KUGEL 0115810Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00801741030796), received between Oct 11, 2017 and Aug 25, 2026 — classified as 17 injuries.

The most frequently reported specific device problem is “Defective Device” (13 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryAug 25, 2026Device Appears to Trigger Rejection

  Per information provided: On (b)(6) 2016 - Patient was diagnosed with bilateral inguinal hernias thereby underwent open repair with implant of Modified Kugel Patch (Device 1 - Right and Device 2 - Left). Per operative notes, "A right groin incision was made to the external oblique which was dissected to the inguinal ligament. The hernia sac was dissected out. A Modified Kugel Patch (Device 1) was placed onto the right inguinal floor and secured it with sutures. A left groin incision was made in a symmetric mirror fashion, and the exposure was identical as described on the right. The hernia sac was dissected out. A Modified Kugel Patch (Device 2) was placed into the left inguinal floor and secured it with sutures." On (b)(6) 2018 - Patient was diagnosed with bilateral recurrent inguinal hernias, groin pain, adhesion thereby underwent laparoscopic repair with implant of 3DMax Light Mesh (Device 3 - Right and Device 4 - Left) and explant of Modified Kugel Patch (Device 1 and Device 2). Per operative notes, "A right groin incision was made through old incision. The hernia sac was dissected out. There was visible mesh (Device 1) protruding. The peritoneum was inadvertently entered. Prev

  Patient problems: Adhesion(s); Hernia; Pain

  MAUDE report 50433162 ↗
• InjuryApr 2, 2026Patient-Device Incompatibility

  AS REPORTED, ON (B)(6) 2026 THE PATIENT UNDERWENT HERNIA REPAIR WITH IMPLANTATION OF A MODIFIED KUGEL PATCH. POSTOPERATIVELY, THE PATIENT PRESENTED WITH "PAIN IN THE OPERATIVE AREA, PHYSICAL EXAMINATION REVEALED THAT THE UPPER PORTION OF THE INCISION WAS RED, SWOLLEN, HYPERTONIC, AND NON-FLUCTUATING, A LIGHT RED CLEAR FLUID WAS VISIBLE ON PROBING AND FLUID BUILDUP OCCURS IN THE PATIENT'S WOUND."

  Patient problems: Erythema; Implant Pain; Seroma; Swelling/ Edema

  MAUDE report 24766458 ↗
• InjuryMar 31, 2026Patient-Device Incompatibility

  AS REPORTED, ON (B)(6) 2026 THE PATIENT UNDERWENT RIGHT-SIDED DIRECT INGUINAL HERNIA REPAIR WITH IMPLANTATION OF A MODIFIED KUGEL PATCH. POSTOPERATIVELY, THE PATIENT PRESENTED WITH "WITH SLIGHT PAIN IN THE OPERATIVE AREA, PHYSICAL EXAMINATION, REDNESS AND SWELLING IN THE UPPER PART OF THE INCISION, HIGH TENSION, NO FLUCTUATING SENSATION, AND OOZING OF LIGHT RED CLEAR FLUID ON PROBING, WITH ENHANCED ATTENTION."

  Patient problems: Erythema; Implant Pain; Seroma; Swelling/ Edema

  MAUDE report 24741642 ↗
• InjuryOct 22, 2024Material Deformation; Material Deformation

  AS REPORTED, DURING AN INGUINAL HERNIA REPAIR IN 2016, THE PATIENT WAS IMPLANTED WITH A MODIFIED KUGEL PATCH. IN 2021, THE PATIENT EXPERIENCED DISCOMFORT AND PAIN. IT WAS REPORTED THAT WHEN THE PATIENT WAS INVESTIGATED FOR A DIFFERENT CONDITION, IT WAS FOUND THAT THE MESH WAS BENT, AND FLUID WAS ACCUMULATING IN THE AREA OF THE PAIN. AS REPORTED, ¿IT IS NOT UNBEARABLE PAIN, BUT IT IS A HINDRANCE TO DAILY LIFE.¿

  Patient problems: Discomfort; Pain; Seroma

  MAUDE report 20506374 ↗
• InjuryOct 20, 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 MODIFIED KUGEL HERNIA PATCH ON (B)(6) 2012. 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 DEVICE WAS DEFECTIVE.

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

  MAUDE report 10705826 ↗
• InjuryJan 23, 2020Defective 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 UNSPECIFIED BARD/DAVOL 3DMAX MESH AND MODIFIED KUGEL HERNIA PATCH. 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) 2013. 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: Adhesion(s); Hernia; Injury; Pain

  MAUDE report 9621303 ↗
• InjuryJun 5, 2019Migration or Expulsion of Device; Defective Device; Detachment of Device or Device Component; Migration or Expulsion of Device; Defective Device; Detachment of Device or Device Component

  THE FOLLOWING WAS ALLEGED BY THE PATIENT'S ATTORNEY: ON (B)(6) 2014: THE PATIENT UNDERWENT SURGERY FOR REPAIR OF AN INCARCERATED HERNIA. A KUGEL PATCH WAS IMPLANTED TO REPAIR THE HERNIA DEFECT. ON (B)(6) 2016: THE PATIENT UNDERWENT AN ADDITIONAL SURGERY TO REMOVE THE MESH. DURING THE PROCEDURE IT WAS FOUND THAT THE MESH HAD SEPARATED FROM HER ABDOMINAL WALL AND A BALL OF MESH WAS FOUND IN HER ABDOMINAL CAVITY, CAUSING THE HERNIA TO REAPPEAR. PATIENT WAS INJURED SEVERELY AND PERMANENTLY. AS ALLEGED, PATIENT WAS INJURED SEVERELY AND PERMANENTLY. AS ALLEGED, PATIENT HAS SUFFERED AND WILL CONTINUE TO SUFFER PHYSICAL PAIN AND MENTAL ANGUISH. AS REPORTED, PATIENT SUFFERED AND FROM CHRONIC PAIN, AS WELL AS PSYCHOLOGICAL STRESS AND DEPRESSION DUE TO THE ALLEGED DEFECTIVE KUGEL PATCH.

  Patient problems: Disability; Hernia; Injury

  MAUDE report 8671779 ↗
• InjuryMar 25, 2019Defective Device; Material Deformation; Insufficient Device Problem Information; Patient Device Interaction Problem; Migration; Defective Device; Material Deformation; Insufficient Device Problem Information; Patient Device Interaction Problem; Migration

  ATTORNEY ALLEGES THAT ON (B)(6) 2004, THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL MODIFIED KUGEL HERNIA PATCH. 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 MODIFIED KUGEL HERNIA PATCH. AS REPORTED, THE ATTORNEY ALLEGES PRODUCT IS DEFECTIVE AND THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS.

  Patient problems: Hernia; Injury; Pain

  MAUDE report 8448326 ↗
• InjuryMar 12, 2019Defective 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: (B)(6) 2007: THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL MODIFIED KUGEL HERNIA PATCH. 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 MODIFIED KUGEL HERNIA PATCH. AS REPORTED, THE ATTORNEY ALLEGES PRODUCT IS DEFECTIVE AND THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS.

  Patient problems: Adhesion(s); Hernia; Injury; Pain

  MAUDE report 8412923 ↗
• InjuryDec 14, 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: (B)(6) 2007: 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." ADDENDUM PER ADDITIONAL 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 LAR

  Patient problems: Adhesion(s); Disability; Injury; Nerve Damage; Pain; Scar Tissue

  MAUDE report 8166929 ↗
• InjuryDec 10, 2018Defective Device; Insufficient Device Problem Information; Patient Device Interaction Problem; Migration; Defective Device; Insufficient Device Problem Information; Patient Device Interaction Problem; Migration

  THE FOLLOWING WAS ALLEGED BY THE PATIENT'S ATTORNEY: (B)(6) 2014: THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF TWO (2) UNSPECIFIED BARD/DAVOL MODIFIED KUGEL PATCH (DEVICE#1 AND DEVICE #2) . THE PATIENT IS ONLY MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE TWO (2) MODIFIED KUGEL HERNIA PATCH (DEVICE #1 AND DEVICE #2) . 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 8147191 ↗
• InjuryDec 10, 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: (B)(6) 2014: THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF TWO (2) UNSPECIFIED BARD/DAVOL MODIFIED KUGEL PATCH (DEVICE#1 AND DEVICE #2) . THE PATIENT IS ONLY MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE TWO (2) MODIFIED KUGEL HERNIA PATCH (DEVICE #1 AND DEVICE #2) . 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; No Clinical Signs, Symptoms or Conditions; Pain

  MAUDE report 8147184 ↗
• InjuryApr 10, 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) 2012 - THE PATIENT UNDERWENT SURGERY WITH IMPLANT OF AN UNSPECIFIED BARD/DAVOL KUGEL HERNIA 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: Disability; Hernia; Injury; Pain

  MAUDE report 7412425 ↗
• InjuryFeb 23, 2018Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  THE FOLLOWING WAS ALLEGED BY THE PATIENT'S ATTORNEY: ON (B)(6) 2010: THE PATIENT UNDERWENT SURGERY FOR REPAIR OF A LEFT INGUINAL HERNIA. AS REPORTED, THE PATIENT'S HERNIA WAS REPAIRED WITH A BARD/DAVOL MODIFIED KUGEL HERNIA PATCH, REFERENCE NUMBER 0115810, LOT NUMBER HUUD0491. ON (B)(6) 2012: THE PATIENT UNDERWENT AN ADDITIONAL SURGERY TO REPAIR RECURRENT HERNIA AFTER THE KUGEL PATCH FAILED AND TO REMOVE THE KUGEL PATCH, WHICH HAS ENTRAPPED THE ILIOHYPOGASTRIC AND ILIOINGUINAL NERVES. 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: Disability; Hernia; Inflammation; Nerve Damage; Pain; Scar Tissue

  MAUDE report 7293339 ↗
• InjuryJan 9, 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: (B)(6) 2011: THE PATIENT UNDERWENT AN ABDOMINAL SURGERY FOR AN INGUINAL HERNIA. THE PATIENT'S HERNIA WAS REPAIRED WITH A BARD/DAVOL KUGEL PATCH, (B)(4), LOT NUMBER HUUD0491. (B)(6) 2013: THE PATIENT UNDERWENT SURGERY TO HAVE A RECURRENCE REPAIR. AS ALLEGED, THE PATIENT 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 7175405 ↗
• InjuryNov 7, 2017Defective Device; Material Deformation; Patient Device Interaction Problem; Migration; Defective Device; Material Deformation; Patient Device Interaction Problem; Migration

  THE FOLLOWING WAS REPORTED TO DAVOL BY THE PATIENT'S ATTORNEY: (B)(6) 2010 - THE PATIENT UNDERWENT SURGERY FOR REPAIR OF AN INGUINAL HERNIA, THE PATIENT'S HERNIA WAS REPAIRED WITH A MODIFIED KUGEL PATCH. (B)(6) 2011 - THE PATIENT UNDERWENT AN ADDITIONAL SURGERY TO REMOVE THE PREVIOUSLY PLACED MODIFIED KUGEL MESH, WHICH FAILED, AND REPAIR RECURRENT INGUINAL HERNIA. THE ATTORNEY ALLEGES THE PATIENT EXPERIENCED PAIN, DOCTOR VISITS, SUBSEQUENT PROCEDURES AND WAS INJURED SEVERELY AND PERMANENTLY. ADDENDUM PER ADDITIONAL INFORMATION PROVIDED: (B)(6) 2010 - PATIENT WAS DIAGNOSED WITH RIGHT SCROTAL HERNIA AND UNDERWENT OPEN REPAIR WITH MODIFIED KUGEL PATCH (DEVICE #1). PER THE OPERATIVE REPORT DETAILS, "THE MASSIVE HERNIA SAC WAS RETRACTED AND REDUCED. THE TESTICLE WAS PLACED BACK IN PROPER POSITION AND A LARGE, MODIFIED KUGEL PATCH WAS PLACED AND SUTURED". (B)(6) 2010 - PATIENT WAS DIAGNOSED WITH LEFT INGUINAL HERNIA AND UNDERWENT REPAIR WITH MODIFIED KUGEL PATCH (DEVICE #2). PER THE OPERATIVE NOTES, "THE DIRECT SPACE HERNIA WAS NOTED AND A MODIFIED KUGEL PATCH WAS PLACED AND SUTURED". (B)(6) 2011 - PATIENT DEVELOPED RIGHT GROIN PAIN, RECURRENT RIGHT INGUINAL HERNIA AND UNDERWENT OPEN REP

  Patient problems: Abscess; Adhesion(s); Cellulitis; Disability; Hernia; Pain; Seroma

  MAUDE report 7007213 ↗
• InjuryOct 11, 2017Hole In Material; Defective Device; Insufficient Device Problem Information; Patient Device Interaction Problem; Hole In Material; Defective Device; Insufficient Device Problem Information; Patient Device Interaction Problem

  THE FOLLOWING WAS REPORTED TO DAVOL BY THE PATIENT'S ATTORNEY: (B)(6) 2006 - THE PATIENT UNDERWENT AN OPEN ABDOMINAL SURGERY FOR A VENTRAL INCISIONAL HERNIA. THE PATIENT'S HERNIA WAS REPAIRED WITH A FOUR INCH MODIFIED KUGEL PATCH. (B)(6) 2006 - THE PATIENT PRESENTED TO THE ER WITH COMPLAINTS OF PAIN, SWELLING AND REDNESS OF LOWER ABDOMEN. THE PATIENT WAS ALLEGEDLY FOUND TO HAVE "AN ABSCESS." THE PATIENT UNDERWENT AN INCISION AND DRAINAGE OF THE ABSCESS IN HER LOWER ABDOMINAL WALL. (B)(6) 2015 - THE PATIENT UNDERWENT SURGERY TO HAVE LAPAROSCOPIC REPAIR OF AN INCARCERATED VENTRAL HERNIA. THE ATTENDING SURGEON STATED "SEVERE ADHERENCE OF BLADDER TO OLD MESH AND HAD A HOLE IN IT." THE PATIENT WAS SENT TO RECOVERY AND DISCHARGED TWO DAYS LATER. THE ATTORNEY ALLEGES THE PATIENT EXPERIENCED ADHESIONS, SWELLING, ABSCESS AND WAS SERIOUSLY AND PERMANENTLY INJURED. ADDENDUM PER ADDITIONAL INFORMATION PROVIDED. (B)(6) 2006 - THE PATIENT WAS DIAGNOSED WITH REDUCIBLE VENTRAL INCISIONAL HERNIA AND UNDERWENT OPEN REPAIR WITH THE IMPLANT OF MODIFIED KUGEL MESH. PER THE OPERATIVE NOTES," THE HERNIA SAC WAS SHARPLY DISSECTED OUT FROM THE DEFECT. A KUGEL MESH PATCH (MODIFIED KUGEL MESH) MEASURING 4 IN

  Patient problems: Abscess; Adhesion(s); Bacterial Infection; Disability; Internal Organ Perforation; Pain

  MAUDE report 6942336 ↗