Kugel 0010102Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00801741016349), received between Sep 27, 2017 and Jul 30, 2026 — classified as 16 injuries.

The most frequently reported specific device problem is “Defective Device” (14 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryJul 30, 2026Patient-Device Incompatibility

  Per information provided:(b)(6) 2004 - Patient was diagnosed with recurrent ventral incisional hernia (x2) thereby underwent open repair with the implant of two Kugel Patch (Device 1 and 2). Per op notes, "In the lower portion, hernia sac was encountered. The upper border of the fascial defect was noted to be the edge of the previous Gore-Tex patch repair. The patient had a history of a previous hernia repair with mesh. A medium Kugel Patch (Device 1) was placed over the defect using prolene sutures. The fascia at the midline was closed; the Gore-Tex patch to the edge of the fascia, where it had pulled away. The upper portion of the scar was incised; the hernia sac was encountered. A large Kugel Patch (Device 2) was placed beneath the previous Gore-Tex patch." (Note: The previously placed Gore-Tex patch was unknown during this procedure)(b)(6) 2015 - Patient was diagnosed with sepsis, small bowel obstruction and had abdominal pain thereby underwent lysis of adhesions. Per op notes, "Two layers of abdominal wall mesh (Device 1 and 2) were encountered into the abdomen. There were omental and small bowel adhesions to the abdominal wall mesh. Lysis of adhesions was performed."

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

  MAUDE report 50078388 ↗
• InjuryJan 8, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2005 ¿ PATIENT WAS DIAGNOSED WITH UPPER MIDLINE LARGE VENTRAL INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF KUGEL PATCH (DEVICE 1 AND DEVICE 2). PER OPERATIVE NOTES, ¿THE OLD INCISION WAS REOPENED. THERE WERE TWO LARGE DEFECTS UP NEAR THE XIPHOID AND DOWN TOWARDS THE UMBILICUS. A TWO LARGE KUGEL PATCHES (DEVICE 1 AND DEVICE 2) WERE PLACED IN A HORIZONTAL MANNER AND OVERLAPPED JUST VERY SLIGHTLY. AT THE POINT OF OVERLAP, THEY WERE SUTURED TOGETHER.¿ ON (B)(6) 2011 ¿ PATIENT WAS DIAGNOSED WITH PARAESOPHAGEAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF SYNTHETIC MESH. PER OPERATIVE NOTES, ¿THE HERNIA HAD BEEN COMPLETELY REDUCED. A LARGE PIECE OF MESH (DEVICE 1 AND DEVICE 2) THROUGHOUT THE ENTIRETY OF INCISION WAS IDENTIFIED. PATIENT DID HAVE A LARGE AMOUNT OF OMENTUM PROTECTING BOWEL BELOW THE MESH. ADHESIONS WERE LYSED JUST GET INTO THE ABDOMEN. GASTROSCOPY WAS DONE AND THE GE JUNCTION WAS IDENTIFIED INTRAABDOMINALLY. PARTIALLY TOOK DOWN THE WRAP, BUT IN DOING SO DEVELOPED A SMALL GASTROTOMY IN THE LATERAL PORTION OF THE FUNDUS INVOLVED IN WRAP. THIS WAS A PINHOLE, AND BILE WAS DRAINING OUT OF IT. THE ENTIRE PARAESOPHAGEA

  Patient problems: Adhesion(s)

  MAUDE report 24006482 ↗
• InjuryJul 27, 2022Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF TWO UNSPECIFIED BARD/DAVOL KUGEL HERNIA PATCHES ON (B)(6) 2006. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE 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 ALLEGED THAT THE PATIENT UNDERWENT SURGERY AND REMOVAL OF DENSE ADHESIONS ON (B)(6) 2019. IT IS ALSO ALLEGED THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

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

  MAUDE report 15115573 ↗
• InjuryJul 27, 2022Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF TWO UNSPECIFIED BARD/DAVOL KUGEL HERNIA PATCHES ON (B)(6) 2006. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE 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 ALLEGED THAT THE PATIENT UNDERWENT SURGERY AND REMOVAL OF DENSE ADHESIONS ON (B)(6) 2019. IT IS ALSO ALLEGED THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

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

  MAUDE report 15115490 ↗
• InjuryJun 17, 2022Defective 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 AN UNSPECIFIED BARD/DAVOL KUGEL HERNIA PATCH ON (B)(6) 2016 AND MARLEX MESH (BARD FLAT MESH) ON (B)(6) 2021. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE BOTH DEVICES. IT IS ALLEGED THAT THE PATIENT¿S FIRST REMOVAL SURGERY OCCURRED ON (B)(6) 2021. 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 14730838 ↗
• InjuryMar 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 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. 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.

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

  MAUDE report 9810283 ↗
• InjuryJul 17, 2019Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information; Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information

  ATTORNEY ALLEGES THAT ON (B)(6) 2010, THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL KUGEL HERNIA PATCH. IT IS ALLEGED THAT ON (B)(6) 2011, THE PATIENT HAD UNSPECIFIED INJURIES RELATED TO A DEFECT IN THE KUGEL HERNIA PATCH AND UNDERWENT CORRECTIVE SURGERY. 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: Adhesion(s); Disability; Hernia; Injury; Pain

  MAUDE report 8800402 ↗
• InjuryMay 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 KUGEL HERNIA PATCH ON (B)(6) 2016. 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 KUGEL HERNIA PATCH. AS REPORTED, THE ATTORNEY ALLEGES PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Hematoma; Injury

  MAUDE report 8584088 ↗
• InjuryApr 24, 2019Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information; Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information

  ATTORNEY ALLEGES THAT ON (B)(6) 2004, THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL KUGEL HERNIA PATCH. 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: Adhesion(s); Disability; Hernia; Injury; Pain

  MAUDE report 8546964 ↗
• InjuryApr 18, 2019Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information; Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information

  IT IS ALLEGED BY THE PATIENT'S ATTORNEY THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL KUGEL HERNIA PATCH ON (B)(6) 2009. 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 BARD/DAVOL KUGEL HERNIA PATCH . AS REPORTED, THE ATTORNEY ALLEGES PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Adhesion(s); Hernia; Injury; Purulent Discharge; Unspecified Infection

  MAUDE report 8529338 ↗
• InjuryFeb 25, 2019Defective Device; Material Deformation; Insufficient Device Problem Information; Defective Device; Material Deformation; Insufficient Device Problem Information

  THE FOLLOWING WAS ALLEGED BY THE PATIENT'S ATTORNEY: ON (B)(6) 2013: THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL KUGEL PATCH. ON (B)(6) 2016: THE PATIENT HAD UNSPECIFIED INJURIES RELATED TO A DEFECT IN THE KUGEL PATCH AND UNDERWENT REVISION SURGERY. THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE KUGEL PATCH. 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; Obstruction/Occlusion; Pain

  MAUDE report 8367943 ↗
• InjuryFeb 6, 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: ON (B)(6) 2010: THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL KUGEL HERNIA PATCH. THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE BARD/DAVOL 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: Abscess; Disability; Drug Resistant Bacterial Infection; Inflammation; Injury; Pain

  MAUDE report 8312190 ↗
• InjuryMar 7, 2018Defective Device; Insufficient Device Problem Information; Patient Device Interaction Problem; Defective Device; Insufficient Device Problem Information; Patient Device Interaction Problem

  IT IS ALLEGED BY THE PATIENTS ATTORNEY THAT ON (B)(6) 2003 THE PATIENT UNDERWENT SURGERY FOR REPAIR OF AN INCISIONAL HERNIA. AS REPORTED, THE PATENTS HERNIA WAS REPAIRED WITH A LARGE OVAL KUGEL PATCH (REFERENCE NUMBER 0010102.) IT IS ALLEGED THAT ON (B)(6) 2011 THE PATIENT UNDERWENT AN ADDITIONAL SURGERY TO REMOVE THE PREVIOUSLY PLACED MESH AND REPAIR THE RECURRENT HERNIA. IT IS ALLEGED THE PATIENT ENDURED ADDITIONAL SURGERIES TO TREAT MESH-RELATED COMPLICATIONS. AS ALLEGED, THE PATIENT WAS INJURED SEVERELY AND PERMANENTLY AND HAS SUFFERED AND WILL CONTINUE TO SUFFER PHYSICAL PAIN DUE TO THE ALLEGED DEFECTIVE KUGEL PATCH.

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

  MAUDE report 7319902 ↗
• InjuryFeb 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: ON (B)(6) 2009: THE PATIENT UNDERWENT A VENTRAL HERNIA REPAIR WITH MESH. AS REPORTED, THE PATIENT'S HERNIA WAS REPAIR WITH A BARD DAVOL 14 X 17 OVAL KUGEL PATCH, PRODUCT CODE NO. 0010102. ON (B)(6) 2011: THE PATIENT PRESENTED TO THE HOSPITAL WITH COMPLAINTS OF CHRONIC ABDOMINAL PAIN, RECURRENT HERNIA AND INFECTED MESH AND UNDERWENT A SURGICAL PROCEDURE TO REMOVE THE INFECTED MESH AND REPAIR THE RECURRENT VENTRAL 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: Adhesion(s); Bacterial Infection; Disability; Fibrosis; Hernia; Pain; Purulent Discharge; Unspecified Infection

  MAUDE report 7245936 ↗
• InjurySep 27, 2017Break; Defective Device; Patient Device Interaction Problem; Break; Defective Device; Patient Device Interaction Problem

  THE FOLLOWING WAS REPORTED TO DAVOL BY THE PATIENT'S ATTORNEY: (B)(6) 2003 - THE PATIENT UNDERWENT SURGERY FOR AN INCISIONAL HERNIA WITH IMPLANT OF TWO KUGEL PATCHES. (B)(6) 2014 - THE PATIENT PRESENTED TO THE HOSPITAL WITH COMPLAINTS OF PAIN. THE PATIENT WAS ALLEGEDLY FOUND TO HAVE DISPLACEMENT OF MESH RING AND LEFT INGUINAL HERNIA. (B)(6) 2014 - THE PATIENT UNDERWENT A PROCEDURE TO REMOVE THE FRACTURED ABDOMINAL MESH RING AND LEFT FEMORAL HERNIA REPAIR. THE ATTORNEY ALLEGES THE PATIENT SUFFERED AND WILL CONTINUE TO SUFFER PHYSICAL PAIN. THE ATTORNEY FURTHER ALLEGES THAT THE PATIENT WAS SERIOUSLY AND PERMANENTLY INJURED. ADDENDUM PER ADDITIONAL INFORMATION PROVIDED: (B)(6) 2003 - PATIENT WAS DIAGNOSED WITH INCISIONAL HERNIA AND WAS SCHEDULED FOR OPEN REPAIR. PER OPERATIVE NOTES ¿TWO LARGE OVAL KUGEL PATCHES (DEVICE #1 & DEVICE #2) WERE PLACED INTO THE SUBMUSCULAR POCKET ORIENTED IN A LONGITUDINAL DIRECTION WITH THE TWO PATCHES OVERLAPPING EACH OTHER FOR APPROXIMATELY ONE QUARTER OF THEIR TOTAL LENGTH". (B)(6) 2014 - PATIENT UNDERWENT REMOVAL OF FRACTURED ABDOMINAL MESH RING AND ADDITIONAL LEFT FEMORAL HERNIA REPAIR. PER OPERATIVE NOTES, THE BROKEN END OF THE RING WAS PALPABLE IN T

  Patient problems: Disability; Pain

  MAUDE report 6896807 ↗
• InjurySep 27, 2017Break; Defective Device; Patient Device Interaction Problem; Break; Defective Device; Patient Device Interaction Problem

  THE FOLLOWING WAS REPORTED TO DAVOL BY THE PATIENT'S ATTORNEY: (B)(6) 2003 - THE PATIENT UNDERWENT SURGERY FOR AN INCISIONAL HERNIA WITH IMPLANT OF TWO KUGEL PATCHES. (B)(6) 2014 - THE PATIENT PRESENTED TO THE HOSPITAL WITH COMPLAINTS OF PAIN. THE PATIENT WAS ALLEGEDLY FOUND TO HAVE DISPLACEMENT OF MESH RING AND LEFT INGUINAL HERNIA. (B)(6) 2014 - THE PATIENT UNDERWENT A PROCEDURE TO REMOVE THE FRACTURED ABDOMINAL MESH RING AND LEFT FEMORAL HERNIA REPAIR. THE ATTORNEY ALLEGES THE PATIENT SUFFERED AND WILL CONTINUE TO SUFFER PHYSICAL PAIN. THE ATTORNEY FURTHER ALLEGES THAT THE PATIENT WAS SERIOUSLY AND PERMANENTLY INJURED. ADDENDUM PER ADDITIONAL INFORMATION PROVIDED: (B)(6) 2003 - PATIENT WAS DIAGNOSED WITH INCISIONAL HERNIA AND WAS SCHEDULED FOR OPEN REPAIR. PER OPERATIVE NOTES ¿TWO LARGE OVAL KUGEL PATCHES (DEVICE #1 & DEVICE #2) WERE PLACED INTO THE SUBMUSCULAR POCKET ORIENTED IN A LONGITUDINAL DIRECTION WITH THE TWO PATCHES OVERLAPPING EACH OTHER FOR APPROXIMATELY ONE QUARTER OF THEIR TOTAL LENGTH". (B)(6) 2014 - PATIENT UNDERWENT REMOVAL OF FRACTURED ABDOMINAL MESH RING AND ADDITIONAL LEFT FEMORAL HERNIA REPAIR. PER OPERATIVE NOTES, THE BROKEN END OF THE RING WAS PALPABLE IN T

  Patient problems: Disability; Pain

  MAUDE report 6896780 ↗