PerFix 0117060Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00801741030956), received between Nov 27, 2017 and Dec 11, 2025 — classified as 16 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Defective Device” (13 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 11, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  AS REPORTED, ON (B)(6) 2025 DURING A PROCEDURE UPON OPENING THE PERFIX LIGHT PLUG PACKAGE, THEY "FOUND HAIR MIXED INSIDE" THE INNER PACKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23777247 ↗
• InjuryApr 12, 2024Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  PER INFORMATION PROVIDED BY PATIENT'S ATTORNEY: (B)(6) 2012 - PATIENT WAS DIAGNOSED WITH RIGHT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF PERFIX PLUG (DEVICE #1). PER OPERATIVE NOTES, ¿THE INDIRECT HERNIA SAC WAS REDUCED. A LARGE PERFIX PLUG (DEVICE #1) WAS PLACED THROUGH THE DEFECT, TACKED IT INTO THE PLACE WITH SUTURE. THEN, AN ONLAY PATCH WAS PLACED TO THE PUBIC TUBERCLE, THE CONJOINED TENDON AND SHELVING PORTION OF THE INGUINAL LIGAMENT.¿ (B)(6) 2013 - PATIENT WAS DIAGNOSED WITH ABDOMINAL PAIN. (B)(6) 2014 - PATIENT CONSULTED FOR BILATERAL GROIN PAIN. (B)(6) 2014 - PATIENT WAS DIAGNOSED WITH INCARCERATED LEFT INGUINAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT OF 3DMAX MESH (DEVICE #2). PER OPERATIVE NOTES, ¿INDIRECT HERNIA DEFECT WITH THE PERITONEUM OVERLYING SPERMATIC CORD WAS DISSECTED. A MEDIUM 3DMAX MESH (DEVICE #2) WAS USED AND TACKED TO THE PUBIC TUBERCLE. A PERFIX PLUG (DEVICE #1) NOTED TO HAVE DENSE ADHESIONS AND REACTIONARY TISSUE TO THE MESH ITSELF." (B)(6) 2014 - PATIENT COMPLAINTS OF LEFT LOWER ABDOMINAL DISCOMFORT, HERNIA PAIN AND DIAGNOSED WITH INGUINAL HERNIA. (B)(6) 2015 - PATIENT CONSULTED FOR STRANGULATED RIGHT INGUIN

  Patient problems: Hernia; Pain; Seroma

  MAUDE report 19096534 ↗
• MalfunctionSep 26, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, DURING AN OPEN SURGICAL PROCEDURE, THE SURGEON NOTED THAT THE THREAD CONNECTING THE PETAL WAS FRAYED AND DETACHED FROM THE PERFIX LIGHT PLUG. IT WAS REPORTED THAT THE SURGEON DOES NOT TRIM OR RESHAPE THE MESH PRIOR TO ITS USAGE. AS REPORTED AS THERE WAS NO PROBLEM WITH THE SHAPE AND PROPERTIES OF THE PERFIX LIGHT PLUG AND THE PETAL WAS NOT DETACHED FROM THE PLUG AS SUCH THE SURGEON DECIDED TO USE THE MESH FOR THE REPAIR. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17817505 ↗
• MalfunctionJul 25, 2023Material Separation; Material Separation

  AS REPORTED, THE SURGEON TRIED TO FIX THE PERFIX LIGHT PLUG BY LIGATING IT WITH A THREAD AND TWO PETALS DETACHED (TORE OFF). AS REPORTED THE SURGEON HAD PULLED THE THREAD BUT NOT THE PLUG ITSELF. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17393031 ↗
• MalfunctionMar 1, 2023Material Separation; Material Separation

  AS REPORTED, DURING AN OPEN INGUINAL HERNIA REPAIR PROCEDURE, THE PETAL OF PERFIX PLUG LIGHT MESH DETACHED DURING INSERTION AND WAS REMOVED FROM THE PATIENT BODY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16463563 ↗
• InjuryJan 12, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED, DURING AN INGUINAL HERNIA REPAIR PROCEDURE ON (B)(6) 2021, THE PATIENT WAS IMPLANTED WITH A BARD/DAVOL PERFIX PLUG LIGHT. IT WAS REPORTED THAT ONE WEEK POST IMPLANT, THE PATIENT EXPERIENCED AN ALLERGIC REACTION (RASH) ON (B)(6) 2021. AS REPORTED, THE SURGEON SUSPECTS THAT THERE COULD BE OTHER FACTORS (SURGEON'S GLOVES, SUTURE MATERIAL, DISINFECTANT SOLUTION) OF CAUSING AN ALLERGIC REACTION BESIDES THE MESH, THE HOSPITAL IS CURRENTLY INVESTIGATING THE CAUSE AND THE SURGEON IS PLANNING FOR A PATCH TEST.

  Patient problems: Rash

  MAUDE report 13235249 ↗
• InjuryMay 31, 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 PLUG ON (B)(6) 2016. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE PERFIX 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: Adhesion(s); Hernia; Insufficient Information; Scar Tissue

  MAUDE report 11907507 ↗
• 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 11163095 ↗
• MalfunctionNov 5, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  AS REPORTED, IT WAS IDENTIFIED THAT WHILE OPENING THE PACKAGE ON (B)(6) 2020, A FOREIGN MATERIAL LIKE FRAYED THREAD WAS FOUND ON THE PERFIX LIGHT PLUG. THE DEVICE WAS USED AFTER REMOVING THE FOREIGN MATERIAL. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10790538 ↗
• InjuryAug 21, 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) 2017. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE 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 SUSTAINED PERSONAL INJURY, EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Hernia; Injury; Pain; Scar Tissue

  MAUDE report 10439508 ↗
• InjuryJul 10, 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 TWO UNSPECIFIED BARD/DAVOL PERFIX LIGHT PLUGS ON (B)(6) 2015 AND (B)(6) 2018. 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; Pain

  MAUDE report 10256478 ↗
• InjuryJun 10, 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 UNSPECIFIED BARD/DAVOL KUGEL HERNIA PATCH AND PERFIX LIGHT PLUG ON (B)(6) 2011 AND/OR (B)(6) 2018. 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 10137944 ↗
• InjuryMar 21, 2020Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  THE FOLLOWING IS BASED ON INFORMATION PROVIDED VIA MAUDE EVENT REPORT MW5093145 AND ADDITIONAL INFORMATION PROVIDED BY THE CONTACT. ON (B)(6) 2015 THE PATIENT UNDERWENT OPEN BILATERAL INGUINAL HERNIA REPAIR AND WAS IMPLANTED WITH TWO BARD PERFIX PLUG MESH. (DEVICE #1 RIGHT SIDE, DEVICE #2 LEFT SIDE). TWO MONTHS POST IMPLANT THE PATIENT PRESENTED TO HIS DOCTOR WITH STABBING PAINS. HIS DOCTOR TOLD HIM NOT TO WORRY AND WOULD NOT SEE HIM AGAIN. ON (B)(6) 2020 THE PATIENT UNDERWENT A REVISION PROCEDURE ON THE RIGHT SIDE. AS REPORTED THE PERFIX PLUG (DEVICE #1) WAS REMOVED AND THE RECURRENT HERNIA WAS REPAIRED WITH A NON BARD POLYPROPYLENE MESH DEVICE. DURING THIS PROCEDURE TWO DAMAGED NERVES WERE REMOVED AND LYSIS OF ADHESIONS WAS PERFORMED ON THE RIGHT TESTICLE CHORD TO FREE UP THE TESTICLE. AS REPORTED THE PATIENT WILL UNDERGO REVISION SURGERY ON THE LEFT SIDE ONCE THE HOSPITAL STARTS PERFORMING NON EMERGENCY SURGERIES AGAIN. THE LEFT SIDE REVISION SURGERY AS REPORTED, WILL INCLUDE REMOVAL OF MESH AND ANY DAMAGED NERVES AND INSPECTION OF THE SPERMATIC CHORD TO LEFT TESTICLE. AS REPORTED THE PATIENT CONTINUES WITH PAIN IN THE INNER THIGH AREA AND POSSIBLE BONE DAMAGE. ADDENDUM PER LEGA

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

  MAUDE report 9863311 ↗
• InjuryMar 21, 2020Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  THE FOLLOWING IS BASED ON INFORMATION PROVIDED VIA MAUDE EVENT REPORT MW5093145 AND ADDITIONAL INFORMATION PROVIDED BY THE CONTACT. ON (B)(6) 2015 THE PATIENT UNDERWENT OPEN BILATERAL INGUINAL HERNIA REPAIR AND WAS IMPLANTED WITH TWO BARD PERFIX PLUG MESH. (DEVICE #1 RIGHT SIDE, DEVICE #2 LEFT SIDE). TWO MONTHS POST IMPLANT THE PATIENT PRESENTED TO HIS DOCTOR WITH STABBING PAINS. HIS DOCTOR TOLD HIM NOT TO WORRY AND WOULD NOT SEE HIM AGAIN. ON (B)(6) 2020 THE PATIENT UNDERWENT A REVISION PROCEDURE ON THE RIGHT SIDE. AS REPORTED THE PERFIX PLUG (DEVICE #1) WAS REMOVED AND THE RECURRENT HERNIA WAS REPAIRED WITH A NON BARD POLYPROPYLENE MESH DEVICE. DURING THIS PROCEDURE TWO DAMAGED NERVES WERE REMOVED AND LYSIS OF ADHESIONS WAS PERFORMED ON THE RIGHT TESTICLE CHORD TO FREE UP THE TESTICLE. AS REPORTED THE PATIENT WILL UNDERGO REVISION SURGERY ON THE LEFT SIDE ONCE THE HOSPITAL STARTS PERFORMING NON EMERGENCY SURGERIES AGAIN. THE LEFT SIDE REVISION SURGERY AS REPORTED, WILL INCLUDE REMOVAL OF MESH AND ANY DAMAGED NERVES AND INSPECTION OF THE SPERMATIC CHORD TO LEFT TESTICLE. AS REPORTED THE PATIENT CONTINUES WITH PAIN IN THE INNER THIGH AREA AND POSSIBLE BONE DAMAGE.

  Patient problems: Nerve Damage; Pain

  MAUDE report 9863310 ↗
• InjuryJun 26, 2019Defective Device; Insufficient Device Problem Information; Patient Device Interaction Problem; Migration; Defective Device; Insufficient Device Problem Information; Patient Device Interaction Problem; Migration

  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: Adhesion(s); Hernia; Injury

  MAUDE report 8737345 ↗
• InjuryJun 3, 2019Defective Device; Insufficient Device Problem Information; Defective Device; Insufficient Device Problem Information

  IT IS ALLEGED BY THE PATIENT¿S ATTORNEY THAT THE PATIENT WAS A RECIPIENT OF A BARD /DAVOL PERFIX LIGHT PLUG (DEVICE #1) (HERE IN AFTER ¿PERFIX LIGHT PLUG¿). IT IS ALLEGED BY THE PATIENT¿S ATTORNEY THAT ON OR ABOUT (B)(6) 2014, THE PATIENT UNDERWENT SURGERY FOR REPAIR OF MASSIVE INGUINAL HERNIA. AS ALLEGED, A BARD/DAVOL PERFIX LIGHT PLUG (DEVICE #1), WAS IMPLANTED TO REPAIR THE HERNIA DEFECT. IT WAS ALLEGED BY THE PATIENT¿S ATTORNEY THAT ON OR ABOUT (B)(6) 2017, THE PATIENT UNDERWENT AN ADDITIONAL SURGERY TO REMOVE THE PERFIX LIGHT PLUG (DEVICE #1), AGAIN TO REPAIR THE MASSIVE INGUINAL HERNIA, AND TO PLACE A NEW PERFIX PLUG (DEVICE #2) IN THE PATIENT. ALLEGEDLY, AS A RESULT, THE PATIENT WAS INJURED SEVERELY AND PERMANENTLY. AS ALLEGED, PATIENT HAS SUFFERED AND WILL CONTINUE TO SUFFER PHYSICAL PAIN AND MENTAL ANGUISH. AS REPORTED, PATIENT SUFFERED AND FROM CHRONIC PAIN, AS WELL AS PSYCHOLOGICAL STRESS AND DEPRESSION DUE TO THE ALLEGED DEFECTIVE PERFIX PLUG (DEVICE #2).

  Patient problems: Disability; Hernia; Injury

  MAUDE report 8664303 ↗
• InjuryMay 6, 2019Patient Device Interaction Problem; Patient Device Interaction Problem

  PER FDA REPORT MW5085555 - "MY SON HAD GOTTEN A RIGHT INGUINAL HERNIA AND SENT IN FOR OPERATION ON (B)(6) 2016. HE HAD A MESH PERFIX LIGHT PLUG- MFR: DAVOL, A DIV. OF BARD, MODEL 0117060, LOT # HUAP0309. MY SON WAS IN SO MUCH PAIN AFTER SURGERY, WHAT WAS SUPPOSED TO BE SAME DAY SURGERY ENDED UP BEING 5 DAYS IN HOSPITAL. THE PAIN STARTED A DAY AFTER HE GOT THE MESH PUT IN. MY SON SWORE THAT THE HERNIA WAS NOT FIXED. HE WAS STILL IN MAJOR PAIN. A FEW MONTHS LATER, I TOOK HIM BACK TO EMERGENCY ROOM BECAUSE OF PAIN AND THE DRS SAID HE HAD A HERNIA AGAIN BUT IT WAS TOO SMALL TO REPAIR. MY SON HAS CONSTANT PAIN IN HIS GROIN. HE ALSO HAS RADIATING PAIN WHICH IS IN HIS BELLY BUTTON ACROSS ONE SIDE BY HIS KIDNEY INTO HIS BACK AREA. I HAVE TAKEN HIM TO EMERGENCY ROOM TWO MORE TIMES SINCE THE LAST AND DRS KEEP SAYING THEY CANNOT SEE THE ISSUE AND WHY HE HAS PAIN. THEY HAD SEEN THAT THE HERNIA WAS THERE BUT NO STEPS HAVE BEEN TAKEN TO REPAIR OR CHECK THE STATUS OF THE MESH THAT WAS PLACED IN HIM DURING HIS OPERATION FOR THE INGUINAL HERNIA. MY SON HAS GOOD AND BAD DAYS. BUT WHEN THE PAIN STARTS UP, MY SON IS IN SO MUCH PAIN THAT IT IS UNBEARABLE. THERE IS TENDERNESS AND SWELLING IN THE AREA. H

  Patient problems: Hernia; Pain; Vomiting

  MAUDE report 8583688 ↗
• InjuryJan 30, 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) 2011:THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL 3DMAX (DEVICE #1) AND AN UNSPECIFIED BARD/DAVOL PERFIX PLUG (DEVICE #2). THE PATIENT IS ONLY MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE 3DMAX (DEVICE #1) AND THE PERFIX PLUG (DEVICE #2). 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: Disability; Hernia; Injury; Pain; Scar Tissue

  MAUDE report 8291021 ↗
• InjuryJan 4, 2019Defective Device; Material Protrusion/Extrusion; Defective Device; Material Protrusion/Extrusion

  THE FOLLOWING WAS ALLEGED BY THE PATIENT'S ATTORNEY: (B)(6) 2012: THE PATIENT UNDERWENT UMBILICAL HERNIA REPAIR. A PERFIX PLUG LIGHT (DEVICE #1) WAS IMPLANTED IN THE PATIENT DURING THIS REPAIR. (B)(6) 2015: THE PATIENT UNDERWENT INCISIONAL HERNIA REPAIR. A VENTRALEX ST (DEVICE #2) WAS IMPLANTED IN THE PATIENT DURING THIS REPAIR. (B)(6) 2014: THE PATIENT UNDERWENT REMOVAL OF THE FAILED PERFIX PLUG LIGHT (DEVICE #1). UPON OPENING THE PATIENT THE PHYSICIAN NOTED ¿PLUG WAS PROTRUDING INTO THE ABDOMEN AND SMALL BOWEL WAS STUCK TO IT.¿ (B)(6) 2016: THE PATIENT UNDERWENT REMOVAL OF THE FAILED VENTRALEX ST (DEVICE #2). THE PHYSICIAN NOTED ¿LACERATED SEGMENT OF A 2-CM AREA OF BOWEL THAT HAD BEEN TORN FROM IT ATTACHMENT AT THE EDGE OF THE HERNIA.¿ 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 8217659 ↗
• InjuryOct 12, 2018Defective Device; Material Deformation; Defective Device; Material Deformation

  THE FOLLOWING WAS ALLEGED BY THE PATIENT'S ATTORNEY: ON (B)(6) 2015: THE PATIENT UNDERWENT RIGHT INGUINAL HERNIA REPAIR. A PERFIX LIGHT PLUG WAS IMPLANTED IN PATIENT DURING THIS REPAIR. ON (B)(6) 2018: THE PATIENT UNDERWENT A RECURRENT HERNIA OPERATION DUE TO RIGHT GROIN PAIN. THE PHYSICIAN NOTED, ¿PALPATION DEMONSTRATED AN ADDITIONAL FOREIGN BODY CONSISTENT WITH A POTENTIAL PLUG OF MESH. IT WAS THICKENED, FLATTENED, CONTRACTED.¿ NI/NI/NI: THE PATIENT CONTINUES TO SUFFER COMPLICATIONS RELATED TO THE PERFIX LIGHT PLUG. THE PERFIX LIGHT PLUG IMPLANTED IN PATIENT FAILED TO REASONABLY PERFORM AS INTENDED. THE PERFIX LIGHT PLUG 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, IMPAIRMENT.

  Patient problems: Disability; Hernia; Injury

  MAUDE report 7962577 ↗
• InjuryJun 13, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT ON (B)(6) 2017 THE PATIENT UNDERWENT A LEFT INGUINAL HERNIA REPAIR AND WAS IMPLANTED WITH DAVOL PERFIX LIGHT PLUG. AS REPORTED, THE PATIENT EXPERIENCED SEVERE PAIN IN HIS LEFT GROIN AND UNDERWENT MULTIPLE INJECTIONS OF STEROIDS FOR THE PAIN AND INFLAMMATION. AS REPORTED, THE PATIENT WAS GIVEN STEROID INJECTIONS FOR A 4 WEEK PERIOD AFTER IMPLANT OF THE PERFIX LIGHT PLUG. AS REPORTED THE PATIENT HAS SEEN SEVERAL SPECIALIST SINCE THE IMPLANT FOR COMPLAINTS OF STOMACH PAIN, SWELLING AT THE BOTTOM OF THE INCISION SITE AS WELL AS A REOCCURRING ABSCESS WITH PURULENT DISCHARGE. AS REPORTED, THE PATIENT HAS SEEN A GASTROENTEROLOGIST AND UNDERWENT AN UPPER ENDOSCOPY AND CT SCANS WHICH WERE REPORTED TO BE NORMAL. AS REPORTED, THE PATIENT HAD LAST SEEN A DOCTOR A FEW MONTHS AGO AND WAS TOLD THE ISSUES HE IS EXPERIENCING ARE ¿MOST LIKELY DUE TO THE MESH BEING ATTACHED TO HIS NERVES.¿ THE PATIENT REPORTS THAT, HE WILL BE FOLLOWING UP WITH ANOTHER SURGEON TO DISCUSS HIS OPTIONS. AS REPORTED THE PATIENT HAS LOST OVER 20LBS SINCE THE IMPLANT PROCEDURE.

  Patient problems: Abscess; Inflammation; Pain

  MAUDE report 7595657 ↗
• MalfunctionNov 27, 2017Torn Material; Torn Material

  THE FOLLOWING WAS REPORTED TO DAVOL: IT WAS REPORTED THAT THE BARD/DAVOL PERFIX LIGHT PLUG "OPENED" INADVERTENTLY DURING RIGHT INGUINAL HERNIA REPAIR SURGERY AND THE MESH PARTIALLY TORE OFF. ANOTHER MESH WAS IMPLANTED TO COMPLETE THE CASE. THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7060848 ↗