Bard 0118003Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741031120), received between Aug 27, 2026 and Aug 27, 2026 — classified as 1 injury.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryAug 27, 2026Patient-Device Incompatibility

  Per information provided:(b)(6)2011 - Patient was diagnosed with ventral hernia and parastomal hernia thereby underwent open repair with the implant of SepraMesh IP (Device 1) and Parastomal Patch (Device 2). Per op notes, "Attention to the incisional ventral hernia, a SepraMesh IP (Device 1) was placed to the anterior abdominal wall. Then a midline incision was made, the Parastomal Patch (Device 2) was placed around the stoma to cover the hernia defect using tacks."(b)(6)2012 - Patient was diagnosed with infected mesh thereby underwent repair with removal of mesh (Device 1 and 2) and lysis of adhesions. Per op notes, "A vertical midline incision was made at the prior scar. There was an abscess cavity between the mesh and the linea alba which was drained. Explanted the prior placed SepraMesh IP (Device 1) from the right and left rectus sheath. Then attention to the second mesh that was placed around the colostomy, and were able to dissect free the mesh (Device 2) and explanted around the stoma. Lysis of adhesions was performed. Then a biologic mesh was placed."

  Patient problems: Abscess; Adhesion(s); Scar Tissue; Unspecified Infection

  MAUDE report 50476015 ↗