PerFix 0112780Recalls & reported problems

Summary

The FDA's MAUDE database contains 230 adverse event reports that list this exact device (DI 00801741016622), received between Mar 15, 2013 and Sep 30, 2026 — classified as 1 death, 224 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Defective Device” (180 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 230 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Patient-Device Incompatibility

  Patient problems: Hernia

  MAUDE report 50949395 ↗
• InjurySep 25, 2026Patient-Device Incompatibility

  Per information provided:(b)(6) 2010 - Patient was diagnosed with right inguinal hernia thereby underwent open repair with the implant of PerFix Plug (Device 1). Per op notes, "An incision to the right groin, a large PerFix Plug (Device 1) was placed to the inguinal floor using sutures."(b)(6) 2011 - Patient was diagnosed with recurrent right inguinal hernia thereby underwent open repair with the implant of two PerFix Plugs (Device 2 and 3). Per op notes, "An Incision was carried down through the previous incision to the subcutaneous tissue. Identification of the femoral vessels, there was a defect laterally to the cord for which the extra large PerFix Plug (Device 2) was placed. Upon palpation a femoral defect was palpated and a small PerFix Plug (Device 3) was placed in the defect and sutured."(b)(6) 2021 - Patient was diagnosed with recurrent right inguinal hernia thereby underwent repair with removal of all previous meshes (Device 1, 2 and 3) and implant of 3DMax Mid Mesh (Device 4). Per op notes, "The peritoneum was densely adherent to the previous mesh plug, which was actually intraabdominal. Able to dissect this off the plug and separate the peritoneum from the cord structur

  Patient problems: Adhesion(s); Hernia

  MAUDE report 50895526 ↗
• InjuryJul 30, 2026Patient-Device Incompatibility

  Per information provided:On (b)(6) 2009 - Patient was diagnosed with left inguinal hernia thereby underwent open repair with the implant of two PerFix Plugs (Device 1 and 2). Per op notes, "The left inguinal area was approached, two extra-large PerFix Plugs (Device 1 and 2) were placed into the inguinal canal to the abdomen using prolene sutures." On (b)(6) 2010 - Patient was diagnosed with recurrent left inguinal hernia thereby underwent repair with removal of mesh (Device 1 and 2). Per op notes, "The old scar was opened and carried down. Encountered an inflammatory response with mesh, patch and plug. The two meshes (Device 1 and 2) were removed then a synthetic mesh was placed."

  Patient problems: Hernia; Inflammation; Scar Tissue

  MAUDE report 50078387 ↗
• InjuryJun 23, 2026Device Appears to Trigger Rejection

  PER INFORMATION PROVIDED: ON (B)(6) 2009 - PATIENT WAS DIAGNOSED WITH RECURRENT BILATERAL INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF PERFIX PLUG (DEVICE 1 AND 2). PER OP NOTES, "A LARGE DIRECT INGUINAL HERNIA WAS IDENTIFIED ON THE RIGHT AND SAME ON THE LEFT. A PERFIX PLUG (DEVICE 1) WAS PLACED ON THE RIGHT AND A PERFIX PLUG (DEVICE 2) WAS PLACED ON THE LEFT AND SECURED WITH SUTURE." ON (B)(6) 2016 - PATIENT WAS DIAGNOSED WITH RECURRENT BILATERAL INGUINAL HERNIA THEREBY UNDERWENT ROBOTIC ASSISTED REPAIR WITH IMPLANT OF 3DMAX MESH (DEVICE 3 AND 4). PER OP NOTES, "AN INCISION WAS MADE AT THE UMBILICUS. BILATERAL INGUINAL HERNIAS WERE IDENTIFIED. THE PERITONEUM ABOVE THE HERNIA WAS OPENED. IT WAS MORE OF AN EVENTRATION OF MESH. THE HERNIA SAC WAS REDUCED AND, ON BOTH SIDES, MEDIUM MESHES (DEVICE 3 AND 4) WERE PLACED AND SECURED WITH SUTURE. THE PERITONEUM WAS RE-CLOSED WITH SUTURE."

  Patient problems: Hernia

  MAUDE report 25590895 ↗
• InjuryJun 18, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2019- PATIENT WAS DIAGNOSED WITH RECURRENT LEFT INGUINAL HERNIA, RIGHT INGUINAL HERNIA, THEREBY UNDERWENT ROBOTIC ASSISTED LAPAROSCOPIC REPAIR WITH IMPLANT OF PERFIX PLUGS (DEVICE 1 AND 3), 3DMAX LIGHT MESHES (DEVICE 2 AND 4). PER OP NOTES, "ON THE LEFT INGUINAL REGION, AN INDIRECT HERNIA SAC WAS IDENTIFIED AND WAS DISSECTED. IN THE RIGHT INGUINAL REGION, HERNIA SAC WAS IDENTIFIED AND DISSECTED. A PERFIX PLUG (DEVICE 1) WAS PLACED OVER THE INTERNAL RING AND WAS SUTURED. A 3DMAX LIGHT MESH (DEVICE 2) WAS PLACED ASWELL AS SUPERIORLY AND LATERALLY USING SUTURES. ON THE LEFT INGUINAL REGION, PERFIX PLUG (DEVICE 3) WAS PLACED AND SUTURED AND THE 3DMAX LIGHT MESH (DEVICE 4) WAS PLACED AND SECURED MEDIALLY, SUPERIORLY AND LATERALLY USING SUTURES." (B)(6) 2019 - PATIENT WAS DIAGNOSED WITH RECURRENT RIGHT INGUINAL HERNIA, PAIN, THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF SYNTHETIC MESH. PER OP NOTES, "IN THE RIGHT INGUINAL REGION, HERNIA WITH PALPABLE MESH WAS IDENTIFIED. AN INCARCERATED INDIRECT HERNIA SAC WAS IDENTIFIED ON THE LATERAL SURFACE OF THE CORD AND THE HERNIA SAC WAS DISSECTED. A SYNTHETIC MESH WAS PLACED AND SUTURED."

  Patient problems: Hernia; Pain

  MAUDE report 25552000 ↗
• InjuryMay 7, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2007: PATIENT WAS DIAGNOSED WITH UMBILICAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF PERFIX PLUG (DEVICE 1). PER OPERATIVE NOTES, ¿IN THE INFRAUMBILICAL AREA, THE HERNIA SAC IN UMBILICUS WAS FREED AND EXCISED CIRCUMFERENTIALLY. AN EXTRA-LARGE PERFIX PLUG (DEVICE 1) WAS PLACED IN THE HERNIA DEFECT AND SECURED WITH SUTURES IN CIRCUMFERENTIAL FASHION AROUND THE UMBILICUS. THE WOUND WAS IRRIGATED AND SUBCUTANEOUS TISSUES WERE APPROXIMATED USING SUTURES.¿ (B)(6) 2014: PATIENT WAS DIAGNOSED WITH RECURRENT ABDOMINAL WALL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRALEX ST MESH (DEVICE 2). PER OPERATIVE NOTES, ¿THE HERNIA RIGHT TO THE UMBILICUS WAS NOTED. THE PRIOR UMBILICAL REPAIR WITH MESH (DEVICE 1) WAS NOTED AND HERNIA WAS DISSECTED FREE AND REDUCED INTO PREPERITONEAL SPACE. THE PRIOR OLD MESH (DEVICE 1) WAS NOTED AND LEFT IN-SITU. A MEDIUM ROUND VENTRALEX ST MESH (DEVICE 1) WAS PLACED IN PREPERITONEAL SPACE AND SECURED IT WITH SUTURES. THE WOUND WAS IRRIGATED AND CLOSED WITH SUTURES.¿ (B)(6) 2020: PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL HERNIA WITH PAIN THEREBY UNDERWENT ROBOTIC ASSISTED LAPAROSCOPIC REPAIR WITH REMOVAL OF

  Patient problems: Hernia; Pain

  MAUDE report 25110830 ↗
• MalfunctionApr 24, 2026Detachment of Device or Device Component

  AS REPORTED, ON (B)(6) 2026 DURING INGUINAL HERNIA SURGERY ACCORDING TO RUTKOW WHILE SPREADING THE PERFIX PLUG BENEATH THE FASCIA USING A FINGER, IT WAS OBSERVED THAT THE INNER PLUG STRUCTURE HAD DETACHED FROM THE TWO OUTER PLUG STRUCTURES. UPON INSPECTION, A BREAK IN THE NYLON THREAD CONNECTING THESE COMPONENTS WAS IDENTIFIED. REPORTEDLY, THE PLUG WAS HANDLED ACCORDING TO THE STANDARD PROCEDURE AND IT WAS GRASPED FROM THE INSIDE AT THE TIP OF THE PLUG USING AN OVERHOLT, PLACED CAREFULLY INTO THE HERNIA DEFECT BENEATH THE TRANSVERSALIS FASCIA, AND THE OVERHOLT WAS THEN REMOVED. THEN FIXATION OF THE INNER LIP OF THE PLUG TO THE FASCIA. IT WAS ALSO REPORTED THAT THE PERFIX PLUG WAS NOT CUT OR RESHAPED BEFORE INSERTING IT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24981710 ↗
• InjuryApr 9, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2010 - PATIENT WAS DIAGNOSED WITH BILATERAL INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF PERFIX PLUG (DEVICE 1, 2, 3, 4 AND 5). PER OP NOTES, ¿AN INCISION WAS MADE FROM THE PUBIC TUBERCLE TO MID INGUINAL POINT. A SMALL DEFECT HERNIA WHERE PREPERITONEAL FAT BULGING OUT WAS IDENTIFIED AND IT WAS THE SITE OF THE INCISIONAL HERNIA FROM THE APPENDIX INCISION ON THE RIGHT FROM WHICH THE FAT WAS EXCISED. IT WAS REPAIRED WITH A PERFIX PLUG (DEVICE 1) AND SECURED WITH SUTURES. THE DIRECT AND INDIRECT HERNIA SAC WAS IDENTIFIED AND THE INDIRECT HERNIA SAC WAS LIGATED ON ITSELF AND PUSHED IN THE PREPERITONEAL SPACE. AND PLUGGED WITH A SAME PLUG (DEVICE 2 AND 3) ON RIGHT AND SURROUNDING FASCIA WAS STABILIZED WITH A SUTURE. THE MESH WAS SUTURED TO THE SHELVING EDGE OF INGUINAL LIGAMENT. THE LEFT SIDED HERNIA WAS THE SAME EXCEPT FOR THE HERNIA COMPONENT OF THE APPENDICEAL INCISION. THE TESTIS WERE PULLED BACK IN THE SCROTUM. A PERFIX PLUG (DEVICE 4 AND 5) WERE PLACED IN THE LEFT AND SECURED WITH SUTURES.¿ ON (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH INCARCERATED UMBILICAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRALEX MESH (DEVIC

  Patient problems: Hernia; Pain; Scar Tissue

  MAUDE report 24834691 ↗
• InjuryApr 9, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2011, PATIENT WAS DIAGNOSED WITH BILATERAL INGUINAL HERNIAS THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF FOUR PERFIX PLUGS (DEVICE 1, 2,3 AND 4). PER OPERATIVE NOTES, "IN THE LEFT GROIN, A DIRECT AND INDIRECT INGUINAL HERNIA WAS NOTED. THE TRANSVERSALIS FASCIA OF THE DIRECT HERNIA WAS EXCISED AND A LARGE PERFIX PLUG (DEVICE 1) WAS PLACED AND CLOSED WITH SUTURES. THE INDIRECT HERNIA WAS SEPARATED FROM THE CORD STRUCTURES AND REDUCED BACK INTO ABDOMEN. A SMALL PERFIX PLUG (DEVICE 2) WAS PLACED OVER THE FLOOR OF THE INGUINAL CANAL AND APPROXIMATED WITH SUTURES. IN THE RIGHT GROIN, A LARGE DIRECT HERNIA AS WELL AS INDIRECT HERNIA WAS NOTED. THE DIRECT HERNIA WAS REDUCED, EXTRA-LARGE PERFIX PLUG (DEVICE 3) WAS PLACED AND EXTERNAL OBLIQUE WAS CLOSED OVER THE PLUG WITH SUTURES. TO THE INDIRECT HERNIA, THE SAC WAS REDUCED AND ANOTHER SMALL PERFIX PLUG (DEVICE 4) WAS PLACED AND SECURED WITH SUTURES." ON (B)(6) 2012, PATIENT WAS DIAGNOSED WITH RECURRENT RIGHT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH REMOVAL OF SMALL PERFIX PLUG (DEVICE 4) AND IMPLANT OF PERFIX PLUG (DEVICE 5). PER OPERATIVE NOTES, "THROUGH THE PRIOR SCAR IN THE RIGHT GROIN, THE

  Patient problems: Hernia; Scar Tissue

  MAUDE report 24829658 ↗
• InjuryMar 31, 2026Migration

  PER INFORMATION PROVIDED: ON (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF PERFIX PLUG (DEVICE 1). PER OPERATIVE NOTES, "FROM THE PRIOR INCISION IN THE MIDLINE, THE HERNIA SAC WITH SCAR TISSUES WERE NOTED. THE ENTIRE SAC WAS EXCISED AND REDUCED. THE DEFECT WAS CLOSED AND REAPPROXIMATED WITH SUTURES. A PERFIX PLUG (DEVICE 1) WAS PLACED OVER THE DEFECT AND SUTURED TO THE SURROUNDING FASCIA." ON (B)(6) 2016 - PATIENT WAS DIAGNOSED WITH INCARCERATED INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH REMOVAL OF OLD MESH (DEVICE 1) AND IMPLANT OF BARD FLAT MESH (DEVICE 2). PER OPERATIVE NOTES, "THROUGH THE PRIOR MIDLINE, THE HERNIA SAC WAS ISOLATED AND OLD MESH PLUG (DEVICE 1) MIGRATED INTO PERITONEAL CAVITY. THE SAC AND MESH (DEVICE 1) WERE EXCISED, AND FASCIA WAS REAPPROXIMATED WITH SUTURES. THE BARD FLAT MESH (DEVICE 2) WAS PLACED OVER THE DEFECT AND SUTURED TO SURROUNDING FASCIA." ON (B)(6) 2016 - PATIENT HAD PAIN, RECURRENT HERNIA REPAIR. (NOTE: THERE IS NO OPERATIVE NOTES PROVIDED FOR THIS PROCEDURE IN MEDICAL RECORDS.)

  Patient problems: Hernia

  MAUDE report 24740307 ↗
• InjuryFeb 24, 2026Patient-Device Incompatibility

  AS REPORTED BY PATIENT IN SUMMARY VIA ANSM REPORT (B)(4). DATE OF OCCURRENCE: (B)(6) 2021 DESCRIPTION OF THE INCIDENT: (B)(6) 2021 THE PATIENT UNDERWENT DIRECT AND INDIRECT LEFT INGUINAL HERNIA REPAIR WITH MESH PLACEMENT (BARD PERFIX PLUG AND PATCH (ONLAY)). PER SURGICAL REPORT, FINAL DIAGNOSIS: THIS IS A PATIENT PRESENTING WITH LEFT INGUINAL-SCROTAL PAIN, WHICH PROMPTED A VISIT TO THE EMERGENCY DEPARTMENT. THE PAIN HAS BEEN PRESENT FOR AROUND 20 YEARS, BUT IN THE LAST FEW DAYS IT HAS INTENSIFIED AND RADIATED TO THE TESTICLE. DETAILED DESCRIPTION: THE PATIENT IS IN THE SUPINE POSITION. LEFT INGUINAL INCISION. OPENING OF THE APONEUROSIS OF THE RECTUS ABDOMINIS MUSCLE. WE DISSECT A DIRECT HERNIA APPROXIMATELY 3 CM IN DIAMETER AFTER SEPARATING THE ELEMENTS OF THE SPERMATIC CORD. NOTE THAT THE SPERMATIC VEINS ARE TURGID AND BLUISH, INDICATING IMPAIRED VENOUS RETURN, WHICH MAY EXPLAIN THE PAIN RADIATING TO THE LEFT TESTICLE. INCISION OF THE TRANSVERSALIS FASCIA. PREPERITONEAL DISSECTION. PLACEMENT OF AN EXTRA-LARGE PLUG, WHICH WILL BE SECURED TO COOPER'S LIGAMENT WITH A POLYSORB SUTURE. CLOSURE OF THE TRANSVERSALIS FASCIA. DISSECTION OF THE CORD SHOWING A SPIKE OF AN INDIRECT LEFT INGUI

  Patient problems: Neuralgia; Paresthesia

  MAUDE report 24430366 ↗
• InjuryFeb 24, 2026Patient-Device Incompatibility

  AS REPORTED BY PATIENT IN SUMMARY VIA ANSM REPORT (NO: (B)(4). DATE OF OCCURRENCE: ON (B)(6) 2021. DESCRIPTION OF THE INCIDENT: ON (B)(6) 2021, THE PATIENT UNDERWENT DIRECT AND INDIRECT LEFT INGUINAL HERNIA REPAIR WITH MESH PLACEMENT (BARD PERFIX PLUG AND PATCH (ONLAY)). PER SURGICAL REPORT, FINAL DIAGNOSIS: THIS IS A PATIENT PRESENTING WITH LEFT INGUINAL-SCROTAL PAIN, WHICH PROMPTED A VISIT TO THE EMERGENCY DEPARTMENT. THE PAIN HAS BEEN PRESENT FOR AROUND 20 YEARS, BUT IN THE LAST FEW DAYS IT HAS INTENSIFIED AND RADIATED TO THE TESTICLE. DETAILED DESCRIPTION: THE PATIENT IS IN THE SUPINE POSITION. LEFT INGUINAL INCISION. OPENING OF THE APONEUROSIS OF THE RECTUS ABDOMINIS MUSCLE. WE DISSECT A DIRECT HERNIA APPROXIMATELY 3 CM IN DIAMETER AFTER SEPARATING THE ELEMENTS OF THE SPERMATIC CORD. NOTE THAT THE SPERMATIC VEINS ARE TURGID AND BLUISH, INDICATING IMPAIRED VENOUS RETURN, WHICH MAY EXPLAIN THE PAIN RADIATING TO THE LEFT TESTICLE. INCISION OF THE TRANSVERSALIS FASCIA. PREPERITONEAL DISSECTION. PLACEMENT OF AN EXTRA-LARGE PLUG, WHICH WILL BE SECURED TO COOPER'S LIGAMENT WITH A POLYSORB SUTURE. CLOSURE OF THE TRANSVERSALIS FASCIA. DISSECTION OF THE CORD SHOWING A SPIKE OF AN INDIRE

  Patient problems: Neuralgia; Paresthesia

  MAUDE report 24430365 ↗
• InjuryFeb 18, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2012- PATIENT WAS DIAGNOSED WITH INCISIONAL HERNIA, THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRIO MESH (DEVICE 1), BARD SOFT MESH (DEVICE 2). PER OP NOTES, ¿THE HERNIA DEFECT IN THE ABDOMINAL REGION WAS DISSECTED. A VENTRIO MESH (DEVICE 1) WAS PLACED PREPERITONEAL AND SUTURED. A BARD SOFT MESH (DEVICE 2) WAS PLACED AS AN ONLAY TO THE FASCIA AND SUTURED¿. (B)(6) 2012 - PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA, THEREBY UNDERWENT OPEN REPAIR WITH EXPLANT OF VENTRIO MESH (DEVICE 1), BARD SOFT MESH (DEVICE 2) AND IMPLANT OF ALLOMAX SURGICAL GRAFT (DEVICE 3), BARD FLAT MESH (DEVICE 4). PER OP NOTES, ¿THE PREVIOUSLY MADE SCAR WAS REMOVED. THE SAC IN THE ABDOMINAL REGION ALONG WITH THE PREVIOUSLY PLACED MESH WAS REMOVED. AN ALLOMAX SURGICAL GRAFT (DEVICE 3) WAS PLACED INTRA ABDOMINALLY AND SUTURED. A BARD FLAT MESH (DEVICE 4) WAS PLACED AS AN ONLAY AND SUTURED¿. (B)(6) 2013- PATIENT WAS DIAGNOSED WITH INCISIONAL HERNIA, THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF PERFIX PLUG (DEVICE 5) AND BARD FLAT MESH (DEVICE 6). PER OP NOTES, ¿IN MIDLINE INCISION, AN OPENING IN THE FASCIA WAS IDENTIFIED AND A PERFIX PLUG (DEVICE 5) WAS PLACED AND

  Patient problems: Adhesion(s); Hernia; Pain

  MAUDE report 24374673 ↗
• InjuryFeb 14, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2012- PATIENT WAS DIAGNOSED WITH INCISIONAL HERNIA, THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRIO MESH (DEVICE 1), BARD SOFT MESH (DEVICE 2). PER OP NOTES, ¿THE HERNIA DEFECT IN THE ABDOMINAL REGION WAS DISSECTED. A VENTRIO MESH (DEVICE 1) WAS PLACED PREPERITONEAL AND SUTURED. A BARD SOFT MESH (DEVICE 2) WAS PLACED AS AN ONLAY TO THE FASCIA AND SUTURED¿. (B)(6) 2012 - PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA, THEREBY UNDERWENT OPEN REPAIR WITH EXPLANT OF VENTRIO MESH (DEVICE 1), BARD SOFT MESH (DEVICE 2) AND IMPLANT OF ALLOMAX SURGICAL GRAFT (DEVICE 3), BARD FLAT MESH (DEVICE 4). PER OP NOTES, ¿THE PREVIOUSLY MADE SCAR WAS REMOVED. THE SAC IN THE ABDOMINAL REGION ALONG WITH THE PREVIOUSLY PLACED MESH WAS REMOVED. AN ALLOMAX SURGICAL GRAFT (DEVICE 3) WAS PLACED INTRA ABDOMINALLY AND SUTURED. A BARD FLAT MESH (DEVICE 4) WAS PLACED AS AN ONLAY AND SUTURED¿. (B)(6) 2013- PATIENT WAS DIAGNOSED WITH INCISIONAL HERNIA, THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF PERFIX PLUG (DEVICE 5) AND BARD FLAT MESH (DEVICE 6). PER OP NOTES, ¿IN MIDLINE INCISION, AN OPENING IN THE FASCIA WAS IDENTIFIED AND A PERFIX PLUG (DEVICE 5) WAS PLACED AND

  Patient problems: Adhesion(s); Hernia; Pain

  MAUDE report 24340584 ↗
• InjuryFeb 13, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2007: PATIENT WAS DIAGNOSED WITH INCARCERATED LEFT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF FOUR PERFIX PLUGS (DEVICE 1, 2, 3 AND 4). PER OPERATIVE NOTES, ¿A LARGE INGUINOSCROTAL HERNIA IN THE LEFT SIDE WHICH WAS CHRONICALLY INCARCERATED WAS NOTED. THE HERNIA WAS REDUCED AND EXCISED. THREE EXTRA-LARGE PERFIX PLUG WAS SUTURED TOGETHER TO THE INGUINAL LIGAMENT INFERIORLY AND AN ANOTHER PERFIX PLUG (DEVICE 4) WAS PLACED IN THE REVERSE WITH END UNDER THE LATERAL EDGE OF THE TRANSVERSALIS ARCH AND SECURED WITH SUTURES AND TACKS.¿ ON (B)(6) 2010: PATIENT WAS DIAGNOSED WITH RECURRENT LEFT INGUINAL HERNIA AND PAIN THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF SYNTHETIC MESH. PER OPERATIVE NOTES, ¿A LARGE RECURRENT LEFT INGUINAL SCROTAL HERNIA WAS NOTED. THE MIDLINE FASCIA CONTAINING HERNIA CONTENTS AND SCAR TISSUES WERE EXCISED. THE SAC WAS STUCK TO THE PIECES OF PRIOR MESHES (DEVICE 1, 2, 3 AND 4) IN THE SCROTUM. THE SAC WAS REDUCED OFF THE PALPABLE MESHES AND A LARGE SHEET OF SYNTHETIC MESH WAS PLACED OVER THE DEFECT AND SECURED TO THE PUBIC TUBERCLE WITH SUTURES. THE MIDLINE FASCIA WAS CLOSED USING SUTURES.¿

  Patient problems: Hernia; Pain; Scar Tissue

  MAUDE report 24331443 ↗
• InjuryFeb 12, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2007 ¿ PATIENT WAS DIAGNOSED WITH INCARCERATED LEFT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF FOUR PERFIX PLUGS (DEVICE 1, 2, 3 AND 4). PER OPERATIVE NOTES, ¿A LARGE INGUINOSCROTAL HERNIA IN THE LEFT SIDE WHICH WAS CHRONICALLY INCARCERATED WAS NOTED. THE HERNIA WAS REDUCED AND EXCISED. THREE EXTRA-LARGE PERFIX PLUG WAS SUTURED TOGETHER TO THE INGUINAL LIGAMENT INFERIORLY AND AN ANOTHER PERFIX PLUG (DEVICE 4) WAS PLACED IN THE REVERSE WITH END UNDER THE LATERAL EDGE OF THE TRANSVERSALIS ARCH AND SECURED WITH SUTURES AND TACKS.¿ ON (B)(6) 2010 - PATIENT WAS DIAGNOSED WITH RECURRENT LEFT INGUINAL HERNIA AND PAIN THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF SYNTHETIC MESH. PER OPERATIVE NOTES, ¿A LARGE RECURRENT LEFT INGUINAL SCROTAL HERNIA WAS NOTED. THE MIDLINE FASCIA CONTAINING HERNIA CONTENTS AND SCAR TISSUES WERE EXCISED. THE SAC WAS STUCK TO THE PIECES OF PRIOR MESHES (DEVICE 1,2,3 AND 4) IN THE SCROTUM. THE SAC WAS REDUCED OFF THE PALPABLE MESHES AND A LARGE SHEET OF SYNTHETIC MESH WAS PLACED OVER THE DEFECT AND SECURED TO THE PUBIC TUBERCLE WITH SUTURES. THE MIDLINE FASCIA WAS CLOSED USING SUTURES.¿

  Patient problems: Hernia; Pain; Scar Tissue

  MAUDE report 24322270 ↗
• InjuryFeb 11, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2013 ¿ PATIENT WAS DIAGNOSED WITH DIRECT RIGHT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF PERFIX PLUGS (DEVICE 1, 2). PER OP NOTES, ¿THE INGUINAL FLOOR APPEARED TO BE BLOWN OUT AND THERE WAS A LARGE DIRECT HERNIA SAC. THE DEFECT WAS CLOSED BY PLACING TWO EXTRA LARGE PERFIX PLUGS (DEVICE 1, 2) IN THE PREPERITONEAL SPACE AND SUTURED TO THE EDGES OF THE FASCIAL DEFECT. A MARLEX PATCH WAS THEN PLACED OVER THE INGUINAL FLOOR WITH A HOLE CREATED FOR THE CORD CONTENTS AND SUTURED. NERVES WERE RESECTED.¿ (B)(6) 2018 ¿ PATIENT HAD RECURRENT RIGHT INGUINAL HERNIA THEREBY UNDERWENT REVISION SURGERY. (NOTE: THERE IS NO OP NOTES PROVIDED FOR THIS PROCEDURE IN MEDICAL RECORDS) ATTORNEY ALLEGES ABSCESS, BOWEL OBSTRUCTION, INFECTION, PAIN AND SUFFERING.

  Patient problems: Abscess; Hernia; Obstruction/Occlusion; Pain; Unspecified Infection

  MAUDE report 24313622 ↗
• InjuryJan 9, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2009 - PATIENT WAS DIAGNOSED WITH RIGHT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF PERFIX PLUG (DEVICE 1). PER OP NOTES, ¿THE DIRECT HERNIA SAC WAS IDENTIFIED AND DISSECTED FREE. A PERFIX PLUG (DEVICE 1) WAS PLACED IN THE DEFECT AND SECURED WITH SUTURES. A ONLAY PATCH WAS PLACED IN THE FLOOR OF THE CANAL AND SUTURED.¿ (B)(6) 2016 - PATIENT WAS DIAGNOSED WITH RECURRENT RIGHT INGUINAL HERNIA AND LEFT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF PERFIX PLUGS (DEVICE 2 AND 3). PER OP NOTES, ¿ON THE RIGHT GROIN, A DIRECT HERNIA DEFECT WAS IDENTIFIED AND NO EVIDENCE OF INDIRECT HERNIA. THE PRIOR PLUG (DEVICE 1) WAS NOTED. A PERFIX PLUG (DEVICE 2) WITH ONLAY PATCH WAS PLACED AND SECURED USING SUTURES. ON THE LEFT GROIN, ANOTHER DIRECT HERNIA WAS IDENTIFIED AND THERE WAS NO EVIDENCE OF INDIRECT HERNIA. A PERFIX PLUG (DEVICE 3) WAS PLACED AND SUTURED.¿ (B)(6) 2019 - PATIENT WAS DIAGNOSED WITH INCARCERATED RECURRENT LEFT INGUINAL AND RECURRENT RIGHT INGUINAL HERNIAS THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF PERFIX PLUGS (DEVICE 4 AND 5). PER OP NOTES, ¿ON THE LLQ, INCARCERATED DIRECT HERNIA DEFECT WAS IDENTIFIED AND RED

  Patient problems: Hernia

  MAUDE report 24021677 ↗
• InjuryDec 18, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2014 - PATIENT WAS DIAGNOSED WITH INDIRECT AND DIRECT RIGHT SCROTAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF PERFIX PLUGS (DEVICE 1 AND 2). PER OP NOTES, ¿RIGHT SCROTAL SAC WAS IDENTIFIED, AND THE CONTENTS WERE PARTIALLY REDUCED. TWO-THIRDS OF HIS SMALL BOWEL WAS NOTED IN THE RIGHT SCROTAL SAC AND REDUCED BACK INTO PERITONEAL CAVITY. SEPARATE HERNIA SACS WERE IDENTIFIED INVOLVING THE RIGHT COLON AND EXCISED. TWO PERFIX PLUGS (DEVICE 1 AND 2) WERE PLACED INTO THE DEFECT AND SECURED WITH SUTURES.¿ (B)(6) 2017 - PATIENT WAS DIAGNOSED WITH RECURRENT INCARCERATED RIGHT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH EXCISION OF PERFIX PLUGS (DEVICE 1 AND 2). PER OP NOTES, ¿A SCAR FROM PREVIOUS HERNIA REPAIR WAS IDENTIFIED IN THE RIGHT GROIN REGION. A LARGE, INDURATED MASS CONSISTENT WITH THE PREVIOUS PLUGS (DEVICE 1 AND 2) WERE NOTED IN THE INGUINAL CANAL. THE HERNIA SAC WAS REDUCED, AND THE PLUGS (DEVICE 1 AND 2) WERE EXCISED COMPLETELY, AND HERNIA WAS REPAIRED WITH SUTURES.¿

  Patient problems: Hernia; Scar Tissue

  MAUDE report 23836379 ↗
• InjuryNov 21, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2015 ¿ PATIENT WAS DIAGNOSED WITH PANTALOON LEFT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF PERFIX PLUG (DEVICE 1, 2). PER OP NOTES, ¿PATIENT HAD VERY LARGE LIPOMA ON THE CORD WAS SKELETONIZED OFF AND RE-INVAGINATED INTO THE INDIRECT SPACE. A SMALL PERFIX PLUG (DEVICE 1) WAS PLACED AND TACKED CIRCUMFERENTIALLY. A DIRECT HERNIA WAS NOTED AND A EXTRA LARGE PERFIX PLUG (DEVICE 2) WAS PLACED INTO DIRECT DEFECT AND A ONLAY PATCH PLACED OVER TOP OF PUBIC TUBERCLE USING SUTURES.¿ ATTORNEY ALLEGES PAIN, NUMBNESS AND BURNING SENSATION ON LEFT GROIN.

  Patient problems: Pain

  MAUDE report 23614121 ↗
• InjuryNov 5, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2005- PATIENT WAS DIAGNOSED WITH RIGHT SCROTAL HERNIA, LEFT INGUINAL HERNIA, DIRECT AND UMBILICAL HERNIA, THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF PERFIX PLUGS (DEVICE 1 AND 2). PER OP NOTES, ¿IN THE RIGHT INGUINAL REGION, LARGE HERNIA SAC WITH OMENTUM WAS IDENTIFIED AND REDUCED. AN EXTRA-LARGE PERFIX PLUG (DEVICE 1) WAS PLACED IN THE RIGHT INGUINAL REGION AND SUTURED. CORRESPONDING MESH WAS PLACED IN THE FLOOR OF THE CANAL AND SUTURED. THEN IN LEFT INGUINAL REGION, HERNIA WAS IDENTIFIED AND REDUCED. A PERFIX PLUG (DEVICE 2) WAS PLACED UNDERNEATH THE CORD STRUCTURE AND SUTURED¿. ON (B)(6) 2005- PATIENT WAS DIAGNOSED WITH LEFT INGUINAL HERNIA, THEREBY UNDERWENT OPEN REPAIR WITH EXPLANT OF PERFIX PLUG (DEVICE 2) AND IMPLANT OF SYNTHETIC MESH. PER OP NOTES, ¿IN THE LOWER ABDOMEN AND LEFT GROIN REGION, THE PREVIOUSLY PLACE PERFIX PLUG (DEVICE 2) WAS REMOVED, WHERE A LARGE DIRECT SAC IN THE FLOOR OF THE CANAL WAS IDENTIFIED AND REDUCED. A SYNTHETIC MESH WAS PLACED AND SUTURED. ON (B)(6) 2011- PATIENT WAS DIAGNOSED WITH BILATERAL INGUINAL HERNIAS WITH RIGHT SCROTAL PAIN, THEREBY UNDERWENT LAPAROSCOPIC REPAIR CONVERTED TO OPEN REPAIR WITH PARTIAL E

  Patient problems: Hernia

  MAUDE report 23474564 ↗
• MalfunctionAug 19, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  AS REPORTED, THE PERFIX PLUG WAS CONTAMINATED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22844029 ↗
• InjuryJun 18, 2025Material Deformation; Material Deformation

  PER INFORMATION PROVIDED: (B)(6) 2016 - PATIENT WAS DIAGNOSED WITH RIGHT DIRECT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF PERFIX PLUG (DEVICE #1). PER OPERATIVE NOTES, "A LARGE DIRECT DEFECT WAS NOTED AND INVERTED. A PERFIX PLUG (DEVICE #1) WAS PLACED IN THE HERNIA SAC AND SUTURED. THE ONLAY PATCH WAS PLACED ON THE FLOOR OF THE CANAL. SECOND PIECE OF MESH (DEVICE #4) WAS NOTED." (B)(6) 2016 - PATIENT WAS DIAGNOSED WITH RECURRENT DIRECT RIGHT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF PERFIX PLUGS (DEVICE #2, #3). PER OPERATIVE NOTES, "SEROMA CAVITY WAS NOTED AND RESECTED. THE DEFECT WAS MEDIAL, THE PREVIOUS PATCH (DEVICE #1) HAD PULLED AWAY FROM THE SUPERIOR ASPECT. TWO PERFIX PLUGS (DEVICE #2, #3) WERE SUTURED INFERIORLY TO THE MESH. THE PATCH WAS PLACED TO THE FLOOR OF THE CANAL." (B)(6) 2016 - PATIENT UNDERWENT ASPIRATION OF SEROMA. (B)(6) 2017 - PATIENT WAS DIAGNOSED WITH RECURRENT RIGHT INGUINAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT OF 3DMAX MESH (DEVICE #4). PER OPERATIVE NOTES, "LARGE COMPLEX DEFECT IN RIGHT GROIN WITH LARGE HERNIA SAC WAS NOTED. SMALL HERNIA WAS NOTED IN INDIRECT SPACE AS WELL. SCAR TISS

  Patient problems: Adhesion(s); Hernia; Seroma

  MAUDE report 22286340 ↗
• InjuryMay 12, 2025Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  PER ADDITIONAL INFORMATION PROVIDED: ON (B)(6) 2009: PATIENT WAS DIAGNOSED WITH LARGE LEFT INGUINAL HERNIA, LIPOMA OF THE CORD THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF THREE PERFIX PLUG MESH (DEVICE #1, DEVICE #2, DEVICE #3). PER OPERATIVE NOTES, ¿THREE PERFIX PLUG MESH AND PATCH WAS PLACED AND SUTURED.¿ ON (B)(6) 2012: PATIENT WAS DIAGNOSED WITH MASSIVE RECURRENT LEFT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE EXPLANT OF PERFIX PLUG MESH AND IMPLANT OF PROLOOP MESH. PER OPERATIVE NOTES, ¿PREVIOUSLY PLACED MESH WAS DISSECTED. A PROLOOP MESH WAS PLACED AND SUTURED.¿ ON (B)(6) 2012: PATIENT WAS DIAGNOSED WITH LEFT SCROTAL EXPLORATION; SCROTAL HEMATOMA THEREBY UNDERWENT OPEN REPAIR. ON (B)(6) 2013: PATIENT WAS DIAGNOSED WITH RIGHT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF TWO PERFIX PLUG MESH (DEVICE #4, DEVICE #5). PER OPERATIVE NOTES, ¿TWO EXTRA LARGE PERFIX PLUG MESH (DEVICE #4, DEVICE #5) WAS PLACED AND SUTURED.¿

  Patient problems: Hernia

  MAUDE report 22001727 ↗
• InjuryMay 12, 2025Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  PER ADDITIONAL INFORMATION PROVIDED: ON (B)(6) 2009, PATIENT WAS DIAGNOSED WITH LARGE LEFT INGUINAL HERNIA, LIPOMA OF THE CORD THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF THREE PERFIX PLUG MESH (DEVICE #1, DEVICE #2, DEVICE #3). PER OPERATIVE NOTES, ¿THREE PERFIX PLUG MESH AND PATCH WAS PLACED AND SUTURED.¿ ON (B)(6) 2012, PATIENT WAS DIAGNOSED WITH MASSIVE RECURRENT LEFT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE EXPLANT OF PERFIX PLUG MESH AND IMPLANT OF PROLOOP MESH. PER OPERATIVE NOTES, ¿PREVIOUSLY PLACED MESH WAS DISSECTED. A PROLOOP MESH WAS PLACED AND SUTURED.¿ ON (B)(6) 2012, PATIENT WAS DIAGNOSED WITH LEFT SCROTAL EXPLORATION, SCROTAL HEMATOMA THEREBY UNDERWENT OPEN REPAIR. ON (B)(6) 2013, PATIENT WAS DIAGNOSED WITH RIGHT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF TWO PERFIX PLUG MESH (DEVICE #4, DEVICE #5). PER OPERATIVE NOTES, ¿TWO EXTRA LARGE PERFIX PLUG MESH (DEVICE #4, DEVICE #5) WAS PLACED AND SUTURED.¿

  Patient problems: Hernia

  MAUDE report 22001479 ↗