Kugel 0010104Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741016363), received between Jun 29, 2017 and May 28, 2022 — classified as 5 injuries.

The most frequently reported specific device problem is “Defective Device” (5 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryMay 28, 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 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 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: Fibrosis; Insufficient Information; Pain; Post Operative Wound Infection; Seroma

  MAUDE report 14537985 ↗
• InjurySep 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 KUGEL HERNIA PATCH ON (B)(6) 2006. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE BARD/DAVOL KUGEL HERNIA PATCH. 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: Hernia; Injury; Pain

  MAUDE report 8977461 ↗
• InjuryJun 10, 2019Defective Device; Material Deformation; Insufficient Device Problem Information; Defective Device; Material Deformation; Insufficient Device Problem Information

  ATTORNEY ALLEGES THAT ON (B)(6) 2012, THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL KUGEL HERNIA PATCH. IT IS ALLEGED THAT THE PATIENT HAD UNSPECIFIED INJURIES. 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); Breast Neoplasm; Disability; Hernia; Pain

  MAUDE report 8685437 ↗
• InjuryJun 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 KUGEL HERNIA PATCH ON (B)(6) 2016. 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

  MAUDE report 8668158 ↗
• InjuryJun 29, 2017Break; Defective Device; Break; Defective Device

  THE FOLLOWING WAS REPORTED TO DAVOL BY THE PATIENT'S ATTORNEY: ON (B)(6) 2006 - THE PATIENT UNDERWENT A HERNIA REPAIR SURGICAL PROCEDURE. DURING THE COURSE, THEREOF, HER PHYSICIAN IMPLANTED A BARD HERNIA KUGEL PATCH (0010105) INTO HER BODY. ON (B)(6) 2007 - THE PATIENT UNDERWENT ANOTHER HERNIA REPAIR SURGICAL PROCEDURE. DURING THE COURSE THEREOF, HER PHYSICIAN IMPLANTED A BARD HERNIA KUGEL PATCH (0010104) INTO HER BODY. ON (B)(6) 2015 - ONE OR BOTH OF THE KUGEL PATCHES INSERTED IN THE PATIENT'S BODY BROKE AND IMPALED A LOOP OF HER SMALL BOWEL, CAUSING SEVERE PAIN AND SUFFERING. AFTER LESS INVASIVE METHODS FAILED TO RESOLVE THE SYMPTOMS, A REPAIR AND REMOVAL SURGERY WAS PERFORMED. THE ATTORNEY ALLEGES THE PATIENT EXPERIENCED A RING BREAK, BOWEL INJURY, BOWEL PERFORATION, PAIN, ADDITIONAL SURGICAL PROCEDURE AND EXPLANT.

  Patient problems: Bowel Perforation; Disability; Pain

  MAUDE report 6677906 ↗