PerFix 0112770Recalls & reported problems

Summary

The FDA's MAUDE database contains 376 adverse event reports that list this exact device (DI 00801741016615), received between Dec 18, 2014 and Sep 3, 2026 — classified as 369 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Defective Device” (320 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 376 reports, in the reporter's own words as published by the FDA.

• InjurySep 3, 2026Patient-Device Incompatibility

  Per information provided:On 23-Sep-2015 - Patient was diagnosed with bilateral inguinal hernias thereby underwent open repair with implant of PerFix Plug (Device 1 and 2). Per op notes, "On the right inguinal region, an indirect and a large direct hernia sac were noted and separated from the cord structures. A PerFix Plug (Device 1) with onlay patch was placed and sutured. On the left inguinal region, large direct and indirect hernia defects were noted and reduced. A PerFix Plug (Device 2) with onlay patch was placed and sutured."On (b)(6) 2018 - Patient was diagnosed with chronic bilateral groin pain thereby underwent open repair with excision of PerFix Plug (Device 1 and 2). Per op notes, "On the right inguinal region, the cord structures were densely adherent to the old mesh (Device 1) were taken down. The cord structures were mobilized. The old mesh (Device 1) was excised and removed. On the left inguinal region, the mesh (Device 2) was densely adherent to the cord structures were taken down. The old mesh (Device 2) was excised and removed. Both defects on right and left inguinal region were closed with sutures."

  Patient problems: Adhesion(s); Pain

  MAUDE report 50588123 ↗
• InjuryJun 1, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2006 - 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, "MADE AN INCISION TO THE RIGHT INGUINAL REGION, A PERFIX PLUG (DEVICE 1) WAS PLACED THROUGH THE DEFECT AND SECURED WITH SUTURES. ATTENTION TO THE LEFT SIDE, A PERFIX PLUG (DEVICE 2) WAS PLACED IN THE FLOOR OF THE INGUINAL CANAL AND SECURED WITH SUTURES." ON (B)(6) 2016 - PATIENT WAS DIAGNOSED WITH RECURRENT BILATERAL INGUINAL HERNIAS THEREBY UNDERWENT OPEN REPAIR WITH THE REMOVAL OF MESH (DEVICE 1) AND IMPLANT OF TWO PERFIX PLUGS (DEVICE 3 AND DEVICE 4). PER OP NOTES, "FIRST THE RIGHT SIDE, ADHESIONS OF THE PREVIOUS PLUG WERE STUCK TO THE EXTERNAL CANAL. THE MESH (DEVICE 1) WAS EXCISED AND A PERFIX PLUG (DEVICE 3) WAS PLACED THE PUBIC TUBERCLE USING SUTURES. ON THE LEFT SIDE, THE OLD PLUG (DEVICE 2) AT THE EXTERNAL RING WAS LEFT ALONE. AND A PERFIX PLUG (DEVICE 4) WAS PLACED IN THE INTERNAL CANAL."

  Patient problems: Hernia

  MAUDE report 25353532 ↗
• InjuryMar 3, 2026Material Deformation

  PER INFORMATION PROVIDED: (B)(6) 2014- PATIENT WAS DIAGNOSED WITH RIGHT INGUINAL HERNIA, THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF PERFIX PLUGS (DEVICE 1 AND 2). PER OP NOTES, ¿A LARGE HERNIA SAC WITH OMENTUM WAS IDENTIFIED IN THE RIGHT INGUINAL REGION AND DISSECTED. A PERFIX PLUGS (DEVICE 1 AND 2) WAS PLACED ON THE FLOOR OF THE RIGHT INGUINAL REGION AND SUTURED¿. (B)(6) 2017- PATIENT WAS DIAGNOSED WITH RECURRENT RIGHT INGUINAL HERNIA, THEREBY UNDERWENT ROBOTIC ASSISTED LAPAROSCOPIC REPAIR WITH IMPLANT OF SYNTHETIC MESH. PER OP NOTES, ¿LARGE HERNIAS WERE IDENTIFIED TRANS-ABDOMINALLY AND A VERY LARGE INDIRECT DEFECT WITH EPIGASTRICS WAS IDENTIFIED AND DISSECTED. THE HERNIA WAS REDUCED AND A SYNTHETIC MESH WAS PLACED COVERING THE DEFECT AND SUTURED. THE PREVIOUSLY PLACED MESH (DEVICE 1 AND 2) WAS FOUND TO BE FOLDED UP AND BALLED UP AND WAS DEPLOYED AND SUTURED¿.

  Patient problems: Hernia

  MAUDE report 24492698 ↗
• InjuryMar 2, 2026Material Deformation

  PER INFORMATION PROVIDED: (B)(6) 2007 - 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 CANAL IS APPROACHED BY A LEFT INGUINAL INCISION. TWO PERFIX PLUGS (DEVICE 1 AND 2) WERE PLACED USING PROLENE SUTURES." (B)(6) 2017 - PATIENT WAS DIAGNOSED WITH RECURRENT LEFT INGUINAL HERNIA AND RIGHT DIRECT INGUINAL HERNIA THEREBY UNDERWENT REPAIR WITH THE IMPLANT OF TWO 3DMAX MESHES (DEVICE 3 AND 4). PER OP NOTES, "NOTED TO BE ADHERED TO THE MESH. THERE WAS ROLLEDUP MESH NOTED WITHIN THE LEFT SIDED INGUINAL REGION. THE ENTIRE ROLLED-UP MESH HAD ALSO SOMEWHAT CONTRACTED AND WAS DENSELY SCARRED INTO THE CORD STRUCTURES. TWO LARGE 3DMAX MESH (DEVICE 3 AND 4) WERE PLACED ON BOTH LEFT AND RIGHT SIDE OF THE INGUINAL REGION USING TACKS. "

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

  MAUDE report 24481336 ↗
• InjuryFeb 26, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2008 ¿ PATIENT WAS DIAGNOSED WITH RECURRENT INDIRECT LEFT INGUINAL HERNIA, DIRECT RIGHT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF PERFIX PLUG (LEFT - DEVICE 1, RIGHT - DEVICE 2). PER OP NOTES, ¿ON LEFT INGUINAL AREA, HERNIA SAC WAS NOTED. THE PREVIOUSLY PLACED SYNTHETIC MESH WAS NOTED. THE DEFECT WAS REPAIRED USING A LARGE PERFIX PLUG (DEVICE 1) AND PIECE OF MESH WAS USED TO REINFORCE THE FLOOR. THE RIGHT INGUINAL HERNIA WAS IDENTIFIED. THE DEFECT WAS IDENTIFIABLE AT THE FLOOR OF INGUINAL CANAL. A LARGE PERFIX PLUG (DEVICE 2) WAS PLACED TO SECURED THE REPAIR AND KEYHOLE OVERLAY WAS SECURED USING SUTURES.¿ ON (B)(6) 2017 ¿ PATIENT WAS DIAGNOSED WITH PERSISTENT RIGHT INGUINAL PAIN THEREBY UNDERWENT OPEN REPAIR. PER OP NOTES, ¿ON LEFT GROIN, A RECURRENT HERNIA WAS NOTED. ON RIGHT GROIN, SCAR TISSUE WAS NOTED AND SUTURES WERE REMOVED. ADHESIONS TO CORD STRUCTURE WERE WRAPPED MORE WITH THE MESH (DEVICE 2) LATERALLY.¿

  Patient problems: Hernia

  MAUDE report 24455563 ↗
• InjuryFeb 18, 2026Material Deformation

  PER INFORMATION PROVIDED: (B)(6) 2015 ¿ PATIENT UNDERWENT HERNIA REPAIR WITH THE IMPLANT OF PERFIX PLUGS (DEVICE 1, 2). (NOTE: THERE IS NO OP NOTES PROVIDED FOR THIS PROCEDURE IN MEDICAL RECORDS) (B)(6) 2017 ¿ AS PER NOTE, SURGEON INFORMED THAT PATIENT UNDERWENT RIGHT INGUINAL HERNIA REPAIR 2 YEARS AGO AND WAS DIAGNOSED WITH INCARCERATED RECURRENT RIGHT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE REMOVAL OF MESHES (DEVICE 1, 2) AND IMPLANT OF PERFIX PLUG (DEVICE 3). PER OP NOTES, ¿ADHESION BETWEEN THE INCARCERATED CORD WITH CONTENTS WERE TAKEN DOWN. A LARGE FLOOR DEFECT WAS ADJACENT TO DEEP RING. THERE WAS A LARGE MESH BALL STUCK INTO THE AREA AND CREATING A LOT OF ADHESIONS. THE MESH BALL (DEVICE 1,2) WAS REMOVED. AN EXTRA LARGE PERFIX PLUG (DEVICE 3) WAS SEWED IN MULTIPLE AREAS TO EDGES OF REMNANT FLOOR. A PATCH WAS PLACED AND REINFORCED THE FLOOR AND SEWN TO FACIA OF PUBIC TUBERCLE USING SUTURES.¿

  Patient problems: Adhesion(s); Hernia

  MAUDE report 24377167 ↗
• 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 24021675 ↗
• InjuryJan 8, 2026Patient-Device Incompatibility

  PER MEDICAL RECORD AND PLAINTIFF PROFILE FORM: (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH LEFT DIRECT AND INDIRECT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF PERFIX PLUG (DEVICE 1 AND DEVICE 2). PER OPERATIVE NOTES, ¿A LEFT GROIN INCISION WAS MADE. BOTH DIRECT AND INDIRECT HERNIA SACS WERE DISSECTED OUT. TWO LARGE PERFIX PLUG (DEVICE 1 AND DEVICE 2) WERE PLACED INTO THE DIRECT AND INDIRECT INGUINAL FLOOR AND SECURE IT WITH SUTURES.¿ (B)(6) 2015 ¿ PATIENT WAS DIAGNOSED WITH RIGHT DIRECT AND INDIRECT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF PERFIX PLUG (DEVICE 3 AND DEVICE 4). PER OPERATIVE NOTES, ¿A RIGHT GROIN INCISION WAS MADE INTO RIGHT INGUINAL FLOOR. BOTH DIRECT AND INDIRECT HERNIA SACS WERE DISSECTED OUT. TWO PERFIX PLUG (DEVICE 3 AND DEVICE 4) WERE PLACED INTO THE RIGHT INGUINAL FLOOR AND SECURE IT WITH SUTURES.¿ (B)(6) 2016 ¿ PATIENT WAS DIAGNOSED WITH LEFT INGUINAL PAIN; RECURRENT LEFT INGUINAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF 3DMAX MESH (DEVICE 5). PER OPERATIVE NOTES, ¿A SUPRAUMBILICAL INCISION WAS MADE. LEFT INGUINAL HERNIA SAC WAS DISSECTED OUT. PREVIOUSLY PLACED MESHES (DEVICE 1 AND DEVICE 2) WERE INTACT

  Patient problems: Adhesion(s); Hernia; Pain

  MAUDE report 24003009 ↗
• InjuryDec 12, 2025Device Appears to Trigger Rejection; Material Deformation; Device Appears to Trigger Rejection; Material Deformation

  PER INFORMATION PROVIDED: ON (B)(6) 2009 ¿ PATIENT WAS DIAGNOSED WITH INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF COMPOSIX KUGEL MESH (DEVICE 1). PER OP NOTES, ¿PATIENT HAD DEVELOPED A LARGER HERNIA FROM CHOLECYSTECTOMY TROCAR SITE. THE HERNIA SAC WAS FOUND, AND A COMPOSIX KUGEL MESH (DEVICE 1) WAS PLACED INSIDE THE ABDOMINAL CAVITY AND ANCHORED TO THE FASCIAL RING USING SUTURES.¿ ON (B)(6) 2009 ¿ PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF PERFIX PLUG (DEVICE 2). PER OP NOTES, ¿A LARGE HERNIA PALPABLE IN RIGHT PARAMEDIAN AREA. THE PIECE OMENTUM WAS DISSECTED FREE. A PERFIX PLUG AND MESH (DEVICE 2) WAS ANCHORED TO FASCIAL RING AND SUTURED.¿ (B)(6) 2010 - PATIENT WAS DIAGNOSED MULTIPLE RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE REMOVAL OF COMPOSIX KUGEL MESH (DEVICE 1) AND PERFIX PLUG (DEVICE 2). PER OP NOTES, ¿THE LARGE HERNIA IN THE UPPER MIDLINE WAS IDENTIFIED AND ALSO HAD ANOTHER RIGHT SIDED DEFECT RIGHT OF THE UMBILICUS SLIGHTLY LOWER WHERE PERFIX PLUG (DEVICE 1) WAS PLACED. BOTH THE MESHES (DEVICE 1, 2) WERE CURLED UP WITH CHRONIC INFLAMMATION AND WAS PROTRUDING INTO TH

  Patient problems: Hernia; Inflammation

  MAUDE report 23788640 ↗
• InjuryNov 28, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2004 ¿ PATIENT WAS DIAGNOSED WITH BILATERAL INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF PERFIX PLUG (LEFT - DEVICE 1, RIGHT - DEVICE 2). PER OP NOTES, ¿ON LEFT INGUINAL, THERE WAS AN OBVIOUS HERNIA SAC. A LARGE PERFIX PLUG (DEVICE 1) WAS PLACED INTO INGUINAL FLOOR AND ANCHORED TO MEDIAL ASPECT OF CONJOINED TENDON. THEN, A MESH ONLAY WAS PLACED OVER THE TOP OF FLOOR TO THE PUBIC TUBERCLE USING SUTURES. ON RIGHT SIDE, THE DEFECT WAS REPAIRED AS MIRROR IMAGE OF LEFT SIDE USING A LARGE PERFIX PLUG AND PATCH (DEVICE 2).¿ (B)(6) 2016 ¿ PATIENT HAD PAIN AND WAS DIAGNOSED WITH BILATERAL RECURRENT INGUINAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT OF 3DMAX LIGHT MESHES (LEFT - DEVICE 3, RIGHT ¿ DEVICE 4). PER OP NOTES, ¿ON THE RIGHT SIDE, PERFIX PLUG (DEVICE 2) WAS ENCOUNTERED IN DIRECT SPACE. DEFECTS WERE MADE IN PERITONEUM. ON LEFT SIDE, THE MESH (DEVICE 1) WAS NOTED IN INDIRECT SPACE. A LARGE PIECE OF 3DMAX LIGHT MESH (DEVICE 3) WAS PLACED INTO PREPERITONEAL SPACE USING TACKS. ON RIGHT SIDE, 3DMAX LIGHT MESH (DEVICE 4) WAS INTRODUCED AND FIXED IN A SIMILAR FASHION OF LEFT.¿

  Patient problems: Hernia; Pain

  MAUDE report 23670867 ↗
• InjuryNov 21, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2002 - PATIENT WAS DIAGNOSED WITH BILATERAL INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF PERFIX PLUG (DEVICE 1 AND 2). (NOTE: THERE IS NO OPERATIVE NOTES PROVIDED FOR THIS PROCEDURE) ON (B)(6) 2008 - PATIENT WAS DIAGNOSED WITH COLOVESICAL FISTULA AND ADHESIONS THEREBY UNDERWENT LAPAROSCOPIC CONVERTED TO OPEN REPAIR. PER OP NOTES, ¿DENSE ADHESIONS OF OMENTUM AND SIGMOID COLON WAS TAKEN DOWN. THE ADHESIONS IN BOTH LEFT AND RIGHT LOWER QUADRANT WERE LYSED. THE COLOVESICAL FISTULA WAS NOTED NEAR BLADDER AND EXCISED THE FISTULA. THE SIGMOID COLON ADHESIONS WERE LYSED, AND A PART OF COLON WAS EXCISED. FIBROTIC TISSUE IN INGUINAL REGION WAS EXCISED AND SUTURED.¿

  Patient problems: Adhesion(s); Fibrosis; Fistula

  MAUDE report 23614196 ↗
• InjuryNov 21, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2008 ¿ PATIENT WAS DIAGNOSED WITH BILATERAL INGUINAL HERNIAS THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF PERFIX PLUG (DEVICE 1, 2). PER OP NOTES, ¿ATTENTION TO LEFT SIDE, THE INGUINAL FLOOR APPEARED TO BE RUPTURED WAS REPAIRED USING A PERFIX PLUG (DEVICE 1) AND SECOND LAYER OF MESH WAS PLACED OVER THE PUBIC TUBERCLE AND SUTURED. ATTENTION TO THE RIGHT SIDE, SMALL INDIRECT HERNIA SAC WAS NOTED. A LARGE PERFIX PLUG (DEVICE 2) WAS PLACED, AND LAYER OF MESH WAS PLACED TO POUPART LIGAMENT USING SUTURES.¿ ATTORNEY ALLEGES THAT PATIENT HAD BOWEL OBSTRUCTION, NERVE DAMAGE, PAIN AND EMOTIONAL INJURIES. IT IS ALSO ALLEGED THAT PATIENT HAD SWELLING, SORE AND PAIN IN GROIN AREA, NUMBNESS UNDERNEATH SCROTUM, BLEEDING.

  Patient problems: Nerve Damage; Obstruction/Occlusion; Pain

  MAUDE report 23614059 ↗
• InjuryOct 23, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2012 - PATIENT WAS DIAGNOSED WITH INCARCERATED BILATERAL INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF TWO PERFIX PLUG (DEVICE 1 ¿ RIGHT AND DEVICE 2 ¿ LEFT). PER OPERATIVE NOTES, ¿AN INCISION WAS MADE INTO THE ABDOMEN. BOTH HERNIA SACS WERE DISSECTED OUT. A PERFIX PLUG (DEVICE 1) WAS PLACED INTO THE RIGHT INGUINAL REGION AND SECURE IT WITH SUTURE. INTO THE LEFT SIDE A PERFIX PLUG (DEVICE 2) WAS PLACED AND SECURE IT WITH SUTURE.¿ ON (B)(6) 2020 - PATIENT WAS DIAGNOSED WITH BILATERAL RECURRENT INGUINAL HERNIA WITHOUT OBSTRUCTION, THEREBY UNDERWENT ROBOTIC ASSISTED REPAIR WITH IMPLANT OF TWO SYNTHETIC MESHES. PER OPERATIVE NOTES, ¿A MIDLINE INCISION WAS MADE IN THE SUPRAUMBILICAL REGION. BOTH HERNIA SACS WERE DISSECTED OUT. TWO SYNTHETIC MESHES WERE PLACED INTO LEFT AND RIGHT INGUINAL REGION AND SECURE IT WITH SUTURES.¿

  Patient problems: Hernia

  MAUDE report 23365870 ↗
• InjuryOct 21, 2025Migration; Migration

  PER ADDITIONAL INFORMATION PROVIDED: ON (B)(6) 2001- PATIENT WAS DIAGNOSED WITH GIANT DIRECT RIGHT INGUINAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR CONVERTED TO OPEN REPAIR WITH IMPLANT OF PERFIX PLUG (DEVICE #1 AND #2). PER OP NOTES, ¿LARGE DIRECT DEFECT WAS IDENTIFIED AND WAS REDUCED. PERFIX PLUG (DEVICE #1 AND #2) WERE PLACED TO REDUCE OCCLUDE THE DIRECT DEFECT. PERFIX PLUG PATCH WAS THEN PLACED ON TOP OF THE PLUG AND ON THE INGUINAL FLOOR.¿ ON (B)(6) 2010- PATIENT WAS DIAGNOSED WITH INFECTED MESH WITH EROSION INTO SMALL BOWEL AND ADHESIONS, RIGHT GROIN PAIN, THEREBY UNDERWENT OPEN REPAIR WITH PARTIAL EXPLANT OF PERFIX PLUG (DEVICE #1 AND #2) PER OP NOTES, ¿POCKET OF PURULENT MATERIAL WAS NOTED AND DRAINED. UPON INTRAABDOMINAL EXAMINATION, IT BECAME EVIDENT THAT THE MESH HAD ERODED INTO THE SMALL BOWEL. INFECTED PERFIX PLUG (DEVICE #1 AND #2) WAS PARTIALLY REMOVED. THERE ARE LOT OF ADHESIONS IN THE SMALL BOWEL WHICH IS TAKEN DOWN AND SUTURED.¿

  Patient problems: Adhesion(s); Pain; Unspecified Infection

  MAUDE report 23345387 ↗
• InjurySep 2, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2006 ¿ PATIENT WAS DIAGNOSED WITH LARGE BILATERAL INGUINAL HERNIA THEREBY UNDERWENT OPEN WITH IMPLANT OF PERFIX PLUGS (DEVICE # 1) AND (DEVICE # 2). PER OPERATIVE NOTES, ¿THE LEFT INGUINAL HERNIA WAS NOTED AND A LARGE PERFIX PLUG (DEVICE #1) WAS PLACED IN THE LATERAL ASPECT OF THE CANAL WALL AND AN ONLAY MESH WAS PLACED AFFIXED TO THE FASCIA. IN THE RIGHT INGUINAL REGION, THE SMALL SAC WAS IDENTIFIED AND A PERFIX PLUG (DEVICE #2) WAS PLACED INTO THE LATERAL DEFECT OF THE POSTERIOR CANAL AND AN ONLAY MESH WAS PLACED AFFIXED TO THE FASCIA AS SIMILAR AS LEFT SIDE.¿ ON (B)(6) 2006 ¿ PATIENT WAS DIAGNOSED WITH SUTURE AND MESH GRANULOMA OF OLD LEFT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR. PER OPERATIVE NOTES, ¿THE ENTIRE FIRM MASS WAS EXCISED IN ITS ENTIRETY AND IT APPEARED TO BE A GRANULOMA SECONDARY TO MESH (DEVICE # 1).¿ ON (B)(6) 2006 ¿ PATIENT WAS DIAGNOSED WITH SUTURE AND MESH GRANULOMA OF LEFT INGUINAL THEREBY UNDERWENT OPEN REPAIR WITH PARTIAL REMOVAL OF MESH (DEVICE # 1). PER OPERATIVE NOTES, ¿A LARGE PORTION OF MESH GRANULOMA WAS EXCISED INCLUDING SOME SUTURE GRANULOMAS. THE MESH THAT HAD BEEN PLACED PREVIOUSLY AROUND THE EXTERNAL CANAL

  Patient problems: Fibrosis; Granuloma; Scar Tissue

  MAUDE report 22934503 ↗
• InjuryAug 8, 2025Migration; Migration

  PER INFORMATION PROVIDED: (B)(6) 2012 ¿ PATIENT HAD BILATERAL HERNIA REPAIR WITH (NON-BARD/DAVOL) IMPLANT OF 3X6 INCH SURGIPRO POLYPROPYLENE MESH ON THE LEFT AND A SYMMETRICAL 3X6 INCH POLYPROPYLENE MESH ON THE RIGHT (NO PRODUCT IDENTIFIERS PROVIDED AND THERE IS NO MENTION OF THE ALLEGED BARD MESH IMPLANTED IN 2012 AS WAS ALLEGED IN THE INITIAL LEGAL CLAIM). (B)(6) 2016 ¿ PATIENT HAD RECURRENT BILATERAL INGUINAL HERNIA AND UNDERWENT IMPLANT OF 2 PERFIX PLUGS. PATIENT WAS DIAGNOSED WITH RECURRENT BILATERAL INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF PERFIX PLUGS (DEVICE #1, #2). PER OPERATIVE NOTES, ¿ON RIGHT, ILIOINGUINAL NERVE WAS DISSECTED. A LARGE RECURRENCE WAS FOUND LATERAL TO CORD AND A LARGE PERFIX PLUG (DEVICE #1) WAS PLACED INTO DEFECT AND SUTURED. THEN, ONLAY MESH WAS SUTURED TO PUBIC TUBERCLE USING SUTURES. ON LEFT, MEDIAL RECURRENCE WAS REPAIRED USING A PERFIX PLUG AND ONLAY KEYHOLE MESH (DEVICE #2) WHICH WERE PLACED AND SUTURED TO SHELVING EDGE OF INGUINAL LIGAMENT.¿ ATTORNEY ALLEGES MESH MIGRATION, MESH SHRINKAGE AND PAIN.

  Patient problems: Pain

  MAUDE report 22746980 ↗
• InjuryAug 5, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2008 ¿ PATIENT WAS DIAGNOSED WITH INDIRECT BILATERAL INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH TWO PERFIX PLUG (DEVICE #1 AND #2). PER OPERATIVE NOTES, ¿IN THE RIGHT SIDE, INDIRECT HERNIA SAC WAS IDENTIFIED AND REDUCED. A LARGE PERFIX PLUG (DEVICE #1) WAS PLACED IN THE PERITONEAL SPACE AND SUTURED AND TACKED IN PLACE. SIMILARLY IN LEFT SIDE, LARGE INDIRECT SAC WAS REDUCED AND LARGE PERFIX PLUG (DEVICE #2) WAS PLACED IN PREPERITONEAL SPACE AND SECURED IN PLACE WITH SUTURES.¿ (B)(6) 2012 - PATIENT WAS DIAGNOSED WITH BILATERAL INGUINODYNIA AND RECURRENT RIGHT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH REMOVAL OF ALL MESHES, NEURECTOMY AND IMPLANT OF BARD SOFT MESH PRE-SHAPED W/KEYHOLE ON BOTH SIDES (DEVICE #3 AND #4). PER OPERATIVE NOTES, ¿IN RIGHT SIDE, EXTENSIVE DENSE SCLEROTIC FIBROSIS AND SCARRING WITHIN INGUINAL CANAL WAS NOTED. THE GENITOFEMORAL NERVE WAS IDENTIFIED AND TRANSECTED. THE MESH (DEVICE #1) WAS SEEN DENSELY ADHERENT AND REMOVED. A LARGE INDIRECT DEFECT WITH INTERNAL RING DEFECT WAS IDENTIFIED AND LARGE BARD SOFT MESH PRE-SHAPED W/KEYHOLE (DEVICE #3) WAS PLACED AND SECURED WITH SUTURES. IN LEFT SIDE, FIBROSIS WAS NOTED

  Patient problems: Adhesion(s); Fibrosis; Nerve Damage

  MAUDE report 22714546 ↗
• InjuryJul 24, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2014 - PATIENT WAS DIAGNOSED WITH RIGHT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF TWO PERFIX PLUGS (DEVICE #1 AND #2). PER OP NOTES, "TWO PERFIX PLUGS (DEVICE #1 AND #2) WERE PLACED TO THE PUBIS MEDIALLY, COOPER'S LIGAMENT INFERIORLY AND TRANSVERSALIS SUPERIORLY." (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH RECURRENT RIGHT INGUINAL HERNIA, MESH PAIN AND INFECTION THEREBY UNDERWENT REPAIR WITH REMOVAL OF MESH (DEVICE #1& #2). PER OP NOTES, "THERE WERE 2 PLUGS IDENTIFIED. BOTH PLUGS (DEVICE #1 AND #2) WERE THEN DISSECTED FREE FROM THE SURROUNDING TISSUE. THE PLUGS (DEVICE #1 AND #2) WERE REMOVED".

  Patient problems: Hernia; Pain; Unspecified Infection

  MAUDE report 22585182 ↗
• InjuryJul 15, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2010 ¿ PATIENT WAS DIAGNOSED WITH LEFT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF PREFIX PLUG (DEVICE #1, #2). PER OPERATIVE NOTES, ¿A MEDIUM SIZED DIRECT WAS NOTED. A LARGE AND EXTRA-LARGE PREFIX PLUG (DEVICE #1, #2) WERE SEWN TOGETHER TO ONE LARGER PLUG AND PLACED TO DIRECT SPACE AND ONLAY PATCH WAS PLACED ALONG THE FLOOR OF GROIN AND SECURED TO PUBIC TUBERCLE, COOPER¿S LIGAMENT AND INGUINAL LIGAMENT USING SUTURES.¿ ON (B)(6) 2017 ¿ PATIENT HAD ACUTE DIVERTICULITIS WITH ABSCESS AND ADHESION WITH CLOSED LOOP OBSTRUCTION THEREBY UNDERWENT SMALL BOWEL RESECTION. PER OPERATIVE NOTES, ¿THERE WERE MULTIPLE LOOPS OF SMALL BOWEL DENSELY ADHERENT TO THE PELVIC FLOOR WAS DISSECTED FREE. THERE WAS FRANK PURULENT DISCHARGE ON OPENING THE ABSCESS CAVITY AND LOOP OF BOWEL WERE RESECTED.¿ ON (B)(6) 2018 ¿ PATIENT WAS DIAGNOSED WITH INFECTION AND LEFT INGUINAL PAIN THEREBY UNDERWENT OPEN REPAIR WITH REMOVAL OF MESH (DEVICE #1, #2). PER OPERATIVE NOTES, ¿THERE WAS A SWELLING WHERE A LARGE MESH PLUG (DEVICE #1, #2) WAS NOTED. DENSE ADHESIONS IN THE SUBCUTANEOUS TISSUES AND FASCIA WERE DIVIDED. THE INFECTED MESH WAS DIVIDED TOWARDS THE PERI

  Patient problems: Obstruction/Occlusion; Purulent Discharge; Unspecified Infection

  MAUDE report 22505400 ↗
• InjuryJul 7, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2007 - PATIENT WAS DIAGNOSED WITH BILATERAL DIRECT AND INDIRECT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF PERFIX PLUGS (DEVICE #1, #2). PER OPERATIVE NOTES, "ON BOTH GROIN, HERNIA SACS WERE MOBILIZED AND THE FLOOR WAS REPAIRED USING PERFIX PLUGS (DEVICE #1, #2). THE PATCHES WERE ALSO SUTURED." (B)(6) 2013 - PATIENT WAS DIAGNOSED WITH RECURRENT RIGHT INGUINAL HERNIA THEREBY UNDERWENT REPAIR WITH THE IMPLANT OF PERFIX PLUG (DEVICE #3). PER OPERATIVE NOTES, "THE PREVIOUSLY PLACED MESH (DEVICE #1) WAS INCISED, A DIRECT HERNIA WAS NOTED CLOSE TO THE INGUINAL RING WITH A LIPOMA OF THE CORD. THIS WAS REDUCED. A PERFIX PLUG (DEVICE #3) WAS PLACED INTO THE DEFECT AND SUTURED. AN ONLAY PATCH WAS SECURED TO THE RECTUS SHEATH." (B)(6) 2019 - PATIENT WAS DIAGNOSED WITH BILATERAL RECURRENT INGUINAL HERNIA THEREBY UNDERWENT ROBOTIC ASSISTED LAPAROSCOPIC REPAIR WITH THE IMPLANT OF SYNTHETIC MESHES. PER OPERATIVE NOTES, "THE PRIOR MESH PLUG WAS NOTED WITH HERNIA SAC. SYNTHETIC MESHES WERE PLACED AND TACKED."

  Patient problems: Hernia

  MAUDE report 22410411 ↗
• InjuryJun 27, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2011 - PATIENT WAS DIAGNOSED WITH INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF VENTRIO HERNIA PATCH (DEVICE #1). PER OP NOTES, ¿A VENTRIO HERNIA PATCH (DEVICE #1) WAS TACKED UP TO THE ANTERIOR ABDOMINAL WALL WITH STAPLES.¿ ON (B)(6) 2014 - PATIENT WAS DIAGNOSED WITH RIGHT FEMORAL HERNIA WITH OBSTRUCTION AND ISCHEMIC BOWEL THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF PERFIX PLUG (DEVICE #2). PER OP NOTES, ¿A PERFIX PLUG & PATCH (DEVICE #2) WAS PLACED TO THE INGUINAL LIGAMENT USING PROLENE SUTURES.¿ ON (B)(6) 2017 - PATIENT WAS DIAGNOSED WITH RIGHT COLON CANCER AND A LARGE RIGHT GROIN INCISIONAL HERNIA THEREBY UNDERWENT REMOVAL OF MESH (DEVICE #1 & #2). PER OP NOTES, ¿ADHESIONS TO THE PREVIOUS MESH WERE DISSECTED OFF THE MESH. THE MESH (DEVICE #1 & #2) WAS COMPLETELY EXCISED ON BOTH SIDES OF THE ABDOMINAL WALL.¿ ON (B)(6) 2017 - PATIENT WAS DIAGNOSED WITH INCARCERATED INCISIONAL HERNIA, RECURRENT RIGHT GROIN THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF PERFIX PLUG (DEVICE #3). PER OP NOTES, ¿AN EXTRA-LARGE PLUG (DEVICE #3) WAS PLACED AND SUTURED WITH PROLENE SUTURES.¿

  Patient problems: Adhesion(s)

  MAUDE report 22345792 ↗
• InjuryApr 25, 2025Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  PER INFORMATION PROVIDED BY PATIENT'S ATTORNEY: (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH BILATERAL INGUINAL SCROTAL HERNIAS THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF THREE PERFIX PLUG (LEFT - DEVICE #1 & DEVICE #2, RIGHT - DEVICE #3). PER OPERATIVE NOTES,¿ AS TESTICLE WAS INTIMATELY ASSOCIATED WITH THE HERNIA SAC, ORCHIECTOMY WAS PERFORMED. THE INCARCERATED SIGMOID COLON FREED FROM THE SURROUNDING HERNIA SAC AND PLACED WITH TWO LARGE PERFIX PLUG (DEVICE #1 & DEVICE #2) AND SUTURED. AFTER THE PLUG PLACEMENT, EXTRA LARGE PATCH WAS PLACED IN THE FLOOR OF THE INGUINAL CANAL. TO THE RIGHT, A LARGE PERFIX PLUG (DEVICE #3) WAS PLACED TO THE FLOOR OF THE INGUINAL CANAL AND TACKED.¿ (B)(6) 2016 - PATIENT WAS DIAGNOSED WITH INFECTED MESH THEREBY UNDERWENT OPEN REPAIR WITH EXPLANT OF ALL THE PERFIX PLUG (LEFT - DEVICE #1 & DEVICE #2, RIGHT - DEVICE #3). PER OPERATIVE NOTES, "SEROMA AND CHRONIC DRAINAGE WERE NOTED AROUND THE PREVIOUSLY PLACED MESH. THE INDURATED TISSUE AND MESH (DEVICE #3) WERE REMOVED. ON THE LEFT SIDE SIMILAR DEBRIDEMENT WAS PERFORMED AND MESH (DEVICE #1 & DEVICE #2) EXPLANTED. ATTORNEY ALLEGED THAT THE PATIENT HAD ABSCESS, INFECTION, PAIN, HERNIA RECURRENCE AND EMOTIONA

  Patient problems: Seroma; Unspecified Infection

  MAUDE report 21908872 ↗
• InjuryApr 25, 2025Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  PER INFORMATION PROVIDED BY PATIENT'S ATTORNEY: (B)(6) 2016 - PATIENT WAS DIAGNOSED WITH LARGE BILATERAL DIRECT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF THREE PERFIX PLUG (RIGHT - DEVICE #1, #2 AND LEFT - DEVICE #3). PER OPERATIVE NOTES, ¿THE CONTENTS OF THE DIRECT HERNIA DEFECT ON RIGHT SIDE WERE FREED AND REDUCED. THE HERNIA SAC WAS STAPLED AND TWO LARGE PERFIX PLUG (DEVICE #1, #2) WERE PLACED, SECURED USING ONLAY PATCH AND SUTURED. THE CONTENTS OF THE DIRECT HERNIA DEFECT ON LEFT SIDE WERE FREED UP AND REDUCED. A LARGE PERFIX PLUG (DEVICE #3) WAS PLACED, SECURED WITH ONLAY MESH AND SUTURED.¿ (B)(6)2017 - PATIENT WAS DIAGNOSED WITH RECURRENT RIGHT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF PERFIX PLUG (DEVICE #4). PER OPERATIVE NOTES, ¿THE INDIRECT HERNIA SAC WAS IDENTIFIED AND SEPARATED FROM THE CORD STRUCTURES. EXCESS SAC WAS TRIMMED AND REDUCED. A SMALL PERFIX PLUG (DEVICE #4) WAS PLACED AND SECURED WITH SUTURES. TOO MUCH OF SCAR TISSUE WAS PRESENT FOR AN ONLAY PATCH.¿ ATTORNEY ALLEGES THAT THE PATIENT HAD NERVE DAMAGE, PAIN, HERNIA RECURRENCE AND EMOTIONAL INJURIES.

  Patient problems: Hematoma; Hernia; Scar Tissue

  MAUDE report 21908871 ↗
• InjuryFeb 25, 2025Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  PER INFORMATION PROVIDED: (B)(6) 2007 - PATIENT WAS DIAGNOSED WITH REDUCIBLE LEFT DIRECT AND INDIRECT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF PERFIX PLUG (DEVICE #1, #2). PER OPERATIVE NOTES, "SCAR TISSUE WAS NOTED IN PUBIC TUBERCLE, THE SPERMATIC CORD AND HERNIA SAC WERE DISSECTED DOWN. THE INDIRECT HERNIA SAC WAS EXCISED. A SMALL DIRECT INGUINAL HERNIA WAS REDUCED. A PERFIX PLUG (DEVICE #1) WAS PLACED INTO DIRECT HERNIA SPACE SECURED. A PERFIX PLUG (DEVICE #2) WAS SECURED IN THE DEEP INGUINAL RING AND SUTURED. THE ON-LAY PATCH WAS SECURED TO PUBIC TUBERCLE. THE ILIOINGUINAL NERVE WAS DIVIDED AS IT WAS RUNNING THROUGH SCAR TISSUE IN LINE OF DISSECTION." (B)(6) 2017 - PATIENT WAS DIAGNOSED WITH RECURRENT RIGHT AND LEFT INGUINAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF SYNTHETIC MESHES AND EXPLANT OF PERFIX PLUGS (DEVICE #1, #2). PER OPERATIVE NOTES, "ON RIGHT SIDE, ADHESIONS WERE NOTED TO THE PERITONEUM. A LARGE HERNIA WAS NOTED AND NOTED TO BE DIRECT. THE PREVIOUS UNKNOWN PLUG WAS VISIBLE AND ADHERENT TO MULTIPLE STRUCTURES AND WERE NOT UNIDENTIFIABLE THESE WERE TAKEN DOWN AS POSSIBLE. BLEEDING WAS NOTED AND CONTROLLED AS THE BLADDER W

  Patient problems: Adhesion(s); Hernia; Pain; Scar Tissue

  MAUDE report 21456266 ↗
• InjuryFeb 20, 2025Defective Device; Patient Device Interaction Problem; Migration; Defective Device; Patient Device Interaction Problem; Migration

  PER INFORMATION PROVIDED: (B)(6) 2009: PATIENT HAD BILATERAL INGUINAL HERNIA, THEREBY UNDERWENT REPAIR WITH THE IMPLANT OF TWO PERFIX PLUG. (B)(6) 2015: PATIENT HAD EXPLORATION OF GROIN AND LYSIS OF ADHESION. ATTORNEY ALLEGES THAT THE PATIENT HAD ADHESION, MESH MIGRATION, MESH WAS NOT ABLE TO BE REMOVED, PAIN AND SUFFERING. IT IS ALSO ALLEGED THAT THE PATIENT SUFFERED FROM CHRONIC PAIN HAS LIMITED HIS MOBILITY IN HIS EMPLOYMENT AS A MECHANIC AS WELL AS IN HIS ACTIVITIES OF DAILY LIFE. PLAINTIFF BELIEVES THAT HE MAY HAVE NERVE DAMAGE DUE TO THE MESH AND IS IN A PAIN MANAGEMENT PROGRAM ATTEMPTING TO RELIVE HIS PAIN.

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

  MAUDE report 21420674 ↗