Visilex 0112910Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741016646), received between Aug 16, 2018 and Oct 13, 2020 — classified as 3 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryOct 13, 2020Defective 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 UNSPECIFIED BARD/DAVOL VISILEX ON (B)(6) 2006, PERFIX PLUG ON (B)(6) 2016 AND PHASIX ON (B)(6) 2020. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE VISILEX AND PERFIX PLUG. 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); Disability; Injury; Pain

  MAUDE report 10669192 ↗
• InjuryAug 23, 2018Defective Device; Insufficient Device Problem Information; Patient Device Interaction Problem; Defective Device; Insufficient Device Problem Information; Patient Device Interaction Problem

  THE FOLLOWING WAS ALLEGED BY THE PATIENT'S ATTORNEY: (B)(6) 2005 OR (B)(6) 2012: THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL COMPOSIX E/X (DEVICE #1) OR AN UNSPECIFIED BARD/DAVOL COMPOSIX KUGEL (DEVICE #2) OR AN UNSPECIFIED BARD/DAVOL VISILEX (DEVICE #3). (B)(6) 2006: THE PATIENT HAD UNSPECIFIED INJURIES. THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE COMPOSIX E/X (DEVICE #1), COMPOSIX KUGEL (DEVICE #2) AND VISILEX (DEVICE #3). THE PATIENT'S 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: Bacterial Infection; Disability; Injury; Pain; Purulent Discharge; Seroma

  MAUDE report 7809231 ↗
• InjuryAug 16, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  THE FOLLOWING WAS REPORTED TO DAVOL: ON (B)(6) 2000 - THE PATIENT UNDERWENT THE REPAIR OF AN INGUINAL HERNIA WITH THE IMPLANT OF A DAVOL PERFIX PLUG (DEVICE #1). AS REPORTED FOLLOWING IMPLANT THE PATIENT FREQUENTLY EXPERIENCED PAIN. ON (B)(6) 2012 - THE PATIENT UNDERWENT EXPLORATORY SURGERY DUE TO HAVING PAIN IN THE AREA OF THE REPAIR. DURING THIS PROCEDURE THE SURGEON DISCOVERED THE MESH (DEVICE #1) WAS "BALLED UP", DUE TO THIS THE SURGEON REMOVED THE PERFIX PLUG AND REPLACED IT WITH A VISILEX MESH (DEVICE #2). FOLLOWING THE SECOND SURGERY IT IS REPORTED THAT THE PATIENT CONTINUES TO HAVE PAIN IN THE AREA OF THE REPAIR. AS REPORTED THE AREA IS SWOLLEN, AND "HAS NOT FELT RIGHT SINCE THE FIRST HERNIA SURGERY WAS PERFORMED."

  Patient problems: Pain; Swelling

  MAUDE report 7788358 ↗