KUGEL 0115814Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00801741030819), received between Jul 10, 2017 and May 15, 2025 — classified as 8 injuries, 1 malfunction.

The most frequently reported specific device problem is “Defective Device” (6 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryMay 15, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED, IN (B)(6) 2023 THE PATIENT WAS IMPLANTED WITH A MODIFIED KUGEL HERNIA PATCH AFTER WHICH HE EXPERIENCED LOWER BACK PAIN AND URINARY ABNORMALITIES.

  Patient problems: Pain; Unspecified Kidney or Urinary Problem

  MAUDE report 22025167 ↗
• InjuryMar 5, 2025Defective Device; Patient Device Interaction Problem; Migration; Defective Device; Patient Device Interaction Problem; Migration

  PER INFORMATION PROVIDED BY PATIENT¿S ATTORNEY: ON (B)(6) 2013, PATIENT WAS DIAGNOSED WITH SYMPTOMATIC LEFT INCARCERATED INDIRECT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF MODIFIED KUGEL PATCH (DEVICE #1). PER OPERATIVE NOTES, ¿INDIRECT SAC WAS SEPARATED FROM CORD. HERNIA SAC CONTAIN INCARCERATED OMENTUM WAS REDUCED INTO THE PERITONEAL CAVITY. THE MODIFIED KUGEL PATCH (DEVICE #1) WAS PLACED EXTRAPERITONEALLY COVERING DIRECT, INDIRECT AND FEMORAL SPACES, AND ATTACHED TO THE PERIOSTEUM OF COOPER LIGAMENT WITH A SINGLE SUTURE.¿. ON (B)(6) 2014, PATIENT WAS DIAGNOSED WITH SYMPTOMATIC RECURRENT LEFT INGUINAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT OF 3DMAX MESH (DEVICE #2). PER OPERATIVE NOTES, ¿ADHESIONS ARE TAKEN DOWN. HERNIA FILLED WITH FAT WAS REMOVED. THE PREVIOUSLY PLACED MESH (DEVICE #1) HAD MIGRATED INFERIORLY. THE 3DMAX MESH (DEVICE #2) FOR A LEFT INGUINAL HERNIA WAS PLACED INTO THE EXTRAPERITONEAL SPACE OVER PUBIC TUBERCLE AND TACKED.¿. ON 2014, PATIENT WAS DIAGNOSED WITH SYMPTOMATIC RECURRENT INCARCERATED LEFT INDIRECT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF BARD FLAT MESH (DEVICE #3). PER OPERATIVE NOTES

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

  MAUDE report 21525994 ↗
• MalfunctionMar 30, 2023Break; Break

  AS REPORTED, WHILE OPENING THE PACKAGE OF MODIFIED KUGEL MESH, IT WAS NOTICED THAT THE "ELASTIC RING" (PET RECOIL RING) OF THE MESH WAS BROKEN. IT WAS REPORTED THAT THERE WAS NO PHYSICAL DAMAGE IDENTIFIED TO THE STERILE PACKAGE AND/OR OUTER CARTON. IT WAS ALSO REPORTED THAT THE PROCEDURE COMPLETED USING ANOTHER MODIFIED KUGEL MESH. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16652986 ↗
• InjuryMay 31, 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 UNSPECIFIED BARD/DAVOL 3DMAX AND MODIFIED KUGEL HERNIA PATCH. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST MODIFIED KUGEL HERNIA PATCH WHICH WAS IMPLANTED ON (B)(6) 2008. 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); Insufficient Information; Pain

  MAUDE report 11908577 ↗
• InjuryMar 5, 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 TWO BARD/DAVOL 3DMAX ON (B)(6) 2007 AND MODIFIED KUGEL HERNIA PATCH ON (B)(6) 2008. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST ALL DEVICES. ATTORNEY ALLEGES THAT THE PATIENT SUSTAINED INJURIES ON (B)(6) 2008 AND (B)(6) 2018. 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: Disability; Injury; Pain

  MAUDE report 9792006 ↗
• InjuryAug 14, 2018Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information; Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information

  THE FOLLOWING WAS ALLEGED BY THE PATIENT'S ATTORNEY: ON (B)(6) 2011: THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD /DAVOL MODIFIED KUGEL HERNIA PATCH. THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE BARD/DAVOL MODIFIED 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: Disability; Hernia; Injury; Pain

  MAUDE report 7781402 ↗
• InjuryMar 22, 2018Defective Device; No Apparent Adverse Event; Insufficient Device Problem Information; Defective Device; No Apparent Adverse Event; 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 HERNIA PATCH (DEVICE 1) AND AN UNSPECIFIED BARD/DAVOL VENTRALEX (DEVICE 2). 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: Disability; No Clinical Signs, Symptoms or Conditions; Pain

  MAUDE report 7363247 ↗
• InjuryNov 30, 2017Device Appears to Trigger Rejection; Defective Device; Patient Device Interaction Problem; Device Appears to Trigger Rejection; Defective Device; Patient Device Interaction Problem

  THE FOLLOWING WAS REPORTED TO DAVOL BY THE PATIENT'S ATTORNEY: (B)(6) 2009 - THE PATIENT UNDERWENT A SURGERY FOR A LEFT INGUINAL HERNIA, A TENSION-FREE MODIFIED KUGEL PATCH WAS IMPLANTED TO REPAIR THE HERNIA. (B)(6) 2015 - THE PATIENT UNDERWENT SURGERY FOR THE REMOVAL OF HIS KUGEL PATCH. DURING THE PROCEDURE, IT IS ALLEGED THE SURGEON NOTED EXTENSIVE FIBROSIS AND "ENTRAPMENT OF THE POSTERIOR MARGIN OF THE CORD ONTO THE UNDERLYING MESH." 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) 2009 - PATIENT WAS DIAGNOSED WITH RECURRENT LEFT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF MODIFIED KUGEL PATCH (DEVICE #1). PER OPERATIVE NOTES, "A LARGE DIRECT HERNIA WAS IDENTIFIED. BOWEL WAS ENCOUNTERED WITHIN THE HERNIA SAC. THE PREPERITONEAL SPACE WAS BLUNTLY DISSECTED. A MODIFIED KUGEL PATCH (DEVICE #1) WAS THEN PLACED IN THE PREPERITONEAL SPACE. AN ONLAY MESH WAS PLACED OVER THE ANTERIOR INGUINAL FLOOR AND SUTURED." (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH RECURRENT LEFT INGUINAL HERNIA AND UNDERWENT OPEN REPAIR WITH MESH REMOVAL (DEVICE #1) AND

  Patient problems: Disability; Fibrosis; Hernia; Pain

  MAUDE report 7070547 ↗
• InjuryJul 10, 2017Migration or Expulsion of Device; Migration or Expulsion of Device

  THE FOLLOWING WAS REPORTED TO DAVOL BY THE FDA VIA MEDWATCH 3500A REPORT: NOTE: SEE ATTACHED PDF OF 3500A MEDWATCH REPORT (B)(4) AND THROUGH FOLLOW UP WITH CONTACT. ON (B)(6) 2017 THE PATIENT UNDERWENT A LEFT INCARCERATED INGUINAL HERNIA REPAIR WITH IMPLANT OF A BARD MODIFIED KUGEL HERNIA PATCH. PER CONTACT THE PATCH WAS SOAKED IN ANTIBIOTIC SOLUTION AND THEN PLACED IN THE PREPERITONEAL SPACE VIA THE INTERNAL RING. THE STRAPS WERE RETRACTED ANTERIORLY. SUPERIOR STRAP WAS SUTURED TO THE INTERNAL OBLIQUE MUSCLE WITH 2-0 PDS MATTRESS SUTURE. INFERIOR STRAP WAS SUTURED TO THE INTERNAL OBLIQUE MUSCLE WITH 2-0 PDS MATTRESS SUTURE. EXCESS STRAPS WERE EXCISED. AS REPORTED ON (B)(6) 2017, FOUR DAYS POST IMPLANT; THE PATIENT PRESENTED TO THE HOSPITAL ER WITH TESTICULAR SWELLING, PAIN AND DYSURIA AND UNDERWENT AN ADDITIONAL PROCEDURE. PER CONTACT AN ANTERIOR CYSTOTOMY WAS PERFORMED. A LARGE PIECE OF MESH WAS RETRIEVED INSIDE THE BLADDER. THE PATCH WAS REMOVED COMPLETELY. THERE WAS AN APPROXIMATE 1 CM HOLE IDENTIFIED IN THE BLADDER WALL, WHICH WAS CLOSED WITH A RUNNING STITCH OF 2-0 CHROMIC SUTURE.

  Patient problems: Internal Organ Perforation; Pain; Swelling

  MAUDE report 6699338 ↗