Bard 0118004Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741031137), received between Apr 19, 2018 and Dec 14, 2018 — classified as 2 injuries.

The most frequently reported specific device problem is “Defective Device” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryDec 14, 2018Defective Device; Insufficient Device Problem Information; Defective Device; Insufficient Device Problem Information

  THE FOLLOWING WAS REPORTED TO DAVOL BY THE PATIENT'S ATTORNEY: (B)(6) 2007 - THE PATIENT UNDERWENT HERNIA REPAIR WITH IMPLANT OF A CK PARASTOMAL BARD HERNIA PATCH. (B)(6) 2018 - THE PATIENT UNDERWENT REMOVAL OF THE FAILED BARD MESH. AS REPORTED THE PATIENT CONTINUES TO EXPERIENCE COMPLICATIONS RELATED TO BARD MESH. THE PATIENT'S ATTORNEY ALLEGES THE PATIENT HAS BEEN INJURED, SUSTAINED SEVERE AND PERMANENT PAIN, SUFFERING, ANXIETY, DEPRESSION, DISABILITY AND IMPAIRMENT DUE TO THE ALLEGED DEFECTIVE BARD MESH.

  Patient problems: Disability; Hernia; Pain

  MAUDE report 8165545 ↗
• InjuryApr 19, 2018Defective Device; Insufficient Device Problem Information; Defective Device; Insufficient Device Problem Information

  THE FOLLOWING WAS ALLEGED BY THE PATIENT'S ATTORNEY: (B)(6) 2011 - PATIENT UNDERWENT SURGERY FOR IMPLANT OF A BARD/DAVOL BARD PARASTOMAL 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; Injury; Pain

  MAUDE report 7442656 ↗