KUGEL 0115808Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00801741030789), received between Aug 8, 2017 and Feb 20, 2025 — classified as 20 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 20, 2025Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  PER INFORMATION PROVIDED: (B)(6) 2007 - PATIENT WAS DIAGNOSED WITH BILATERAL INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF TWO MODIFIED KUGEL PATCH (DEVICE #1 - LEFT, DEVICE #2 - RIGHT). PER OPERATIVE NOTES, ¿ON THE LEFT, THE PATIENT HAD A LARGE DIRECT INGUINAL HERNIA. THE HERNIA SAC WAS REDUCED BACK DOWN INTO THE ABDOMINAL CAVITY. A BARRED MODIFIED KUGEL PATCH (DEVICE #1) WAS PLACED IN THE PRE-PERITONEAL SPACE. THE ONLAY PIECE WAS THEN PLACED DOWN ONTO THE INGUINAL FLOOR, AND SUTURED INFERIOR MEDIALLY TO THE CONJOINED TENDON, AND THE PUBIC TUBERCLE, AND LATERALLY TO THE INGUINAL LIGAMENT. ON THE RIGHT SIDE, THE PATIENT HAD A LARGER DIRECT HERNIA WHICH WAS REPAIRED AS SAME AS LEFT SIDE, USING MODIFIED KUGEL PATCH (DEVICE #2).¿ (B)(6) 2010 - PATIENT HAD ILIOINGUINAL NERVE BLOCK. (B)(6) 2011 - PATIENT WAS DIAGNOSED WITH BILATERAL ILIOINGUINAL NEUROPATHY AND BILATERAL GROIN PAIN THEREBY UNDERWENT OPEN REPAIR. PER OPERATIVE NOTES, ¿ON RIGHT SIDE, THE ILIOINGUINAL NERVE WAS COMING OUT OF THE EXTERNAL INGUINAL RING AND ENTRAPPED IN SCAR TISSUE WAS DISSECTED. THE PREVIOUSLY PLACED MESH (DEVICE #2) WAS DIRECTLY BENEATH THE EXTERNAL OBLIQUE APONEUROSIS AND NERVE ENTRAPPE

  Patient problems: Necrosis; Nerve Damage; Pain; Scar Tissue

  MAUDE report 21419715 ↗
• InjuryNov 13, 2024Defective Device; Material Deformation; Patient Device Interaction Problem; Defective Device; Material Deformation; Patient Device Interaction Problem

  PER ADDITIONAL INFORMATION PROVIDED: ON (B)(6) 2010: PATIENT WAS DIAGNOSED WITH INCISIONAL VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF VENTRIO MESH (DEVICE #1). PER OPERATIVE NOTES, ¿PATIENT HAD MULTIPLE HERNIAS ALONG THE COURSE OF THE INCISION. A VENTRIO MESH (DEVICE #1) WAS PLACED AND SECURED CIRCUMFERENTIALLY TO THE ABDOMINAL WALL USING SUTURES.¿ ON (B)(6) 2014: PATIENT WAS DIAGNOSED WITH CHRONIC ABDOMINAL PAIN; ADHESIONS THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH LYSIS OF ADHESIONS AND REMOVAL OF VENTRIO MESH (DEVICE #1). PER OPERATIVE NOTES, ¿IN MULTIPLE AREAS OF SMALL BOWEL, THERE WAS EROSION INTO THE MESH AND A PORTION OF MESH HAD TO BE CUT AND ALSO A SEGMENT OF THE MESH WAS ERODED INTO THE LIVER, PORTION OF THE LIVER HAD TO BE EXCISED. ONCE THE LYSIS OF ADHESIONS WAS COMPLETE, THE COMPLETE MESH WAS DISSECTED FREE FROM THE ABDOMINAL WALL ALONG WITH SUTURES.¿ ON (B)(6) 2015: PATIENT WAS DIAGNOSED WITH CHRONIC VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH REMOVAL OF SCAR. ON (B)(6) 2015: PATIENT WAS DIAGNOSED WITH RIGHT GROIN PAIN; REDUCIBLE RIGHT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF MODIFIED KUGEL HERNIA PATCH (DEVICE #2).

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

  MAUDE report 20672575 ↗
• InjuryFeb 17, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  PER JOURNAL ARTICLE: HERNIA WEEK 2022 YOKOHAMA: ABSTRACTS OF SCIENTIFIC MEETINGS OF THE JAPANESE HERNIA SOCIETY, VOL. 20: INGUINAL HERNIA MESH INFECTION AFTER COLOSTOMY. IN (B)(6) 2017, THE PATIENT UNDERWENT REPAIR OF A RIGHT INGUINAL HERNIA VIA AN ANTERIOR APPROACH, WITH THE IMPLANT OF A MODIFIED KUGEL MESH. IN (B)(6) 2019, THE PATIENT EXPERIENCED A VESICO CONSTRICTOR FISTULA DUE TO SIGMOID COLON DIVERTICULITIS. IN (B)(6) 2019, THE PATIENT UNDERWENT LAPAROSCOPIC SIGMOID COLON RESECTION AND ILEAL COLOSTOMY. IN EARLY (B)(6) 2020, SWELLING AND PAIN WERE OBSERVED IN THE RIGHT INGUINAL REGION, AND A CT SCAN REVEALED A SUBCUTANEOUS ABSCESS AND ABSCESS FORMATION AROUND THE MESH, WHICH LED TO HOSPITALIZATION. AFTER ADMISSION, A CATHETER WAS INSERTED AND DRAINED FROM THE SUBCUTANEOUS AND MESH ABSCESSES, RESPECTIVELY, AND THE ABSCESS CAVITY WAS REDUCED, AND BOTH SYMPTOMS AND BLOOD SAMPLING IMPROVED. THE CAUSE OF THE MESH INFECTION WAS THE PRESENCE OF A COLOSTOMY NEAR THE UPPER EDGE OF THE MESH, AND INFECTION FROM THE COLOSTOMY WAS CONSIDERED A POSSIBLE CAUSE OF THE MESH INFECTION. ONE WEEK AFTER DRAINAGE, ILEAL COLOSTOMY WAS PERFORMED. AFTER THE COLOSTOMY WAS CLOSED, WE CONFIRMED THAT THE A

  Patient problems: Abscess; Unspecified Infection

  MAUDE report 16396698 ↗
• InjurySep 30, 2021Defective 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 MODIFIED KUGEL HERNIA PATCH ON (B)(6) 2006. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE MODIFIED 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: Hernia; Insufficient Information; Pain

  MAUDE report 12553298 ↗
• InjuryJul 24, 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) 2011. 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: Abscess; Hematoma; Impaired Healing; Inflammation; Injury; Unspecified Infection

  MAUDE report 10319074 ↗
• InjuryJun 11, 2020Defective Device; Material Deformation; Insufficient Device Problem Information; Migration; Defective Device; Material Deformation; Insufficient Device Problem Information; Migration

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF UNSPECIFIED BARD/DAVOL MODIFIED KUGEL HERNIA PATCH AND VENTRALIGHT ST ON (B)(6) 2018. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST BOTH DEVICES. ATTORNEY ALSO 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: Hernia; Injury; Scar Tissue

  MAUDE report 10141821 ↗
• InjuryApr 21, 2020Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information; Defective Device; Insufficient Device Problem Information

  Attorney alleges that the patient underwent surgery for implant of unspecified Bard/Davol Composix Kugel on (b)(6) 2011, PerFix Plug (RT Indirect Inguinal) and Modified Kugel Patch (RT Inguinal) on 05-Apr-2012, Modified Kugel Patch (LT Inguinal) and Perfix Plug (LT Inguinal) on (b)(6) 2012. As reported, the patient is making a claim for an adverse patient outcome against the PerFix Plug (RT Indirect Inguinal), Modified Kugel Patch (RT Inguinal), Modified Kugel Patch (LT Inguinal) and Perfix Plug (LT Inguinal). It is alleged that the patient sustained unspecified injuries on (b)(6) 2013. Attorney also 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.Addendum per additional information provided:(b)(6) 2011 - Patient was diagnosed with umbilical hernia thereby underwent laparoscopic repair with implant of Composix Kugel (Device 1). Per op notes, ¿Incision was made just below the hernia sac. The hernia sac contained preperitoneal fat wa

  Patient problems: Disability; Injury; Pain

  MAUDE report 9980203 ↗
• 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 THE IMPLANT OF AN UNSPECIFIED BARD/DAVOL MODIFIED KUGEL HERNIA PATCH ON (B)(6) 2006. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST MODIFIED 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: Abscess; Bacterial Infection; Disability; Fistula; Hernia; Injury; Pain

  MAUDE report 9817695 ↗
• InjuryDec 4, 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 MODIFIED KUGEL HERNIA PATCH (DEVICE #1) AND AN UNSPECIFIED BARD/DAVOL PERFIX PLUG ON (B)(6) 2013. 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 MODIFIED KUGEL HERNIA PATCH (DEVICE #1). AS REPORTED, THE ATTORNEY ALLEGES PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Hernia; Injury

  MAUDE report 9411853 ↗
• InjurySep 19, 2019Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information; Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information

  ATTORNEY ALLEGES THAT ON (B)(6) 2012, THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL MODIFIED KUGEL HERNIA PATCH. IT IS ALLEGED THAT ON (B)(6) 2014, THE PATIENT HAD UNSPECIFIED INJURIES RELATED TO A DEFECT IN THE MODIFIED KUGEL HERNIA PATCH AND UNDERWENT REVISION SURGERY. 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: Adhesion(s); Disability; Hernia; Injury; Pain

  MAUDE report 9088980 ↗
• InjuryJun 25, 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 MODIFIED KUGEL HERNIA PATCH ON (B)(6) 2010. IT IS ALSO ALLEGED BY PATIENT'S ATTORNEY THAT THE PATIENT HAD UNSPECIFIED INJURIES RELATED TO A DEFECT IN THE MODIFIED KUGEL HERNIA PATCH, AND UNDERWENT REVISION SURGERY ON (B)(6) 2013. 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: Disability; Injury; Nerve Damage; Pain

  MAUDE report 8732727 ↗
• InjuryMar 16, 2019Defective Device; 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 MODIFIED KUGEL PATCH (DEVICE #1) AND AN UNSPECIFIED BARD/DAVOL PERFIX PLUG (DEVICE #2) ON (B)(6) 2012. IT IS ALSO ALLEGED BY THE PATIENT'S ATTORNEY THAT ON (B)(6) 2013, PATIENT HAD UNSPECIFIED INJURIES. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE MODIFIED KUGEL PATCH (DEVICE #1) AND THE PERFIX PLUG (DEVICE #2). 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; Injury; Nerve Damage; Pain; Scar Tissue

  MAUDE report 8426389 ↗
• InjurySep 26, 2018Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information; Defective Device; Insufficient Device Problem Information

  THE FOLLOWING WAS ALLEGED BY THE PATIENT'S ATTORNEY: (B)(6) 2010: THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL MODIFIED KUGEL. (B)(6) 2011: THE PATIENT HAD UNSPECIFIED INJURIES. THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE MODIFIED KUGEL. 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; Injury; Nerve Damage; Pain; Scar Tissue

  MAUDE report 7909864 ↗
• InjuryJun 11, 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) 2012 - THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL KUGEL HERNIA PATCH. ON (B)(6) 2014 - THE PATIENT HAD UNSPECIFIED INJURIES. AS ALLEGED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE KUGEL 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 7589712 ↗
• InjuryMay 21, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  THE FOLLOWING WAS REPORTED VIA (B)(6). IT WAS REPORTED THAT ON (B)(6) 2010 THE PATIENT WAS IMPLANTED WITH A DAVOL MODIFIED KUGEL MESH. AS REPORTED THE MESH HAS PROLAPSED INTO THE INGUINAL CANAL. IT IS REPORTED THAT THE PATIENT EXPERIENCES DAILY SEARING, STABBING PAIN SIMILAR TO "APPENDICITIS ATTACKS" THAT WAKES HER FROM SLEEP. IT IS REPORTED THAT THE PAIN AFFECTS THE GROIN AND DOWN THE INNER THIGH AND THE CONTACT REPORTS THAT "IT MAKES MY LARGE TOENAIL GO DARK BLUE/BLACK WHEN I SIT FOR LONGER PERIODS." AS REPORTED THE PATIENT TAKES PAIN MEDICATION AND HAS COMPLETED TWO PAIN COURSES AND SHE IS AWAITING FURTHER TREATMENT FROM A PAIN SPECIALIST. IT IS REPORTED THAT THE PATIENT IS "CONSIDERING REMOVAL SURGERY BY A SPECIALIST WHICH IS VERY RISKY AND DAMAGE TO NERVES AND A CHANCE OF DEATH OCCURRING AS WELL."

  Patient problems: Pain; Prolapse

  MAUDE report 7529059 ↗
• InjuryFeb 16, 2018Defective Device; Material Deformation; Patient Device Interaction Problem; Defective Device; Material Deformation; Patient Device Interaction Problem

  THE FOLLOWING WAS ALLEGED BY THE PATIENT'S ATTORNEY: ON (B)(6) 2010: THE PATIENT UNDERWENT OPEN LEFT INGUINAL HERNIA REPAIR. THE PATIENT'S HERNIA WAS REPAIRED WITH A BARD/DAVOL SMALL CIRCLE L7.5CM MODIFIED KUGEL PATCH, PRODUCT CODE 0115808. ON (B)(6) 2010: THE PATIENT PRESENTED TO THE HOSPITAL WITH COMPLAINTS OF LEFT GROIN PAIN AND WAS FOUND TO HAVE EXPOSED MESH THAT HAD COME APART AND UNDERWENT AN OPEN MESH REMOVAL PROCEDURE. 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: Abdominal Pain; Disability; Injury; Pain

  MAUDE report 7278396 ↗
• InjuryFeb 13, 2018Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  THE FOLLOWING WAS ALLEGED BY THE PATIENT'S ATTORNEY: ON (B)(6) 2008: THE PATIENT UNDERWENT OPEN PROCEDURE FOR AN INGUINAL HERNIA. AS REPORTED, THE PATIENT'S HERNIA WAS REPAIRED WITH A BARD/DAVOL 7.6CM OVAL {MODIFIED} KUGEL PATCH, PRODUCT CODE 0115808. ON (B)(6) 2016: THE PATIENT PRESENTED TO THE HOSPITAL WITH COMPLAINTS OF SEVERE PAIN AND WAS FOUND TO HAVE RECURRENT HERNIAS WITH INCARCERATION. ON (B)(6) 2016: THE PATIENT UNDERWENT A LAPAROSCOPIC BILATERAL HERNIA REPAIR AND REDUCTION OF INCARCERATED HERNIA. AS REPORTED, HIS RECURRENT HERNIAS WERE REPAIRED WITH A BARD/DAVOL 3DMAX AND BARD/DAVOL VENTRALEX MESH. 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 7268443 ↗
• InjuryDec 6, 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) 2006 - THE PATIENT UNDERWENT AN ABDOMINAL SURGERY FOR A RIGHT INGUINAL HERNIA REPAIR, A MODIFIED KUGEL PATCH WAS IMPLANTED TO REPAIR THE HERNIA. (B)(6) 2007 - THE PATIENT UNDERWENT SURGERY TO HAVE AN EXPLORATORY LAPAROTOMY, DRAINAGE OF PELVIC ABSCESS AND TO REMOVE THE ALLEGEDLY INFECTED MESH. THE ATTORNEY ALLEGES THE PATIENT'S HERNIA REPAIR SURGERY FAILED, RESULTING IN MUCH PAIN, DOCTOR VISITS, SUBSEQUENT PROCEDURE AND WAS INJURED SERIOUSLY AND PERMANENTLY. ADDENDUM PER ADDITIONAL INFORMATION PROVIDED: (B)(6) 2006 - PATIENT WAS DIAGNOSED WITH RIGHT INDIRECT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF MODIFIED KUGEL PATCH. PER OPERATIVE NOTES, ¿AN INDIRECT INGUINAL HERNIA SAC WAS DEMONSTRATED AND REDUCED BACK INTO THE PREPERITONEAL SPACE. A PIECE OF A MODIFIED KUGEL PATCH WAS PLACED PREPERITONEALLY AND SPREAD TO ASSURE THAT THERE WAS NO DEVELOPMENT OF HERNIA. THE TAGS WERE CUT. A SECOND PIECE OF ONLAY MESH CUT IN TEARDROP CONFIGURATION TO RECONSTRUCT THE PELVIC FLOOR WAS PLACED. THE CORD AND THE NERVE WERE THEN PLACED THROUGH THE INCISION IN THE MESH AS IT WAS PLACED.¿ (B)(6) 2007- PATIENT WA

  Patient problems: Abscess; Disability; Pain; Unspecified Infection

  MAUDE report 7089017 ↗
• InjuryOct 26, 2017Defective Device; Insufficient Device Problem Information; Patient Device Interaction Problem; Defective Device; Insufficient Device Problem Information; Patient Device Interaction Problem

  THE FOLLOWING WAS REPORTED TO DAVOL BY THE PATIENT'S ATTORNEY: (B)(6) 2012 - THE PATIENT UNDERWENT A LEFT INGUINAL HERNIORRHAPHY FOR A LEFT INGUINAL HERNIA. THE PATIENT'S HERNIA WAS REPAIRED WITH A SMALL CIRCLE MODIFIED KUGEL PATCH. (B)(6) 2017 - THE PATIENT UNDERWENT AN ADDITIONAL SURGERY TO REMOVE THE PREVIOUSLY PLACED KUGEL MESH. THE ATTORNEY ALLEGES THE PATIENT HAS SUFFERED AND WILL CONTINUE TO SUFFER PHYSICAL PAIN AND WAS INJURED SEVERELY AND PERMANENTLY. ADDENDUM PER ADDITIONAL INFORMATION RECEIVED: (B)(6) 2012 - PATIENT WAS DIAGNOSED WITH LEFT INDIRECT INGUINAL HERNIA AND UNDERWENT REPAIR WITH MODIFIED KUGEL HERNIA PATCH. PER OP NOTES ¿THE ROUND LIGAMENT WAS IDENTIFIED. WE FOUND A INDIRECT HERNIA SAC. WE USED A 3.0 MODIFIED KUGEL HERNIA PATCH AND PLACED IN THE PREPERITONEAL SPACE. THE ONLAY MESH WAS THEN PLACED ON THE FLOOR OF THE INGUINAL CANAL AND TACKED IN PLACE." (B)(6) 2017 - PATIENT DEVELOPED WITH ABDOMINAL PAIN, UNDERWENT TOTAL ABDOMINAL HYSTERECTOMY, BILATERAL SALPINGECTOMY AND LEFT ANTEROLATERAL PERITONEAL SURGICAL MESH PARTIAL TRANSECTION. PER THE OPERATIVE NOTES," IN ORDER TO MINIMIZE RISK OF RECURRENT INFLAMMATORY INTRA-ABDOMINAL REACTION TO THE MESH PRESUMABLY U

  Patient problems: Abdominal Pain; Disability; Pain

  MAUDE report 6981658 ↗
• InjuryAug 8, 2017Migration or Expulsion of Device; Migration or Expulsion of Device

  THE FOLLOWING WAS REPORTED VIA MAUDE EVENT REPORT (MW5070786): "HERNIA MESH MIGRATED AND WAS RUBBING AGAINST UTERUS AND WRAPPED AROUND OVARY. CAUSED EXTREME PAIN. DOCTORS THOUGHT IT WAS A DERMOID CYST SO HYSTERECTOMY WAS PERFORMED. DURING SURGERY DOCTOR FOUND THE MESH PROBLEM. HE CUT OUT ABOUT 90% OF THE MESH. THE FOLLOWING WAS REPORTED VIA FOLLOW UP WITH CONTACT: ON (B)(6) 2012 THE PATIENT WAS IMPLANTED WITH A BARD MODIFIED KUGEL HERNIA PATCH IN THE LEFT INGUINAL SPACE DURING HERNIA REPAIR SURGERY. AS REPORTED BY THE PATIENT¿S HUSBAND IN 2017 THE PATIENT STARTED EXPERIENCING CRAMPING, BLOATING, IRREGULAR PERIODS AND PAIN. THE PATIENT PRESENTED TO THE HOSPITAL, SHE WAS GIVEN PAIN MEDICATION AND AN ULTRASOUND WAS PERFORMED. ON THE ULTRASOUND WHAT WAS THOUGHT TO BE TUMORS WERE IDENTIFIED. A FOLLOW UP ULTRASOUND WAS PERFORMED BY THE PATIENT¿S OB AND WHAT WAS THOUGHT TO BE A DERMOID CYST AND A FIBROID TUMOR WERE IDENTIFIED. IT WAS DECIDED THAT THE PATIENT WOULD UNDERGO A HYSTERECTOMY TO ELIMINATE THE TUMORS AND ANY OTHER FUTURE PROBLEMS. ON (B)(6) 2017 THE PATIENT UNDERWENT A HYSTERECTOMY. AS REPORTED, WHILE PERFORMING THE HYSTERECTOMY, THE DOCTOR FOUND THAT WHAT HE FIRST THOUGHT WAS C

  Patient problems: Adhesion(s); Disability; Pain

  MAUDE report 6774814 ↗