PerFix 0117050Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00801741030949), received between Apr 17, 2018 and Sep 30, 2026 — classified as 6 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Defective Device” (3 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.

• InjurySep 30, 2026Patient-Device Incompatibility

  Patient problems: Adhesion(s); Hernia

  MAUDE report 50949388 ↗
• MalfunctionMar 2, 2026Use of Device Problem

  AS REPORTED, AN INGUINAL HERNIA REPAIR PROCEDURE A PERFIX LIGHT PLUG WITH A LABELED EXPIRATION DATE OF 28-JAN-2026 WAS IMPLANTED IN THE PATIENT ON (B)(6) 2026 WHICH WAS BEYOND ITS LABELED EXPIRATION DATE. THERE WAS NO PATIENT INJURY, CHANGE IN COURSE OF TREATMENT, OR ANY MEDICAL/SURGICAL INTERVENTION DUE TO THE ISSUE. AS REPORTED, THE MESH REMAINS IMPLANTED IN THE PATIENT'S BODY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24488473 ↗
• InjuryFeb 26, 2026Migration

  PER INFORMATION PROVIDED: ON (B)(6) 2013 - PATIENT WAS DIAGNOSED WITH RIGHT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF PERFIX LIGHT PLUGS (DEVICE 1, DEVICE 2). PER OP NOTES, ¿THERE WAS A MODEST-SIZED DIRECT DEFECT FROM PREVIOUS SURGERIES. THE LARGE PERFIX LIGHT PLUG (DEVICE 1) WAS INSERTED INTO THE DEFECT AND SECURED AROUND THE CIRCUMFERENCE WITH SUTURES. A SMALL PERFIX PLUG (DEVICE 2) WAS INSERTED AT THE LEVEL OF THE FEMORAL OPENING TO ELIMINATE RECURRENCE AND AN ONLAY PATCH WAS LAID OVER THE INGUINAL FLOOR USING SUTURES.¿ ON (B)(6) 2014 - PATIENT WAS DIAGNOSED WITH RECURRENT INCARCERATED RIGHT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE REMOVAL OF MESHES (DEVICE 1, 2). PER OP NOTES, ¿SCAR TISSUE AND MESH WERE NOTED. THE MESH (DEVICE 1, 2) HAD PULLED AWAY FROM SHELVING EDGE AND MEDIAL LOCATION WITH RECURRENCE. THE MESHES (DEVICE 1, 2) WERE EXCISED. A NEW PIECE OF SYNTHETIC MESH WAS SEWN INTO PUBIC TUBERCLE USING SUTURES.¿

  Patient problems: Hernia; Scar Tissue

  MAUDE report 24455565 ↗
• MalfunctionMay 9, 2024Expiration Date Error; Expiration Date Error

  AS REPORTED, AN OPEN FEMORAL HERNIA REPAIR PROCEDURE WAS PERFORMED AND A PERFIX LIGHT PLUG WHICH HAD A LABELED EXPIRATION DATE OF (B)(6) 2023 WAS IMPLANTED ON (B)(6) 2024. THERE WAS NO REPORTED PATIENT INJURY, CHANGE IN COURSE OF TREATMENT, OR ANY MEDICAL/SURGICAL INTERVENTION DUE TO THE ISSUE. IT WAS REPORTED, PATIENT VISITED HOSPITAL COUPLE OF DAYS AGO AND SEEMS TO BE DOING WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19277384 ↗
• InjuryJan 11, 2021Material Deformation; Material Deformation

  THE FOLLOWING WAS REPORTED VIA TGA REPORT (AUSTRALIA 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 11148167 ↗
• InjuryOct 1, 2019Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information; Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information

  ATTORNEY ALLEGES THAT ON (B)(6) 2016, THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL PERFIX LIGHT PLUG. 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 PERFIX LIGHT PLUG. AS REPORTED, THE ATTORNEY ALLEGES PRODUCT IS DEFECTIVE AND THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS.

  Patient problems: Adhesion(s); Injury; Nerve Damage; Pain

  MAUDE report 9143364 ↗
• InjuryMay 24, 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) 2012 OR (B)(6) 2014, THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL BARD MESH (DEVICE #1) OR AN UNSPECIFIED 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 PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE BARD MESH (DEVICE #1) AND PERFIX LIGHT PLUG (DEVICE #2). AS REPORTED, THE ATTORNEY ALLEGES PRODUCT IS DEFECTIVE AND THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS.

  Patient problems: Adhesion(s); Hernia; Injury

  MAUDE report 8642351 ↗
• InjuryApr 17, 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) 2016: THE PATIENT UNDERWENT SURGERY IMPLANT OF TWO UNSPECIFIED BARD/DAVOL PERFIX PLUGS (DEVICE #1 AND DEVICE #2). ON (B)(6) 2017: THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL SOFT MESH. AS REPORTED, THE PATIENT IS ONLY MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE BARD PERFIX PLUGS (DEVICE #1 AND DEVICE #2). AS REPORTED, THE ATTORNEY ALLEGES GENERAL ALLEGATIONS AGAINST THE BARD PERFIX PLUGS 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 7435904 ↗