PerFix 0112980Recalls & reported problems

Summary

The FDA's MAUDE database contains 121 adverse event reports that list this exact device (DI 00801741016684), received between Feb 10, 2017 and Sep 30, 2026 — classified as 2 deaths, 119 injuries.

The most frequently reported specific device problem is “Defective Device” (107 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 121 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Patient-Device Incompatibility

  Per information provided:On (b)(6) 2005 - Patient was diagnosed with bilateral inguinal hernia thereby underwent open repair with implant of PerFix Plug (Device 1 ¿ Left and Device 2 ¿ Right). Per operative notes, ¿A transverse supraumbilical incision was made on both sides and carried down to the subcutaneous tissue. On the left side of the inguinal region a hernia sac was identified, which was removed. A PerFix Plug (Device 1) was placed into the right inguinal region and secured it with sutures. Another incision was made into the right side of the inguinal region. There was a hernia sac identified. The hernia sac was dissected out. A PerFix Plug (Device 2) was placed into the right inguinal floor and secured it with sutures.¿On (b)(6) 2013 - Patient was diagnosed with bilateral inguinal hernia, adhesion thereby underwent laparoscopic repair with implant of synthetic mesh. Per operative notes, ¿An incision was made into the inguinal region through previous incision site. There were direct inguinal hernias which were both recurrences, as previously placed PerFix Plug (Device 1 and 2) was identified. During right-sided dissection, the PerFix Plug (Device 2) was adhered to the perit

  Patient problems: Adhesion(s); Hernia

  MAUDE report 50942742 ↗
• InjuryAug 25, 2026Material Deformation

  Per information provided:(b)(6) 2013- Patient was diagnosed with recurrent right inguinal hernia, left inguinal hernia, thereby underwent open repair with implant of PerFix Plugs (Device 1 and 2). Per op notes, "In the right inguinal region, previously placed mesh was found pulled away and there was hernia with omentum. The omentum was reduced an dwas repaired by placing PerFix Plug (Device 1) and sutured. Then on the left inguinal region, direct hernia was identified and was dissected. An extra large PerFix Plug (Device 2) was placed and sutured." (b)(6) 2016- Patient was diagnosed with recurrent bilateral inguinal hernias, thereby underwent robotic repair with implant of synthetic mesh. Per op notes, "Some adhesions in the right inguinal area along with indirect hernia was identified. There was a recurrent direct hernia and the PerFix Plug (Device 1) was found pulled away from pubic tubercle area. A synthetic mesh was placed covering the entire inguinal canal and sutured. There was a large piece of mesh (PerFix Plug-Device 2) was found crumpled up and stuck to the spermatic cord. There was a recurrent indirect hernia. Another synthetic mesh was then placed and sutured."

  Patient problems: Hernia

  MAUDE report 50427833 ↗
• InjuryJul 30, 2026Material Deformation

  Per information provided:On (b)(6) 2013 - Patient was diagnosed with recurrent ventral incisional hernia and left inguinal hernia thereby underwent open recurrent ventral incisional hernia repair with the implant of Ventrio Mesh (Device 1) and left inguinal hernia repair with the implant of PerFix Plug (Device 2). Per op notes, "A midline incision was made, Ventrio Mesh (Device 1) was placed towards the abdominal cavity using prolene sutures. Attention to the left inguinal hernia, where a left incision was performed. A PerFix Plug (Device 2) was placed to the abdomen using sutures." On (b)(6) 2016 - Patient was diagnosed with recurrent ventral incisional hernia hereby underwent laparoscopic repair with the removal of both meshes (Device 1 and 2) and implant of Ventrio ST Mesh (Device 3). Per op notes, "Patient had recurrent ventral incisional hernia which had been repaired previously with two meshes. Extensive intra-abdominal adhesions were taken down. The more recent mesh (Device 1 and 2) which had been placed appeared to have folded over on itself. Both meshes (Device 1 and 2) were removed from the abdominal wall. A Ventrio ST Mesh (Device 3) was secured to the old mesh inferiorl

  Patient problems: Adhesion(s); Hernia

  MAUDE report 50078391 ↗
• InjuryApr 7, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2010 ¿ PATIENT WAS DIAGNOSED WITH PANTALOON RIGHT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF TWO PERFIX PLUGS (DEVICE 1, 2). PER OP NOTES, ¿A DIRECT HERNIA WAS IDENTIFIED EMANATING THROUGH HESSELBACH'S TRIANGLE. A EXTRA LARGE PERFIX PLUG (DEVICE 1) WAS PLACED IN THE PREPERITONEAL SPACE. AN INDIRECT HERNIA SAC WAS LOCATED ANTEROMEDIALLY ON THE CORD. A EXTRA LARGE PERFIX PLUG (DEVICE 2) WAS PLACED THROUGH INTERNAL RING AND INTO PREPERITONEAL SPACE. THE FLOOR OF INGUINAL CANAL WAS REENFORCED WITH MESH PATCH AND SECURED MEDIALLY TO PUBIC TUBERCLE AND ILIOPUBIC TRACT USING SUTURES.¿ (B)(6) 2016 ¿ PATIENT WAS DIAGNOSED WITH RECURRENT RIGHT INGUINAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT OF SYNTHETIC MESH. PER OP NOTES, ¿THE HERNIA SAC WAS DISSECTED OFF THE CORD STRUCTURES. THE PERITONEUM WAS ADHERED TO PREVIOUSLY PLACED MESH (DEVICE 1, 2) THROUGH A DIRECT DEFECT. A SYNTHETIC MESH WAS PLACED IN DEFECT AND CLOSED.¿

  Patient problems: Adhesion(s); Hernia

  MAUDE report 24798395 ↗
• InjuryOct 16, 2025Material Deformation; Material Deformation

  PER INFORMATION PROVIDED: (B)(6) 2017 ¿ PATIENT WAS DIAGNOSED WITH UMBILICAL HERNIA AND INCISIONAL VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRALEX ST MESH (DEVICE 1) AND PERFIX PLUG (DEVICE 2). PER OPERATIVE NOTES, ¿A SMALL UMBILICAL HERNIA AND INCISIONAL VENTRAL HERNIA WITH SAC IN THE LEFT LOWER QUADRANT WAS REDUCED. A VENTRALEX ST MESH WAS PLACED IN UMBILICAL REGION (DEVICE 1) AND EXTRA-LARGE PERFIX PLUG (DEVICE 2) WAS PLACED OVER THE HERNIA IN LEFT LOWER QUADRANT AND SECURED WITH SUTURES.¿ (B)(6) 2019 ¿ PATIENT WAS DIAGNOSED WITH MESHOMA OF VENTRAL MESH (DEVICE 2) AND PAIN THEREBY UNDERWENT OPEN REPAIR WITH REMOVAL OF MESH (DEVICE 2) AND IMPLANT OF BARD SOFT MESH (DEVICE 3). PER OPERATIVE NOTES, ¿THE MESH (DEVICE 2) WAS SEEN PALPATED UNDER THE SCAR IN THE LEFT LOWER QUADRANT. THE MESHOMA WAS ENCOUNTERED AND EXCISED COMPLETELY. THE FASCIA WAS CLOSED WITH SUTURES AND BARD SOFT MESH (DEVICE 3) WAS PLACED AND SECURED WITH SUTURES.¿

  Patient problems: Pain; Scar Tissue

  MAUDE report 23308393 ↗
• InjurySep 4, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2013 - PATIENT WAS DIAGNOSED WITH RIGHT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF PERFIX PLUG (DEVICE #1 & #2). PER OP NOTES, "A PERFIX PLUG (DEVICE #1 & #2) WAS PLACED AND SUTURED." (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH RECURRENT RIGHT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF PERFIX PLUG (DEVICE #3 & #4). PER OP NOTES, "THE MESH FROM PREVIOUS REPAIR WAS PALPATED. A PERFIX PLUG (DEVICE #3 & #4) WAS PLACED AND SUTURED." (B)(6) 2016 - PATIENT WAS DIAGNOSED WITH RECURRENT RIGHT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE EXPLANT OF PERFIX PLUG (DEVICE #1, #2, #3 & #4). PER OP NOTES, "THE PRIOR MESH (DEVICE #1, #2, #3 & #4) WAS EXCISED, AND PRIMARY SUTURE REPAIR WAS DONE."

  Patient problems: Hernia

  MAUDE report 22960491 ↗
• InjuryAug 1, 2025Migration; Migration

  PER INFORMATION PROVIDED: (B)(6) 2019 - PATIENT WAS DIAGNOSED FOR BILATERAL RECURRENT INGUINAL HERNIAS THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF TWO PERFIX PLUG (LEFT - DEVICE #1 & RIGHT - DEVICE #2). PER OP NOTES, "FOR LEFT INGUINAL DEFECT, A PERFIX PLUG (LEFT - DEVICE #1) WAS PLACED AND SUTURED. FOR RIGHT INGUINAL HERNIA DEFECT, A PERFIX PLUG (RIGHT - DEVICE #2) WAS PLACED AND SUTURED." (B)(6) 2019 - PATIENT WAS DIAGNOSED FOR BILATERAL RECURRENT INGUINAL HERNIAS, MESH MIGRATION THEREBY UNDERWENT ROBOTIC ASSISTED LAPAROSCOPIC REPAIR WITH EXPLANT OF PERFIX PLUG (RIGHT - DEVICE #2) AND IMPLANT OF 3DMAX MESH (RIGHT - DEVICE #3 & LEFT - DEVICE #4). PER OP NOTES, "IN RIGHT SIDE, THE ADHERED MESH (DEVICE #2) MIGRATED WAS DISSECTED AND REMOVED ENTIRELY. A 3DMAX MESH (RIGHT - DEVICE #3) WAS PLACED AND TACKED. IN LEFT SIDE, THE DEFECT WAS REDUCED AND A 3DMAX MESH (LEFT - DEVICE #3) WAS PLACED AND TACKED."

  Patient problems: Adhesion(s); Hernia

  MAUDE report 22685397 ↗
• InjuryJul 31, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2005 ¿ PATIENT WAS DIAGNOSED WITH INDIRECT AND DIRECT LEFT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF PERFIX PLUG (DEVICE #1, #2). PER OP NOTES, ¿THE DIRECT AND INDIRECT HERNIA WAS NOTED. THE SMALL INDIRECT HERNIA WAS FREED UP AND A PERFIX PLUG (DEVICE #1) WAS PLACED THROUGH THE DEFECT AND SECURED USING SUTURES. AN EXTRA LARGE PERFIX PLUG (DEVICE #2) WAS PLACED INTO DIRECT DEFECT AND ONLAY PATCH WAS PLACED AND SECURED USING SUTURES.¿ (B)(6) 2008 ¿ PATIENT HAD PAIN AND WAS DIAGNOSED WITH RECURRENT LEFT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH PARTIAL REMOVAL OF MESH (DEVICE #1, #2). PER OP NOTES, ¿THE HARDENED MASS CONSISTENT WITH PLUG AND OVERLAY PATCH (DEVICE #1, #2) WAS RESECTED. A NEW OVERLAY MESH WAS SEWED IN PLACE USING SUTURES AND A SYNTHETIC MESH WAS ALSO SECURED.¿ (B)(6) 2019 ¿ PATIENT WAS DIAGNOSED WITH RECURRENT LEFT INGUINAL HERNIA, ABSCESS THEREBY UNDERWENT OPEN REMOVAL OF MESH (DEVICE #1, #2) AND IMPLANT OF PHASIX MESH (DEVICE #3). PER OP NOTES, ¿PURULENT FLUID WAS DRAINED INCLUDE GRANULOMA. THE PUS FROM ABSCESS WAS TAKEN. THE INTER-ABDOMINAL MASS WAS RESECTED ALONG WITH MESH (DEVICE #1, #2). AN PHASIX M

  Patient problems: Abscess; Hernia; Purulent Discharge

  MAUDE report 22678011 ↗
• InjuryMay 26, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2018 - PATIENT WAS DIAGNOSED WITH RIGHT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF 2X PERFIX PLUG (DEVICE #1, #2). PER OPERATIVE NOTES, ¿AN INDIRECT HERNIA SAC WAS IDENTIFIED AND DISSECTED. THE CONTENTS OF THE SAC WERE REDUCED AND EXCISED. 2X PERFIX PLUG (DEVICE #1, #2) WERE PLACED AND SUTURED. (B)(6) 2019 - PATIENT WAS DIAGNOSED WITH RECURRENT RIGHT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH EXCISION OF PERFIX PLUG (DEVICE #1, #2) AND IMPLANT OF SYNTHETIC MESH. PER OPERATIVE NOTES, ¿A DIRECT AND INDIRECT HERNIA DEFECT WERE IDENTIFIED, AND THE CONTENTS WERE REDUCED. THE PREVIOUS MESHES (DEVICE #1& #2) WERE ENCOUNTERED AND EXCISED. A SYNTHETIC MESH WAS PLACED AND SUTURED.¿ (B)(6) 2019 - PATIENT WAS DIAGNOSED WITH RECURRENT RIGHT INGUINAL HERNIA THEREBY UNDERWENT ROBOTIC CONVERTED TO OPEN REPAIR WITH IMPLANT OF 3DMAX (DEVICE #3) AND PERFIX PLUG (DEVICE #4). PER OPERATIVE NOTES, ¿THE DENSE ADHESIONS WERE TAKEN DOWN. THE HERNIA DEFECT WAS IDENTIFIED AND REDUCED. A 3DMAX (DEVICE #3) AND PERFIX PLUG (DEVICE #4) WERE PLACED AND SUTURED.

  Patient problems: Adhesion(s); Fibrosis; Hernia

  MAUDE report 22084544 ↗
• InjuryMay 14, 2025Migration; Migration

  AS ALLEGED, THE PATIENT WAS IMPLANTED WITH PERFIX PLUG EXTRA LARGE ON (B)(6) 2013 DURING A HERNIA REPAIR. ALLEGEDLY, THE MESH "FAILED AND HAS CAUSED MANY PROBLEMS IN THE PAST FEW YEARS." "IT IS DETERIORATED MY HEALTH. THE PATCHES COME LOOSE PARTS OF IT IS MISSING SO THEREFORE IT'S IN BODY FLOATING AROUND. THE REST OF IT IS FOLDED OVER ON ITSELF AND HAS COME AWAY FROM THE ORIGINAL REPAIR AREA. AND NOW THERE ARE TWO HERNIAS UNDERNEATH THE OLD HERNIA PATCH. I HAVE HAD CT SCANS AND X-RAYS OF THIS, AND IT SHOWS CLEARLY WHAT IS GOING ON." "I'VE BEEN SUFFERING FOR MORE THAN 10 YEARS AFTER PATCH FAILED. I'M UNABLE TO WORK. I'M IN CONSTANT PAIN. I CANNOT WALK MORE THAN A CITY BLOCK WITHOUT CRAMPING OR SO SORE THAT IT BECOMES IMPOSSIBLE."

  Patient problems: Hernia; Pain

  MAUDE report 22019291 ↗
• InjuryMar 31, 2025Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  PER MEDICAL RECORDS: (B)(6) 2015- PATIENT WAS DIAGNOSED WITH SYMPTOMATIC RIGHT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF BARD PRESHAPED MESH (DEVICE #1) AND PERFIX PLUG (DEVICE #2). PER OPERATIVE NOTES, ¿A LARGE DEEP DIRECT HERNIA SAC WAS REDUCED. AN EXTRA-LARGE PERFIX PLUG (DEVICE #1) WAS SUTURED TO SHELVING EDGE OF POUPART¿S LIGAMENT INFERIORLY AND PUBIC TUBERCLE MEDIALLY AND UNDERNEATH THE CONJOINT TENDON. THE ONLAY BARD PRESHAPED PATCH (DEVICE #2) WAS PLACED AND SUTURED.¿ (B)(6) 2015- PATIENT WAS DIAGNOSED WITH RECURRENT SYMPTOMATIC RIGHT INGUINAL HERNIA THEREBY UNDERWENT ROBOTIC REPAIR WITH THE PARTIAL REMOVAL OF MESH (DEVICE #2). PER OPERATIVE NOTES, ¿THERE WAS A SMALL LEFT INDIRECT AND DIRECT INGUINAL HERNIA. THERE WAS A RECURRENT RIGHT DIRECT INGUINAL HERNIA. PREVIOUS MESH (DEVICE #2) WAS ENCOUNTERED. THE MARLEX MESH (DEVICE #2) WAS NOT DISSECTED OUT COMPLETELY. THE HERNIA WAS REDUCED AND CLOSED USING SUTURE. THE DEFECT WAS REINFORCED WITH A MEDIUM 3DMAX MESH (DEVICE #3). A NOTCH WAS CUT OUT TO INCORPORATE THE PREVIOUS MESH AS WELL AS KEYHOLE (DEVICE #1) REPAIR. THE MESH COVERED THE DEFECT COMPLETELY.¿ ATTORNEY ALLEGES THAT THE PATIENT HAD PAIN, HERN

  Patient problems: Hernia

  MAUDE report 21729220 ↗
• InjuryNov 19, 2024Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  PER ADDITIONAL INFORMATION PROVIDED: (B)(6) 2006 - PATIENT WAS DIAGNOSED WITH REDUCIBLE LEFT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF KUGEL PATCH (DEVICE #1) AND PERFIX PLUG(DEVICE #2) . PER OPERATIVE NOTES, ¿THERE WAS A LARGE DIRECT DEFECT ENCOMPASSING THE ENTIRE FLOOR OF THE INGUINAL CANAL. A KUGEL PATCH (DEVICE #1) WAS PLACED IN THE PREPERITONEAL SPACE, AND THE REPAIR WAS REINFORCED WITH A KEYHOLE MESH (PERFIX PLUG ¿ DEVICE #2) LAID ACROSS TRANSVERSALIS FASCIA. THE MESH WAS SECURED LATERALLY TO THE SHELVING EDGE OF THE INGUINAL LIGAMENT AND MEDIALLY TO THE CONJOINED TENDON.¿ (B)(6) 2007 - PATIENT WAS DIAGNOSED WITH CHRONIC LEFT INGUINAL PAIN THEREBY UNDERWENT OPEN REPAIR WITH REMOVAL OF MESH (DEVICE #1 & #2). PER OPERATIVE NOTES, ¿ THE PREVIOUSLY PLACED MESH (DEVICE #1, #2) WAS DENSELY ADHERENT TO THE PREPERITONEAL TISSUES AND HAD MEDIATED A DENSE INFLAMMATORY REACTION ALONG THE ENTIRE LENGTH OF THE INGUINAL FLOOR. THIS WAS DISSECTED FREE AND SEPARATED THE MESH OFF THE UNDERLYING FATTY TISSUE. THE MESH WAS REMOVED COMPLETELY FROM THE PERITONEAL SPACE.¿ ATTORNEY ALLEGES THAT THE PATIENT HAD ADHESIONS, PAIN, NERVE DAMAGE AND HERNIA RECURRENCE.

  Patient problems: Adhesion(s); Inflammation; Pain

  MAUDE report 20723720 ↗
• InjuryOct 1, 2024Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  PER INFORMATION PROVIDED BY PATIENT'S ATTORNEY: ON (B)(6) 2000 - PATIENT WAS DIAGNOSED WITH REDUCIBLE RIGHT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF TWO PERFIX PLUG (DEVICE #1 & #2). PER OPERATIVE NOTES ¿A LARGE DIRECT INGUINAL HERNIA WAS IDENTIFIED, CONTINUOUS WITH THE INTERNAL RING WITH A PANTALOON TYPE HERNIA. THIS WAS EASILY REDUCED AND SECURED TWO LARGE PERFIX PLUGS TOGETHER WITH SUTURES TO FILL THE DEFECT. THE ONLAY MESH WAS THEN SECURED WITH SUTURE.¿ ON (B)(6) 2000 - PATIENT WAS DIAGNOSED WITH REDUCIBLE LEFT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF TWO PERFIX PLUG (DEVICE #3 & #4). PER OPERATIVE NOTES ¿A LARGE DIRECT/INDIRECT INGUINAL HERNIA WAS IDENTIFIED CONSISTENT WITH A PANTALOON TYPE HERNIA. TWO EXTRA-LARGE PERFIX PLUGS WERE THEN SUTURED TO EACH OTHER AND PLACED TO FILL IN THE DEFECT. A PIECE OF ONLAY MESH WAS THEN USED TO REINFORCE AND SUTURED IN PLACE.¿ ON (B)(6) 2016 - PATIENT WAS DIAGNOSED WITH ABSCESS, RECURRENT BILATERAL INGUINAL HERNIA WITH OBSTRUCTION. ON (B)(6) 2016 - PATIENT WAS DIAGNOSED WITH RECURRENT BILATERAL INGUINAL HERNIA, MESH INFECTION AND LEFT INGUINAL ABSCESS THEREBY UNDERWENT REPAIR WITH BILATERAL MESH EXPL

  Patient problems: Bacterial Infection; Bowel Perforation; Erosion; Fistula; Hernia; Obstruction/Occlusion

  MAUDE report 20345759 ↗
• InjuryOct 1, 2024Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  PER INFORMATION PROVIDED BY PATIENT'S ATTORNEY: (B)(6) 2000 - PATIENT WAS DIAGNOSED WITH REDUCIBLE RIGHT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF TWO PERFIX PLUG (DEVICE #1 & #2). PER OPERATIVE NOTES ¿A LARGE DIRECT INGUINAL HERNIA WAS IDENTIFIED, CONTINUOUS WITH THE INTERNAL RING WITH A PANTALOON TYPE HERNIA. THIS WAS EASILY REDUCED AND SECURED TWO LARGE PERFIX PLUGS TOGETHER WITH SUTURES TO FILL THE DEFECT. THE ONLAY MESH WAS THEN SECURED WITH SUTURE.¿ (B)(6) 2000 - PATIENT WAS DIAGNOSED WITH REDUCIBLE LEFT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF TWO PERFIX PLUG (DEVICE #3 & #4). PER OPERATIVE NOTES ¿A LARGE DIRECT/INDIRECT INGUINAL HERNIA WAS IDENTIFIED CONSISTENT WITH A PANTALOON TYPE HERNIA. TWO EXTRA-LARGE PERFIX PLUGS WERE THEN SUTURED TO EACH OTHER AND PLACED TO FILL IN THE DEFECT. A PIECE OF ONLAY MESH WAS THEN USED TO REINFORCE AND SUTURED IN PLACE.¿ (B)(6) 2016 - PATIENT WAS DIAGNOSED WITH ABSCESS, RECURRENT BILATERAL INGUINAL HERNIA WITH OBSTRUCTION. (B)(6) 2016 - PATIENT WAS DIAGNOSED WITH RECURRENT BILATERAL INGUINAL HERNIA, MESH INFECTION AND LEFT INGUINAL ABSCESS THEREBY UNDERWENT REPAIR WITH BILATERAL MESH EXPLANT (DEVICE

  Patient problems: Bacterial Infection; Bowel Perforation; Erosion; Fistula; Hernia; Obstruction/Occlusion

  MAUDE report 20345735 ↗
• InjuryJan 30, 2023Defective 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) 2012. 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: Hernia; Insufficient Information; Scar Tissue

  MAUDE report 16262839 ↗
• InjuryJan 23, 2023Defective 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) 2015. 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 SUSTAINED PERSONAL INJURY, EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Hernia; Insufficient Information

  MAUDE report 16224427 ↗
• InjuryNov 8, 2022Defective 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 MARLEX MESH (BARD FLAT MESH) AND VENTRALEX HERNIA PATCH ON (B)(6) 2007 AND/OR (B)(6) 2021. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE 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: Hernia; Insufficient Information; Scar Tissue

  MAUDE report 15751786 ↗
• InjuryJul 28, 2022Defective 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 PERFIX 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 15122399 ↗
• InjuryJun 17, 2022Defective Device; Material Deformation; Patient Device Interaction Problem; Defective Device; Material Deformation; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT THE PATIENT WAS IMPLANTED WITH THE BARD/DAVOL PERFIX PLUG AND NON-BARD/DAVOL MESH, COLLECTIVELY KNOWN AS "MESH PRODUCTS". ATTORNEY ALLEGES THAT THE PATIENT WAS IMPLANTED WITH A NON-BARD/DAVOL MESH TO REPAIR A HERNIA IN THE RIGHT LOWER QUADRANT ON OR ABOUT (B)(6) 2012. IT IS ALLEGED THAT AS A DIRECT AND PROXIMATE RESULT OF DEFENDANTS¿ DEFECTIVE DESIGN, MANUFACTURE, MARKETING, DISTRIBUTION, AND/OR SALE OF NON-BARD/DAVOL MESH AND THE PERFIX PLUGS AND PLACING THE DEFECTIVE PRODUCTS INTO THE STREAM OF COMMERCE, THE PATIENT HAS BEEN INJURED AND DAMAGED AS FOLLOWS: IT IS ALLEGED THAT ON (B)(6) 2013, THE PATIENT UNDERWENT REVISION OF THE NON-BARD/DAVOL MESH. IT IS ALLEGED THAT ON OR ABOUT (B)(6) 2013, THE PATIENT UNDERWENT REVISION OF THE NON-BARD/DAVOL MESH, UNDERWENT RIGHT ABDOMINAL HERNIA REPAIR AND WAS IMPLANTED WITH TWO BARD/DAVOL PERFIX PLUGS. IT IS ALSO ALLEGED THAT ON OR ABOUT ON OR ABOUT (B)(6) 2017, THE PATIENT UNDERWENT REMOVAL OF THE MESH PRODUCTS, RIGHT LOWER QUADRANT HERNIA REPAIR AND WAS IMPLANTED WITH A THIRD BARD/DAVOL PERFIX PLUG. IT IS ALLEGED THAT THE PATIENT UNDERWENT REVISION OF THE PERFIX PLUG ON OR ABOUT (B)(6) 2018 AND ON OR ABOUT (B)(6) 2019.

  Patient problems: Adhesion(s); Hernia; Pain; Seroma

  MAUDE report 14738536 ↗
• InjuryJun 17, 2022Defective Device; Material Deformation; Patient Device Interaction Problem; Defective Device; Material Deformation; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT THE PATIENT WAS IMPLANTED WITH THE BARD/DAVOL PERFIX PLUG AND NON-BARD/DAVOL MESH, COLLECTIVELY KNOWN AS "MESH PRODUCTS". ATTORNEY ALLEGES THAT THE PATIENT WAS IMPLANTED WITH A NON-BARD/DAVOL MESH TO REPAIR A HERNIA IN THE RIGHT LOWER QUADRANT ON OR ABOUT (B)(6) 2012. IT IS ALLEGED THAT AS A DIRECT AND PROXIMATE RESULT OF DEFENDANTS¿ DEFECTIVE DESIGN, MANUFACTURE, MARKETING, DISTRIBUTION, AND/OR SALE OF NON-BARD/DAVOL MESH AND THE PERFIX PLUGS AND PLACING THE DEFECTIVE PRODUCTS INTO THE STREAM OF COMMERCE, THE PATIENT HAS BEEN INJURED AND DAMAGED AS FOLLOWS: IT IS ALLEGED THAT ON (B)(6) 2013, THE PATIENT UNDERWENT REVISION OF THE NON-BARD/DAVOL MESH. IT IS ALLEGED THAT ON OR ABOUT (B)(6) 2013, THE PATIENT UNDERWENT REVISION OF THE NON-BARD/DAVOL MESH, UNDERWENT RIGHT ABDOMINAL HERNIA REPAIR AND WAS IMPLANTED WITH TWO BARD/DAVOL PERFIX PLUGS. IT IS ALSO ALLEGED THAT ON OR ABOUT ON OR ABOUT (B)(6) 2017, THE PATIENT UNDERWENT REMOVAL OF THE MESH PRODUCTS, RIGHT LOWER QUADRANT HERNIA REPAIR AND WAS IMPLANTED WITH A THIRD BARD/DAVOL PERFIX PLUG. IT IS ALLEGED THAT THE PATIENT UNDERWENT REVISION OF THE PERFIX PLUG ON OR ABOUT (B)(6) 2018 AND ON OR ABOUT (B)(6) 2019.

  Patient problems: Adhesion(s); Hernia; Pain; Seroma

  MAUDE report 14738515 ↗
• InjuryJun 8, 2022Defective Device; Patient Device Interaction Problem; Migration; Defective Device; Patient Device Interaction Problem; Migration

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF TWO UNSPECIFIED BARD/DAVOL PERFIX PLUGS ON (B)(6) 2004 AND (B)(6) 2008. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST BOTH DEVICES. IT IS ALLEGED THAT THE PATIENT SUSTAINED INJURIES ON (B)(6) 2021. 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: Abscess; Adhesion(s); Erosion; Fistula; Inflammation; Insufficient Information; Pain

  MAUDE report 14629693 ↗
• InjuryMay 21, 2022Defective Device; Patient Device Interaction Problem; Migration; Defective Device; Patient Device Interaction Problem; Migration

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL PERFIX PLUG ON (B)(6) 2002. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST PERFIX PLUG. IT IS ALLEGED THAT THE PATIENT HAD REVISION SURGERY ON (B)(6) 2019. 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); Hernia; Insufficient Information; Pain

  MAUDE report 14466878 ↗
• InjuryMar 14, 2022Defective 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) 2020. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST PERFIX 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; Scar Tissue

  MAUDE report 13757046 ↗
• InjuryMar 8, 2022Defective 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 LIGHT PLUG AND PERFIX PLUG ON (B)(6) 2008 AND/OR (B)(6) 2012. 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: Hernia; Insufficient Information; Scar Tissue

  MAUDE report 13693244 ↗
• DeathFeb 11, 2022Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT ON OR ABOUT (B)(6) 2000, THE PATIENT UNDERWENT RIGHT INGUINAL HERNIA REPAIR USING A MARLEX (PERFIX) PLASTIC PLUG. IT IS ALLEGED THAT ON OR ABOUT (B)(6) 2014, THE PATIENT UNDERWENT LEFT INGUINAL HERNIA REPAIR AND PERFIX PLUG WAS IMPLANTED. IT IS ALLEGED THAT THE PATIENT WAS SUFFERING FROM THIS HERNIA ON THE LEFT SIDE FOR ROUGHLY TWO YEARS. PER LEGAL CLAIM, ON OR ABOUT (B)(6) 2020, THE PATIENT, A MASSAGE THERAPIST, WAS IN THE PROCESS OF GIVING A CLIENT A MESSAGE WHEN HE SUDDENLY STOPPED WORKING BECAUSE HE FELT A CRAMP ON HIS SIDE. WITHIN 2-3 SECONDS, THE PATIENT SUDDENLY FELL BACKWARDS AND COLLAPSED ONTO THE FLOOR. AT THIS TIME THE PATIENT TOLD HIS CLIENT HE WAS FEELING PAIN IN THE SIDE OF HIS STOMACH. IT IS ALLEGED 3-4 MINUTES AFTER THE COLLAPSE, THE PATIENT STOPPED TALKING AND BECOME UNRESPONSIVE. THE PATIENT REGAINED CONSCIOUSNESS AND THAT DURING INTERACTION WITH FIRST RESPONDERS, THE PATIENT ONCE AGAIN FELL UNCONSCIOUS AND CPR WAS ADMINISTERED. THE PATIENT REGAINED A PULSE WHILE IN TRANSPORT TO HOSPITAL, HOWEVER THE PATIENT WAS LATER PRONOUNCED DEAD. ACCORDING TO THE PATIENT¿S WIFE, THE PATIENT WAS FEELING WELL THE NIGHT BEFORE AND THE MORNING OF HIS PASSING

  Patient problems: Bowel Perforation; Unspecified Infection

  MAUDE report 13518286 ↗