KUGEL 0115816Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741030826), received between May 3, 2018 and Dec 3, 2024 — classified as 3 injuries, 1 malfunction.

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryDec 3, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED AND PER MEDICAL RECORDS PROVIDED, THE PATIENT WAS DIAGNOSED WITH A RECURRENT RIGHT INGUINAL HERNIA THEREBY UNDERWENT REPAIR WITH THE IMPLANT OF A MODIFIED KUGEL PATCH ON (B)(6) 2002. ON 01-SEP-2003, DURING A VISIT, THE PATIENT REPORTED RIGHT GROIN PAIN AND DISCOMFORT. ULTRASOUND FINDS NO EVIDENCE OF RECURRENCE.

  Patient problems: Discomfort; Pain

  MAUDE report 20831804 ↗
• MalfunctionSep 25, 2019Unsealed Device Packaging; Unsealed Device Packaging

  AS REPORTED ON (B)(6) 2019 THE BARD MODIFIED KUGEL WAS PULLED FROM HOSPITAL INVENTORY AND, "WHEN THE CIRCULATING NURSE ATTEMPTED TO OPEN THE STERILE PACKAGE, THEY COULD OPEN THE PACKAGE WITHOUT RESISTANCE. THEY ALLEGED THAT THE PACKAGE WAS ORIGINALLY OPENED. THE DEVICE WAS NOT USED." AS REPORTED, THERE WAS NO ABNORMALITY REPORTED WITH THE OUTER PRODUCT PACKAGING.

  Patient problems: No Patient Involvement

  MAUDE report 9115329 ↗
• InjuryJul 30, 2019Defective 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 KUGEL HERNIA PATCH (DEVICE #1) AND AN UNSPECIFIED BARD/DAVOL VENTRIO ST (DEVICE #2) ON (B)(6) 2013. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE KUGEL HERNIA PATCH (DEVICE #1) AND THE VENTRIO ST (DEVICE #2). AS REPORTED, 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: Adhesion(s); Disability; Injury; Pain

  MAUDE report 8842831 ↗
• InjuryMay 3, 2018Defective Device; Material Deformation; Insufficient Device Problem Information; Defective Device; Material Deformation; Insufficient Device Problem Information

  THE FOLLOWING WAS ALLEGED BY THE PATIENT'S ATTORNEY: ON (B)(6) 2011: THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL MODIFIED KUGEL PATCH. IT IS ALLEGED THAT THE PATIENT HAD UNSPECIFIED INJURIES. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE BARD/DAVOL MODIFIED KUGEL PATCH. AS REPORTED, 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: Adhesion(s); Disability; Hernia; Injury; Pain

  MAUDE report 7482758 ↗