2018, (B)(6) 2018 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: Bowel Perforation; Fistula; Hernia; Insufficient Information; Obstruction/Occlusion; Pain; Unspecified Infection

  MAUDE report 14640378 ↗
• InjuryMay 24, 2022Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT THE PATIENT WAS IMPLANTED WITH A BARD/DAVOL COMPOSIX L/P MESH (PRODUCT). ATTORNEY ALLEGES THAT ON (B)(6) 2010, THE PATIENT WAS IMPLANTED WITH THE PRODUCT IN THE COURSE OF AN INCISIONAL HERNIA REPAIR SURGERY. IT WAS 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 WHICH OCCURRED ON (B)(6) 2013. IT IS ALSO 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. IT IS ALLEGED 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 ALLEGED THAT THE PATIENT EXPERIENCED SEVERE PAIN AND SUFFERING, INCLUDING CHRONIC PAIN. IT IS ALLEGED THAT THE PATIENT HAS BEEN TREATED WITH A COURSE OF HOSPITALIZATION, DIAGNOSTIC IMAGING, REVISION SURGERY, SERUM TESTING, ANTIBIOTICS, ANALG

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

  MAUDE report 14488879 ↗
• InjuryJan 3, 2022Defective 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) 2010 AND VENTRALIGHT ST ON (B)(6) 2016. 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 EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

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

  MAUDE report 13140551 ↗
• InjuryOct 21, 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 VENTRALEX HERNIA PATCH ON (B)(6) 2007 AND COMPOSIX L/P ON (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: Insufficient Information; Pain

  MAUDE report 12674295 ↗
• InjuryApr 5, 2021Defective Device; Patient Device Interaction Problem; Migration; Defective Device; Patient Device Interaction Problem; Migration

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL COMPOSIX L/P ON (B)(6) 2018. 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: Abscess; Fistula; Insufficient Information; Unspecified Infection

  MAUDE report 11613930 ↗
• InjurySep 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 AN UNSPECIFIED BARD/DAVOL COMPOSIX L/P ON (B)(6) 2010. 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; Injury; Pain

  MAUDE report 10533572 ↗
• InjurySep 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 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; Injury; Pain

  MAUDE report 10515113 ↗
• InjuryAug 19, 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) 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. ADDENDUM PER ADDITIONAL INFORMATION PROVIDED: (B)(6) 2009 - PATIENT WAS DIAGNOSED WITH INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF COMPOSIX L/P (DEVICE #1). PER OP NOTES, ¿THE HERNIA SAC WAS IDENTIFIED AND OPENED. THE SAC WAS DISSECTED FREE. A COMPOSIX L/P (DEVICE #1) WAS PLACED USING PROLENE SUTURES.¿ (B)(6) 2017 - PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL INCISIONAL HERNIA WITH PAIN THEREBY UNDERWENT OPEN REPAIR WITH EXCISION OF COMPOSIX L/P (DEVICE #1) AND IMPLANT OF SOFT MESH (DEVICE #2). PER OP NOTES, ¿THE HERNIA SAC WAS IDENTIFIED, DISSECTED OUT AND EXCISED. A PIECE OF BILAYER MESH (DEVICE #1) WAS IDENTIFIED DISINTEGRATED FROM ONE SIDE OF ABDOMINAL WALL COMPLETELY WITH PROLENE SUTURES. THE ENTIRE MESH AND THE SUTURES WERE EXCISED. ADHESIONS

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

  MAUDE report 10424458 ↗
• InjuryAug 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 IMPLANT OF UNSPECIFIED BARD/DAVOL COMPOSIX L/P ON (B)(6) 2008 AND PHASIX ON (B)(6) 2018. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE COMPOSIX L/P. IT IS ALLEGED THAT THE PATIENT UNDERWENT SURGERY FOR THE REMOVAL OF HERNIA MESH ON OR ABOUT (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 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; Hernia; Injury; Pain

  MAUDE report 10366154 ↗
• InjuryJul 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 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: Adhesion(s); Injury; Obstruction/Occlusion; Seroma

  MAUDE report 10306512 ↗
• InjuryMay 13, 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 OR ABOUT (B)(6) 2011. 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; Injury; Obstruction/Occlusion; Scar Tissue; Unspecified Infection

  MAUDE report 10054632 ↗
• InjuryApr 15, 2020Device Appears to Trigger Rejection; Defective Device; Insufficient Device Problem Information; Migration; Device Appears to Trigger Rejection; Defective Device; Insufficient Device Problem Information; Migration

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF UNSPECIFIED BARD/DAVOL COMPOSIX L/P AND BARD MESH (BARD FLAT MESH) ON (B)(6) 2012 AND/OR (B)(6) 2015. 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) 2015 AND (B)(6) 2015. 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 9962854 ↗
• InjuryMar 12, 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 COMPOSITE MESH (COMPOSIX MESH) AND VENTRIO ON (B)(6) 2009 AND/OR (B)(6) 2012. 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 9823586 ↗
• InjuryJan 7, 2020Defective 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 UNSPECIFIED BARD/DAVOL COMPOSIX L/P, PERFIX PLUG AND XENMATRIX AB ON (B)(6) 2010 AND/OR (B)(6) 2014 AND/OR (B)(6) 2015. 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); Hernia; Injury

  MAUDE report 9557375 ↗
• InjuryDec 30, 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 COMPOSITE MESH (COMPOSIX MESH) ON (B)(6) 2010. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE COMPOSITE MESH (COMPOSIX MESH). 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 9532752 ↗
• InjuryDec 26, 2019Defective Device; Insufficient Device Problem Information; Defective Device; Insufficient Device Problem Information

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR INCISIONAL HERNIA REPAIR WITH NON-BARD/DAVOL PRODUCT ON OR ABOUT (B)(6) 2009. ON OR ABOUT (B)(6) 2010, THE PATIENT UNDERWENT SURGERY FOR RECURRENT INCISIONAL HERNIA REPAIR WITH COMPOSIX L/P MESH. THE PATIENT UNDERWENT SURGERY FOR REMOVAL OF MESH PRODUCTS ON OR ABOUT (B)(6) 2010. IT IS ALLEGED THAT PATIENT HAD DISABILITY, PERMANENT PERSONAL INJURIES, SUSTAINED SEVERE AND PERMANENT PAIN, SUFFERING, ANXIETY, DEPRESSION, IMPAIRMENT, MENTAL ANGUISH AND EMOTIONAL DISTRESS. ATTORNEY ALLEGES THAT THE DEVICE WAS DEFECTIVE.

  Patient problems: Disability; Injury; Pain

  MAUDE report 9519410 ↗
• InjuryDec 19, 2019Patient Device Interaction Problem; Patient Device Interaction Problem

  AS REPORTED, PER MAUDE EVENT REPORT (MW5091153): "I HAD EXTREME PAIN IN MY ABDOMEN AT WORK AND TOOK OFF THE JOB. I RAN TO MY DOCTORS OFFICE WHO TOLD ME TO GO TO AN EMERGENCY CT SCAN. THE SCAN SHOWED A MASSIVE HERNIA DUE TO MESH FAILURE. I THEN WAS TOLD TO GO TO AN EMERGENCY ROOM. THEY DID ANOTHER CT SCAN AND DIDN'T WANT ME TO LEAVE THE ER ALL HOLIDAY WEEKEND UNTIL I WAS TO HAVE SURGERY. I DECIDED TO WAIT TO SEE MY SURGEON WHO IMPLANTED THE BARD COMPOSIX LP MESH IN 2009. THE FOLLOWING MONDAY 3 DAYS AFTER THE ER. REVISION SURGERY WAS SCHEDULED ASAP WITH MY SURGEON AND HIS PARTNER A MASTER SURGEON TO REMOVE THE FAILED MESH. AFTER 8 DAYS IN THE HOSPITAL AND HAVING A FULL OPEN SURGERY WORSE THAN ANY I HAVE EVER HAD. I AM STILL NOT ABLE TO WORK AFTER 3 MONTHS. MY CAREER IS OVER. I MAY WIND UP DISABLED. IT HAS BEEN VERY PAINFUL AT TIMES THROUGH THE YEARS. INCONTINENCE, PAINFUL SEX, FEVERS, PAIN, BLEEDING, IRREGULAR BM, AND MORE. NO ONE BUT ME POINTED TO THE MESH AND I WAS TOLD IT WAS PROBABLY SOMETHING ELSE. BARD COMPOSIX LP WITH ECHO PS A POSITIONING BALLOON WAS A CLASS 2 RECALL. WHY IS THE SAME MESH WITHOUT RECALLED? THIS MESH HAS WORSE COATING ON IT. EPTFE I ORDERED STICKER PAGE FROM M

  Patient problems: Disability; Hernia; Pain

  MAUDE report 9495159 ↗