Kugel 0010103Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 00801741016356), received between Aug 8, 2017 and Feb 27, 2026 — classified as 25 injuries.

The most frequently reported specific device problem is “Defective Device” (20 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 25 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 27, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2003 - PATIENT WAS DIAGNOSED WITH MID EPIGASTRIC INCISIONAL HERNIA AND LEFT PERIUMBILICAL VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF COMPOSIX KUGEL MESH (DEVICE 1) AND KUGEL PATCH (DEVICE 2). PER OP NOTES, ¿AN INCISION WAS MADE IN THE PREVIOUS GASTRIC UPPER MIDLINE INCISION OVER THE BULGING AREA OF MID EPIGASTRIC REGION. THE FASCIAL DEFECT WAS DELINEATED, AND A COMPOSIX KUGEL MESH (DEVICE 1) WAS PLACED BELOW THE DEFECT IN THE PERITONEAL CAVITY AND SECURED WITH SUTURES. THE VENTRAL HERNIA WAS IDENTIFIED IN THE PERIUMBILICAL REGION TO THE LEFT, AND AN INCISION WAS MADE IN THE LEFT SIDE OF UMBILICUS REGION. A KUGEL PATCH (DEVICE 2) WAS PLACED AND SECURED WITH SUTURES.¿ (B)(6) 2016 - PATIENT WAS DIAGNOSED WITH BOWEL OBSTRUCTION THEREBY UNDERWENT OPEN REPAIR WITH EXCISION OF COMPOSIX KUGEL MESH (DEVICE 1) AND KUGEL PATCH (DEVICE 2). PER OP NOTES, ¿THE PRIOR MIDLINE INCISION WAS INCISED. THE DUAL MESH AND THE INFERIOR EDGE OF THE MESH WAS IDENTIFIED. THE UNDERSURFACE OF THE PATCH WAS FREED FROM ADHESIONS AND DIVIDED IN THE MIDLINE. OMENTUM WAS DENSELY ADHERENT TO THE PROXIMAL PORTION OF THE PATCH AND DISSECTED FREE. MULTIPLE ROUGH AND PO

  Patient problems: Adhesion(s); Obstruction/Occlusion

  MAUDE report 24466399 ↗
• InjuryDec 5, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2008 ¿ PATIENT WAS DIAGNOSED WITH EPIGASTRIC HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF KUGEL PATCH (DEVICE 1). PER OPERATIVE NOTES, ¿A SMALL ROUND KUGEL PATCH (DEVICE 1) WAS PLACED IN THE PREPERITONEAL SPACE AND SUTURED.¿ ON (B)(6) 2009 ¿ PATIENT WAS DIAGNOSED WITH NON-HEALING WOUND THEREBY UNDERWENT OPEN REPAIR WITH REMOVAL OF KUGEL PATCH (DEVICE 1) AND AN IMPLANT OF BARD FLAT MESH (DEVICE 2). PER OPERATIVE NOTES, ¿THE OLD KUGEL PATCH (DEVICE 1) WAS IDENTIFIED AND REMOVED. THE WOUND WAS CLOSED. A BARD FLAT MESH (DEVICE 2) WAS PLACED AND SUTURED.¿ ON (B)(6) 2018 ¿ PATIENT WAS DIAGNOSED WITH INFECTED ABDOMINAL WALL MESH THEREBY UNDERWENT OPEN REPAIR WITH REMOVAL OF BARD FLAT MESH (DEVICE 2). PER OPERATIVE NOTES, ¿THE INFECTED DEBRIDED MESH WAS GRASPED AND EXCISED.¿

  Patient problems: Impaired Healing

  MAUDE report 23729516 ↗
• InjuryDec 9, 2024Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  PER INFORMATION PROVIDED: (B)(6)2004 - PATIENT WAS DIAGNOSED WITH BILATERAL DIRECT INGUINAL HERNIAS AND CORD LIPOMAS THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF KUGEL PATCH (RIGHT - DEVICE #1 & LEFT - DEVICE #2). PER OPERATIVE NOTES, ¿IN THE RIGHT INGUINAL REGION, A SMALL RIGHT CORD LIPOMA WAS RESECTED AND A KUGEL PATCH (RIGHT - DEVICE #1) WAS PLACED AND SUTURED. IN LEFT INGUINAL REGION, LARGE LEFT DIRECT HERNIA INCLUDING A SMALL CORD LIPOMA WAS RESECTED AND A KUGEL PATCH (LEFT - DEVICE #2) WAS PLACED AND SUTURED.¿ (B)(6)2006 - PATIENT WAS DIAGNOSED WITH RECURRENT BILATERAL DIRECT INGUINAL HERNIAS THEREBY UNDERWENT REPAIR WITH THE IMPLANT OF KUGEL PATCH (RIGHT - DEVICE #3 & LEFT - DEVICE #4). (NOTE, THERE WAS NO IMPLANT OP NOTES PROVIDED). (B)(6)2011 - PATIENT WAS DIAGNOSED WITH RECURRENT LEFT FEMORAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF PERFIX PLUG (DEVICE #5) AND EXPLANT OF KUGEL PATCH (LEFT - DEVICE #2 & #4). PER OPERATIVE NOTES, ¿THE PREVIOUSLY PLACED KUGEL PATCH (LEFT - DEVICE #2 & #4) HAD MIGRATED INFERIORLY AT FEMORAL REGION WHICH WAS DISSECTED AWAY AND REMOVED. THE HERNIA SAC WAS DISSECTED AND A PERFIX PLUG (DEVICE #5) WAS PLACED INTO THE FEMORAL R

  Patient problems: Hernia

  MAUDE report 20876447 ↗
• InjuryDec 9, 2024Defective Device; Patient Device Interaction Problem; Migration; Defective Device; Patient Device Interaction Problem; Migration

  PER INFORMATION PROVIDED: (B)(6) 2004 - PATIENT WAS DIAGNOSED WITH BILATERAL DIRECT INGUINAL HERNIAS AND CORD LIPOMAS THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF KUGEL PATCH (RIGHT - DEVICE #1 & LEFT - DEVICE #2). PER OPERATIVE NOTES, ¿IN THE RIGHT INGUINAL REGION, A SMALL RIGHT CORD LIPOMA WAS RESECTED AND A KUGEL PATCH (RIGHT - DEVICE #1) WAS PLACED AND SUTURED. IN LEFT INGUINAL REGION, LARGE LEFT DIRECT HERNIA INCLUDING A SMALL CORD LIPOMA WAS RESECTED AND A KUGEL PATCH (LEFT - DEVICE #2) WAS PLACED AND SUTURED.¿ (B)(6) 2006 - PATIENT WAS DIAGNOSED WITH RECURRENT BILATERAL DIRECT INGUINAL HERNIAS THEREBY UNDERWENT REPAIR WITH THE IMPLANT OF KUGEL PATCH (RIGHT - DEVICE #3 & LEFT - DEVICE #4). (NOTE, THERE WAS NO IMPLANT OP NOTES PROVIDED). (B)(6) 2011 - PATIENT WAS DIAGNOSED WITH RECURRENT LEFT FEMORAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF PERFIX PLUG (DEVICE #5) AND EXPLANT OF KUGEL PATCH (LEFT - DEVICE #2 & #4). PER OPERATIVE NOTES, ¿THE PREVIOUSLY PLACED KUGEL PATCH (LEFT - DEVICE #2 & #4) HAD MIGRATED INFERIORLY AT FEMORAL REGION WHICH WAS DISSECTED AWAY AND REMOVED. THE HERNIA SAC WAS DISSECTED AND A PERFIX PLUG (DEVICE #5) WAS PLACED INTO THE FEMORA

  Patient problems: Hernia

  MAUDE report 20876403 ↗
• InjuryJan 4, 2022Defective Device; Patient-Device Incompatibility; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL KUGEL HERNIA PATCH ON (B)(6) 2004. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE KUGEL HERNIA PATCH. 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; Pain

  MAUDE report 13150147 ↗
• InjuryJun 20, 2021Defective Device; Patient-Device Incompatibility; Patient Device Interaction Problem; Defective Device; Patient-Device Incompatibility; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL KUGEL HERNIA PATCH ON (B)(6) 2015. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE KUGEL HERNIA PATCH. ATTORNEY ALLEGES THAT THE PATIENT HAD SUBSEQUENT SURGICAL INTERVENTION DUE TO THE HERNIA MESH DEVICE. IT IS ALSO ALLEGED THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

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

  MAUDE report 12030255 ↗
• InjuryDec 28, 2020Patient-Device Incompatibility; Patient Device Interaction Problem; Patient-Device Incompatibility; Patient Device Interaction Problem

  AS REPORTED, THE PATIENT WAS IMPLANTED WITH A BARD KUGEL MESH IN 2012 AND HAS BEEN HAVING SOME SYMPTOMS SIMILAR TO THE PATIENT'S CROHN'S DISEASE SYMPTOMS. AS REPORTED, THE PATIENT WENT TO THE DOCTOR WHO DID NOT FIND ANYTHING ON THE X-RAY.

  Patient problems: Adhesion(s); No Information; Obstruction/Occlusion

  MAUDE report 11085363 ↗
• InjuryJul 9, 2020Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information; Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL KUGEL HERNIA PATCH ON (B)(6) 2014. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE KUGEL HERNIA PATCH. 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); Fibrosis; Hernia; Injury; Pain

  MAUDE report 10249180 ↗
• InjuryMay 26, 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 ON (B)(6) 2003 AND TWO KUGEL HERNIA PATCHES ON (B)(6) 2003 AND (B)(6) 2004. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST ALL DEVICES. IT IS ALLEGED THAT THE PATIENT HAD REVISION SURGERY ON (B)(6) 2011. 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. AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Adhesion(s); Disability; Drug Resistant Bacterial Infection; Fistula; Hernia; Injury; Pain

  MAUDE report 10086416 ↗
• InjuryMar 19, 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 KUGEL HERNIA PATCH AND VENTRALIGHT ST ON (B)(6) 2008 AND/OR (B)(6) 2019. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE KUGEL HERNIA PATCH. 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

  MAUDE report 9851849 ↗
• InjuryAug 15, 2019Defective Device; Material Deformation; Insufficient Device Problem Information; Defective Device; Material Deformation; Insufficient Device Problem Information

  ATTORNEY ALLEGES THAT ON (B)(6) 2009, THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL MODIFIED KUGEL HERNIA PATCH. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE MODIFIED KUGEL HERNIA PATCH. 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; Adhesion(s); Disability; Injury; Obstruction/Occlusion; Pain

  MAUDE report 8899459 ↗
• InjuryAug 14, 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 KUGEL HERNIA PATCH ON (B)(6) 2013. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE KUGEL HERNIA PATCH. 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: Disability; Fibrosis; Inflammation; Injury; Necrosis; Pain; Unspecified Infection

  MAUDE report 8894542 ↗
• InjuryAug 1, 2019Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information; Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information

  ATTORNEY ALLEGES THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL COMPOSIX KUGEL HERNIA PATCH ON (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 COMPOSIX KUGEL HERNIA PATCH. AS REPORTED, THE ATTORNEY ALLEGES PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Bowel Perforation; Drug Resistant Bacterial Infection; Granuloma; Hernia; Injury; Scar Tissue

  MAUDE report 8852028 ↗
• InjuryJun 20, 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 KUGEL HERNIA PATCH ON (B)(6) 2013. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE KUGEL HERNIA PATCH. IT IS ALSO ALLEGED BY PATIENT'S ATTORNEY THAT THE PATIENT HAD UNSPECIFIED INJURIES RELATED TO A DEFECT IN THE KUGEL HERNIA PATCH, AND UNDERWENT REVISION SURGERY ON (B)(6) 2017. 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; Adhesion(s); Disability; Hernia; Injury; Pain

  MAUDE report 8718844 ↗
• InjuryMay 31, 2019Defective Device; Insufficient Device Problem Information; Patient Device Interaction Problem; Defective Device; Insufficient Device Problem Information; Patient Device Interaction Problem

  ATTORNEY ALLEGES THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL KUGEL HERNIA PATCH ON (B)(6) 2007. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE KUGEL HERNIA PATCH. 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: Disability; Hematoma; Hernia; Injury; Pain

  MAUDE report 8658228 ↗
• InjuryApr 23, 2019Defective 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 KUGEL HERNIA PATCH (DEVICE #1) ON (B)(6) 2010. IT IS ALLEGED THAT ON (B)(6) 2010 THE PATIENT HAD UNSPECIFIED INJURIES AND UNDERWENT SURGERY WITH IMPLANT OF AN UNSPECIFIED BARD/DAVOL COMPOSIX KUGEL HERNIA PATCH (DEVICE #2). IT IS ALLEGED THE PATIENT HAD UNSPECIFIED INJURIES AND UNDERWENT REVISION SURGERY ON (B)(6) 2012. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE BARD/DAVOL KUGEL HERNIA PATCH AND COMPOSIX KUGEL HERNIA PATCH. 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 8541778 ↗
• InjuryMar 11, 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 AN UNSPECIFIED BARD/DAVOL KUGEL HERNIA PATCH (DEVICE #1). ON (B)(6) 2010: THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL SEPRAMESH IP (DEVICE #2). ON (B)(6) 2011: THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL KUGEL HERNIA PATCH (DEVICE #3). ON (B)(6) 2012: THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL SEPRAMESH IP (DEVICE #4). ON (B)(6) 2013: THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL COMPOSIX E/X (DEVICE #5). AS ALLEGED, 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 BARD/DAVOL KUGEL HERNIA PATCH (DEVICES #1 AND #3), SEPRAMESH IP (DEVICES #2 AND #4), AND COMPOSIX E/X (DEVICE #5). AS REPORTED, THE ATTORNEY ALLEGES PRODUCTS ARE DEFECTIVE AND THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS.

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

  MAUDE report 8409959 ↗
• InjuryMar 11, 2019Defective Device; Insufficient Device Problem Information; Patient Device Interaction Problem; Migration; Defective Device; Insufficient Device Problem Information; Patient Device Interaction Problem; Migration

  THE FOLLOWING WAS ALLEGED BY THE PATIENT'S ATTORNEY: (B)(6) 2010: THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL KUGEL HERNIA PATCH (DEVICE #1). ON (B)(6) 2010: THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL SEPRAMESH IP (DEVICE #2). ON (B)(6) 2011: THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL KUGEL HERNIA PATCH (DEVICE #3). ON (B)(6) 2012: THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL SEPRAMESH IP (DEVICE #4). ON (B)(6) 2013: THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL COMPOSIX E/X (DEVICE #5). AS ALLEGED, 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 BARD/DAVOL KUGEL HERNIA PATCH (DEVICES #1 AND #3), SEPRAMESH IP (DEVICES #2 AND #4), AND COMPOSIX E/X (DEVICE #5). AS REPORTED, THE ATTORNEY ALLEGES PRODUCTS ARE DEFECTIVE AND THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS.

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

  MAUDE report 8409756 ↗
• InjuryNov 5, 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: (B)(6) 2015: THE PATIENT UNDERWENT REPAIR OF A VENTRAL INCISIONAL HERNIA. AS ALLEGED, A BARD/DAVOL 3X3¿ KUGEL PATCH (DEVICE #1)WAS IMPLANTED IN PATIENT DURING THIS REPAIR. (B)(6) 2016: THE PATIENT UNDERWENT SURGERY TO EXPLANT THE FAILED MESH DEVICE AND REPAIR AN INCISIONAL HERNIA. PRIOR TO THE SURGERY THE DOCTORS. NOTED THAT ¿THERE IS A FREE EDGE OF THE MESH IDENTIFIED INFERIORLY AND THERE IS SLIGHT BULGING OF THE INTRA-ABDOMINAL FAT INTO THE AREA OF THE MESH IN A PANNUS-LIKE FASHION. THE PATTERN HERE SUGGESTS DEHISCENCE OF THE MESH ATTACHMENT.¿ DURING THE PROCEDURE, THE OLD MESH AS WELL AS THE HERNIA SAC WERE EXCISED AS ALLEGED A BARD/DAVOL 4.3X5.5¿ VENTRIO (DEVICE #2) WAS IMPLANTED. ON OR ABOUT (B)(6) 2016:THE PATIENT UNDERWENT SURGERY TO EXPLANT THE FAILED MESH DEVICE. DURING THE PROCEDURE, THE DOCTOR NOTED ¿IT WAS READILY FOUND THAT THE PREVIOUSLY PLACED ONLAY MESH WAS COMPLETELY UNINCORPORATED.¿ AS REPORTED, PATIENT CONTINUES TO EXPERIENCE COMPLICATIONS RELATED TO THE BARD/DAVOL KUGEL PATCH (DEVICE #1) AND THE BARD/DAVOL VENTRIO (DEVICE #2). SHE HAS ALREADY AND WILL LIKELY REQUIRE ADDITIONAL SURGERIES TO REPAIR THE DAMAGE FR

  Patient problems: Hernia; Injury; Pain

  MAUDE report 8037142 ↗
• InjuryApr 6, 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) 2003 - THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL KUGEL HERNIA PATCH. AS REPORTED, THE PATIENT'S ATTORNEY ALLEGES A GENERAL CLAIM "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: Adhesion(s); Disability; Hernia; Injury; Pain

  MAUDE report 7403215 ↗
• InjuryFeb 7, 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) 2009: THE PATIENT UNDERWENT A SURGERY TO REPAIR A RIGHT INGUINAL HERNIA. AS REPORTED, THE PATIENT'S HERNIA WAS REPAIRED WITH A BARD/DAVOL KUGEL PATCH. ON (B)(6) 2016: THE PATIENT UNDERWENT SURGERY TO REPAIR RECURRENT RIGHT INGUINAL HERNIA. AS ALLEGED, THE PATIENT WAS SERIOUSLY AND PERMANENTLY INJURED AND HAS SUFFERED AND WILL CONTINUE TO SUFFER PHYSICAL PAIN DUE TO THE ALLEGED DEFECTIVE KUGEL PATCH.

  Patient problems: Disability; Hernia; Pain; Scar Tissue

  MAUDE report 7249522 ↗
• InjuryDec 19, 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) 2007 - THE PATIENT UNDERWENT SURGERY FOR THE REPAIR OF AN INCARCERATED RIGHT FEMORAL HERNIA, A KUGEL PATCH WAS IMPLANTED TO REPAIR THE HERNIA DEFECT. (B)(6) 2015 - THE PATIENT UNDERWENT SURGERY FOR THE REMOVAL OF HER FAILED KUGEL PATCH AND THE REPAIR OF HER FEMORAL HERNIA. DURING THE OPERATION, THE PHYSICIAN NOTED THAT THE KUGEL PATCH PREVIOUSLY IMPLANTED HAD "ROLLED UP." THE KUGEL PATCH WAS DISSECTED AND REMOVED. THE ATTORNEY ALLEGES THE PATIENT HAS SUFFERED AND WILL CONTINUE TO SUFFER PAIN AND WAS SERIOUSLY AND PERMANENTLY INJURED. ADDENDUM PER ADDITIONAL INFORMATION PROVIDED: (B)(6) 2007 - PATIENT WAS DIAGNOSED WITH INCARCERATED RECURRENT RIGHT FEMORAL HERNIA AND UMBILICAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT OF KUGEL PATCH (DEVICE #1) AND VENTRALEX PATCH (DEVICE #2). PER OPERATIVE NOTES, "THE HERNIA SAC WAS IDENTIFIED AT THE UMBILICAL HERNIA DEFECT, THERE WAS AN INCARCERATED OMENTUM WITHIN THE FEMORAL HERNIA AND THE PREVIOUS RIGHT INGUINAL SCAR WAS DISSECTED THROUGH THE PREVIOUS PATCH (NON-BARD/DAVOL). A SMALL ROUND KUGEL PATCH (DEVICE #1) WAS PLACED IN THE PREPERITONEAL SPACE, COVERI

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

  MAUDE report 7130849 ↗
• InjuryNov 8, 2017Defective Device; Detachment of Device or Device Component; Insufficient Device Problem Information; Patient Device Interaction Problem; Defective Device; Detachment of Device or Device Component; Insufficient Device Problem Information; Patient Device Interaction Problem

  THE FOLLOWING WAS REPORTED TO DAVOL BY THE PATIENT'S ATTORNEY: (B)(6) 2012 - THE PATIENT UNDERWENT SURGERY FOR REPAIR OF AN INCISIONAL HERNIA. THE PATIENT'S HERNIA WAS REPAIRED WITH A KUGEL PATCH. (B)(6) 2017 - THE PATIENT UNDERWENT AN ADDITIONAL SURGERY TO REMOVE THE PREVIOUSLY PLACED KUGEL MESH WHICH ALLEGEDLY FAILED. THE ATTORNEY ALLEGES THE PATIENT HAS SUFFERED PHYSICAL PAIN AND WAS INJURED SEVERELY AND PERMANENTLY.

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

  MAUDE report 7011704 ↗
• InjuryAug 16, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  THE FOLLOWING WAS REPORTED VIA MAUDE EVENT REPORT (MW5070931): "HAD PAIN IN ABDOMEN WENT IN FOR LAPAROSCOPIC SURGERY AND DR. FOUND A SPIGELIAN HERNIA USED A 3 INCH ROUND COMPOSIX MESH (KUGEL PATCH) WITH STAY SUTURES FIXED TO THE ABDOMINAL WALL USING A PUNCTURE CLOSURE DEVICE AND TACKING STAPLES. EVER SINCE THE SURGERY I HAVE HAD ABDOMINAL PAIN BUT IT IS A DIFFERENT KIND OF PAIN. I HAVE SEEN ANOTHER SURGEON ABOUT IT. HE SAID MESH CANNOT BE REMOVED BUT COULD DO LAPAROSCOPIC SURGERY AGAIN. HE CAN POSSIBLY REPOSITION THE TACKS. I HAVE BEEN MISERABLE SINCE SURGERY.

  Patient problems: Abdominal Pain; Pain

  MAUDE report 6798898 ↗
• InjuryAug 8, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT ON (B)(6) 2004 THE PATIENT UNDERWENT THE REPAIR OF A LEFT SIDED INGUINAL HERNIA USING A 3" BARD KUGEL MESH. THE CONTACT REPORTS THAT THE PATIENT EXPERIENCED A PROLONGED RECOVERY PERIOD DUE TO INCREASED PAIN. THE PATIENT WAS EVALUATED BY HER SURGEON WHO TOLD HER IT WOULD TAKE AT LEAST A YEAR FOR A FULL RECOVERY. IN THE YEARS FOLLOWING, AS REPORTED THE PAIN HAS NEVER SUBSIDED. THE PATIENT HAS HAD THREE PREGNANCIES WITH NORMAL VAGINAL BIRTHS, HOWEVER, THE CONTACT STATES THE PAIN IN THE LEFT GROIN HAS BECOME WORSE WITH EACH PREGNANCY. AS REPORTED THE PAIN IS LIKE A "PULLING' SENSATION AND THE PAIN, POST HERNIA REPAIR IS WORSE THAN THE PAIN FELT FROM THE ACTUAL HERNIA ITSELF. UPON FURTHER EVALUATION FROM HER MD AND AN MRI (NO FINDINGS) THE CONTACT REPORTS THAT THE PATIENT HAS BEEN ADVISED TO UNDERGO ADDITIONAL EXPLORATORY SURGERY TO DETERMINE THE CAUSE OF THE PAIN. THE PATIENT IS SEEKING ANOTHER OPINION FROM AN EXPERIENCED SURGEON.

  Patient problems: Pain

  MAUDE report 6775298 ↗