Bard® DeBakey® Elastic Knit Fabric 007831Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741041075), received between Dec 14, 2016 and Feb 6, 2017 — classified as 2 injuries.

The most frequently reported specific device problem is “Material Erosion” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 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.

• InjuryFeb 6, 2017Material Erosion; Material Erosion

  MEDICAL RECORDS WERE RECEIVED AND REVIEWED. APPROXIMATELY ELEVEN MONTHS POST ELASTIC KNIT FABRIC PLACEMENT FOR VAGINAL PROLAPSE REPAIR, A SURGICAL PROCEDURE WAS PERFORMED FOR EROSION OF THE MESH. DURING THE PROCEDURE, A RETROPERITONEAL ABSCESS, INFECTION OF THE MESH AND A SINUS TRACT WAS IDENTIFIED. THE MESH WAS REMOVED IN ITS ENTIRETY WITHOUT DIFFICULTY AND THE SINUS TRACT WAS CLOSED. THE PATIENT WAS IN GOOD CONDITION AT THE CONCLUSION OF THE PROCEDURE. NO ADDITIONAL INFORMATION SURROUNDING THIS EVENT WAS PROVIDED IN THE MEDICAL RECORDS RECEIVED

  Patient problems: Abscess; Erosion; Unspecified Infection

  MAUDE report 6303901 ↗
• InjuryDec 14, 2016Material Erosion; Material Erosion

  MEDICAL RECORDS WERE RECEIVED AND REVIEWED. APPROXIMATELY ONE YEAR FOUR MONTHS POST PLACEMENT OF ELASTIC KNIT FABRIC USED TO CREATE A SUBURETHRAL SLING, THE PATIENT WAS IDENTIFIED TO HAVE A NONHEALING INCISION OVER THE SITE WHERE THE SLING HAD BEEN PLACED. THE SURGICAL SITE WAS REOPENED AND THE SLING WAS REMOVED IN ITS ENTIRETY. THE PATIENT WAS TRANSFERRED TO RECOVERY IN GOOD CONDITION. NO ADDITIONAL MEDICAL RECORDS WERE RECEIVED FOR THIS PATIENT.

  Patient problems: Erosion

  MAUDE report 6173294 ↗