PerFix 0117160Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00801741030994), received between Mar 16, 2018 and Feb 23, 2022 — classified as 8 injuries.

The most frequently reported specific device problem is “Defective Device” (8 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 23, 2022Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT THE PATIENT WAS IMPLANTED WITH A BARD/DAVOL PERFIX LIGHT PLUG MEDIUM (THE PRODUCT). IT IS ALLEGED THAT ON (B)(6) 2013, THE PATIENT WAS IMPLANTED WITH THE PRODUCT IN THE COURSE OF AN INGUINAL HERNIA REPAIR SURGERY. IT IS ALLEGED THAT FURTHER TO THE PATIENT'S IMPLANTATION WITH THE PRODUCT, PATIENT SUFFERED THE DEVELOPMENT OF CHRONIC PAIN, INFLAMMATION, SWELLING, BOWEL OBSTRUCTION, GASTROINTESTINAL MALFUNCTION, AND HERNIA RECURRENCE, NECESSITATING FURTHER REPARATIVE SURGERY WHICH OCCURRED ON (B)(6)2015. IT IS ALLEGED THAT SUBSEQUENT TO THE LATTER SURGERY, THE PATIENT HAS CONTINUED TO SUFFER FROM CHRONIC PAIN, INFLAMMATION, SWELLING, BOWEL OBSTRUCTION, GASTROINTESTINAL MALFUNCTION, AND HERNIA RECURRENCE. ATTORNEY ALLEGES THAT THE PATIENT SUFFERED INJURIES, LOSSES, AND DAMAGES RESULTING FROM NUMEROUS DEFECTS IN THE PRODUCT THAT CREATE AN UNREASONABLY HIGH RISK OF INJURY WITH SEVERE PERMANENT ADVERSE HEALTH CONSEQUENCES. IT IS ALSO ALLEGED THAT THE PATIENT EXPERIENCED SEVERE PAIN AND SUFFERING, INCLUDING CHRONIC PAIN. ATTORNEY ALLEGES THAT THE PATIENT HAS BEEN TREATED WITH A COURSE OF HOSPITALIZATION, DIAGNOSTIC IMAGING, REVISION SURGERY, SERUM TESTING, ANTIBIOTICS,

  Patient problems: Hernia; Inflammation; Obstruction/Occlusion; Pain

  MAUDE report 13586786 ↗
• InjuryJun 2, 2021Defective 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 PERFIX LIGHT PLUG ON (B)(6) 2014. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE PERFIX LIGHT PLUG. 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; Insufficient Information; Pain

  MAUDE report 11921125 ↗
• InjuryFeb 18, 2020Defective Device; Material Deformation; Insufficient Device Problem Information; Defective Device; Material Deformation; Insufficient Device Problem Information

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR THE IMPLANT OF UNSPECIFIED BARD MESH (BARD FLAT MESH) AND BARD/DAVOL PERFIX PLUG LIGHT. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST BARD MESH (BARD FLAT MESH) WHICH WAS IMPLANTED ON (B)(6) 2015. 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: Disability; Hernia; Injury; Pain

  MAUDE report 9719036 ↗
• InjuryJan 7, 2020Defective Device; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Defective Device; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF UNSPECIFIED BARD/ DAVOL 3DMAX MESH (3X) AND PERFIX LIGHT PLUG ON (B)(6) 2014. 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; No Clinical Signs, Symptoms or Conditions

  MAUDE report 9557701 ↗
• InjuryJan 11, 2019Device Appears to Trigger Rejection; Defective Device; Insufficient Device Problem Information; Patient Device Interaction Problem; Device Appears to Trigger Rejection; Defective Device; Insufficient Device Problem Information; Patient Device Interaction Problem

  THE FOLLOWING WAS ALLEGED BY THE PATIENT'S ATTORNEY: (B)(6) 2013: THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF TWO (2) UNSPECIFIED BARD/DAVOL PERFIX PLUG LITE (DEVICE #1) AND (DEVICE #2). ON (B)(6) 2015: THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL 3DMAX (DEVICE #3). THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE TWO (2) PERFIX PLUG LITE (DEVICE #1) AND (DEVICE #2) AND 3DMAX (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: Adhesion(s); Disability; Hernia; Injury; Pain; Scar Tissue

  MAUDE report 8241978 ↗
• InjuryJan 4, 2019Defective Device; Insufficient Device Problem Information; Defective Device; Insufficient Device Problem Information

  THE FOLLOWING WAS ALLEGED BY THE PATIENT'S ATTORNEY: (B)(6) 2015: THE PATIENT UNDERWENT LEFT INGUINAL HERNIA REPAIR. A BARD/DAVOL PERFIX LIGHT PLUG (DEVICE #1) WAS IMPLANTED IN THE PATIENT DURING THIS REPAIR. (B)(6) 2015: THE PATIENT UNDERWENT LEFT INGUINAL HERNIA REPAIR. A BARD/DAVOL PERFIX LIGHT PLUG (DEVICE #2) WAS IMPLANTED IN THE PATIENT DURING THIS REPAIR. (B)(6) 2016: THE PATIENT WAS SEEN BY THE PHYSICIAN FOR SEVERE AND CHRONIC PAIN. THE PHYSICIAN NOTED, ¿THIS KIND OF PLUG IS VIRTUALLY IMPOSSIBLE TO REMOVE DOING A LOT OF DAMAGE TO THE TISSUES OF THE INGUINAL CANAL. I WOULD THEREFORE NOT RECOMMEND ANY SURGICAL ATTEMPT TO TRY AND REMOVE THE MESH.¿ THE PATIENT CONTINUES TO SUFFER COMPLICATIONS RELATED TO THE BARD/DAVOL PERFIX LIGHT PLUG (DEVICE #1 AND DEVICE #2). THE MESH IMPLANTED IN THE PATIENT FAILED TO REASONABLY PERFORM AS INTENDED. THE MESH CAUSED SERIOUS INJURY AND HAD TO BE SURGICALLY REMOVED VIA INVASIVE SURGERY, AND NECESSITATED ADDITIONAL INVASIVE SURGERY TO REPAIR THE HERNIA THAT THE MESH WAS INITIALLY IMPLANTED TO TREAT. THE PATIENT HAS BEEN INJURED, SUSTAINED SEVERE AND PERMANENT PAIN, SUFFERING, ANXIETY, DEPRESSION, DISABILITY, AND IMPAIRMENT.

  Patient problems: Disability; Hernia; Injury

  MAUDE report 8218943 ↗
• InjuryMar 23, 2018Defective Device; Insufficient Device Problem Information; Defective Device; Insufficient Device Problem Information

  THE FOLLOWING WAS ALLEGED BY THE PATIENT'S ATTORNEY: ON (B)(6) 2011 - THE PATIENT UNDERWENT RIGHT INGUINAL HERNIA REPAIR PROCEDURE TO INTRODUCE A BARD/DAVOL PERFIX PLUG TO THE PATIENT'S PERITONEAL CAVITY TO REINFORCE TISSUE AFFECTED BY THE HERNIA. SPECIFICALLY, A LARGE PERFIX PLUG, 1.6" X 1.90" (4.1CM X 4.8CM) POSITIVELY IDENTIFIED ON SURGICAL AND OPERATIVE REPORTS WAS IMPLANTED INTO THE PATIENT (DEVICE 1). ON (B)(6) 2013 - THE PATIENT UNDERWENT A SUBSEQUENT SURGERY TO REPAIR A RECURRENT RIGHT SIDE INCARCERATED FEMORAL HERNIA. IT WAS DURING THIS SURGERY THAT A BARD/DAVOL PERFIX LIGHT PLUG, WAS IMPLANTED INTO THE PATIENT. SPECIFICALLY A BARD/DAVOL MEDIUM MESH PERFIX LIGHT PLUG, POSITIVELY IDENTIFIED ON SURGICAL AND OPERATIVE REPORTS WAS IMPLANTED INTO THE PATIENT. (DEVICE 2) THE PATIENT'S ATTORNEY FURTHER ALLEGED THAT "TO THIS DAY, BOTH BARD/DAVOL PERFIX PLUG AND PERFIX LIGHT PLUG REMAIN IMPLANTED IN THE PATIENT. THE PATIENT HAS EXPERIENCED AND CONTINUES TO EXPERIENCE STOMACH PAIN AND RECURRING HERNIAS SINCE THE MULTIPLE PROCEDURES AND HERNIA MESH IMPLANTS. PATIENT HAS DIFFICULTY DIGESTING NUTRIENTS HE CONSUMES WITHOUT PAIN AND BLOATING. THESE INJURES WERE NOT PRESENT BEFORE THE IMP

  Patient problems: Abdominal Pain; Disability; Hernia

  MAUDE report 7366592 ↗
• InjuryMar 16, 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) 2012: THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF A BARD/DAVOL VENTRALEX, REFERENCE NUMBER (B)(4), HUVI0025 (DEVICE #1). ON (B)(6) 2012: THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF A BARD/DAVOL "MARLEX" PERFIX LIGHT LARGE, REFERENCE NUMBER (B)(4), LOT NUMBER HUVB2232 (DEVICE #2) AND A BARD/DAVOL PERFIX LIGHT LARGE, REFERENCE NUMBER (B)(4), LOT NUMBER HUVB2232 (DEVICE #3). ON (B)(6) 2012: THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF A BARD/DAVOL VENTRALEX, REFERENCE NUMBER (B)(4), LOT NUMBER HUVJ0711 (DEVICE #4), AND A BARD/DAVOL VENTRALEX, REFERENCE NUMBER (B)(4), LOT NUMBER HUWA1805 (DEVICE #5). ON (B)(6) 2012: THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF A BARD/DAVOL PERFIX MEDIUM, REFERENCE NUMBER (B)(4), LOT NUMBER HUUG1217 (DEVICE #6). AS REPORTED, THE 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: Abdominal Pain; Disability; Pain

  MAUDE report 7345653 ↗