PerFix 0117070Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 00801741030963), received between Dec 1, 2018 and Jul 1, 2026 — classified as 16 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Defective Device” (11 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 25 most recent of 25 reports, in the reporter's own words as published by the FDA.

• InjuryJul 1, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2010 - PATIENT WAS DIAGNOSED WITH REDUCIBLE LEFT INGUINAL HERNIA, UMBILICAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF PERFIX PLUG (DEVICE 1). PER OP NOTES, "THE LEFT GROIN WAS ADDRESSED. A SMALL HERNIA WAS FREED ALL THE WAY DOWN TO INTERNAL RING. THE INGUINAL RING WAS SLIGHTLY PATULOUS AND A LARGE PERFIX PLUG (DEVICE 1) WAS PLACED INTO THE INTERNAL RING. AN ONLAY PATCH WAS PLACED AROUND THE SPERMATIC CORD STRUCTURES USING SUTURES. THE UMBILICAL HERNIA WAS NOTED. THE DEFECT WAS CLOSED USING SUTURES." (B)(6) 2012 - PATIENT WAS DIAGNOSED WITH LEFT RECURRENT INGUINAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC CONVERTED TO OPEN REPAIR WITH THE IMPLANT OF PERFIX LIGHT PLUGS (DEVICE 2 AND DEVICE 3). PER OP NOTES, "THE MESH PLUG (DEVICE 1) WAS COMPLETELY STUCK WITH DOWN TO THE SURROUNDING TISSUES WITH SEVERE TISSUE REACTION. THE MESH REACTION WAS NOTED. AN DIRECT HERNIA WAS IDENTIFIED. THE FLOOR WAS THICKENED FROM REACTION, SO A LARGE PERFIX LIGHT PLUG (DEVICE 2) WAS PLACED INTO THE AREA. THE INTERNAL RING WAS SURROUNDED BY OLD MESH (DEVICE 1). A SMALL PORTION OF THE PERFIX LIGHT PLUG (DEVICE 3) WAS PLACED AND SECURED TO ASSURE THE RECURRENCE OF I

  Patient problems: Hernia; Scar Tissue

  MAUDE report 25679134 ↗
• InjuryJun 2, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2013 - PATIENT WAS DIAGNOSED WITH RIGHT DIRECT AND INDIRECT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF PERFIX LIGHT PLUG (DEVICE 1 AND 2). PER OP NOTES, "AN INCISION WAS MADE IN THE AREA OVER THE RIGHT INGUINAL LIGAMENT. THE HERNIA SAC WAS IDENTIFIED AND THE SAC WAS DISSECTED FREE OF THE CORD AND REDUCED BACK INTO THE ABDOMINAL CAVITY. A DIRECT INGUINAL HERNIA WAS IDENTIFIED. A LARGE AND MEDIUM PERFIX LIGHT PLUG (DEVICE 1 AND 2) WERE PLACED INTO THE INTERNAL INGUINAL RING AND SECURED IN PLACE WITH SUTURES." (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH RIGHT INGUINAL HERNIA THEREBY UNDERWENT ROBOTIC ASSISTED LAPAROSCOPIC REPAIR WITH IMPLANT OF SYNTHETIC MESH. PER OP NOTES, "AN INCISION WAS MADE BELOW THE UMBILICUS. A LARGE DEFECT WAS NOTED IN THE RIGHT INGUINAL REGION. OMENTUM WAS NOTED TO BE HERNIATED THROUGH THE DEFECT AND IT WAS DISSECTED FREE FROM THE HERNIA SAC WHICH WAS CHRONICALLY SCARRED IN. THE HERNIA SAC WAS REDUCED AND COMPLETELY FREED UP. A SYNTHETIC MESH WAS PLACED AND SECURED WITH SUTURE."

  Patient problems: Hernia; Scar Tissue

  MAUDE report 25363524 ↗
• MalfunctionJan 29, 2026Device Contamination with Chemical or Other Material

  AS REPORTED, ON (B)(6) 2026 WHILE PREPARING FOR AN INGUINAL HERNIA REPAIR PROCEDURE, A HAIR WAS FOUND INSIDE THE PERFIX PLUG LIGHT MESH BOX. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24209487 ↗
• MalfunctionNov 14, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  AS REPORTED, A HAIR WAS FOUND IN THE PERFIX LIGHT PLUG PACKAGE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23556411 ↗
• MalfunctionOct 16, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, DURING AN INGUINAL HERNIA REPAIR ON (B)(6) 2025, USING A PERFIX LIGHT PLUG WHILE "SECURING THE MESH WITH THREADS, THE JOINT (OVERLAPPED PART) OF THE PLUG MESH CAME LOOSE." IT WAS REPORTED THAT THE MESH WAS NOT TRIMMED OR RESHAPED BEFORE USE. ANOTHER MESH WAS USED, AND THE SURGERY WAS COMPLETED WITHOUT ANY PROBLEMS. THERE WAS NO PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23315674 ↗
• MalfunctionJun 14, 2024Material Separation; Material Separation

  AS REPORTED, DURING AN ABDOMINAL WALL SCAR HERNIA REPAIR PROCEDURE USING MESH AND PLUG TECHNIQUE, WHEN THE PERFIX LIGHT PLUG IS PLACED IN A HERNIA DEFECT, NOTED THE PART OF THE MEDIAL PETAL OF THE PLUG TO BE DETACHED. IT WAS REPORTED THAT THE DETACHED PETAL WAS REMOVED, AND THE PROCEDURE WAS COMPLETED USING THE SAME PLUG. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19536879 ↗
• InjuryApr 30, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  ATTORNEY ALLEGES MULTIPLE PATIENTS HE REPRESENTS HAVE EXPERIENCE UNSPECIFIED INJURY AND ALLEGE THEY MAY HAVE REQUIRED ADDITIONAL MEDICAL/SURGICAL TREATMENT. ATTORNEY ALLEGES THIS PATIENT WAS TREATED WITH A PERFIX LIGHT PLUG. CASE-SPECIFIC DETAILS NOT PROVIDED.

  Patient problems: Abdominal Pain; Insufficient Information

  MAUDE report 19211440 ↗
• MalfunctionMar 28, 2024Material Separation; Material Separation

  AS REPORTED, DURING AN OPEN INGUINAL HERNIA REPAIR PROCEDURE, THE PERFIX LIGHT PLUG TORE WHEN SUTURING. THE MESH WAS IMMEDIATELY REMOVED AND ANOTHER PLUG WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18994564 ↗
• MalfunctionJan 11, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  AS REPORTED, AFTER INSERTING THE MESH (PERFIX LIGHT PLUG) DURING SURGERY, THE MESH (PETAL) TORE OFF WHEN PULLED GENTLY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18491365 ↗
• InjuryApr 22, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED, DURING AN LEFT INGUINAL HERNIA REPAIR PROCEDURE ON (B)(6) 2015, THE PATIENT WAS IMPLANTED WITH A BARD/DAVOL PERFIX LIGHT PLUG. IT WAS REPORTED THAT POST-IMPLANT, THE PATIENT EXPERIENCED PAIN, "FEELING OF MESH OUT OF PLACE" AND ABDOMINAL DISCOMFORT. IT WAS ALSO REPORTED THAT THE PATIENT HAS BEEN DEALING WITH GASTROESOPHAGEAL REFLUX DISEASE (GERD) FOR MANY YEARS. AS REPORTED, A CT SCAN, ULTRASOUND, AND MRI WAS PERFORMED AND THERE WERE NO FINDINGS. THE PATIENT HAS BEEN TAKING PAIN MEDICATION.

  Patient problems: Discomfort; Pain

  MAUDE report 14188193 ↗
• MalfunctionDec 31, 2021Material Frayed; Material Frayed

  AS REPORTED, AFTER OPENING THE PACKAGE OF A BARD/DAVOL PERFIX LIGHT PLUG ON (B)(6) 2021, THE MESH WAS NOTED TO BE FRAYED. THE MESH WAS NOT USED ON THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13124782 ↗
• InjuryJul 13, 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 PERFIX PLUG LIGHT (X2) AND SOFT MESH (X3) ON (B)(6) 2017 (X2) AND/OR (B)(6) 2017 (X2) AND/OR (B)(6) 2018. AS REPORTED THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST PERFIX PLUG LIGHT (X2) AND SOFT MESH (X2). 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); Insufficient Information; Nerve Damage; Pain

  MAUDE report 12156998 ↗
• InjuryJul 13, 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 PERFIX PLUG LIGHT (X2) AND SOFT MESH (X3) ON (B)(6) 2017 (X2) AND/OR (B)(6) 2017 (X2) AND/OR (B)(6) 2018. AS REPORTED THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST PERFIX PLUG LIGHT (X2) AND SOFT MESH (X2). 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); Insufficient Information; Nerve Damage; Pain

  MAUDE report 12156993 ↗
• InjuryJan 13, 2021Defective Device; Material Deformation; Insufficient Device Problem Information; Patient Device Interaction Problem; Defective Device; Material Deformation; Insufficient Device Problem Information; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF UNSPECIFIED BARD/DAVOL PERFIX LIGHT PLUG (X2) ON (B)(6) 2016 (X2). AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST BOTH 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: Adhesion(s); Erosion; Injury; Nerve Damage; Pain; Scar Tissue

  MAUDE report 11163091 ↗
• InjuryJan 11, 2021Material Deformation; Material Deformation

  THE FOLLOWING WAS REPORTED VIA TGA REPORT ((B)(6) FDA): AS REPORTED THE COMPLAINT CITES THE USE OF TWO PERFIX LIGHT PLUGS. THE TGA REPORT STATES, "I WENT TO SEE A SURGEON REGARDING RIGHT HAND SIDE PAIN, I DID A DYE CT TEST AND A SMALL INGUINAL SAC WAS FOUND ON THE LEFT. I WENT IN TO HAVE THE HERNIA REPAIR DONE, I HAD 2 PLUGS PUT IN AND A LARGE MESH ON A GENITAL FEMORAL HERNIA THAT WAS NOT DETECTED ON DYE CT SCAN. PATIENT OUTCOME/CONSEQUENCES: CUTANEOUS FEMORAL NERVE, MESHOMA, INTERNAL BLEEDING [REDACTED] WAS SURPRISED I LASTED AS LONG AS I DID. AFTER REMOVING THE MESH TO THE GENITAL FEMORAL AREA THERE WAS NO HERNIA FOUND. I HAVE ONGOING CHRONIC PAIN WHICH SEEN A NEUROSTIMULATOR WAS PLACED IN MY BACK. I HAVE LOST MY DYSFUNCTIONAL IN MY SEX LIFE. RECENTLY I HAVE STARTED COMING DOWN TO WITH CRPS, I AM DUE TO HAVE A KETAMINE INFUSION TO LESSEN THE PAIN. THE MESH THAT WAS PUT IN PLACE DID NOT NEED TO BE THERE, ALSO THIS MESH HAS CAUSED ME CHRONIC PAIN AND NOW I AM SUFFERING CRPS."

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Inflammation; Pain

  MAUDE report 11148168 ↗
• MalfunctionNov 20, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, DURING AN UNSPECIFIED PROCEDURE ON (B)(6) 2020, THE PHYSICIAN TRIED TO IMPLANT THE PERFIX LIGHT PLUG, LARGE INTO THE PATIENT'S BODY. THE PHYSICIAN NOTED THAT THE INNER PETAL WAS DETACHED WHILE INSERTING INTO THE PATIENT AND THE MESH WAS NOT IMPLANTED. THE SURGEON IS AN EXISTING USER OF THE DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10874733 ↗
• InjuryJun 9, 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 PERFIX LIGHT PLUG ON (B)(6) 2015. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE PERFIX LIGHT PLUG. ATTORNEY ALLEGES THAT THE PATIENT SUSTAINED PERSONAL INJURY DUE TO THE HERNIA MESH DEVICE. IT IS ALLEGED THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Injury; Neuralgia

  MAUDE report 10132408 ↗
• InjuryApr 9, 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 PERFIX LIGHT PLUG ON (B)(6) 2017. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE PERFIX LIGHT PLUG. ATTORNEY ALLEGES THAT THE PATIENT SUSTAINED UNSPECIFIED INJURY DUE TO THE HERNIA MESH DEVICE. IT IS ALSO ALLEGED THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Injury; Obstruction/Occlusion; Pain

  MAUDE report 9944704 ↗
• InjuryOct 10, 2019Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information; Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information

  ATTORNEY ALLEGES THAT ON (B)(6) 2013, THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL PERFIX PLUG (DEVICE #1). IT IS ALLEGED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL 3DMAX LIGHT. AS REPORTED, THE PATIENT IS ONLY MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE PERFIX PLUG (DEVICE #1). 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; Injury; Pain

  MAUDE report 9176549 ↗
• InjuryJun 26, 2019Defective Device; Insufficient Device Problem Information; Patient Device Interaction Problem; Defective Device; Insufficient Device Problem Information; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT ON (B)(6) 2014 AND (B)(6) 2015, THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL PERFIX LIGHT PLUG (DEVICE #1 AND DEVICE #2). IT IS ALLEGED THAT THE PATIENT HAD SUBSEQUENT SURGICAL INTERVENTION DUE TO THE HERNIA MESH DEVICE. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE TWO PERFIX LIGHT PLUG (DEVICE #1 AND DEVICE #2). AS REPORTED, THE ATTORNEY ALLEGES PRODUCT IS DEFECTIVE AND THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS.

  Patient problems: Injury; Pain

  MAUDE report 8737331 ↗
• MalfunctionJun 4, 2019Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  THE FOLLOWING WAS REPORTED TO DAVOL BY THE (B)(6) CENTER: IT WAS REPORTED THAT ON (B)(6) 2019 A FOREIGN MATERIAL WAS FOUND AFTER OPENING THE PERFIX LIGHT PLUG PACKAGE. AS REPORTED THE PROBLEM WAS NOTED OUT OF THE PACKAGE AND THE DEVICE WAS NOT USED TO TREAT THE PATIENT. THERE WAS NO PATIENT INJURY REPORTED. AS REPORTED THE SAMPLE IS NOT AVAILABLE FOR RETURN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8666929 ↗
• InjuryDec 17, 2018Defective Device; Material Deformation; Insufficient Device Problem Information; Patient Device Interaction Problem; Defective Device; Material Deformation; 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 AN UNSPECIFIED BARD/DAVOL PERFIX PLUG LIGHT. IT IS ALLEGED THAT THE PATIENT HAD SUBSEQUENT SURGICAL INTERVENTION DUE TO THE HERNIA MESH DEVICE. 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.¿ ADDENDUM PER ADDITIONAL INFORMATION PROVIDED: (B)(6) 2013 - PATIENT WAS DIAGNOSED WITH MULTIPLE VENTRAL INCISIONAL HERNIA THEREBY UNDERWENT REPAIR WITH IMPLANT OF PERFIX LIGHT PLUG. (B)(6) 2014 - PATIENT WAS DIAGNOSED WITH SMALL VENTRAL INCISIONAL HERNIA THERE BY UNDERWENT EXPLORATION ABDOMINAL WITH EXPLANATION OF PERFIX LIGHT PLUG. (B)(6) 2017 - PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL INCISIONAL HERNIA THERE BY UNDERWENT FOR REPAIR. ATTORNEY ALLEGES THAT THE PATIENT HAD ADHESIONS, BOWEL OBSTRUCTION, BOWEL PERFORATION, MESH SHRINKAGE, HERNIA RECURRENCE, FIBROTIC, INFLAMMED TISSUE SURROUNDING THE MESH, PAIN AND SUFFERING. THE STRESS, SEVERE PAIN AND DISCOMFORT RESULTING FROM THE MESH PREVENTED PLAIN

  Patient problems: Adhesion(s); Bowel Perforation; Disability; Fibrosis; Hernia; Injury; Nerve Damage; Obstruction/Occlusion; Pain

  MAUDE report 8169665 ↗
• InjuryDec 3, 2018Defective 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 BILATERAL INGUINAL HERNIA REPAIR. A BARD/DAVOL PERFIX LIGHT PLUG (DEVICE #1 AND DEVICE #2) WAS IMPLANTED IN THE PATIENT DURING THIS REPAIR. ON (B)(6) 2015: THE PATIENT UNDERWENT REMOVAL OF THE FAILED PERFIX LIGHT PLUG (DEVICE #1 AND DEVICE #2) AND PATIENT'S TESTICLE. THE PATIENT CONTINUES TO SUFFER COMPLICATIONS RELATED TO THE MESH. 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 8125894 ↗
• InjuryDec 3, 2018Defective 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 BILATERAL INGUINAL HERNIA REPAIR. A BARD/DAVOL PERFIX LIGHT PLUG (DEVICE #1 AND DEVICE #2) WAS IMPLANTED IN THE PATIENT DURING THIS REPAIR. ON (B)(6) 2015: THE PATIENT UNDERWENT REMOVAL OF THE FAILED PERFIX LIGHT PLUG (DEVICE #1 AND DEVICE #2) AND PATIENT'S TESTICLE. THE PATIENT CONTINUES TO SUFFER COMPLICATIONS RELATED TO THE MESH. 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 8125890 ↗
• InjuryDec 1, 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)2015: THE PATIENT UNDERWENT RIGHT INGUINAL HERNIA REPAIR. A BARD/DAVOL PERFIX LIGHT PLUG WAS IMPLANTED IN THE PATIENT DURING THIS REPAIR. (B)(6)2017: THE PATIENT UNDERWENT REMOVAL OF THE FAILED PERFIX LIGHT PLUG. THE PATIENT CONTINUES TO SUFFER COMPLICATIONS RELATED TO THE MESH. 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 PERFIX LIGHT PLUG WAS INITIALLY IMPLANTED TO TREAT. THE PATIENT HAS BEEN INJURED, SUSTAINED SEVERE AND PERMANENT PAIN, SUFFERING, ANXIETY, DEPRESSION, DISABILITY, AND IMPAIRMENT. ADDENDUM PER ADDITIONAL INFORMATION PROVIDED: (B)(6)2015 - PATIENT WAS DIAGNOSED WITH INDIRECT RIGHT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF PERFIX LIGHT PLUG (DEVICE #1). PER OPERATIVE NOTES, "THE HERNIA SAC WAS DISSECTED FROM CORD STRUCTURES. THE CORD STRUCTURES WERE SCARRED. THE HERNIA SAC WAS OPENED AND FOUND TO BE EMPTY, THE CORD LIPOMA WAS EXCISED. A PERFIX LIGHT PLUG (DEVICE #1) WAS CUT AND PLACED IN USUAL FA

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

  MAUDE report 8122539 ↗