Kugel 0010105Recalls & reported problems

Summary

The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 00801741016370), received between Jun 29, 2017 and Aug 26, 2026 — classified as 40 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Defective Device” (33 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 25 most recent of 42 reports, in the reporter's own words as published by the FDA.

• InjuryAug 26, 2026Patient-Device Incompatibility

  Patient problems: Fibrosis; Nerve Damage; Pain

  MAUDE report 50458137 ↗
• InjuryMay 19, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2006 - PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF KUGEL PATCH (DEVICE 1). PER OP NOTES, "THE OLD INCISION WAS OPENED. THE MESH WAS NOTED TO BE BULGED. IT WAS OPENED AND CUT AWAY. A MEDIUM KUGEL PATCH (DEVICE 1) WAS PLACED IN THE UNDERSIDE OF THE FASCIA AND SECURED WITH SUTURE. AND THE MESH WHICH LEFT WAS SECURED WITH SUTURE." (NOTE: THE PRIOR MESH VISUALIZED DURING THIS PROCEDURE WAS UNKNOWN). (B)(6) 2008 - PATIENT WAS DIAGNOSED WITH VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRALEX MESH (DEVICE 2). PER OP NOTES, "A TRANSVERSE INCISION WAS MADE ABOVE THE UMBILICUS. A FASCIAL DEFECT WAS IDENTIFIED ON THE LEFT OF THE MIDLINE AND NO SIGNIFICANT HERNIA SAC WAS PRESENT. THE SUTURES FROM THE PREVIOUS REPAIR IN THE MESH WERE PRESENT AND WERE REMOVED. THE OMENTUM WAS ADHERENT TO THE ANTERIOR ABDOMINAL WALL AROUND THE FASCIAL DEFECT AND WAS FREED UP. A LARGE VENTRALEX MESH (DEVICE 2) WAS PLACED INTO THE DEFECT AND SECURED WITH SUTURES." (B)(6) 2010 - PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH EXCISION OF KUGEL PATCH (DEVICE 1) AND VENTRALEX

  Patient problems: Fibrosis; Hernia; Inflammation

  MAUDE report 25215616 ↗
• InjuryMar 31, 2026Migration

  PER INFORMATION PROVIDED: (B)(6) 2016 - PATIENT WAS DIAGNOSED WITH INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF VENTRIO ST MESH (DEVICE 1) AND KUGEL HERNIA PATCH (DEVICE 2). PER OP NOTES, "A VENTRIO ST MESH (DEVICE 1) AND A KUGEL HERNIA PATCH (DEVICE 2) WERE PLACED TO THE ABDOMINAL WALL USING SUTURES." (B)(6) 2016 - PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT REPAIR. PER OP NOTES, "INCISION WAS MADE OVER THE HERNIA DEFECT, CARRIED DOWN THROUGH THE SUBCUTANEOUS TISSUE. A SYNTHETIC MESH WAS PLACED TO THE DEFECT USING SUTURES." (B)(6) 2017 - PATIENT HAD ABDOMINAL WALL ABSCESS THEREBY UNDERWENT INCISION AND DRAINAGE OF ABDOMINAL WALL ABSCESS WITH EXCISION OF CHRONIC CYST/ABSCESS CAVITY. PER OP NOTES, "THERE WAS PURULENT FLUID, WHICH WAS ASPIRATED OUT." (B)(6) 2019 - PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL HERNIA, INFECTED MESH AND SMALL BOWEL OBSTRUCTION THEREBY UNDERWENT REPAIR WITH REMOVAL OF MESH (DEVICE 1 AND 2). PER OP NOTES, "THE ANTERIOR VENTRAL INCISIONAL HERNIA WHERE THE PRIOR MESH HAD BROKEN DOWN AND SEPARATED IN THE MIDLINE. PERFORMED LYSIS OF ADHESIONS, INFLAMMATORY MASS OF THE MESHOMA WERE TOOK DOWN. EXCISED THE CHRO

  Patient problems: Hernia; Obstruction/Occlusion; Unspecified Infection

  MAUDE report 24741223 ↗
• MalfunctionJul 22, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  AS REPORTED, DURING INSPECTION, A FOREIGN OBJECT (DEAD INSECT) WAS FOUND INSIDE AN UNOPENED KUGEL PATCH PRODUCT BOX AND UNOPENED FILM. IT WAS REPORTED THAT THERE WAS NO DAMAGE NOTICED ON THE OUTER/INNER SHELL PACKAGE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22563631 ↗
• MalfunctionNov 21, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  PER JOURNAL ARTICLE, ¿TRANSPERINEAL REPAIR OF SECONDARY PERINEAL HERNIA USING A MESH WITH A MEMORY-RECOIL RING." THE AIM OF THIS STUDY WAS TO EVALUATE THE EFFECTIVENESS OF TRANSPERINEAL REPAIR OF SECONDARY PERINEAL HERNIA (SPH) USING A MESH WITH A MEMORY-RECOIL RING. THE ARTICLE DESCRIBES SEVEN PATIENTS WITH SECONDARY PERINEAL HERNIA WHO UNDERWENT TRANSPERINEAL REPAIR (TPR) BETWEEN JULY 2010 AND MAY 2022 WERE RETROSPECTIVELY ANALYZED. ALL SPHS DEVELOPED AFTER ABDOMINOPERINEAL RESECTIONS IN PATIENTS WITH ANORECTAL MALIGNANCIES. THE ARTICLE CONCLUDED THAT TRANSPERINEAL REPAIR (TPR) USING A MESH WITH A MEMORY-RECOIL RING IS SAFE, FEASIBLE AND PROMISING TECHNIQUE FOR SPH REPAIRS. THIS MDR REPRESENTS PATIENT #2. THE ARTICLE DESCRIBES A 75-YEAR-OLD MALE PATIENT WITH SECONDARY PERINEAL HERNIA DEVELOPED AFTER ABDOMINOPERINEAL RESECTIONS IN PATIENT WITH ANORECTAL MALIGNANCIES WHO UNDERWENT TRANSPERINEAL REPAIR (TPR) WITH A KUGEL PATCH. THE ARTICLE NOTES THE PATIENT EXPERIENCED POST OPERATIVE PAIN.

  Patient problems: Pain

  MAUDE report 18184210 ↗
• InjuryNov 21, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  PER JOURNAL ARTICLE, ¿TRANSPERINEAL REPAIR OF SECONDARY PERINEAL HERNIA USING A MESH WITH A MEMORY-RECOIL RING." THE AIM OF THIS STUDY WAS TO EVALUATE THE EFFECTIVENESS OF TRANSPERINEAL REPAIR OF SECONDARY PERINEAL HERNIA (SPH) USING A MESH WITH A MEMORY-RECOIL RING. THE ARTICLE DESCRIBES SEVEN PATIENTS WITH SECONDARY PERINEAL HERNIA WHO UNDERWENT TRANSPERINEAL REPAIR (TPR) BETWEEN JULY 2010 AND MAY 2022 WERE RETROSPECTIVELY ANALYZED. ALL SPHS DEVELOPED AFTER ABDOMINOPERINEAL RESECTIONS IN PATIENTS WITH ANORECTAL MALIGNANCIES. THE ARTICLE CONCLUDED THAT TRANSPERINEAL REPAIR (TPR) USING A MESH WITH A MEMORY-RECOIL RING IS SAFE, FEASIBLE AND PROMISING TECHNIQUE FOR SPH REPAIRS. THIS MDR REPRESENTS PATIENT #3. THE ARTICLE DESCRIBES A 78-YEAR-OLD FEMALE PATIENT WITH SECONDARY PERINEAL HERNIA DEVELOPED AFTER ABDOMINOPERINEAL RESECTIONS IN PATIENT WITH ANORECTAL MALIGNANCIES WHO UNDERWENT TRANSPERINEAL REPAIR (TPR) WITH A KUGEL PATCH. THE ARTICLE STATES THERE WAS AN ¿INTRAOPERATIVE VAGINAL INJURY¿ WHICH WAS CLOSED WITH ABSORBABLE SUTURES. PATIENT EXPERIENCED POST OPERATIVE COMPLICATIONS OF PERINEAL WOUND INFECTION, PAIN, AND VAGINAL FISTULA. THE VAGINAL FISTULA RESOLVED WITH CONSERVATIVE

  Patient problems: Fistula; Pain; Post Operative Wound Infection

  MAUDE report 18182840 ↗
• InjuryNov 17, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  JOURNAL ARTICLE, ¿TRANSPERINEAL REPAIR OF SECONDARY PERINEAL HERNIA USING A MESH WITH A MEMORY-RECOIL RING. THE AIM OF THIS STUDY WAS TO EVALUATE THE EFFECTIVENESS OF TRANSPERINEAL REPAIR OF SECONDARY PERINEAL HERNIA (SPH) USING A MESH WITH A MEMORY-RECOIL RING. THE ARTICLE DESCRIBES SEVEN PATIENTS WITH SECONDARY PERINEAL HERNIA WHO UNDERWENT TRANSPERINEAL REPAIR (TPR) BETWEEN JULY 2010 AND MAY 2022 WERE RETROSPECTIVELY ANALYZED. ALL SPHS DEVELOPED AFTER ABDOMINOPERINEAL RESECTIONS IN PATIENTS WITH ANORECTAL MALIGNANCIES. THE ARTICLE CONCLUDED THAT TRANSPERINEAL REPAIR (TPR) USING A MESH WITH A MEMORY-RECOIL RING IS SAFE, FEASIBLE AND PROMISING TECHNIQUE FOR SPH REPAIRS. THIS MDR REPRESENTS PATIENT #1. THE ARTICLE DESCRIBES A 74-YEAR-OLD MALE PATIENT WITH SECONDARY PERINEAL HERNIA DEVELOPED AFTER ABDOMINOPERINEAL RESECTIONS IN PATIENT WITH ANORECTAL MALIGNANCIES WHO UNDERWENT TRANSPERINEAL REPAIR (TPR) WITH A SMALL KUGEL PATCH. PATIENT HAD POST OPERATIVE COMPLICATIONS INCLUDING PERINEAL WOUND INFECTION, RECURRENT PERINEAL HERNIA, AND PAIN WHICH WAS OBSERVED DURING FOLLOW-UPS AND CT EXAMINATIONS.

  Patient problems: Hernia; Pain; Post Operative Wound Infection

  MAUDE report 18163111 ↗
• InjuryMay 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 AN UNSPECIFIED BARD/DAVOL KUGEL HERNIA PATCH ON (B)(6) 2019. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE KUGEL HERNIA PATCH. 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: Insufficient Information; Seroma; Unspecified Infection

  MAUDE report 14350814 ↗
• InjuryMar 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 AN UNSPECIFIED BARD/DAVOL KUGEL HERNIA PATCH ON (B)(6) 2012. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE KUGEL HERNIA PATCH. 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: Abscess; Hernia; Insufficient Information; Unspecified Infection

  MAUDE report 13737865 ↗
• InjuryFeb 21, 2022Defective Device; 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)2008. As reported, the patient is making a claim for an adverse patient outcome against the Kugel Hernia Patch. Attorney alleges that the patient had subsequent surgical intervention due to the Hernia Mesh device. It is also alleged that the patient sustained personal injury, experienced emotional distress and the device was defective.Addendum per additional information provided:(b)(6)2008 ¿ Patient was diagnosed with left indirect inguinal hernia thereby underwent open repair with the implant of Kugel Patch. Per op notes, ¿The ilioinguinal nerve was dissected free. The hernia sac was noted. A medium oval Kugel Patch was placed in the preperitoneal space and secured to the inguinal ligament using sutures.¿(b)(6)2020 ¿ Patient was diagnosed with chronic left groin pain thereby underwent open repair with the removal of mesh. Per op notes, ¿The mesh was thick and heavy, found underneath the direct space in preperitoneal position. The mesh was densely stuck to the epigastric vessel and to spermatic cord structure. Part of mesh appeared to be in intensely scarred into

  Patient problems: Insufficient Information; Pain; Scar Tissue

  MAUDE report 13566665 ↗
• InjuryNov 2, 2021Migration or Expulsion of Device; Migration or Expulsion of Device

  PER JOURNAL ARTICLE, ¿A CASE REPORT FOR MESH (KUGEL PATCH) MIGRATION INTO BLADDER AFTER RIGHT HERNIA REPAIR. ¿ SOURCE: THE 85TH ANNUAL MEETING OF THE EASTERN SECTION OF JAPANESE UROLOGICAL ASSOCIATION (2020). PATIENT WAS DIAGNOSED WITH A RIGHT INGUINAL HERNIA AND UNDERWENT REPAIR. A MESH (MEDIUM OVAL KUGEL PATCH) WAS IMPLANTED DURING THIS REPAIR. THE PATIENT DEVELOPED ACUTE ABDOMEN, AND ABDOMINAL CT REVEALED FREE AIR, ASCITES, AND INTESTINAL OBSTRUCTION. A LAPAROTOMY WAS PERFORMED AND EXPOSURE OF THE MESH TO THE ABDOMINAL CAVITY WAS OBSERVED. IT WAS THOUGHT TO BE DUE TO MESH INFECTION. URINE OUTFLOW WAS OBSERVED IN THE DRAIN AFTER SURGERY, AND IN OCTOBER OF THE SAME YEAR, A CYSTOSCOPE REVEALED AN EXPOSURE OF THE MESH ON THE RIGHT WALL OF THE BLADDER. IN THE SAME MONTH, PARTIAL BLADDER RESECTION AND MESH REMOVAL WERE PERFORMED. IT IS POSSIBLE THAT THE BLADDER WAS INJURED DURING HERNIA TREATMENT, BUT SINCE THERE WAS NO PROBLEM WITH THE POSTOPERATIVE COURSE, IT IS HIGHLY PROBABLE THAT IT OCCURRED FOLLOWING MESH INFECTION. THE HEALTH INJURY TO THE PATIENT WAS UNKNOWN.

  Patient problems: Ascites; Obstruction/Occlusion; Unspecified Infection

  MAUDE report 12739721 ↗
• InjuryJun 28, 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 THE IMPLANT OF UNSPECIFIED BARD MESH (BARD FLAT MESH) AND BARD/DAVOL KUGEL HERNIA PATCH. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST KUGEL HERNIA PATCH WHICH WAS IMPLANTED ON (B)(6) 2016. 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. ADDENDUM PER ADDITIONAL INFORMATION PROVIDED: (B)(6) 2016 ¿ PATIENT WAS DIAGNOSED WITH INCISIONAL VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF KUGEL PATCH (DEVICE #1). PER OP NOTES, ¿A SMALL BOWEL HERNIATION WHICH WAS INCARCERATED INTO THE HERNIA SAC WAS NOTED. THE KUGEL PATCH(DEVICE #1) WAS PLACED IN THE UNDERLAY FASHION IN THE SUB INTERNAL OBLIQUE POSITION COVERING THE HERNIA DEFECT AND SUTURED.¿ (B)(6) 2020 ¿ PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL VENTRAL HERNIA THEREBY UNDERWENT ROBOTIC REPAIR WITH THE IMPLANT OF BARD FLAT MESH (DEVICE #2). PER OP NOTES, ¿THE HERNIA DEFECT WAS IDENTIFIED. THE ADHESIOLYSIS WERE DONE. AN OLD PIECE OF MESH (DEVICE #1) WAS LEFT IN SITU, WHICH APPEA

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

  MAUDE report 12074929 ↗
• InjuryDec 17, 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) 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. ADDENDUM PER ADDITIONAL INFORMATION PROVIDED: (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH BILATERAL INGUINAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT OF TWO KUGEL HERNIA PATCH (DEVICE #1 & #2). PER OP NOTES, ¿TWO KUGEL HERNIA PATCH (DEVICE #1 & #2) WERE PLACED INTO THE PRE-PERITONEAL SPACE ON BOTH LEFT & RIGHT-SIDE USING TACKERS.¿ (B)(6) 2017 - PATIENT WAS DIAGNOSED WITH RECURRENT LEFT INGUINAL HERNIA THEREBY UNDERWENT REPAIR. PER OP NOTES, ¿THE ILIOINGUINAL NERVE WAS IDENTIFIED, THIS WAS DISSECTED FREE FROM THE CORD RETRACTED LATERALLY. A SYNTHETIC MESH WAS PLACED.¿

  Patient problems: Disability; Hernia; Injury; Nerve Damage; Pain

  MAUDE report 11028056 ↗
• InjurySep 28, 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 UNSPECIFIED BARD/DAVOL KUGEL HERNIA PATCH ON (B)(6) 2006 AND PERFIX PLUG ON (B)(6) 2006. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST 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 ALSO ALLEGED THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Disability; Hernia; Injury; Pain

  MAUDE report 10597840 ↗
• InjuryJul 7, 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 UNSPECIFIED BARD/DAVOL MODIFIED KUGEL HERNIA PATCH AND MESH KUGEL MEDIUM OVAL ON (B)(6) 2015. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST BOTH DEVICES. ATTORNEY ALLEGES THAT THE PATIENT HAD SUBSEQUENT SURGICAL INTERVENTION DUE TO THE HERNIA MESH DEVICE. IT IS ALSO ALLEGED THAT THE PATIENT SUSTAINED PERSONAL INJURY, EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Injury; Pain

  MAUDE report 10238757 ↗
• InjuryJul 7, 2020Defective Device; Insufficient Device Problem Information; Migration; Defective Device; Insufficient Device Problem Information; Migration

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF UNSPECIFIED BARD/DAVOL MODIFIED KUGEL HERNIA PATCH AND MESH KUGEL MEDIUM OVAL ON (B)(6) 2015. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE BOTH DEVICES. ATTORNEY ALLEGES THAT THE PATIENT HAD SUBSEQUENT SURGICAL INTERVENTION DUE TO THE HERNIA MESH DEVICE. IT IS ALSO ALLEGED THAT THE PATIENT SUSTAINED PERSONAL INJURY, EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Hernia; Injury; Pain

  MAUDE report 10238755 ↗
• InjuryJun 16, 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 THE IMPLANT OF AN UNSPECIFIED BARD/DAVOL KUGEL HERNIA PATCH ON (B)(6) 2007. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST 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: Disability; Hernia; Injury; Pain

  MAUDE report 10157664 ↗
• InjuryMay 26, 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 UNSPECIFIED BARD/DAVOL COMPOSIX KUGEL HERNIA PATCH ON (B)(6) 2003 AND TWO KUGEL HERNIA PATCHES ON (B)(6) 2003 AND (B)(6) 2004. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST ALL DEVICES. 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; Drug Resistant Bacterial Infection; Fistula; Hernia; Injury; Pain

  MAUDE report 10086408 ↗
• InjuryMay 19, 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 UNSPECIFIED BARD/DAVOL KUGEL HERNIA PATCH (X2) ON (B)(6) 2004. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST 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 ALSO ALLEGED THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Disability; Hernia; Injury; Pain

  MAUDE report 10068642 ↗
• InjuryApr 8, 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 THE IMPLANT OF AN UNSPECIFIED BARD/DAVOL KUGEL HERNIA PATCH ON (B)(6) 2007. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST KUGEL HERNIA PATCH. ATTORNEY ALLEGES THAT THE PATIENT HAD SUBSEQUENT SURGICAL INTERVENTION DUE TO THE HERNIA MESH DEVICE. IT IS ALSO ALLEGED THAT THE PATIENT SUSTAINED PERSONAL INJURY, EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Hernia; Injury; Pain

  MAUDE report 9936844 ↗
• InjuryMar 5, 2020Defective Device; Insufficient Device Problem Information; Migration; Defective Device; Insufficient Device Problem Information; Migration

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL KUGEL HERNIA PATCH ON (B)(6) 2011. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE KUGEL HERNIA PATCH. ATTORNEY ALSO 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. ADDENDUM PER MEDICAL RECORDS AND PLAINTIFF PROFILE FORM: (B)(6) 2011 ¿ PATIENT WAS DIAGNOSED WITH SYMPTOMATIC RIGHT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF KUGEL PATCH MESH. PER OPERATIVE NOTES, ¿ HERNIA SAC WAS DISSECTED FREE FROM CORD STRUCTURES AND A MEDIUM KUGEL PATCH MESH WAS SELECTED AND INSERTED INTO THE INGUINAL FLOOR AND SECURED WITH SUTURES.¿ (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH GROIN PAIN THEREBY UNDERWENT OPEN REPAIR WITH REMOVAL OF MESH. PER OPERATIVE NOTES, ¿ THE MESH DENSELY ADHERENT TO THE PERITONEUM WAS DISSECTED. ADHESIONS BETWEEN OMENTUM AND MESH WERE REMOVED. THE MESH WAS NOTED TO BE EXTENDING D

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

  MAUDE report 9792010 ↗
• InjuryDec 30, 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 COMPOSIX KUGEL HERNIA PATCH ON (B)(6) 2008 AND A KUGEL HERNIA PATCH ON (B)(6) 2008. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST 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 ALSO ALLEGED THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Disability; Hernia; Injury; Pain

  MAUDE report 9530483 ↗
• InjuryDec 17, 2019Defective 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 AN UNSPECIFIED BARD/DAVOL COMPOSIX KUGEL HERNIA PATCH (DEVICE #1) ON (B)(6) 2007, AN UNSPECIFIED BARD/DAVOL KUGEL HERNIA PATCH (DEVICE #2) ON (B)(6) 2010 AND AN UNSPECIFIED BARD/DAVOL BARD SOFT MESH ON (B)(6) 2013. IT IS ALSO ALLEGED BY PATIENT ATTORNEY THAT ON (B)(6) 2009, THE PATIENT HAD UNSPECIFIED INJURIES. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE COMPOSIX KUGEL HERNIA PATCH (DEVICE #1) AND THE KUGEL HERNIA PATCH (DEVICE #2). 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: Disability; Injury; Pain

  MAUDE report 9484011 ↗
• InjuryDec 3, 2019Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information; Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information

  ATTORNEY ALLEGES THAT ON (B)(6) 2011, THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL KUGEL HERNIA PATCH (DEVICE #1) AND AN UNSPECIFIED BARD/DAVOL PERFIX PLUG. 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 KUGEL HERNIA PATCH (DEVICE #1). AS REPORTED, THE ATTORNEY ALLEGES PRODUCT IS DEFECTIVE AND THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS.

  Patient problems: Hernia; Injury; Scar Tissue

  MAUDE report 9402369 ↗
• InjuryNov 5, 2019Defective Device; Insufficient Device Problem Information; Migration; Defective Device; Insufficient Device Problem Information; Migration

  ATTORNEY ALLEGES THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL KUGEL HERNIA PATCH ON (B)(6) 2011. 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 9280502 ↗