PerFix 0112970Recalls & reported problems

Summary

The FDA's MAUDE database contains 228 adverse event reports that list this exact device (DI 00801741016677), received between Feb 27, 2014 and Jun 23, 2026 — classified as 1 death, 226 injuries, 1 malfunction.

The most frequently reported specific device problem is “Defective Device” (192 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 228 reports, in the reporter's own words as published by the FDA.

• InjuryJun 23, 2026Migration

  PER INFORMATION PROVIDED: (B)(6) 2014 - PATIENT WAS DIAGNOSED WITH RECURRENT BILATERAL INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF FOUR PERFIX PLUGS (DEVICE 1, 2, 3 AND 4). PER OP NOTES, "ATTENTION TO THE RIGHT SIDE, TWO PERFIX PLUGS (DEVICE 1 AND 2) WERE PLACED TO THE PREPERITONEAL SPACE USING SUTURES. SIMILAR PROCEDURE WAS THEN DONE ON THE LEFT SIDE, TWO PERFIX PLUGS (DEVICE 3 AND 4) WERE PLACED USING SUTURES." ATTORNEY ALLEGES THAT THE PATIENT HAD MESH MIGRATION, PAIN AND SUFFERING. IT WAS ALSO ALLEGED THAT THE MESH HAS MIGRATE TO THE SURFACE OF THE SKIN AND CONSTANT PAIN.

  Patient problems: Pain

  MAUDE report 25590282 ↗
• InjuryApr 29, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 1999- PATIENT WAS DIAGNOSED WITH LEFT INGUINAL HERNIA THEREBY UNDERWENT REPAIR IMPLANT OF PERFIX PLUGS (DEVICE 1 AND 2). (NOTE: THERE IS NO OPERATIVE NOTES PROVIDED FOR THIS PROCEDURE). (B)(6) 2004 - PATIENT WAS DIAGNOSED WITH RECURRENT LEFT INGUINAL HERNIA, THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH EXPLANT OF PERFIX PLUGS (DEVICE 1 AND 2), IMPLANT OF SYNTHETIC MESH. PER OP NOTES, ¿THE PERFIX PLUGS (DEVICE 1 AND 2) WERE IN GOOD POSITION AND THE RECURRENT HERNIA COULD BE JUST LATERAL TO THE PUBIC TUBERCLE BUT MEDIAL TO PREVIOUS PLUG. THE PERFIX PLUG (DEVICE 1) WAS COMPLETELY EXCISED AND A PERFIX PLUG (DEVICE 2) WAS PARTIALLY EXCISED AND THE REMAINING MESH WAS SUTURED. A SYNTHETIC MESH WAS PLACED IN THE ABDOMINAL CAVITY AND SUTURED¿.

  Patient problems: Hernia

  MAUDE report 25026149 ↗
• InjuryApr 6, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2013 - PATIENT WAS DIAGNOSED WITH BILATERAL INGUINAL HERNIAS THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF TWO PERFIX PLUGS (DEVICE 1 AND 2). PER OP NOTES, "TWO PERFIX PLUGS AND PATCH (DEVICE 1 AND 2) WERE PLACED ON BOTH RIGHT AND LEFT SIDE OF THE INGUINAL FLOOR." (B)(6) 2021 - PATIENT WAS DIAGNOSED WITH BILATERAL INGUINAL HERNIA THEREBY UNDERWENT ROBOTIC REPAIR WITH THE IMPLANT OF TWO 3DMAX MESHES (DEVICE 3 AND 4). PER OP NOTES, "THERE WERE BILATERAL INDIRECT INGUINAL HERNIAS, BOTH INDIRECT INGUINAL HERNIAS WERE REDUCED. PREVIOUS PLUGS WERE NOTICED, TWO 3DMAX MESHES (DEVICE 3 AND 4) WERE PLACED INTO THE PREPERITONEAL SPACE ON BOTH SIDES."

  Patient problems: Hernia

  MAUDE report 24787322 ↗
• InjuryApr 2, 2026Migration

  PER INFORMATION PROVIDED: ON (B)(6) 2008 - PATIENT WAS DIAGNOSED WITH BILATERAL INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF TWO PERFIX PLUGS (DEVICE 1 AND 2). PER OPERATIVE NOTES, "IN THE RIGHT INGUINAL AREA, THE LARGE DIRECT HERNIA WITH SAC WAS DISSECTED DOWN TO THE HERNIA WITH PERITONEAL FAT. THE HERNIA SAC AND BLADDER WALL WAS REDUCED, AND FASCIA WAS CLOSED WITH SUTURES. A LARGE PERFIX PLUG (DEVICE 1) WAS PLACED OVER THE INGUINAL FLOOR OF THE CAVITY AND SECURED WITH SUTURES. IN THE LEFT SIDE, THE DIRECT DEFECT WITH SPERMATIC CORD WAS DISSECTED AND ANOTHER LARGE PERFIX PLUG MESH (DEVICE 2) WAS PLACED AND SECURED IT TO APONEUROSIS FASCIA. THE FASCIA WAS CLOSED AND SECURED IT WITH SUTURES." ON (B)(6) 2013 - PATIENT WAS DIAGNOSED WITH RECURRENT RIGHT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH REMOVAL OF OLD MESH (DEVICE 1) AND IMPLANT OF BARD FLAT MESH (DEVICE 3). PER OPERATIVE NOTES, "THROUGH THE PRIOR REPAIR, THE SCAR TISSUES WERE EXCISED. A DIRECT HERNIA DEFECT WITH OLD MESH (DEVICE 1) PULLED AWAY SUPERIORLY AND MEDIALLY WAS NOTED. THE MESH (DEVICE 1) WAS MOBILISED AND DISSECTED FROM THE SURROUNDING TISSUES. THE PERITONEUM WAS CLOSED WITH SUTURES AND BAR

  Patient problems: Hernia

  MAUDE report 24766472 ↗
• InjuryMar 26, 2026Patient-Device Incompatibility

  PER INFORMATION RECEIVED, ON (B)(6) 2014 ¿ PATIENT WAS DIAGNOSED WITH RIGHT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF PREFIX PLUG (DEVICE 2) AND BARD FLAT MESH (DEVICE 1). PER OP NOTES, ¿A MODERATE SIZED DIRECT DEFECT WAS NOTED. A PREFIX PLUG (DEVICE 2) WAS PLACED THROUGH THE DEFECT BENEATH THE TRANSVERSALIS FASCIA USING SUTURE. A ONLAY BARD FLAT MESH (DEVICE 1) WAS PLACED AND FASTENED NEAR THE PUBIC TUBERCLE.¿ ON (B)(6) 2015 ¿ PATIENT WAS DIAGNOSED WITH CHRONIC RIGHT GROIN PAIN THEREBY UNDERWENT OPEN REPAIR WITH THE REMOVAL OF MESH (DEVICE 1). PER OP NOTES, ¿THERE WAS DENSE SCAR TISSUE AT THE LEVEL OF THE EXTERNAL OBLIQUE. THERE WAS A PALPABLE PLUG (DEVICE 2) IN THE MIDPORTION OF THE DIRECT SPACE WHICH WAS LEFT IN PLACE. A PORTION OF MESH (DEVICE 1) WAS MEDIALLY SLIGHTLY BUCKLED AND EXCISED. A SMALL DEFECT IN THE FASCIA WAS CLOSED USING SUTURES. A SMALL DEFECT IN THE FASCIA WAS CLOSED USING SUTURES. A TRIPLE NEURECTOMY WAS DONE BY FINDING ILIOHYPOGASTRIC JUST ABOVE THE MESH OVER CONJOINT TENDON AND ILIOINGUINAL AND GENITOFEMORAL NERVES. ALL NERVES WERE TRANSECTED.¿

  Patient problems: Nerve Damage; Scar Tissue

  MAUDE report 24707574 ↗
• InjuryMar 26, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2008 - PATIENT WAS DIAGNOSED WITH BILATERAL INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF PERFIX PLUG (DEVICE 1 ¿ RIGHT AND DEVICE 2 - LEFT). PER OPERATIVE NOTES, ¿AN INCISION WAS MADE ON THE RIGHT LOWER QUADRANT. THE RIGHT INGUINAL HERNIA SAC WAS DISSECTED OUT. A PERFIX PLUG (DEVICE 1) WAS PLACED ONTO THE RIGHT INGUINAL FLOOR AND SUTURES. AN INCISION WAS MADE INTO THE LEFT INGUINAL REGION. THE LEFT HERNIA SAC WAS DISSECTED OUT. A PERFIX PLUG (DEVICE 2) WAS PLACED INTO THE LEFT INGUINAL FLOOR AND SECURE IT WITH SUTURES.¿ (B)(6) 2017 - PATIENT WAS DIAGNOSED WITH SCAR TISSUE THEREBY UNDERWENT REPAIR WITH REMOVAL OF SCAR TISSUE. (B)(6) 2018 TO PRESENT - PATIENT WAS EXPERIENCING PAIN AND THEREFORE UNDERWENT PAIN MANAGEMENT.

  Patient problems: Pain; Scar Tissue

  MAUDE report 24705751 ↗
• InjuryMar 26, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) -2015 ¿ PATIENT WAS DIAGNOSED WITH RECURRENT INCARCERATED GIANT RIGHT INGUINOSCROTAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF THREE PERFIX PLUGS (DEVICE 1, 2 AND 3). PER OPERATIVE NOTES, ¿ IN THE RIGHT GROIN AREA, A LARGE HERNIA NECK WAS NOTED AND DISSECTED TO THE LEVEL OF PELVIC BRIM. THE TISSUES ADHERENT TO THE HERNIA SAC WAS DISSECTED CIRCUMFERENTIALLY. THE SAC WAS CLOSED WITH SUTURES. TWO PERFIX PLUGS (DEVICE 1 AND 2) WERE PLACED AND SUTURED TOGETHER INTO THE DEEP INGUINAL RING DEFECT. THE FLOOR WAS REINFORCED AND A LARGE PERFIX PLUG (DEVICE 3) WAS PLACED AND SUTURED IT IN PLACE IN THE INGUINAL FLOOR WITH SUTURES.¿ ON (B)(6) -2017 - PATIENT WAS DIAGNOSED WITH RECURRENT RIGHT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH REMOVAL OF PRIOR MESHES (DEVICE 1, 2 AND 3) AND IMPLANT OF SYNTHETIC MESHES. PER OPERATIVE NOTES ¿THROUGH THE PRIOR RIGHT INGUINAL REPAIR, FIBROTIC TISSUES WERE DISSECTED. HERNIA SAC AND SPERMATIC CORD WERE DISSECTED FREE FROM THE WALLS OF INGUINAL CANAL AND REDUCED. THE HERNIA SAC EXTENDED INTO THE SCROTUM AND FREED FROM SCROTAL CONTENTS. A PIECE OF INCORPORATED MESHES (DEVICE 1,2 AND 3) WAS SEEN LOOSENED AND

  Patient problems: Adhesion(s); Fibrosis; Hernia

  MAUDE report 24695685 ↗
• InjuryMar 26, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2015 ¿ PATIENT WAS DIAGNOSED WITH RECURRENT INCARCERATED GIANT RIGHT INGUINOSCROTAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF THREE PERFIX PLUGS (DEVICE 1, 2 AND 3). PER OPERATIVE NOTES, ¿IN THE RIGHT GROIN AREA, A LARGE HERNIA NECK WAS NOTED AND DISSECTED TO THE LEVEL OF PELVIC BRIM. THE TISSUES ADHERENT TO THE HERNIA SAC WAS DISSECTED CIRCUMFERENTIALLY. THE SAC WAS CLOSED WITH SUTURES. TWO PERFIX PLUGS (DEVICE 1 AND 2) WERE PLACED AND SUTURED TOGETHER INTO THE DEEP INGUINAL RING DEFECT. THE FLOOR WAS REINFORCED AND A LARGE PERFIX PLUG (DEVICE 3) WAS PLACED AND SUTURED IT IN PLACE IN THE INGUINAL FLOOR WITH SUTURES.¿ ON (B)(6) 2017 - PATIENT WAS DIAGNOSED WITH RECURRENT RIGHT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH REMOVAL OF PRIOR MESHES (DEVICE 1, 2 AND 3) AND IMPLANT OF SYNTHETIC MESHES. PER OPERATIVE NOTES ¿THROUGH THE PRIOR RIGHT INGUINAL REPAIR, FIBROTIC TISSUES WERE DISSECTED. HERNIA SAC AND SPERMATIC CORD WERE DISSECTED FREE FROM THE WALLS OF INGUINAL CANAL AND REDUCED. THE HERNIA SAC EXTENDED INTO THE SCROTUM AND FREED FROM SCROTAL CONTENTS. A PIECE OF INCORPORATED MESHES (DEVICE 1,2 AND 3) WAS SEEN LOOSENED AND ME

  Patient problems: Adhesion(s); Fibrosis; Hernia

  MAUDE report 24695683 ↗
• InjuryFeb 26, 2026Migration

  PER INFORMATION PROVIDED: (B)(6) 2016: PATIENT WAS DIAGNOSED WITH RIGHT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF PERFIX PLUG (DEVICE 1 AND 2). PER OP NOTES, ¿A DIRECT INGUINAL HERNIA DEFECT AND INGUINAL FLOOR REVEALED A FASCIAL DEFECT WERE IDENTIFIED AND REDUCED. A PERFIX PLUG (DEVICE 1) WAS PLACED IN THE DIRECT HERNIA DEFECT AND SUTURED. PERFIX PLUG (DEVICE 2) WAS PLACED IN THE FASCIAL DEFECT AND SUTURED. AN ONLAY PATCH WAS TRIMMED AND PLACED IN THE FLOOR AND SUTURED¿ . (B)(6) 2017: PATIENT WAS DIAGNOSED WITH RECURRENT RIGHT INGUINAL HERNIA THEREBY UNDERWENT REPAIR WITH MESH REVISION. PER OP NOTES, ¿TWO PRIOR PLUGS (DEVICE 1 AND 2) WERE NOTED. ONE IN THE INTERNAL RING AND ONE ON THE INGUINAL FLOOR. THICK SCAR TISSUE DOWN TO INGUINAL FLOOR WAS EXCISED. THE SCAR PERFUSED TO PRIOR MESH WAS NOTED. THE PRIOR MESH WAS MIGRATED LATERALLY AND ADHERENT TO INGUINAL LIGAMENT AND DISSECTED FREE. THE HERNIA DEFECT WAS NOTED AND REDUCED. THE PRIOR MESH WAS PULL TO THE MEDIAL ASPECT AND SUTURED TO EXTERNAL OBLIQUE TO REPAIR THE INGUINAL DEFECT AND SUTURED.¿

  Patient problems: Adhesion(s); Hernia

  MAUDE report 24454598 ↗
• InjuryFeb 5, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2014 ¿ PATIENT WAS DIAGNOSED WITH CHRONIC RIGHT GROIN PAIN, ENTRAPMENT OF ILIOINGUINAL NERVE, LEFT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF PERFIX PLUGS (LEFT ¿ DEVICE 1, 2). PER OP NOTES, ¿ON LEFT SIDE, ILIOINGUINAL NERVE WAS EXCISED. THERE WAS A LAXITY AND WEAKNESS OF THE INGUINAL FLOOR. A PIECE OF PERFIX PLUG (DEVICE 1, 2) WERE PLACED OVER THE INGUINAL FLOOR AND SECURED TO CONJOINT TENDON, SHELVING EDGE USING SUTURES. ON RIGHT SIDE, THE PLANES WERE CONSISTENT WITH SCARRING AND INFECTION. THE NERVE AND PORTION OF OLD MESH WAS EXCISED. THE REMAINDER OF MESH WAS INCORPORATED INTO SURROUNDING TISSUE. THE MODERATE SIZED DEFECT WAS NOTED.¿ (NOTE: THE MESH REMOVED FROM RIGHT INGUINAL SIDE IN THIS PROCEDURE WAS UNKNOWN) (B)(6) 2014 ¿ PATIENT HAD INFLAMMATION, SCAR TISSUE, ADHESION THEREBY UNDERWENT OPEN REPAIR WITH THE REMOVAL OF MESHES (DEVICE 1, 2). PER OP NOTES, ¿ON LEFT SIDE, SCAR TISSUE WAS FREED. THE UNDERLYING MESH (DEVICE 1, 2) WAS EXCISED FROM ADHERENT SCAR TISSUE. ON RIGHT GROIN, SCAR TISSUE WAS EXCISED. THE UNKNOWN MESH WAS RETRACTED IN ANTERIOR FASHION. THE UNKNOWN MESH AND OVERLYING BALLED UP MESH NEAR PUBIC TUBERCLE

  Patient problems: Adhesion(s); Inflammation; Scar Tissue

  MAUDE report 24266564 ↗
• InjuryFeb 4, 2026Material Deformation

  PER INFORMATION PROVIDED: (B)(6) 2013 ¿ PATIENT WAS DIAGNOSED WITH RIGHT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF TWO PERFIX PLUGS (DEVICE 1 AND 2). PER OPERATIVE NOTES, ¿A LARGE DIRECT INGUINAL HERNIA WITH INDIRECT COMPONENT WAS NOTED. A LARGE DEFECT WAS DISSECTED FREE, PLACED BACK INTO THE ABDOMINAL CAVITY. AN EXTRA-LARGE PERFIX PLUG (DEVICE 1) WAS PLACED AND SUTURED IN PLACE TO CONJOINED TENDON. THE INTERNAL RING WAS SLIGHTLY LOOSENED AND ANOTHER LARGE PERFIX PLUG (DEVICE 2) WAS PLACED AND SUTURED IN PLACE TO THE INTERNAL RING ALONG WITH PRIOR MESH (DEVICE 1) ITSELF. THE FASCIA WAS CLOSED AND SUTURED CIRCUMFERENTIALLY.¿ (B)(6) 2020 - PATIENT WAS DIAGNOSED WITH RIGHT LOWER QUADRANT PAIN AND MESHOMA THEREBY UNDERWENT ROBOTIC ASSISTED LAPAROSCOPIC REPAIR WITH REMOVAL OF MESHES (DEVICE 1 AND 2) AND IMPLANT OF 3DMAX MESH (DEVICE 3). PER OPERATIVE NOTES, ¿THE MESH PLUGS (DEVICE 1 AND 2) WITH SIGNS OF CHRONIC INFLAMMATION WERE NOTED. THE EXTENSIVE SCAR TISSUE AND SMALL BOWEL AND COLON WERE DISSECTED AWAY FROM THE MESH PLUGS (DEVICE 1 AND 2). THE MESHES (DEVICE 1 AND 2) WERE REMOVED CAREFULLY AND FASCIA WAS CLOSED WITH SUTURES. TO THE FASCIAL DEFECT A RIGHT SIDED, 3

  Patient problems: Inflammation; Pain; Scar Tissue

  MAUDE report 24256466 ↗
• InjuryDec 26, 2025Material Deformation; Material Deformation

  PER INFORMATION PROVIDED: ON (B)(6) 2018- PATIENT WAS DIAGNOSED WITH DIRECT RIGHT INGUINAL HERNIA, THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF PERFIX PLUG (DEVICE 1). PER OP NOTES, ¿A DIRECT RIGHT INGUINAL HERNIA WAS NOTED AND DISSECTED. A PERFIX PLUG (DEVICE 1) WAS PLACED ON THE FLOOR AND SUTURED¿. ON (B)(6) 2018 - PATIENT WAS DIAGNOSED WITH RECURRENT RIGHT INGUINAL HERNIA, THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF PERFIX PLUGS (DEVICE 2 AND 3). PER OP NOTES, ¿SCAR TISSUE WAS IDENTIFIED. RECURRENT HERNIA WAS FOUND ATTACHED LATERALLY TO THE PREVIOUS PLACED PERFIX PLUG (DEVICE 1). THERE WAS A LARGE DIRECT RECURRENT INGUINAL HERNIA WHICH WAS THEN DISSECTED. A PERFIX PLUGS (DEVICE 2 AND 3) WERE PLACED ON THE DEFECTS AND WAS SUTURED¿. ON (B)(6) 2019- PATIENT WAS DIAGNOSED WITH RECURRENT RIGHT INGUINAL HERNIA, THEREBY UNDERWENT OPEN REPAIR WITH EXPLANT OF PERFIX PLUGS (DEVICE 1, 2 AND 3) AND IMPLANT OF PERFIX PLUG (DEVICE 4). PER OP NOTES, ¿EXCESSIVE SCARRING WAS NOTED AND DISSECTED. TWO ROLLED MESHES ONE ATTACHED TO LATERAL PORTION OF URINARY BLADDER WAS IDENTIFIED. PERFIX PLUGS (DEVICE 1, 2 AND 3) WERE EXCISED. PERFIX PLUG (DEVICE 4) WAS PLACED AND SUTURED.¿

  Patient problems: Hernia; Scar Tissue

  MAUDE report 23897314 ↗
• InjuryOct 29, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2005 ¿ PATIENT WAS DIAGNOSED WITH BILATERAL INGUINAL HERNIA AND UMBILICAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF FOUR PERFIX PLUGS (DEVICE 1, 2, 3 AND 4) AND VENTRALEX MESH (DEVICE 5). PER OPERATIVE NOTES, ¿IN THE RIGHT GROIN, LARGE SIZED DIRECT INGUINAL HERNIA WAS DISSECTED FREE FROM FASCIA AND TWO LARGE PERFIX PLUGS (DEVICE 1 AND 2) WAS PLACED AND SUTURED IN POSITION. ON LEFT SIDE, IDENTICAL PROCEDURE WAS FOLLOWED AND ANOTHER TWO LARGE PERFIX PLUG MESH (DEVICE 3 AND 4) WAS PLACED. IN UMBILICAL HERNIA, HERNIA SAC IN INFRAUMBILICAL AREA WAS DISSECTED AND VENTRALEX MESH (DEVICE 5) WAS PLACED AND SUTURED.¿ (B)(6) 2008 ¿ PATIENT WAS DIAGNOSED WITH RECURRENT RIGHT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH REMOVAL OF MESH (DEVICE 1 AND 2) AND IMPLANT OF SYNTHETIC MESH. PER OPERATIVE NOTES, ¿SIGNIFICANT SCARRING WITH LARGE MEDIAL HERNIA DEFECT WAS IDENTIFIED. THE MESH (DEVICE 1 AND 2) WAS DISSECTED FREE FROM THE CORD STRUCTURES AND RECURRENT HERNIA WAS CLOSED AND SYNTHETIC MESH WAS PLACED AND SUTURED.¿ (B)(6) 2009 ¿ PATIENT WAS DIAGNOSED WITH RECURRENT BILATERAL INGUINAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF T

  Patient problems: Hernia

  MAUDE report 23412908 ↗
• InjuryOct 29, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2005 ¿ PATIENT WAS DIAGNOSED WITH BILATERAL INGUINAL HERNIA AND UMBILICAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF FOUR PERFIX PLUGS (DEVICE 1, 2, 3 AND 4) AND VENTRALEX MESH (DEVICE 5). PER OPERATIVE NOTES, ¿IN THE RIGHT GROIN, LARGE SIZED DIRECT INGUINAL HERNIA WAS DISSECTED FREE FROM FASCIA AND TWO LARGE PERFIX PLUGS (DEVICE 1 AND 2) WAS PLACED AND SUTURED IN POSITION. ON LEFT SIDE, IDENTICAL PROCEDURE WAS FOLLOWED AND ANOTHER TWO LARGE PERFIX PLUG MESH (DEVICE 3 AND 4) WAS PLACED. IN UMBILICAL HERNIA, HERNIA SAC IN INFRAUMBILICAL AREA WAS DISSECTED AND VENTRALEX MESH (DEVICE 5) WAS PLACED AND SUTURED.¿ (B)(6) 2008 ¿ PATIENT WAS DIAGNOSED WITH RECURRENT RIGHT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH REMOVAL OF MESH (DEVICE 1 AND 2) AND IMPLANT OF SYNTHETIC MESH. PER OPERATIVE NOTES, ¿SIGNIFICANT SCARRING WITH LARGE MEDIAL HERNIA DEFECT WAS IDENTIFIED. THE MESH (DEVICE 1 AND 2) WAS DISSECTED FREE FROM THE CORD STRUCTURES AND RECURRENT HERNIA WAS CLOSED AND SYNTHETIC MESH WAS PLACED AND SUTURED.¿ (B)(6) 2009 ¿ PATIENT WAS DIAGNOSED WITH RECURRENT BILATERAL INGUINAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF T

  Patient problems: Hernia

  MAUDE report 23412877 ↗
• InjuryOct 29, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2005 ¿ PATIENT WAS DIAGNOSED WITH BILATERAL INGUINAL HERNIA AND UMBILICAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF FOUR PERFIX PLUGS (DEVICE 1, 2, 3 AND 4) AND VENTRALEX MESH (DEVICE 5). PER OPERATIVE NOTES, ¿IN THE RIGHT GROIN, LARGE SIZED DIRECT INGUINAL HERNIA WAS DISSECTED FREE FROM FASCIA AND TWO LARGE PERFIX PLUGS (DEVICE 1 AND 2) WAS PLACED AND SUTURED IN POSITION. ON LEFT SIDE, IDENTICAL PROCEDURE WAS FOLLOWED AND ANOTHER TWO LARGE PERFIX PLUG MESH (DEVICE 3 AND 4) WAS PLACED. IN UMBILICAL HERNIA, HERNIA SAC IN INFRAUMBILICAL AREA WAS DISSECTED AND VENTRALEX MESH (DEVICE 5) WAS PLACED AND SUTURED.¿ (B)(6) 2008 ¿ PATIENT WAS DIAGNOSED WITH RECURRENT RIGHT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH REMOVAL OF MESH (DEVICE 1 AND 2) AND IMPLANT OF SYNTHETIC MESH. PER OPERATIVE NOTES, ¿SIGNIFICANT SCARRING WITH LARGE MEDIAL HERNIA DEFECT WAS IDENTIFIED. THE MESH (DEVICE 1 AND 2) WAS DISSECTED FREE FROM THE CORD STRUCTURES AND RECURRENT HERNIA WAS CLOSED AND SYNTHETIC MESH WAS PLACED AND SUTURED.¿ (B)(6) 2009 ¿ PATIENT WAS DIAGNOSED WITH RECURRENT BILATERAL INGUINAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF T

  Patient problems: Hernia; Pain; Scar Tissue

  MAUDE report 23412281 ↗
• InjuryAug 29, 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 22920818 ↗
• InjuryJun 23, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2013 - PATIENT WAS DIAGNOSED WITH BILATERAL RIGHT FEMORAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF TWO PERFIX PLUG MESH (DEVICE #1 AND DEVICE #2). PER OPERATIVE NOTES, ¿TWO PERFIX PLUG MESH (DEVICE #1 AND DEVICE #2) WAS PLACED AND SUTURED.¿ (B)(6) 2017 - PATIENT WAS DIAGNOSED WITH RIGHT FEMORAL HERNIA RECURRENCE, ADHESION THEREBY UNDERWENT OPEN REPAIR WITH EXPLANT OF TWO PERFIX PLUG MESH (DEVICE #1 AND DEVICE #2), LYSIS OF ADHESION. PER OPERATIVE NOTES, ¿TWO PERFIX PLUG MESH (DEVICE #1 AND DEVICE #2) WAS REMOVED.¿

  Patient problems: Adhesion(s); Hernia

  MAUDE report 22305673 ↗
• InjuryJun 6, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2013 - PATIENT WAS DIAGNOSED WITH BILATERAL INGUINAL HERNIAS THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF BARD FLAT MESH (DEVICE #1) FOR RIGHT INGUINAL HERNIA AND PERFIX PLUG (DEVICE #2) FOR LEFT INGUINAL HERNIA. PER OPERATIVE NOTES, "ON LEFT SIDE, AN INDIRECT HERNIA WAS DISSECTED FROM CORD STRUCTURES. AN PERFIX PLUG ONLAY PATCH (DEVICE #2) WAS PLACED AND SUTURED. ON RIGHT SIDE, A LARGE INDIRECT HERNIA SAC WAS NOTED AND EXCISED. PERFIX PLUG (DEVICE #2) WAS PLACED INTO THE DEFECT, AND A BARD FLAT MESH (DEVICE #1) AND WAS PLACED OVER THE FLOOR AND SUTURED." (B)(6) 2016 - PATIENT RECURRENT RIGHT INGUINAL HERNIA GOT POSTPONED DUE TO THE RISK OF SUDDEN CARDIAC DEATH ASSOCIATED WITH BRUGADA SYNDROME. (B)(6) 2018 - PATIENT WAS DIAGNOSED WITH RECURRENT BILATERAL INGUINAL HERNIAS AND GROIN PAIN AND UMBILICAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT OF 3DMAX MESH (DEVICE #3, #4). PER OPERATIVE NOTES, "ON LEFT SIDE, A DIRECT INGUINAL HERNIA WAS NOTED. THERE IS NO EVIDENCE OF PRIOR MESH. A 3DMAX MESH (DEVICE #4) WAS PLACED AND TACKED. ON RIGHT SIDE, A LARGE DIRECT HERNIA WAS NOTED WITH PREVIOUS MESH PLUG IN INTERNAL RING ADHERENT TO VA

  Patient problems: Adhesion(s); Hernia

  MAUDE report 22160571 ↗
• InjuryJun 4, 2025Patient-Device Incompatibility; Migration; Patient-Device Incompatibility; Migration

  PER INFORMATION PROVIDED: (B)(6) 2011 - PATIENT WAS DIAGNOSED WITH BILATERAL INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF PERFIX PLUG (DEVICE #1 & #2). PER OPERATIVE NOTES, ¿THE LARGE HERNIA SAC WAS IDENTIFIED IN RIGHT INGUINAL REGION AND DISSECTED. A PERFIX PLUG (DEVICE #1) WAS PLACED AND SUTURED. THE SAME PROCEDURE WAS PERFORMED AT LEFT INGUINAL REGION AND IMPLANTED WITH PERFIX PLUG (DEVICE #2).¿ (B)(6) 2017 - PATIENT WAS DIAGNOSED WITH RECURRENT BILATERAL INGUINAL HERNIA WITH PAIN THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH PARTIAL EXCISION OF MESH (DEVICE #1) AND COMPLETE EXCISION OF MESH (DEVICE #2) WITH IMPLANT OF 3D MAX (DEVICE #3 & #4). PER OPERATIVE NOTES, ¿THE PLUG IN RIGHT SIDE EXPANDING TO THE DIRECT SPACE WAS PARTIALLY REMOVED, REMAINING PORTION ADHERENT TO FASCIA WAS LEFT IN PLACE. THE HERNIA DEFECT WAS REPAIRED WITH A LARGE 3D MAX (DEVICE #3) AND TACKED. THE PLUG ON LEFT SIDE MIGRATED TO PUBIC BONE WAS REMOVED ENTIRELY. A DIRECT HERNIA WAS REPAIRED WITH A 3D MAX (DEVICE #4) AND TACKED.¿

  Patient problems: Hernia; Pain

  MAUDE report 22139604 ↗
• InjuryJun 4, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2015 ¿ PATIENT WAS DIAGNOSED WITH LEFT INGUINAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC CONVERTED INTO OPEN REPAIR WITH IMPLANT OF PERFIX PLUG (DEVICE #1). PER OPERATIVE NOTES, A SMALL INDIRECT HERNIA WAS DISSECTED AND REDUCED. A PERFIX PLUG (DEVICE #1) WAS PLACED INTO THE INGUINAL RING AND SECURED WITH SUTURES.¿ (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH RIGHT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF PERFIX PLUG (DEVICE #2). PER OPERATIVE NOTES, ¿THE INDIRECT HERNIA WAS IDENTIFIED AND REDUCED. THE PERFIX PLUG (DEVICE #2) WAS PLACED AND SUTURED.¿ (B)(6) 2017 - PATIENT WAS DIAGNOSED WITH CHRONIC LEFT INGUINAL PAIN THEREBY UNDERWENT OPEN REPAIR WITH REMOVAL OF MESH (DEVICE #1) AND INGUINAL NECRECTOMY. PER OPERATIVE NOTES, ¿THE SCAR TISSUE WAS SEEN ADHERENT TO THE UNDERLYING MESH (DEVICE #1). THE ADHESIONS BETWEEN THE MESH AND CONJOINED TENDONS WERE DISSECTED. THE MESH (DEVICE #1) WAS REMOVED. THE NERVE STRUCTURES IN THE SUPERIOR EDGE OF MESH WERE REMOVED¿ (B)(6) 2018 - PATIENT WAS DIAGNOSED WITH CHRONIC RIGHT INGUINAL PAIN THEREBY UNDERWENT OPEN REPAIR WITH REMOVAL OF MESH (DEVICE #2). PER OPERATIVE NOTES, ¿DUE TO EXTENSIVE SCARRING A

  Patient problems: Fibrosis; Pain; Scar Tissue

  MAUDE report 22139601 ↗
• InjuryMay 16, 2025Defective Device; Patient Device Interaction Problem; Migration; Defective Device; Patient Device Interaction Problem; Migration

  PER INFORMATION PROVIDED: ON (B)(6) 2007 - PATIENT WAS DIAGNOSED WITH RIGHT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF PERFIX PLUG & PATCH (DEVICE #1 & #2). PER OP NOTES, ¿TWO PERFIX PLUGS & PATCH (DEVICE #1 & #2) WERE PLACED AND SUTURED.¿ ON (B)(6) 2009 - PATIENT WAS DIAGNOSED WITH INCARCERATED RECURRENT RIGHT INGUINAL HERNIA THEREBY UNDERWENT REPAIR WITH IMPLANT OF PERFIX PLUG (DEVICE #3). PER OP NOTES, ¿THE MESH (DEVICE #1, #2) WERE WELL SECURED TO THE PUBIC TUBERCLE. AN ANOTHER PERFIX PLUG (DEVICE #3) WAS SUTURED TO THE INGUINAL LIGAMENT INFERIORLY.¿ ON (B)(6) 2012 - PATIENT WAS DIAGNOSED WITH RECURRENT RIGHT INGUINAL HERNIA THEREBY UNDERWENT REPAIR WITH REMOVAL OF MESH (DEVICE #1, #2 & #3). PER OP NOTES, ¿THE PREVIOUS MESH HAD MIGRATED SUPERFICIAL TO THE EXTERNAL RING FORMING A LUMP CAUSING PAIN IN THE GROIN. THE MESH (DEVICE #1, #2 & #3) WAS REMOVED FROM THE RIGHT GROIN. A SYNTHETIC MESH WAS PLACED.¿

  Patient problems: Hernia; Pain

  MAUDE report 22035948 ↗
• InjuryMay 2, 2025Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  ADDENDUM PER ADDITIONAL INFORMATION PROVIDED: (B)(6) 2019- PATIENT WAS DIAGNOSED WITH SYMPTOMATIC INGUINAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC LEFT INGUINAL HERNIORRHAPHY WITH REPAIR OF BOTH DIRECT & INDIRECT DEFECTS USING TWO PERFIX PLUGS & PATCH (DEVICE #1 & #2). PER OPERATIVE NOTES, ¿AN INCISION WAS MADE IN THE LEFT INGUINAL REGION. THE HERNIA SAC WAS DISSECTED AWAY. A PERFIX PLUG (DEVICE #1) WAS PLACED INTO THE INTERNAL RING. THERE WAS ALSO A DIRECT DEFECT FOR WHICH A PERFIX PLUG & PATCH (DEVICE #2) WAS PLACED AROUND THE CORD STRUCTURES USING SUTURES.¿ (B)(6) 2020- PATIENT WAS DIAGNOSED WITH RECURRENT LEFT INGUINAL HERNIA THEREBY UNDERWENT REPAIR. PER OPERATIVE NOTES, ¿INCISION WAS MADE THROUGH THE PREVIOUS LEFT INGUINAL INCISION. DISSECTION WAS CARRIED THROUGH DENSE SCAR. NOTED A SMALL HERNIA DEFECT NOTED ALONG THE CORD STRUCTURES. FOR THIS, A POLYPROPYLENE MESH PLUG WAS ABLE TO BE PLACED, AND IT WAS ABLE TO BE SECURED.¿

  Patient problems: Hernia; Scar Tissue

  MAUDE report 21950052 ↗
• InjuryJan 30, 2025Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  PER ADDITIONAL INFORMATION PROVIDED: (B)(6) 2010 - PATIENT WAS DIAGNOSED WITH UMBILICAL HERNIA AND BILATERAL INGUINAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT OF VENTRIO MESH (DEVICE #1) FOR UMBILICAL HERNIA AND OPEN REPAIR WITH THE IMPLANT OF TWO PERFIX PLUG (DEVICE #2 - RIGHT, DEVICE #3 - LEFT) FOR BILATERAL INGUINAL HERNIA. PER OPERATIVE NOTES, ¿UMBILICAL HERNIA WAS IDENTIFIED. A CIRCULAR PIECE OF VENTRIO MESH (DEVICE #1) WAS SECURED BY TACKERS. RIGHT DIRECT INGUINAL HERNIA WAS REPAIRED USING A PERFIX PLUG (DEVICE #2) IN THE INTERNAL RING AND PATCH WAS PLACED ONTO THE PUBIC TUBERCLE TO INGUINAL LIGAMENT. THE PROCEDURE WAS REPEATED ON LEFT DIRECT INGUINAL HERNIA USING PERFIX PLUG (DEVICE #3).¿ (B)(6) 2011 - PATIENT HAD BILATERAL INGUINAL PAIN THEREBY UNDERWENT OPEN REPAIR WITH THE PARTIAL REMOVAL OF MESHES (DEVICE #2, DEVICE #3). PER OPERATIVE NOTES, ¿THE MESHES (DEVICE #2, #3) WERE NOT COMPLETELY REMOVED. THE AREA WAS NOTED TO BE SEVERELY SCARRED. THIS WAS DONE ON BOTH SIDES OF THE INGUINAL REGIONS.¿ (B)(6) 2014 - PATIENT HAD LEFT UPPER QUADRANT ABDOMINAL PAIN AND ADHESION THEREBY UNDERWENT LAPAROSCOPIC REPAIR. PER OPERATIVE NOTES, ¿ADHESIONS TO THE ABDOMINA

  Patient problems: Pain; Scar Tissue

  MAUDE report 21273481 ↗
• InjuryJan 29, 2025Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  PER INFORMATION PROVIDED BY PATIENT'S ATTORNEY: ON (B)(6) 2010 - PATIENT WAS DIAGNOSED WITH LEFT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF PERFIX PLUG (DEVICE #1). PER OPERATIVE NOTES, ¿THERE WAS A LARGE DIRECT HERNIA SAC. AN EXTRA-LARGE PERFIX PLUG (DEVICE #1) AND ONLAY MESH GRAFT WERE THEN SECURED USING SUTURES.¿ ON (B)(6) 2013 - PATIENT WAS DIAGNOSED WITH RIGHT DIRECT & INDIRECT INGUINAL HERNIAS THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF TWO PERFIX PLUG (DEVICE #2 & #3). PER OPERATIVE NOTES, "A LARGE DIRECT HERNIA SAC WAS IDENTIFIED AND REDUCED INTO THE PREPERITONEAL SPACE. AN EXTRA-LARGE PERFIX PLUG (DEVICE #2) WAS SECURED INTO THE INGUINAL LIGAMENT. THERE WAS A SMALL INDIRECT HERNIA, A LARGE PERFIX PLUG (DEVICE # 3) WAS SECURED INTO THE TRANSVERSALIS FASCIA. THE ONLAY PATCH WAS THEN LAID ON THE FLOOR OF THE CANAL.¿ NI-NI-2013 TO PRESENT - PATIENT UNDERWENT PAIN MANAGEMENT FOR SEVERE AND CHRONIC PAIN IN THE GROIN. NI-APR-2013 TO NI-SEP-2017 - PATIENT HAD HERNIA COMPLICATIONS. (B)(6) 2013 TO NI-NI-2018 - PATIENT HAD EPIDURAL STEROID INJECTION FOR CERVICAL RADICULAR PAIN. ATTORNEY ALLEGED THAT THE PATIENT HAD BOWEL OBSTRUCTION, FISTULAE, INFECTION,

  Patient problems: Hernia; Pain

  MAUDE report 21264834 ↗
• InjurySep 19, 2024Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  ADDENDUM PER ADDITIONAL INFORMATION PROVIDED: (B)(6) 2010 - PATIENT WAS DIAGNOSED WITH INCARCERATED LEFT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF PERFIX PLUG (DEVICE #1). PER OPERATIVE NOTES, ¿ONCE ALL THE SAC HAS BEEN PULLED UP AND REDUCED, THE CORD IS CLEARLY IDENTIFIED. A LARGE PLUG IS PLACED INTO THE DEFECT AND SUTURED.¿ (B)(6) 2010 - PATIENT PRESENTS WITH PAIN. (B)(6) 2010 - PATIENT WAS DIAGNOSED WITH RECURRENT LEFT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH REMOVAL OF PERFIX PLUG (DEVICE #1) AND IMPLANT OF PERFIX PLUG (DEVICE #2). PER OPERATIVE NOTES, ¿THE MESH WAS PALPABLE AND IT WAS DISSECTED FREE FROM AREA WHICH IS INFERIOR TO THE MESH. THE MESH WAS REMOVED WITH SHARP AND BLUNT DISSECTION. THEN, A LARGE PERFIX PLUG (DEVICE #2) WAS SELECTED AND PLACED INTO THE RESULTING DEFECT USING SUTURES." (B)(6) 2011 - PATIENT COMPLAINS OF INCISIONAL PAIN AND PRESENTS WITH LEFT GROIN HERNIA RECURRENCE WHICH CONTAIN BULGE THAT GOES DOWN TOWARDS THE PUBIC TUBERCLE AND A LITTLE BEYOND. (B)(6) 2011 - PATIENT WAS DIAGNOSED WITH SYMPTOMATIC RECURRENT LEFT INGUINAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT OF SYNTHETIC MESH. PER OPERATIVE NO

  Patient problems: Hernia; Pain; Scar Tissue

  MAUDE report 20254974 ↗