KUGEL 0115812Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741030802), received between Sep 1, 2021 and Feb 27, 2026 — classified as 3 injuries.

The most frequently reported specific device problem is “Material Deformation” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 27, 2026Material Deformation

  PER INFORMATION PROVIDED: ON (B)(6) 2011 - PATIENT WAS DIAGNOSED WITH BILATERAL INGUINAL HERNIAS THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF MODIFIED KUGEL HERNIA PATCH (DEVICE 1 AND 2). PER OP NOTES, ¿ON THE RIGHT INGUINAL REGION, A LARGE DIRECT HERNIA DEFECT WAS NOTED WITH BOWEL CONTENTS IN SCROTUM WERE REDUCED. A MODIFIED KUGEL HERNIA PATCH (DEVICE 1) WAS PLACED AND SUTURED. ON THE LEFT INGUINAL REGION, A DIRECT HERNIA DEFECT WAS NOTED AND REDUCED. A MODIFIED KUGEL HERNIA PATCH (DEVICE 2) WAS PLACED AND SUTURED¿. ON (B)(6) 2014 - PATIENT WAS DIAGNOSED WITH RECURRENT LEFT INGUINAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH EXCISION OF MODIFIED KUGEL HERNIA PATCH (DEVICE 2) AND IMPLANT OF BARD FLAT MESH (DEVICE 3). PER OP NOTES, ¿THE PREVIOUS MESH (DEVICE 2) WAS STUCK IN INCISION SITE AND CURLED UP AND NOT COVERING THE DEFECT. A NEW DEFECT WAS IDENTIFIED OVER THIS. THE HERNIA SAC WAS REDUCED. THE PRIOR MESH (DEVICE 2) WAS EXCISED. A BARD FLAT MESH (DEVICE 3) WAS PLACED AND TACKED.¿ ON (B)(6) 2017 - PATIENT WAS DIAGNOSED WITH ADHESIONS AND MESH PROTRUSION ON RIGHT GROIN THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH EXCISION OF MODIFIED KUGEL HERNIA PATCH (DEVICE 1). PER OP NO

  Patient problems: Hernia

  MAUDE report 24469926 ↗
• InjuryJan 11, 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/DAVOL MODIFIED KUGEL HERNIA PATCH AND PERFIX PLUG. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE MODIFIED KUGEL HERNIA PATCH WHICH WAS IMPLANTED ON (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: Hernia; Insufficient Information; Pain

  MAUDE report 13224651 ↗
• InjurySep 1, 2021Material Deformation; Material Deformation

  AS REPORTED, DURING AN ABDOMINAL WALL SCAR HERNIA REPAIR PROCEDURE IN 2009, THE PATIENT UNDERWENT IMPLANT OF A BARD/DAVOL KUGEL PATCH (DEVICE 1). AS REPORTED, ON (B)(6) 2015, THE PATIENT UNDERWENT REPAIR OF A RECURRENT OPEN VENTRAL INCISIONAL HERNIA DURING WHICH THE KUGEL PATCH WAS REMOVED AND A BARD/DAVOL MODIFIED KUGEL PATCH (DEVICE 2) WAS IMPLANTED. AS REPORTED, ON (B)(6) 2021 THE MESH (DEVICE 2) WAS EXPLANTED BECAUSE OF SUSPECTED MESH INFECTION AND FISTULA FORMATION. AS REPORTED, UPON EXAMINATION OF THE EXPLANTED MESH, IT WAS NOTED THAT THE RECOILING RING WAS FOLDED AND STUCK IN THE INTESTINAL TRACT.

  Patient problems: Adhesion(s); Unspecified Infection

  MAUDE report 12408297 ↗