Bard 0118001Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741031106), received between Jun 18, 2018 and May 25, 2022 — classified as 2 injuries.

The most frequently reported specific device problem is “Defective Device” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMay 25, 2022Defective Device; Patient Device Interaction Problem; Migration; Defective Device; Patient Device Interaction Problem; Migration

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL CK PARASTOMAL PATCH ON (B)(6) 2011. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE CK PARASTOMAL PATCH. ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT 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); Impaired Healing; Insufficient Information; Pain; Unspecified Infection

  MAUDE report 14497553 ↗
• InjuryJun 18, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT (B)(6) YEARS AGO (2009) THE PATIENT WAS IMPLANTED WITH A PARASTOMAL HERNIA PATCH. AS REPORTED IN (B)(6) 2018 THE PATIENT PRESENTED WITH WEIGHT LOSS AND ABDOMINAL PAIN. THE PATIENT UNDERWENT A CT SCAN AND A COLONOSCOPY, WHICH SHOWED SOME INFLAMMATION AT THE LEVEL OF RECTUS SHEATH. A FEW WEEKS LATER THE PATIENT UNDERWENT ANOTHER CT SCAN WHICH SHOWED LIVE BOWEL OBSTRUCTION. THE PATIENT UNDERWENT IMMEDIATE FLEXIBLE SIGMOIDOSCOPY AND ONE COULD SEE THE MESH WITHIN THE LUMEN OF THE STOMA. INTRA-ABDOMINAL MESH ERODED INTO THE COLOSTOMY CAUSING LARGE BOWEL OBSTRUCTION. DUE TO OTHER MEDICAL REASONS, THE PATIENT IS UNSUITABLE FOR LABORATORY AND IS LIKELY TO DIE SECONDARY TO THIS. PER THE PATIENT'S SURGEON HE HAS A PACEMAKER AND CARDIAC ISSUES THAT WOULD INCREASE HIS MORTALITY RISK IF HE UNDERWENT LAPAROTOMY. FOLLOWING THE FLEXIBLE SIGMOIDOSCOPY THE PATIENT ELECTED TO HAVE A LIQUID DIET FOR A FURTHER WEEK AND LOST A FURTHER 5 KG. ON (B)(6) 2018 THE PATIENT UNDERWENT A PROCEDURE TO REMOVE SOME OF THE MESH PARASTOMAL. PER THE SURGEON THIS WAS VERY DIFFICULT, BUT THE PATIENT TOLERATED UNDER NO ANAESTHETIC AND SLIGHT IMPROVEMENT IN WAY THROUGH STOMA. MESH ERODED THROUGH RECTUS

  Patient problems: Bowel Perforation; Erosion; Obstruction/Occlusion

  MAUDE report 7609018 ↗