BARD 0112700Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00801741016547), received between Dec 18, 2017 and Oct 31, 2025 — classified as 17 injuries.

The most frequently reported specific device problem is “Defective Device” (15 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryOct 31, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH RIGHT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF PERFIX PLUG (DEVICE 1). PER OPERATIVE NOTES, ¿AN INCISION WAS MADE ON THE FLOOR OF THE INGUINAL CANAL. HERNIA SAC WAS DISSECTED OUT. A PERFIX PLUG (DEVICE 1) WAS PLACED INTO THE INTERNAL RING AND SECURE IT WITH SUTURES.¿ ON (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH RECURRENT RIGHT INGUINAL HERNIA, ADHESION THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF PRE-SHAPED MESH (DEVICE 2). PER OPERATIVE NOTES, ¿AN INCISION WAS MADE THROUGH THE OLD INCISION. PREVIOUSLY PLACED PERFIX PLUG (DEVICE 1) WAS PULLED AWAY FROM INGUINAL FLOOR. ALL ADHESIONS WERE TAKEN DOWN. PRE-SHAPED MESH (DEVICE 2) WAS PLACED INTO THE SHELVING PORTION OF INGUINAL LIGAMENT AND SECURE IT WITH SUTURES.¿ ON (B)(6) 2016 - PATIENT WAS DIAGNOSED WITH RECURRENT RIGHT INGUINAL HERNIA, ADHESION THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH EXPLANT OF PERFIX PLUG (DEVICE 1) AND PRE-SHAPED MESH (DEVICE 2) AND IMPLANT OF SYNTHETIC MESH. PER OPERATIVE NOTES, ¿A SUPRAUMBILICAL INCISION WAS MADE. INDIRECT RIGHT INGUINAL HERNIA SAC WAS DISSECTED OUT. PREVIOUSLY PLACED PERFIX PLUG (DEVICE 1) AND PRE

  Patient problems: Adhesion(s); Hernia

  MAUDE report 23439920 ↗
• InjuryApr 11, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED, THE PATIENT UNDERWENT AN OPEN LEFT INGUINAL HERNIA REPAIR ON (B)(6) 2022. ABOUT 3 WEEKS POST OP THE PATIENT HAD SIGNIFICANT SWELLING IN THE LEFT GROIN, AND TESTICLE. HE FOLLOWED UP WITH THE SURGEON WHO DRAINED SOME FLUID FROM THE SURGICAL SITE, CLEANED OUT THE AREA AND RECLOSED THE INCISION USING A GLUE. AS REPORTED, THE PATIENT HAS EXPERIENCED NERVE PAIN EVER SINCE. THE PATIENT WAS SUBSEQUENTLY DIAGNOSED WITH A RECURRENT HERNIA AND WAS TOLD HE WILL NEED ANOTHER SURGERY. THE REVISION PROCEDURE HAS NOT YET BEEN SCHEDULED.

  Patient problems: Fluid Discharge; Hernia; Neuralgia; Swelling/ Edema

  MAUDE report 19087718 ↗
• InjuryFeb 16, 2024Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF UNSPECIFIED BARD/DAVOL MARLEX MESH (BARD FLAT MESH) AND BARD PRE-SHAPED MESH ON (B)(6) 2007. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST BOTH THE DEVICES. 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: Insufficient Information; Pain

  MAUDE report 18719669 ↗
• InjuryMar 18, 2022Defective Device; Patient-Device Incompatibility; Patient Device Interaction Problem; Defective Device; Patient-Device Incompatibility; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL MARLEX MESH (BARD FLAT MESH) ON (B)(6) 2014. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE MARLEX MESH (BARD FLAT 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: Hernia; Insufficient Information; Pain

  MAUDE report 13803247 ↗
• InjuryNov 11, 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 VENTRIO PATCH ON (B)(6) 2011 AND BARD MESH (BARD FLAT MESH) ON (B)(6) 2011. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST BOTH DEVICES. 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; Pain

  MAUDE report 10822511 ↗
• InjuryOct 16, 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 MESH (BARD FLAT MESH) (X2) ON (B)(6) 2016 AND (B)(6) 2017. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST BOTH DEVICES. 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; Pain

  MAUDE report 10693349 ↗
• InjuryOct 15, 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 MESH (BARD FLAT MESH) (X2) ON (B)(6) 2016 AND (B)(6) 2017. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST BOTH DEVICES. 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: Hernia; Injury; Pain; Scar Tissue

  MAUDE report 10682217 ↗
• InjuryAug 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 MESH (BARD FLAT MESH) ON (B)(6) 2010. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE BARD MESH (BARD FLAT 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; Nerve Damage; Pain

  MAUDE report 10371994 ↗
• InjuryMay 10, 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 THE IMPLANT OF AN UNSPECIFIED BARD MESH (BARD FLAT MESH) ON (B)(6) 2012. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST BARD MESH (BARD FLAT MESH). IT IS ALLEGED 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: Adhesion(s); Inflammation; Injury; Pain

  MAUDE report 10041598 ↗
• InjuryDec 2, 2019Defective Device; Insufficient Device Problem Information; Patient Device Interaction Problem; Migration; Defective Device; Insufficient Device Problem Information; Patient Device Interaction Problem; Migration

  ATTORNEY ALLEGES PER SHORT FORM (SEE ATTACHED) THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL BARD MESH ON (B)(6) 2013. IT IS ALSO ALLEGED BY PATIENT'S ATTORNEY THAT ON (B)(6) 2013, THE PATIENT HAD UNSPECIFIED INJURIES RELATED TO A DEFECT IN THE BARD MESH, AND UNDERWENT CORRECTIVE SURGERY. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE BARD MESH. 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: Disability; Fibrosis; Injury; Nerve Damage; Pain

  MAUDE report 9396050 ↗
• InjuryAug 26, 2019Defective Device; Material Deformation; Insufficient Device Problem Information; Defective Device; Material Deformation; Insufficient Device Problem Information

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL BARD [FLAT} MESH ON (B)(6) 2010. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE BARD MESH. 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; Inflammation; Injury; Pain

  MAUDE report 8931486 ↗
• InjuryMar 29, 2019Defective Device; Insufficient Device Problem Information; Patient Device Interaction Problem; Defective Device; Insufficient Device Problem Information; Patient Device Interaction Problem

  PER LEGAL COMPLAINT: ON (B)(6)2012 - PATIENT UNDERWENT SURGERY DURING WHICH THE PATIENT WAS IMPLANTED WITH AN UNSPECIFIED BARD/DAVOL [FLAT] MESH. THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE [FLAT] 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." ADDENDUM: IT IS ALLEGED THAT ON (B)(6) 2014, THE PATIENT HAD UNSPECIFIED INJURIES RELATED TO A DEFECT IN THE BARD/DAVOL FLAT MESH, AND UNDERWENT REVISION SURGERY.

  Patient problems: Disability; Hernia; Injury; Nerve Damage; Pain; Scar Tissue

  MAUDE report 8465422 ↗
• InjuryJul 25, 2018Defective Device; Insufficient Device Problem Information; Defective Device; Insufficient Device Problem Information

  THE FOLLOWING WAS ALLEGED BY THE PATIENT'S ATTORNEY: ON (B)(6) 2017: THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF A BARD/DAVOL PERFIX PLUG (DEVICE #1) REFERENCE NUMBER 0112980. ON (B)(6) 2017: THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF A BARD/DAVOL BARD MESH PRE-SHAPED (DEVICE #2) REFERENCE NUMBER 0112700. ON (B)(6) 2018 - THE PATIENT HAD UNSPECIFIED INJURIES. THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE PERFIX PLUG (DEVICE #1) AND BARD MESH PRE-SHAPED (DEVICE #2). 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: Disability; Injury; Pain

  MAUDE report 7720067 ↗
• InjuryMar 20, 2018Defective Device; Insufficient Device Problem Information; Patient Device Interaction Problem; Migration; Defective Device; Insufficient Device Problem Information; Patient Device Interaction Problem; Migration

  THE FOLLOWING WAS ALLEGED BY THE PATIENT'S ATTORNEY: (B)(6) 2012 - THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL FLAT MESH. AS REPORTED, THE PATIENT'S ATTORNEY ALLEGES A GENERAL CLAIM "FOR PAST, PRESENT, AND FUTURE DAMAGES, INCLUDING BUT NOT LIMITED TO, MENTAL AND PHYSICAL PAIN AND SUFFERING FOR SEVERE AND PERMANENT PERSONAL INJURIES SUSTAINED".

  Patient problems: Disability; Nerve Damage; Pain; Scar Tissue

  MAUDE report 7352568 ↗
• InjuryFeb 7, 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: ON (B)(6) 2011: THE PATIENT UNDERWENT SURGERY FOR REPAIR OF A RIGHT INGUINAL HERNIA. A BARD/DAVOL MESH PRE-SHAPED, REFERENCE NUMBER 0112700, WAS IMPLANTED TO REPAIR THE HERNIA DEFECT. ON (B)(6) 2015: THE PATIENT UNDERWENT AN ADDITIONAL SURGERY TO REPAIR RECURRENT RIGHT INGUINAL HERNIA. AS ALLEGED, THE PATIENT WAS INJURED SEVERELY AND PERMANENTLY AND HAS SUFFERED AND WILL CONTINUE TO SUFFER PHYSICAL PAIN DUE TO THE ALLEGED DEFECTIVE MARLEX.

  Patient problems: Disability; Hernia; Pain

  MAUDE report 7247944 ↗
• InjuryDec 28, 2017Defective Device; Defective Device

  THE FOLLOWING IS BASED ON A REVIEW OF MEDICAL RECORDS PROVIDED TO DAVOL BY THE PATIENT'S ATTORNEY: (B)(6) 1997 - THE PATIENT WAS DIAGNOSED WITH VAGINAL VAULT PROLAPSE, ENTEROCELE AND SYMPTOMATIC PELVIC RELAXATION. THE PATIENT UNDERWENT AN ABDOMINAL SACROCOLPOPEXY WITH IMPLANT OF A BARD PRE-SHAPED MESH. (B)(6) 1999 - (B)(6) 1999 - THE PATIENT PRESENTED TO THE HOSPITAL WITH COMPLAINTS OF ABDOMINAL PAIN AND CHRONIC CONSTIPATION. THE PATIENT WAS ADMITTED TO THE INTENSIVE CARE UNIT WITH A PRIMARY DIAGNOSIS OF PERFORATION OF HER BOWEL AND A SECONDARY DIAGNOSIS OF SEPSIS WITH RIGHT GROIN EMBOLISM. (B)(6) 1999 - THE PATIENT WAS DIAGNOSED WITH PERFORATED SIGMOID COLON SECONDARY TO STERCORAL COLITIS. THE PATIENT UNDERWENT A TWO PART PROCEDURE WHICH INCLUDED A SMALL BOWEL RESECTION AND COLOSTOMY FORMATION WITH EXPLANT OF THE BARD PRE-SHAPED MESH AND REMOVAL OF A RIGHT GROIN EMBOLISM. PER OPERATIVE DETAILS AND FINDINGS "THE SMALL BOWEL APPEARED TO BE ADHERENT TO A PIECE OF MESH (DAVOL) WHICH APPEARED TO BE SECONDARY TO A PRIOR SURGERY. SHE HAD LOTS OF ADHESIONS BETWEEN THE INTESTINE AND THE MESH. THE SMALL BOWEL WAS REMOVED FROM THE MESH, AND THE SMALL BOWEL WAS ABLE TO BE EVISCERATED. THERE W

  Patient problems: Adhesion(s); Bowel Perforation; Sepsis

  MAUDE report 7150796 ↗
• InjuryDec 18, 2017Defective Device; Insufficient Device Problem Information; Patient Device Interaction Problem; Defective Device; Insufficient Device Problem Information; Patient Device Interaction Problem

  IT IS ALLEGED BY THE PATIENTS ATTORNEY THAT ON (B)(6) 2009, THE PATIENT UNDERWENT SURGERY FOR REPAIR OF AN INGUINAL HERNIA. AS REPORTED, A BARD/DAVOL MARLEX REFERENCE NUMBER 0112700, LOT NUMBER HUSL1076 WAS IMPLANTED TO REPAIR THE HERNIA DEFECT. IT IS ALLEGED THAT A YEAR LATER ON (B)(6) 2010, THE PATIENT UNDERWENT AN ADDITIONAL SURGERY TO REPAIR THE HERNIA DEFECT AND "REMOVE IT." AS ALLEGED, THE PATIENT WAS INJURED SEVERELY AND PERMANENTLY AND HAS SUFFERED AND WILL CONTINUE TO SUFFER PHYSICAL PAIN DUE TO THE ALLEGED DEFECTIVE MARLEX.

  Patient problems: Abdominal Pain; Disability; Hematoma; Hernia; Pain

  MAUDE report 7124378 ↗