Bard 0118002Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741031113), received between Aug 27, 2018 and Sep 21, 2021 — classified as 1 death, 4 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. How this data works · Data updated Oct 13, 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.

• InjurySep 21, 2021Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT A PARASTOMAL HERNIA REPAIR SURGERY AND WAS IMPLANTED WITH A BARD/DAVOL CK PARASTOMAL HERNIA PATCH ON (B)(6) 2017. IT IS ALLEGED THAT FURTHER TO THE IMPLANTATION WITH THE PRODUCT, THE PATIENT SUFFERED THE DEVELOPMENT OF AN ENTEROCUTANEOUS FISTULA, WHICH SUSTAINED INFECTION, CAUSING ABSCESSING. IT IS ALLEGED THAT DIAGNOSTIC IMAGING SUBSEQUENTLY REVEALED IRREGULAR TISSUE THICKENING IN THE MIDLINE ABDOMINAL WALL WITH ENTRAPMENT OF SMALL BOWEL. THE PRODUCT HAD ADHERED TO THE PATIENT'S SMALL BOWEL, RESULTING IN VOLVULUS, OBSTRUCTION AND ISCHEMIA. IT IS ALLEGED THAT THE PATIENT WAS REFERRED FOR REPARATIVE SURGERY TO REMOVE THE PRODUCT, WHICH OCCURRED ON (B)(6) 2017. IT IS ALSO ALLEGED THAT THE PATIENT HAS SUFFERED INJURIES, LOSSES, AND DAMAGES RESULTING FROM NUMEROUS DEFECTS IN THE PRODUCT THAT CREATE AN UNREASONABLY HIGH RISK OF INJURY WITH SEVERE PERMANENT ADVERSE HEALTH CONSEQUENCES. ATTORNEY ALLEGES THAT THE PATIENT EXPERIENCED SEVERE PAIN AND SUFFERING, INCLUDING CHRONIC PAIN. IT IS ALSO ALLEGED THE PATIENT WAS TREATED WITH A COURSE OF HOSPITALIZATION, DIAGNOSTIC IMAGING, REVISION SURGERY, SERUM TESTING, ANTIBIOTICS, ANALGESICS AND REST. AT

  Patient problems: Abscess; Fistula; Obstruction/Occlusion

  MAUDE report 12510669 ↗
• InjuryJul 3, 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 AN UNSPECIFIED BARD/DAVOL CK PARASTOMAL PATCH ON (B)(6) 2012. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE CK PARASTOMAL PATCH. IT IS ALLEGED THAT THE PATIENT UNDERWENT REVISION SURGERY ON (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: Adhesion(s); Hernia; Insufficient Information; Pain

  MAUDE report 12112779 ↗
• InjuryOct 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 AN UNSPECIFIED BARD/DAVOL PARASTOMAL HERNIA PATCH ON (B)(6) 2008. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST PARASTOMAL 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: Adhesion(s); Disability; Hernia; Injury; Obstruction/Occlusion; Pain

  MAUDE report 10643409 ↗
• DeathMay 18, 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 COMPOSIX KUGEL HERNIA PATCH ON (B)(6) 2013. AS REPORTED, THE PLAINTIFF IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE COMPOSIX KUGEL HERNIA PATCH. ATTORNEY ALLEGES WRONGFUL DEATH OF THE PATIENT. 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 PLAINTIFF." IT IS ALSO ALLEGED THAT THE PLAINTIFF EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Abscess; Adhesion(s); Death; Disability; Erosion; Inflammation; Injury; Obstruction/Occlusion

  MAUDE report 10064393 ↗
• InjuryAug 27, 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) 2007: THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL PARASTOMAL. THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE BARD/DAVOL PARASTOMAL. 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: Abdominal Pain; Adhesion(s); Disability; Inflammation; Injury; Obstruction/Occlusion; Pain; Scar Tissue

  MAUDE report 7819102 ↗