PerFix 0117170Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00801741031007), received between Jul 26, 2017 and Jan 9, 2026 — classified as 20 injuries, 1 malfunction.

The most frequently reported specific device problem is “Defective Device” (19 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• InjuryJan 9, 2026Patient-Device Incompatibility

  PER ADDITIONAL INFORMATION PROVIDED: ON (B)(6) 2017 - PATIENT WAS DIAGNOSED WITH LARGE RECURRENT LEFT INDIRECT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF TWO PERFIX LIGHT PLUGS (DEVICE 1 AND 2). PER OP NOTES, "INCISION WAS MADE IN THE LEFT INGUINAL REGION. TWO PERFIX LIGHT PLUGS (DEVICE 1 AND 2) WERE PLACED TO THE INGUINAL RING USING PROLENE SUTURES." ON (B)(6) 2022 - PATIENT WAS DIAGNOSED WITH INFECTED MESH THEREBY UNDERWENT REPAIR WITH REMOVAL OF MESHES (DEVICE 1 AND 2). PER OP NOTES, "AN ELLIPTICAL INCISION WAS MADE AT THE SITE OF THE EXPOSED MESH. IDENTIFIED A PIECE OF MESH (DEVICE 1) AND WAS REMOVED. FOUND A DIFFERENT PIECE OF MESH (DEVICE 2) THAT EXTENDED TO THE PUBIC TUBERCLE MEDIALLY THAT WAS REMOVED."

  Patient problems: Unspecified Infection

  MAUDE report 24020078 ↗
• InjuryMay 12, 2025Defective Device; Patient-Device Incompatibility; Defective Device; Patient-Device Incompatibility

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF PERFIX LIGHT PLUG ON (B)(6) 2019. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST PERFIX LIGHT 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: Insufficient Information; Pain

  MAUDE report 22003205 ↗
• InjuryMar 6, 2025Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  PER INFORMATION PROVIDED: (B)(6) 2015 PATIENT WAS DIAGNOSED WITH BILATERAL SYMPTOMATIC INGUINAL HERNIAS THEREBY UNDERWENT LAPAROSCOPIC TOTAL EXTRAPERITONEAL REPAIR WITH THE IMPLANT OF 3DMAX MESHES (DEVICE #1 & #2). PER OPERATIVE NOTES, "ON RIGHT SIDE, THERE WAS SCAR TISSUE AND THE POSTERIOR PERITONEUM WAS STUCK IN THE AREA. A DIRECT INGUINAL HERNIA WAS NOTED, A 3DMAX MESH (DEVICE #1) WAS POSITIONED AND TACKED TO THE PUBIC TUBERCLE AND ROLLED OUT OVER THE INGUINAL HERNIA AND TUCKED INTO THE SULCUS. ON LEFT SIDE, AN INDIRECT HERNIA WAS PULLED DOWN AND SWEPT OFF THE CORD AND REDUCED. ANOTHER 3DMAX MESH (DEVICE #2) WAS TACKED DOWN LATERALLY AND INFERIORLY INTO SULCUS COVERING THE DEFECT." (B)(6) 2015 - PATIENT VISITED HOSPITAL FOR PAIN AND WAS DIAGNOSED WITH LEFT INGUINAL HERNIA. (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH RECURRENT LEFT INDIRECT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF PERFIX LIGHT PLUG (DEVICE #3). PER OPERATIVE NOTES, "THE HERNIA SAC WAS IDENTIFIED, THICKENED AND SCARRED. THE PREVIOUSLY PLACED MESH (DEVICE #2) WAS IDENTIFIED MEDIALLY AND INFERIORLY. A PERFIX LIGHT PLUG (DEVICE #3) WAS PLACED IN PREPERITONEAL SPACE AND SUTURED. THE ONLAY MESH WA

  Patient problems: Abdominal Pain; Hematoma; Hernia; Obstruction/Occlusion

  MAUDE report 21535736 ↗
• InjurySep 12, 2021Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT THE PATIENT WAS IMPLANTED WITH TWO BARD/DAVOL PERFIX PLUG IN COURSE OF AN INGUINAL HERNIA REPAIR SURGERY ON (B)(6) 2008. IT IS ALLEGED THAT FURTHER TO THE IMPLANTATION WITH THE PRODUCT, THE PATIENT SUFFERED THE DEVELOPMENT OF MESH FAILURE, HERNIA RECURRENCE, INFECTION AND CHRONIC PAIN. ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT A CORRECTIVE REVISION SURGERY ON (B)(6) 2010 AND ALSO ON (B)(6) 2011. ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT A CORRECTIVE REVISION SURGERY WITH BARD/DAVOL PERFIX PLUG LIGHT ON (B)(6) 2015. ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT A CORRECTIVE REVISION SURGERY ON (B)(6) 2016. ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT A CORRECTIVE REVISION SURGERY WITH BARD/DAVOL VENTRALEX ST ON (B)(6) 2017. ATTORNEY ALLEGES THAT THE PATIENT HAS 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. ATTORNEY ALLEGES THAT THE PATIENT SUFFERED PERMANENT INJURIES INCLUDING SCARRING, DISFIGUREMENT, HERNIA RECURRENCE, INFECTION AND CHRONIC PAIN. ATTORNEY ALLEGES THAT THE PATIENT HAD PAIN, SUFFERING AND DISABILITY. ATTORNE

  Patient problems: Hernia; Pain; Unspecified Infection

  MAUDE report 12457901 ↗
• InjuryMay 20, 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 UNSPECIFIED BARD/DAVOL 3DMAX MESH, BARD MESH (BARD FLAT MESH), MARLEX (BARD FLAT MESH) AND PERFIX LIGHT PLUG ON (B)(6) 2016 AND/OR (B)(6) 2019. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST ALL DEVICES. 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: Hernia; Insufficient Information

  MAUDE report 11853654 ↗
• InjuryOct 18, 2020Defective Device; Insufficient Device Problem Information; Defective Device; Insufficient Device Problem Information

  ATTORNEY ALLEGES THAT ON OR ABOUT (B)(6) 2014, THE PATIENT UNDERWENT SURGERY FOR REPAIR OF A RIGHT INGUINAL HERNIA AND A BARD/DAVOL PERFIX LIGHT PLUG, LARGE WAS IMPLANTED TO REPAIR THE HERNIA DEFECT. ON OR ABOUT (B)(6) 2017, THE PATIENT UNDERWENT AN ADDITIONAL SURGERY TO REPAIR A LEFT INGUINAL HERNIA. A BARD/DAVOL PERFIX PLUG, LARGE WAS IMPLANTED TO REPAIR THE HERNIA DEFECT. ON OR ABOUT (B)(6) 2019, THE PATIENT UNDERWENT AN EXPLANTATION OF THE LEFT GROIN PLUG AND PATCH-PLUG AND PATCH REPAIR OF RECURRENT LEFT INGUINAL HERNIA. IT IS ALLEGED THAT THE PATIENT WAS INJURED SEVERELY AND PERMANENTLY. THE PATIENT SUFFERED PAIN, DISABILITY, HOSPITALIZATIONS AND ADDITIONAL SURGERIES. IT IS ALSO ALLEGED THAT THE PATIENT HAS SUFFERED AND WILL CONTINUE TO SUFFER PHYSICAL PAIN, CHRONIC PAIN, MENTAL ANGUISH, PSYCHOLOGICAL STRESS, DEPRESSION, HAS UNDERGONE AND WILL LIKELY REQUIRE MEDICAL TREATMENTS AND OTHER FORMS OF CARE. ATTORNEY ALSO ALLEGES THAT THE DEVICE WAS DEFECTIVE.

  Patient problems: Disability; Injury; Pain

  MAUDE report 10694759 ↗
• InjurySep 28, 2020Defective Device; Insufficient Device Problem Information; Defective Device; Insufficient Device Problem Information

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR REPAIR OF A RIGHT INGUINAL HERNIA ON OR ABOUT (B)(6) 2017. TWO BARD/DAVOL PERFIX LIGHT PLUGS WERE IMPLANTED TO REPAIR THE HERNIA DEFECT. IT IS ALLEGED THAT THE PATIENT UNDERWENT AN ADDITIONAL SURGERY ON OR ABOUT (B)(6) 2019 TO REPAIR AND/OR REMOVE THE DEFECTED MESH. THE PATIENT WAS INJURED SEVERELY AND PERMANENTLY. THE PATIENT HAS SUFFERED AND WILL CONTINUE TO SUFFER PHYSICAL PAIN AND MENTAL ANGUISH. IT IS ALLEGED THAT THE PATIENT SUFFERED PAIN, DISABILITY, HOSPITALIZATIONS AND ADDITIONAL SURGERIES. IT IS ALSO ALLEGED THAT THE PATIENT HAS SUFFERED AND CONTINUES TO SUFFER FROM CHRONIC PAIN, PSYCHOLOGICAL STRESS, DEPRESSION AND HAS UNDERGONE AND WILL LIKELY REQUIRE IN THE FURTHER OTHER FORMS OF CARE AND MEDICAL TREATMENTS. IT IS FURTHER ALLEGED THAT THE DEVICE WAS DEFECTIVE.

  Patient problems: Disability; Injury; Pain

  MAUDE report 10597372 ↗
• InjuryNov 22, 2019Defective Device; Insufficient Device Problem Information; Defective Device; Insufficient Device Problem Information

  IT IS ALLEGED BY PATIENT'S ATTORNEY THAT ON OR ABOUT (B)(6) 2008, PATIENT UNDERWENT SURGERY FOR A REPAIR OF A LEFT INGUINAL HERNIA. AS ALLEGED A BARD/DAVOL PERFIX PLUG (DEVICE #1), WAS IMPLANTED TO REPAIR THE HERNIA DEFECT. IT IS ALLEGED BY THE PATIENT'S ATTORNEY THAT ON OR ABOUT (B)(6) 2010, PATIENT UNDERWENT SURGERY FOR A REPAIR OF A RIGHT INGUINAL HERNIA. AS ALLEGED, A BARD/DAVOL PERFIX LIGHT PLUG (DEVICE #2), WAS IMPLANTED TO REPAIR THE HERNIA DEFECT. IT IS ALSO ALLEGED BY THE PATIENT'S ATTORNEY THAT ON OR ABOUT (B)(6) 2011, PATIENT UNDERWENT SURGERY FOR A REPAIR OF AN UMBILICAL HERNIA. AS ALLEGED, A BARD/DAVOL PERFIX LIGHT PLUG (DEVICE #3), (NOTE: LOT NUMBER NOT VALID FOR REFERENCE NUMBER) WAS IMPLANTED TO REPAIR THE HERNIA DEFECT. IT IS ALLEGED BY THE PATIENT'S ATTORNEY THAT ON OR ABOUT (B)(6) 2018, PATIENT UNDERWENT AN ADDITIONAL SURGERY TO REMOVE THE PERFIX LIGHT PLUG (DEVICE #3) THAT WAS PREVIOUSLY IMPLANTED ON (B)(6) 2011 AND AGAIN REPAIR THE VENTRAL HERNIA DEFECT. AS ALLEGED, PATIENT HAS SUFFERED AND CONTINUES TO SUFFER FROM CHRONIC PAIN, AS WELL AS PSYCHOLOGICAL STRESS AND DEPRESSION. AS REPORTED, PATIENT HAS UNDERGONE AND WILL LIKELY REQUIRE IN THE FURTHER OTHER FORMS

  Patient problems: Disability; Hernia; Injury

  MAUDE report 9363748 ↗
• InjuryNov 18, 2019Defective Device; Insufficient Device Problem Information; Defective Device; Insufficient Device Problem Information

  THE FOLLOWING WAS ALLEGED BY THE PATIENT'S ATTORNEY: ON (B)(6) 2012: THE PATIENT UNDERWENT SURGERY FOR REPAIR OF A RIGHT INGUINAL HERNIA, A PERFIX PLUG WAS IMPLANTED TO REPAIR THE HERNIA DEFECT. ON (B)(6) 2018: THE PATIENT UNDERWENT AN ADDITIONAL SURGERY TO REMOVE THE PERFIX PLUG AND AGAIN REPAIR THE RIGHT INGUINAL HERNIA. ON (B)(6) 2018: THE PATIENT UNDERWENT A RIGHT SCROTAL ORCHIECTOMY, AS A RESULT, THE PATIENT WAS INJURED SEVERELY AND PERMANENTLY. PATIENT HAS SUFFERED AND WILL CONTINUE TO SUFFER PHYSICAL PAIN AND MENTAL ANGUISH. PATIENT HAS SUFFERED AND CONTINUES TO SUFFER FROM CHRONIC PAIN, AS WELL AS PSYCHOLOGICAL STRESS AND DEPRESSION. PATIENT HAS UNDERGONE AND WILL LIKELY REQUIRE IN THE FURTHER OTHER FORMS OF CARE AND MEDICAL TREATMENTS.

  Patient problems: Disability; Injury; Pain

  MAUDE report 9338772 ↗
• InjurySep 5, 2019Defective Device; Insufficient Device Problem Information; Defective Device; Insufficient Device Problem Information

  THE FOLLOWING WAS ALLEGED BY THE PATIENT'S ATTORNEY: ON (B)(6) 2012: THE PATIENT UNDERWENT SURGERY FOR REPAIR OF A RIGHT INGUINAL HERNIA. A PERFIX LIGHT PLUG WAS IMPLANTED TO REPAIR THE HERNIA DEFECT. ATTORNEY ALLEGES THE PERFIX LIGHT PLUG WAS DEFECTIVE AT THE TIME OF IMPLANT. ON (B)(6) 2017: THE PATIENT UNDERWENT AN ADDITIONAL SURGERY TO REPAIR AND/OR REMOVE THE DEFECTED MESH. ON (B)(6) 2018: THE PATIENT WAS FIRST INFORMED THAT THE PRESENCE OF THE PERFIX LIGHT PLUG IN HIS BODY COULD BE THE CAUSE OF HIS INJURIES. THE PATIENT WAS INJURED SEVERELY AND PERMANENTLY. ATTORNEY ALLEGES THE PATIENT HAS SUFFERED AND WILL CONTINUE TO SUFFER PHYSICAL PAIN AND MENTAL ANGUISH. ATTORNEY ALLEGES THE PATIENT HAS SUFFERED AND CONTINUES TO SUFFER FROM CHRONIC PAIN AS WELL AS PSYCHOLOGICAL STRESS DEPRESSION.

  Patient problems: Disability; Injury; Pain

  MAUDE report 8967121 ↗
• InjuryAug 5, 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 BARD MESH (DEVICE #1) OR AN UNSPECIFIED PERFIX LIGHT PLUG (DEVICE #2) OR AN UNSPECIFIED BARD/DAVOL PERFIX PLUG ON (B)(6) 2013 OR (B)(6) 2014. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE BARD/DAVOL BARD MESH (DEVICE #1) AND THE BARD/DAVOL PERFIX LIGHT PLUG (DEVICE #2). IT IS ALLEGED THAT THE PATIENT HAD SUBSEQUENT SURGICAL INTERVENTION DUE TO THE HERNIA MESH DEVICE. AS REPORTED, THE ATTORNEY ALLEGES PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Hernia; Injury

  MAUDE report 8861743 ↗
• InjuryJan 11, 2019Defective 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) 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

  MAUDE report 8241969 ↗
• 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. ON (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. ON (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 8218959 ↗
• InjuryNov 27, 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: ON (B)(6) 2011: THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL BARD FLAT MESH (DEVICE #1) AND AN UNSPECIFIED BARD/DAVOL PERFIX LIGHT PLUG (DEVICE #2). NI/NI/NI: THE PATIENT HAD UNSPECIFIED INJURIES. THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE BARD FLAT MESH (DEVICE #1) AND PERFIX LIGHT PLUG (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; Hernia; Injury; Pain

  MAUDE report 8108265 ↗
• InjuryOct 15, 2018Defective Device; Insufficient Device Problem Information; Defective Device; Insufficient Device Problem Information

  THE FOLLOWING WAS ALLEGED BY THE PATIENT'S ATTORNEY: (B)(6) 2012: THE PATIENT UNDERWENT SURGERY FOR REPAIR OF A RIGHT INGUINAL HERNIA. THE BARD/DAVOL PERFIX LIGHT PLUG (DEVICE #1) WAS IMPLANTED TO REPAIR THE HERNIA DEFECT. NI/NINI: THE PATIENT HAS HAD TO UNDERGO VARIOUS REVISION SURGERIES AND MEDICAL PROCEDURES INCLUDING, BUT NOT LIMITED TO VARIOUS SURGICAL PROCEDURES IN AN ATTEMPT TO REMOVE THE ERODED MESH. (B)(6) 2013: THE PATIENT UNDERWENT AN ADDITIONAL SURGERY TO REPAIR A RIGHT FEMORAL HERNIA AND UMBILICAL HERNIA. THE BARD/DAVOL PERFIX LIGHT PLUG (DEVICE #2) WAS IMPLANTED TO REPAIR THE HERNIA DEFECT. PATIENT WAS INJURED SEVERELY AND PERMANENTLY. PATIENT HAS SUFFERED AND CONTINUES TO SUFFER FROM CHRONIC DEBILITATING PAIN, AS WELL AS SIGNIFICANT PSYCHOLOGICAL STRESS AND DEPRESSION. THE PATIENT HAS UNDERGONE AND WILL LIKELY REQUIRE IN THE FURTHER OTHER FORMS OF CARE AND MEDICAL TREATMENTS.

  Patient problems: Disability; Injury; Pain

  MAUDE report 7967096 ↗
• InjuryOct 15, 2018Material Erosion; Defective Device; Material Erosion; Defective Device

  THE FOLLOWING WAS ALLEGED BY THE PATIENT'S ATTORNEY: ON (B)(6) 2012: THE PATIENT UNDERWENT SURGERY FOR REPAIR OF A RIGHT INGUINAL HERNIA. THE BARD/DAVOL PERFIX LIGHT PLUG (DEVICE #1) WAS IMPLANTED TO REPAIR THE HERNIA DEFECT. NI/NI/NI: THE PATIENT HAS HAD TO UNDERGO VARIOUS REVISION SURGERIES AND MEDICAL PROCEDURES INCLUDING, BUT NOT LIMITED TO VARIOUS SURGICAL PROCEDURES IN AN ATTEMPT TO REMOVE THE ERODED MESH. ON (B)(6) 2013: THE PATIENT UNDERWENT AN ADDITIONAL SURGERY TO REPAIR A RIGHT FEMORAL HERNIA AND UMBILICAL HERNIA. THE BARD/DAVOL PERFIX LIGHT PLUG (DEVICE #2) WAS IMPLANTED TO REPAIR THE HERNIA DEFECT. PATIENT WAS INJURED SEVERELY AND PERMANENTLY. PATIENT HAS SUFFERED AND CONTINUES TO SUFFER FROM CHRONIC DEBILITATING PAIN, AS WELL AS SIGNIFICANT PSYCHOLOGICAL STRESS AND DEPRESSION. THE PATIENT HAS UNDERGONE AND WILL LIKELY REQUIRE IN THE FURTHER OTHER FORMS OF CARE AND MEDICAL TREATMENTS.

  Patient problems: Disability; Injury; Pain

  MAUDE report 7967088 ↗
• InjuryMar 16, 2018Defective 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

  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 0010302, HUVI0025 (DEVICE #1). ON (B)(6) 2012: THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF A BARD/DAVOL "MARLEX" PERFIX LIGHT LARGE, REFERENCE NUMBER 0117170, LOT NUMBER HUVB2232 (DEVICE #2) AND A BARD/DAVOL PERFIX LIGHT LARGE, REFERENCE NUMBER 0117170, LOT NUMBER HUVB2232 (DEVICE #3). ON (B)(6) 2012: THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF A BARD/DAVOL VENTRALEX, REFERENCE NUMBER 0010302, LOT NUMBER HUVJ0711 (DEVICE #4), AND A BARD/DAVOL VENTRALEX, REFERENCE NUMBER 0010302, LOT NUMBER HUWA1805 (DEVICE #5). ON (B)(6) 2012: THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF A BARD/DAVOL PERFIX MEDIUM, REFERENCE NUMBER 0117160, 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: Disability; No Clinical Signs, Symptoms or Conditions; Pain

  MAUDE report 7345651 ↗
• InjuryMar 16, 2018Defective 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

  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 0010302, HUVI0025 (DEVICE #1). ON (B)(6) 2012: THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF A BARD/DAVOL "MARLEX" PERFIX LIGHT LARGE, REFERENCE NUMBER 0117170, LOT NUMBER HUVB2232 (DEVICE #2) AND A BARD/DAVOL PERFIX LIGHT LARGE, REFERENCE NUMBER 0117170, LOT NUMBER HUVB2232 (DEVICE #3). ON (B)(6) 2012: THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF A BARD/DAVOL VENTRALEX, REFERENCE NUMBER 0010302, LOT NUMBER HUVJ0711 (DEVICE #4), AND A BARD/DAVOL VENTRALEX, REFERENCE NUMBER 0010302, LOT NUMBER HUWA1805 (DEVICE #5). ON (B)(6) 2012: THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF A BARD/DAVOL PERFIX MEDIUM, REFERENCE NUMBER 0117160, 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: Disability; No Clinical Signs, Symptoms or Conditions; Pain

  MAUDE report 7345647 ↗
• InjuryMar 9, 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) 2010, (B)(6) 2013 AND (B)(6) 2015: THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF BARD/DAVOL PERFIX PLUG (DEVICE #1) OR PERFIX LIGHT PLUG (DEVICE #2). 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: Disability; Hernia; Pain

  MAUDE report 7328818 ↗
• InjuryMar 9, 2018Device Appears to Trigger Rejection; Defective Device; Material Deformation; Insufficient Device Problem Information; Patient Device Interaction Problem; Device Appears to Trigger Rejection; Defective Device; Material Deformation; Insufficient Device Problem Information; Patient Device Interaction Problem

  THE FOLLOWING WAS ALLEGED BY THE PATIENT'S ATTORNEY: (B)(6) 2010, (B)(6) 2013 AND (B)(6) 2015: THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF BARD/DAVOL PERFIX PLUG (DEVICE #1) OR PERFIX LIGHT PLUG (DEVICE #2). 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: Disability; Fibrosis; Hernia; Inflammation; Pain

  MAUDE report 7328746 ↗
• MalfunctionJul 26, 2017Material Frayed; Material Deformation; Material Frayed; Material Deformation

  CONTACT ALLEGED THAT THE SURGEON WAS TRIMMING THE ONLAY PORTION OF THE PLUG AND PATCH AND THE MATERIAL FRAYED. SURGEON USED ANOTHER OF THE SAME TO COMPLETE THE CASE WITHOUT ISSUE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6745717 ↗