DULEX 0120301Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741011894), received between Nov 6, 2020 and Apr 19, 2022 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryApr 19, 2022Material Disintegration; Patient-Device Incompatibility; Material Disintegration; Patient-Device Incompatibility

  AS REPORTED, DURING AN INCISIONAL HERNIA REPAIR PROCEDURE ON (B)(6) 2004, THE PATIENT WAS IMPLANTED WITH A BARD/DAVOL DULEX MESH. IT WAS REPORTED, ABOUT 6 YEARS LATER IN 2010 THE PATIENT UNDERWENT ADDITIONAL SURGERY TO REMOVE ABDOMINAL WALL SCARRING. AS REPORTED ON (B)(6) 2021, THE PATIENT EXPERIENCED EXCRUCIATING PAIN AND PRESENTED TO THE HOSPITAL EMERGENCY ROOM. AS REPORTED, A CT SCAN WAS PERFORMED AND IDENTIFIED 2 BOWEL BLOCKAGES AND A TWISTED AREA OF BOWEL. IT WAS REPORTED THE SURGEON WOULD NOT PERFORM ANY SURGICAL PROCEDURE AND ADMINISTERED A ¿DYE¿ TO TEMPORARILY RESOLVE THE BLOCKAGES AND TWISTED BOWEL. AS REPORTED, THE PATIENT HAS CONTINUED WITH SIGNIFICANT ABDOMINAL BLOATING/SWELLING, AND THE PATIENT¿S ABDOMEN IS HARD TO THE TOUCH AND PAINFUL. AS REPORTED THE PATIENT HAS TRIED MULTIPLE REMEDIES SUCH AS GAS-X, MINT TEA, MULTIPLE DOCTOR VISITS WITH NO RELIEF. CONTACT REPORTS THE PATIENT EXPERIENCED HEALTH ISSUES RELATED TO THE ¿MESH DISINTEGRATING AND ALLOWS INTESTINES TO GROW INTO THE MESH.¿ PER THE CONTACT, THE MESH HAS ¿WELDED ITSELF AGAINST THE BOWELS AND SKIN CAUSING TROUBLE EATING AND BLOATING.¿ IT IS REPORTED THAT THE PATIENT IS WAITING FOR SURGERY IN THE NEAR FUTURE.

  Patient problems: Abdominal Pain; Adhesion(s); Obstruction/Occlusion

  MAUDE report 14141672 ↗
• InjuryDec 4, 2020Defective Device; Insufficient Device Problem Information; Defective Device; Insufficient Device Problem Information

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL DULEX MESH ON OR ABOUT (B)(6) 2016. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE DULEX MESH. ATTORNEY ALLEGES THAT THE PATIENT HAD SUBSEQUENT SURGICAL INTERVENTION DUE TO THE HERNIA MESH DEVICE. IT IS ALSO ALLEGED THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Injury

  MAUDE report 10949417 ↗
• InjuryNov 6, 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 AN UNSPECIFIED BARD/DAVOL DULEX MESH ON (B)(6) 2007. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE DULEX MESH. 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 10800136 ↗