PerFix 0117180Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00801741031014), received between Sep 5, 2019 and Nov 19, 2024 — classified as 13 injuries.

The most frequently reported specific device problem is “Defective Device” (12 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryNov 19, 2024Device Appears to Trigger Rejection; Defective Device; Material Deformation; Patient Device Interaction Problem; Device Appears to Trigger Rejection; Defective Device; Material Deformation; Patient Device Interaction Problem

  PER INFORMATION PROVIDED BY THE PATIENT'S ATTORNEY: (B)(6) 2010 - PATIENT WAS DIAGNOSED WITH LEFT DIRECT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF PERFIX LIGHT PLUG (DEVICE #1). PER OPERATIVE NOTES, ¿THE HERNIA SAC WAS DISSECTED OFF. A PERFIX LIGHT PLUG (DEVICE #1) WAS PLACED AT THE LEVEL OF PUBIC TUBERCLE AND SECURED BY TACKERS.¿ (B)(6) 2013 - PATIENT WAS DIAGNOSED WITH RECURRENT LEFT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF TWO PERFIX LIGHT PLUG (DEVICE #2 AND DEVICE #3). PER OPERATIVE NOTES, ¿PREVIOUSLY PLACED PERFIX LIGHT PLUG (DEVICE #1) WAS IDENTIFIED. THERE WAS A SMALL DEFECT AT THE PUBIC TUBERCLE THEN A PERFIX LIGHT PLUG (DEVICE #3) WAS PLACED AS AN ONLAY MESH USING SUTURES. A PERFIX LIGHT PLUG (DEVICE #2) WAS PLACED THROUGH THE INTERNAL INGUINAL RING AND SECURED BY STAPLES.¿ (B)(6) 2014 - PATIENT WAS DIAGNOSED WITH RECURRENT LEFT DIRECT INGUINAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE REMOVAL OF TWO PERFIX LIGHT PLUG (DEVICE #1) AND (DEVICE #3) AND IMPLANT OF SYNTHETIC MESH. PER OPERATIVE NOTES, ¿A LARGE LEFT DIRECT INGUINAL HERNIA WAS IDENTIFIED. A PERFIX LIGHT PLUGS (DEVICE #1) AND (DEVICE #3) WERE PROTRUDING

  Patient problems: Fibrosis; Hernia; Inflammation

  MAUDE report 20722743 ↗
• InjuryNov 7, 2024Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  PER ADDITIONAL INFORMATION PROVIDED: (B)(6) 2013 - PATIENT WAS DIAGNOSED WITH INCISIONAL WALL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF VENTRIO ST (DEVICE #1) & PERFIX LIGHT PLUG (DEVICE #2). PER OPERATIVE NOTES, ¿HERNIA SAC WAS IDENTIFIED AND REDUCED. FOR THE UPPER SUPRAUMBILICAL HERNIA SITE, A VENTRIO ST (DEVICE #1) WAS PLACED AGAINST THE ANTERIOR ABDOMINAL WALL. FOR THE INFRAUMBILICAL HERNIA SITE, A PERFIX LIGHT PLUG (DEVICE #2) WAS SUTURED IN PLACE. THERE WAS OLD VENTRAL WALL MESH WHICH COULD BE SEEN WHICH WAS DIVIDED UPON DISSECTING DOWN TO THE FASCIA.¿ (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH INCARCERATED RECURRENT VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH EXPLANTATION OF MESHES (DEVICE #1 & #2) FROM PERITONEAL CAVITY AND REPAIR OF RECURRENT INCARCERATED VENTRAL HERNIA WITH IMPLANT OF VENTRIO ST (DEVICE #3). PER OPERATIVE NOTES, ¿TWO PREVIOUS PIECES OF MESH WERE IDENTIFIED. THE MESH APPEARED WELL INCORPORATED INTO THE ANTERIOR ABDOMINAL WALL AND HAD DENSE ADHESIONS TO UNDERLYING BOWEL WERE DISSECTED OFF. BOTH PIECES OF MESH (DEVICE #1 & #2) WERE EXPLANTED AND A VENTRIO ST (DEVICE #3) MESH WAS PLACED INTO THE ANTERIOR ABDOMINAL WALL.¿ ATTORNEY ALLEGES TH

  Patient problems: Adhesion(s); Hernia; Obstruction/Occlusion

  MAUDE report 20627787 ↗
• InjuryNov 29, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  AS PER NMPA (CHINA FDA): AS REPORTED, THE PATIENT UNDERWENT RIGHT INDIRECT HERNIA HIGH LIGATION AND TENSION-FREE HERNIA REPAIR ON (B)(6) 2022 WITH THE IMPLANT OF BARD/DAVOL PERFIX PLUG LIGHT. LOCAL SKIN FLUSHING OCCURRED ON (B)(6) 2022, THE FOURTH DAY AFTER THE OPERATION, WHICH GRADUALLY SUBSIDED THROUGH DISINFECTION, AND NO OBVIOUS ABNORMALITY WAS FOUND.

  Patient problems: Local Reaction

  MAUDE report 15880601 ↗
• InjuryOct 21, 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) 2015. 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; Scar Tissue

  MAUDE report 12672357 ↗
• InjuryJul 28, 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 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 12239602 ↗
• InjuryOct 27, 2020Defective 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 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 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 10739145 ↗
• InjuryOct 20, 2020Defective Device; Insufficient Device Problem Information; Defective Device; Insufficient Device Problem Information

  ATTORNEY ALLEGES THAT ON OR ABOUT (B)(6) 2014, THE PATIENT UNDERWENT A SURGERY FOR THE REPAIR OF LEFT INGUINAL HERNIA AND TWO BARD/DAVOL PERFIX LIGHT PLUGS WERE IMPLANTED TO REPAIR THE HERNIA DEFECT. IT IS ALLEGED THAT ON OR ABOUT (B)(6) 2014, THE PATIENT UNDERWENT AN ADDITIONAL SURGERY FOR EXCISION OF A CHRONIC HEMATOMA IN THE LEFT GROIN WITH A PRIMARY REPAIR OF AN 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; Hematoma; Injury

  MAUDE report 10705459 ↗
• InjuryOct 20, 2020Defective Device; Insufficient Device Problem Information; Defective Device; Insufficient Device Problem Information

  ATTORNEY ALLEGES THAT ON OR ABOUT (B)(6) 2014, THE PATIENT UNDERWENT A SURGERY FOR THE REPAIR OF LEFT INGUINAL HERNIA AND TWO BARD/DAVOL PERFIX LIGHT PLUGS WERE IMPLANTED TO REPAIR THE HERNIA DEFECT. IT IS ALLEGED THAT ON OR ABOUT (B)(6) 2014, THE PATIENT UNDERWENT AN ADDITIONAL SURGERY FOR EXCISION OF A CHRONIC HEMATOMA IN THE LEFT GROIN WITH A PRIMARY REPAIR OF AN INGUINAL HERNIA. THE PATIENT WAS INJURED SEVERELY AND PERMANENTLY. ATTORNEY ALLEGES THAT THE PATIENT HAD PAIN, DISABILITY, HOSPITALIZATIONS AND ADDITIONAL SURGERIES. IT IS ALSO ALLEGED THAT THE PATIENT SUFFERED AND CONTINUES TO SUFFER FROM CHRONIC PAIN, PSYCHOLOGICAL STRESS AND DEPRESSION. IT IS ALSO ALLEGED THAT THE PATIENT HAS UNDERGONE AND WILL LIKELY REQUIRE IN THE FURTHER OTHER FORMS OF CARE AND MEDICAL TREATMENTS. IT IS ALLEGED THAT THE DEVICE WAS DEFECTIVE.

  Patient problems: Disability; Hematoma; Injury

  MAUDE report 10705455 ↗
• 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 10597370 ↗
• InjurySep 10, 2020Device Appears to Trigger Rejection; Defective Device; Material Deformation; Insufficient Device Problem Information; Device Appears to Trigger Rejection; Defective Device; Material Deformation; Insufficient Device Problem Information

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL PERFIX LIGHT PLUG ON (B)(6) 2016. 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; Injury

  MAUDE report 10515033 ↗
• InjuryJul 24, 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/DAVOL PERFIX LIGHT PLUG ON (B)(6) 2012. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST PERFIX LIGHT PLUG. 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

  MAUDE report 10318639 ↗
• InjuryApr 18, 2020Defective Device; Insufficient Device Problem Information; Migration; Defective Device; Insufficient Device Problem Information; Migration

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR THE IMPLANT OF UNSPECIFIED BARD/ DAVOL PERFIX LIGHT PLUG AND VENTRALIGHT ST. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST PERFIX LIGHT PLUG WHICH WAS IMPLANTED ON (B)(6) 2012. ATTORNEY ALLEGES THAT THE PATIENT HAD SUBSEQUENT SURGICAL INTERVENTION DUE TO THE HERNIA MESH DEVICE. IT IS ALSO ALLEGED THAT THE PATIENT SUSTAINED PERSONAL INJURY, EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Adhesion(s); Hernia; Injury

  MAUDE report 9975638 ↗
• InjurySep 5, 2019Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information; Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information

  ATTORNEY ALLEGES THAT ON (B)(6) 2012, 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: Abscess; Inflammation; Injury; Unspecified Infection

  MAUDE report 8967225 ↗