PerFix 0112750Recalls & reported problems

Summary

The FDA's MAUDE database contains 163 adverse event reports that list this exact device (DI 00801741016592), received between Jul 11, 2017 and Sep 25, 2026 — classified as 163 injuries.

The most frequently reported specific device problem is “Defective Device” (139 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 163 reports, in the reporter's own words as published by the FDA.

• InjurySep 25, 2026Material Deformation

  Patient problems: Hernia; Pain; Scar Tissue

  MAUDE report 50899360 ↗
• InjuryAug 26, 2026Patient-Device Incompatibility

  Per information provided:(b)(6) 2008 - Patient was diagnosed with bilateral inguinal hernias thereby underwent open repair with implant of PerFix Plug (Device 1 and 2). Per op notes, ¿A left groin incision was made. The inguinal canal was dissected out. The indirect sac was also excised. A small indirect defect was noted. A PerFix Plug (Device 1) was placed and secured with suture. The floor of the canal was reconstructed with mesh sewn to the pubic tubercle. Similar repair was performed to the right groin. A small indirect sac was identified and excised. A PerFix Plug (Device 2) was placed and the floor was reconstructed with the same mesh and secured with suture.¿ (b)(6) 2012 - Patient was diagnosed with recurrent right inguinal hernia thereby underwent open repair with partial excision of PerFix Plug (Device 2) and implant of synthetic mesh and Bard Mesh Pre-Shaped (Device 3). Per op notes, ¿An incision was made through the old scar. The old mesh was fused to the underside of the external oblique and was freed up. The prior mesh (Device 2) was noted in the direct area. An obvious direct hernia defect was noted on palpation. The PerFix Plug (Device 2) was partially resected. The

  Patient problems: Hernia

  MAUDE report 50458144 ↗
• InjuryJul 1, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2014 - PATIENT WAS DIAGNOSED WITH LEFT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF PERFIX PLUG (DEVICE 1). PER OP NOTES, "THE LEFT DEEP INGUINAL HERNIA DEFECT WAS PALPATED AND NOTED. A SMALL INCISION WAS MADE IN THE LEFT GROIN AREA AND IN THE LEFT INGUINAL AREA. A PERFIX PLUG (DEVICE 1) WAS PLACED INTO THE HERNIA DEFECT AND TACKED WITH SUTURES." (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH RECURRENT LEFT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF PERFIX PLUG (DEVICE 2). PER OP NOTES, "A LARGER INCISION WAS MADE. SPERMATIC CORD WAS IDENTIFIED RIGHT ABOVE THE PUBIC BONE. THE TESTICLE WAS DISSECTED OUT FROM THE LEFT HEMISCROTUM. THE HERNIA DEFECT WAS IDENTIFIED. A PERFIX PLUG (DEVICE 2) WAS PLACED AND TACKED DOWN TO THE COOPER'S LIGAMENT. THE FASCIA WAS THEN REAPPROXIMATED WITH SUTURE." (NOTE: THE PREVIOUSLY PLACED MESH WAS NOT SEEN DURING THIS PROCEDURE) (B)(6) 2017 - PATIENT WAS DIAGNOSED WITH RECURRENT LEFT INGUINAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF 3DMAX MESH (DEVICE 3). PER OP NOTES, "A STAB INCISION WAS MADE. THE LEFT SIDE INGUINAL HERNIA WAS IDENTIFIED. MINOR ADHESIONS BETWEEN THE OMENT

  Patient problems: Adhesion(s); Hernia

  MAUDE report 25680005 ↗
• InjuryJun 1, 2026Migration

  PER INFORMATION PROVIDED: ON (B)(6) 2017 ¿ PATIENT WAS DIAGNOSED WITH TWO INCISIONAL HERNIAS THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF PERFIX PLUGS (DEVICE 1, 2). PER OP NOTES, ¿THE FAT WAS GRADUALLY FREED UP AT THE EDGES OF THE TWO DEFECTS. A SMALL AND MEDIUM PERFIX PLUGS (DEVICE 1 AND DEVICE 2) WERE PLACED AND SECURED TO DEFECT USING SUTURES.¿ ON (B)(6) 2019 ¿ PATIENT HAD RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT REPAIR WITH THE REMOVAL OF MESH (DEVICE 1, DEVICE 2). (NOTE: THERE IS NO OP NOTES PROVIDED FOR THIS PROCEDURE IN MEDICAL RECORDS). ATTORNEY ALLEGES ADHESIONS, HERNIA RECURRENCE, MESH MIGRATION, PAIN AND SUFFERING.

  Patient problems: Adhesion(s); Hernia; Pain

  MAUDE report 25347553 ↗
• InjuryApr 23, 2026Patient-Device Incompatibility

  AS PER ANSM REPORT ((B)(4)): AS REPORTED, ON (B)(6) 2021 THE PATIENT UNDERWENT RIGHT INGUINAL HERNIA REPAIR WITH THE IMPLANT OF PERFIX PLUG. DESCRIPTION OF THE INCIDENT: PAIN SINCE AN OPERATION FOR A RIGHT-SIDED INGUINAL HERNIA ON (B)(6) 2021, SLIGHTLY LESSENED SINCE A FURTHER OPERATION ON (B)(6) 2023 (RESECTION OF A NODULE OPPOSITE THE SCAR FROM THE FIRST OPERATION): SENSATION OF NUMBNESS AROUND THE SCAR, EXTERNAL AND INTERNAL PAIN (SPERMATIC CANAL, RIGHT TESTICLE, VISCERA), FREQUENT AND URGENT URGE TO URINATE, WITH THE LAST DROP TAKING A WHILE TO COME OUT AFTERWARDS. NO PAIN OR SYMPTOMS DESCRIBED IN THIS AREA PRIOR TO THE OPERATION, NOT EVEN BETWEEN THE TIME THE HERNIA APPEARED AND THE OPERATION. CURRENT CONDITION: THESE PAINS ARE HINDERING THE REHABILITATION. I AM UNDERGOING FOLLOWING BACK AND JOINT PROBLEMS (PRESENT FOR 15 YEARS), A BURNOUT IN (B)(6) 2023, PARTLY LINKED TO THESE PAINS; THE OPERATION ON (B)(6) 2023 DID NOT IMPROVE THE SITUATION. ON SICK LEAVE SINCE THEN; MDPH CASE PENDING. ACTIONS TAKEN BY THE HEALTHCARE FACILITY TO MANAGE THE PATIENT: NONE.

  Patient problems: Micturition Urgency; Numbness; Pain

  MAUDE report 24968682 ↗
• InjuryApr 14, 2026Patient-Device Incompatibility

  AS PER ANSM N°R2609411: DATE OF EVENT OCCURRENCE: 14-APR-2022. AS REPORTED, THE PATIENT UNDERWENT IMPLANT OF PERFIX PLUG ON (B)(6) 2022. DESCRIPTION OF THE INCIDENT: "SINCE MY IMPLANT WAS PLACED, I HAVE BEEN EXPERIENCING PAIN, ESPECIALLY AFTER PHYSICAL EXERTION." CURRENT CONDITION OF THE PATIENT: THIS PAIN INTERFERES WITH MY DAILY LIFE. ACTIONS TAKEN AT THE HEALTHCARE FACILITY TO MANAGE THE PATIENT: NR.

  Patient problems: Pain

  MAUDE report 24876209 ↗
• InjuryApr 7, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2019 - PATIENT WAS DIAGNOSED WITH THREE ABDOMINAL WALL INCISIONAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF VENTRALIGHT ST MESH (DEVICE 1) AND PERFIX PLUG (DEVICE 2) AND ONE SYNTHETIC MESH. PER OPERATIVE NOTES, ¿AN INCISION WAS MADE INTO THE PERITONEAL CAVITY. THE HERNIA SAC WAS DISSECTED OUT. A VENTRALIGHT ST MESH (DEVICE 1) WAS PLACED INTO THE PERITONEAL CAVITY AND SUTURES. A PERFIX PLUG (DEVICE 2) AND ONE SYNTHETIC MESH WAS PLACED TOGETHER WITH PREVIOUSLY PLACED (DEVICE 1) INTO THE PERITONEAL CAVITY AND SUTURES.¿ ON (B)(6) 2020 ¿ PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA, PAIN, ADHESION THEREBY UNDERWENT OPEN REPAIR WITH EXPLANT OF VENTRALEX ST MESH (DEVICE 1) AND PERFIX PLUG (DEVICE 2) AND SYNTHETIC MESH AND IMPLANT OF VENTRIO ST MESH (DEVICE 3). PER OPERATIVE NOTES, ¿A MIDLINE INCISION WAS MADE THROUGH THE PRIOR MIDLINE SURGICAL SCARS FROM THE UPPER EPIGASTRIC AREA. THE HERNIA SAC WAS DISSECTED OUT. THERE WERE DENSE ADHESIONS INTO THE ABDOMEN. ALL ADHESIONS WERE TAKEN DOWN. PREVIOUSLY PLACED VENTRALEX ST MESH (DEVICE 1) AND PERFIX PLUG (DEVICE 2) AND SYNTHETIC MESH WAS DISSECTED OUT FROM PERITONEAL SPACE. A 7.

  Patient problems: Adhesion(s); Hernia; Pain

  MAUDE report 24800642 ↗
• InjuryMar 9, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2008 - PATIENT WAS DIAGNOSED WITH UMBILICAL HERNIA AND RIGHT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRALEX MESH (DEVICE 1) AND PERFIX PLUG (DEVICE 2). PER OP NOTES, "INCISION TO THE UMBILICAL HERNIA, A VENTRALEX MESH (DEVICE 1) WAS PLACED TO THE ABDOMINAL WALL USING PROLENE SUTURES. ATTENTION TO THE RIGHT INGUINAL HERNIA, PLACED A SMALL PERFIX PLUG (DEVICE 2) INTO THE INGUINAL REGION USING PROLENE SUTURES." (B)(6) 2017 - PATIENT WAS DIAGNOSED WITH INCISIONAL HERNIA AND RIGHT FLANK MASS THEREBY UNDERWENT REPAIR WITH REMOVAL OF OLD MESH (DEVICE 1 AND 2). PER OP NOTES, "THERE APPEARED TO BE HERNIA ABOVE THE OLD UMBILICAL HERNIA. THE MESH (DEVICE 1 AND 2) WERE THEN EXCISED. A SYNTHETIC MESH WAS PLACED."

  Patient problems: Pain

  MAUDE report 24543289 ↗
• InjuryFeb 12, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2014 ¿ PATIENT WAS DIAGNOSED WITH BILATERAL INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF TWO PERFIX PLUG MESHES (DEVICE 1 AND 2). PER OPERATIVE NOTES, ¿IN THE RIGHT SIDE, THE HERNIA SAC WAS LATERAL TO THE RECTUS MUSCLE AND SAC WAS PUSHED BACK ON THE FASCIAL MARGINS. A SMALL PERFIX PLUG (DEVICE 1) WAS PLACED AND SECURED TO THE RING WITH SUTURES. IN THE LEFT SIDE, THE HERNIAL DEFECT WAS REDUCED FROM THE INGUINAL CANAL LATERAL TO THE PUBIC TUBERCLE. THE SAC WAS INVERTED AND ANOTHER SMALL SIZE PERFIX PLUG (DEVICE 2) WAS PLACED AND SECURED TO FASCIAL EDGES WITH SUTURES.¿ (B)(6) 2018 ¿ PATIENT WAS DIAGNOSED WITH RECURRENT BILATERAL INGUINAL HERNIA AND PAINFUL MESH PLUG (DEVICE 1 AND 2) THEREBY UNDERWENT OPEN REPAIR WITH RESECTION OF PRIOR MESHES (DEVICE 1 AND 2) AND IMPLANT OF SYNTHETIC MESH. PER OPERATIVE NOTES, ¿A LARGE RECURRENT BILATERAL INGUINAL HERNIAS WERE NOTED. BOTH MESH PLUGS (DEVICE 1 AND 2) WERE RESECTED BY EXISTING FROM ALL ADJACENT STRUCTURES. THE LARGE HERNIA SAC ON THE RIGHT SIDE WAS RESECTED, AND SMALL LEFT SIDE SAC WAS IMBRICATED WITH SUTURES. A SYNTHETIC MESH WAS PLACED OVER THE INGUINAL CANAL AND SUTURED. THE EXTENSIVE

  Patient problems: Adhesion(s); Hernia; Pain

  MAUDE report 24326901 ↗
• InjuryJan 2, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2014 - PATIENT WAS DIAGNOSED WITH RIGHT INGUINAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT OF 3DMAX MESH (DEVICE 1). PER OP NOTES, "A 3DMAX MESH (DEVICE 1) WAS PLACED IN THE PREPERITONEAL SPACE ON THE RIGHT SIDE COVERING BOTH THE DIRECT AND INDIRECT SPACE AS WELL AS THE FEMORAL SPACE." ON (B)(6) 2014 - PATIENT WAS DIAGNOSED WITH LEFT INGUINAL HERNIA THEREBY UNDERWENT REPAIR WITH THE IMPLANT OF PERFIX PLUG (DEVICE 2). (NOTES: NO OP NOTES WERE PROVIDED). ON (B)(6) 2016 - PATIENT WAS DIAGNOSED WITH RECURRENT INGUINAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC BILATERAL REPAIR WITH THE REMOVAL OF MESH (DEVICE 1) AND IMPLANT OF VENTRIO MESH (DEVICE 3) AND COMPOSIX KUGEL MESH (DEVICE 4). PER OP NOTES, "PATIENT HAD RECURRENT HERNIAS ON BOTH THE LEFT AND RIGHT SIDE. ON THE PATIENT'S LEFT SIDE, THERE IS A PLUG (DEVICE 2) VISIBLE IN THE INDIRECT SPACE. ON THE RIGHT SIDE, A FLAT MESH (DEVICE 1) IS PRESENT COVERING THE ENTIRE GROIN. THE GROIN WAS REINFORCED ON BOTH THE LEFT AND RIGHT SIDE USING A VENTRIO MESH (DEVICE 3) TOWARDS THE PERITONEAL CAVITY. THE PATIENT WAS SEEN TO HAVE AN THIN BLADDER WALL WHICH HAD TORN WHERE IT WAS ADHERENT TO THE

  Patient problems: Hernia

  MAUDE report 23941271 ↗
• InjuryNov 5, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2010 - PATIENT WAS DIAGNOSED WITH RECURRENT RIGHT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF BARD FLAT MESH (DEVICE 1). PER OP NOTES, ¿THE HERNIA SAC WAS NOTED AND EXCISED. A BARD FLAT MESH (DEVICE 1) WAS PLACED AND TACKED USING SUTURES.¿ (B)(6) 2017 - PATIENT WAS DIAGNOSED WITH RECURRENT RIGHT INGUINAL HERNIA AND LEFT INGUINAL HERNIA THEREBY UNDERWENT ROBOTIC ASSISTED LAPAROSCOPIC REPAIR WITH IMPLANT OF 3DMAX LIGHT (DEVICE 2 AND 3). PER OP NOTES, ¿THE HERNIA SAC WAS NOTED ON THE RIGHT SIDE AND REDUCED. A 3DMAX LIGHT (DEVICE 2) WAS PLACED AND SUTURED. ANOTHER HERNIA SAC WAS NOTED ON THE LEFT SIDE AND REDUCED. A 3DMAX LIGHT (DEVICE 3) WAS PLACED AND SUTURED.¿ (B)(6) 2018 - PATIENT WAS DIAGNOSED WITH RECURRENT RIGHT INGUINAL HERNIA WITH NEURALGIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF PERFIX PLUG (DEVICE 4). PER OP NOTES, ¿THE HERNIA SAC WAS NOTED AND THE ILIOINGUINAL NERVE WAS EMANATING UNDER THE PRIOR MESHES (DEVICE 1 AND 2) WAS DIVIDED AND RESECTED. THE PRIOR MESHES (DEVICE 1 AND 2) WERE NOTED WITH TACKS. A PERFIX PLUG (DEVICE 4) WAS PLACED AND SUTURED.¿ (B)(6) 2020 - PATIENT WAS DIAGNOSED WITH RECURRENT RIGHT INGUINAL HER

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

  MAUDE report 23474571 ↗
• InjurySep 12, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2007 - PATIENT WAS DIAGNOSED WITH BILATERAL INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF TWO PERFIX PLUGS (DEVICE 1 AND 2). PER OP NOTES, "ATTENTION TO THE RIGHT SIDE, A MEDIUM SIZED PERFIX PLUG AND PATCH (DEVICE 1) WAS PLACED INTO THE INTERNAL RING USING PROLENE SUTURES. ATTENTION TO THE LEFT SIDE, A SMALL PERFIX PLUG AND PATCH (DEVICE 2) WAS PLACED INTO THE INTERNAL RING USING PROLENE SUTURES." (B)(6) 2018 - PATIENT WAS DIAGNOSED WITH BILATERAL RECURRENT INGUINAL HERNIA THEREBY UNDERWENT REPAIR WITH REMOVAL OF MESH (DEVICE 1 AND 2). PER OP NOTES, "PATIENT HAD RECURRENT HERNIA ON BOTH RIGHT AND LEFT. NOTED THE PREVIOUSLY PLACED MESH (DEVICE 1 AND 2) AND WERE REMOVED. TWO SYNTHETIC MESHES WERE PLACED ON BOTH RIGHT AND LEFT."

  Patient problems: Hernia

  MAUDE report 23035786 ↗
• InjuryJul 21, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2005 ¿ PATIENT WAS DIAGNOSED WITH INCARCERATED UMBILICAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF PERFIX PLUG (DEVICE #1). PER OP NOTES, ¿THE HERNIA SAC WAS SEPARATED FROM OVERLYING UMBILICUS. A SMALL PERFIX PLUG (DEVICE #1) WAS PLACED JUST DEEP TO FASCIA USING SUTURES.¿ (B)(6) 2007 - PATIENT WAS DIAGNOSED WITH INCISIONAL VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE REMOVAL OF MESH (DEVICE #1) AND IMPLANT OF VENTRALEX MESH (DEVICE #2). PER OP NOTES, ¿THE PREVIOUS HERNIA AND NEW HERNIA MADE INTO SINGLE DEFECT. A PERFIX PLUG (DEVICE #1) WAS EXCISED AND A VENTRALEX MESH (DEVICE #2) WAS PLACED DEEP TO ABDOMINAL WALL AND POSITIONED USING SUTURES.¿ (B)(6) 2008 ¿ PATIENT WAS DIAGNOSED WITH CHRONIC ABDOMINAL PAIN , ADHESION, DELAMINATED MESH THEREBY UNDERWENT LAPAROSCOPIC TO OPEN REPAIR WITH REMOVAL OF MESH (DEVICE #2) AND IMPLANT OF VENTRALEX MESH (DEVICE #3). PER OP NOTES, ¿ADHESIONS HAD BEEN TAKEN DOWN AND THE MESH (DEVICE #2) WAS PROFOUNDLY CONTRACTED AND DELAMINATED FROM THE ABDOMINAL WALL SURFACE WAS EXCISED. A LARGE VENTRALEX MESH (DEVICE #3) WAS SECURED TO PERITONEAL SURFACE USING TACKS.¿ (B)(6) 2008 ¿ PATIENT WAS DIAGNOSED

  Patient problems: Hernia

  MAUDE report 22556295 ↗
• InjuryJul 2, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2006 - PATIENT WAS DIAGNOSED WITH SMALL RIGHT DIRECT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF SMALL BARD KUGEL PATCH (DEVICE #1). PER OPERATIVE NOTES, ¿A SMALL BARD KUGEL PATCH (DEVICE #1) WAS PLACED AND SUTURED.¿ (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH RECURRENT RIGHT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT SMALL BARD KUGEL PATCH (DEVICE #2). PER OPERATIVE NOTES, ¿A SMALL BARD KUGEL PATCH (DEVICE #2) WAS PLACED AND SUTURED.¿ (B)(6) 2016 - PATIENT WAS DIAGNOSED WITH RECURRENT RIGHT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF THE PERFIX PLUG MESH (DEVICE #3). PER OPERATIVE NOTES, ¿A PERFIX PLUG MESH (DEVICE #3) WAS PLACED AND SUTURED.¿ (B)(6) 2018 - PATIENT WAS DIAGNOSED WITH RECURRENT RIGHT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF MEDIUM PERFIX PLUG (DEVICE #4). PER OPERATIVE NOTES, ¿A MEDIUM PERFIX PLUG (DEVICE #4) WAS PLACED AND SUTURED.¿ THIS FILE REPRESENTS PERFIX PLUG (DEVICE #3).

  Patient problems: Hernia

  MAUDE report 22380760 ↗
• InjuryJun 7, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2010 ¿ PATIENT WAS DIAGNOSED WITH REDUCIBLE LEFT INGUINAL HERNIA AND INCARCERATED UMBILICAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF PERFIX PLUG (DEVICE #1) FOR LEFT INGUINAL HERNIA. PER OP NOTES, ¿A SMALL PERFIX PLUG (DEVICE #1) PLACED INTO THE PROPERITONEAL SPACE THROUGH THE INTERNAL RING AND ONLAY PATCH WAS PLACED OVER THE INTERNAL RING SECURED USING SUTURES. AN UMBILICAL HERNIA WAS REPAIRED USING SUTURES.¿ (B)(6) 2014 ¿ PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT OF COMPOSIX L/P MESH (DEVICE #2). PER OP NOTES, ¿DENSE ADHESIONS TO THE PREVIOUS HERNIA MESH WERE TAKEN DOWN COMPLETELY. THE PREVIOUSLY PLACED MESH WAS WELL INTACT. A COMPOSIX L/P MESH (DEVICE #2) WAS PLACED OVER THE DEFECT AND TACKED.¿ (B)(6) 2015 ¿ PATIENT HAD ABDOMINAL PAIN AND WAS DIAGNOSED WITH RECURRENT INCARCERATED ABDOMINAL WALL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE REMOVAL OF MESHES (DEVICE #1, #2) AND IMPLANT OF XENMATRIX AB (DEVICE #3). PER OP NOTES, ¿PREVIOUSLY PLACED MESHES (DEVICE #1, #2) WERE DISSECTED FREE FROM THE SURROUNDING FASCIA WERE EXCISED. ADHESIONS WERE LYSED. A XENMATRIX A

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

  MAUDE report 22163701 ↗
• InjuryMay 28, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED, THE PATIENT WAS IMPLANTED WITH PERFIX PLUG DURING AN INDIRECT INGUINAL HERNIA ON (B)(6) 2025. IT WAS REPORTED TWO WEEKS POST OP SHE HAD SUFFERED LIMITED FUNCTION IN HER UPPER ARMS, PAIN, AND DIFFICULTY LIFTING HEAVY OBJECTS WITH ARMS. PER SURGEON THERE ARE NO SYMPTOMS OR PAIN AT THE SURGICAL SITE IN THE GROIN WHERE THE MESH WAS IMPLANTED, AND SURGICAL SITE AREA WAS HEALING NORMALLY. THE PATIENT FOLLOWED UP WITH THE SURGEON AGAIN TWO MONTHS POST OP WHO STATES THE PATIENT STILL REPORTS UPPER BODY PAIN AND WEAKNESS, AND JOINT ISSUES. HOWEVER, THERE IS NO FLUID OR LESIONS OR RECURRENT HERNIA AT THE SITE OF THE HERNIA REPAIR. THE PATIENT'S SURGEON REPORTS HE DOES NOT FEEL THE PATIENT'S REPORTED SYMPTOMS ARE RELATED TO THE MESH, BUT THE PATIENT BELIEVES THE ISSUES ARE LINKED TO THE HERNIA REPAIR.

  Patient problems: Pain

  MAUDE report 22100507 ↗
• InjuryMay 16, 2025Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  PER ADDITIONAL INFORMATION PROVIDED: ON (B)(6) 2006 - PATIENT WAS DIAGNOSED WITH BILATERAL INGUINAL AND UMBILICAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF 3DMAX MESH (DEVICE #1 - LEFT INGUINAL), SYNTHETIC MESH (RIGHT INGUINAL) AND VENTRALEX MESH (DEVICE #2 - UMBILICUS). PER OPERATIVE NOTES, ¿THE HERNIA DEFECT OF UMBILICUS WAS IDENTIFIED AND REDUCED. A VENTRALEX MESH (DEVICE #2) WAS PLACED AND SUTURED. DIRECT HERNIA DEFECTS WERE IDENTIFIED IN BOTH INGUINAL REGIONS WERE REDUCED. A 3DMAX MESH (DEVICE #1) ON THE LEFT SIDE AND SYNTHETIC MESH ON THE RIGHT SIDE WERE PLACED AND SUTURED. ¿ ON (B)(6) 2008 - PATIENT WAS DIAGNOSED WITH RECURRENT LEFT INGUINAL HERNIA AND PAIN THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF PERFIX PLUG (DEVICE #3). PER OPERATIVE NOTES, ¿THE DIRECT HERNIA DEFECT WAS IDENTIFIED WHERE THE PRIOR MESH WAS SEPARATED. THE HERNIA DEFECT WAS REDUCED. A PERFIX PLUG WAS PLACED AND SUTURED. ¿ ON (B)(6) 2009 - PATIENT WAS DIAGNOSED WITH RECURRENT LEFT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF PERFIX PLUG (DEVICE #4). PER OPERATIVE NOTES, ¿A SMALL HERNIA DEFECT WAS IDENTIFIED AND REDUCED. A PERFIX PLUG (DEVICE #4) WAS PLACED AND S

  Patient problems: Hernia; Pain

  MAUDE report 22035247 ↗
• InjuryMay 6, 2025Defective Device; Patient-Device Incompatibility; Defective Device; Patient-Device Incompatibility

  AS ALLEGED PER PATIENT (PRO SE): IT WAS ALLEGED THAT THE PATIENT WAS DIAGNOSED WITH DIRECT AND INDIRECT RIGHT INGUINAL HERNIA THEREBY UNDERWENT REPAIR WITH THE IMPLANT OF TWO PERFIX PLUGS (DEVICE #1 AND #2) ON (B)(6) 2011. IT WAS ALLEGED THAT "PATIENT SUFFERED PERSISTENT SYMPTOMS, CONSTANT DULL PAIN AND NUMBNESS IN THE MESH AREA EVEN WHEN STILL, SHARP PAINS WHEN LEANING AGAINST OBJECTS, AND POSSIBLE SEXUAL SIDE EFFECTS. THESE ISSUES LED TO A REFERRAL FROM MY ORIGINAL SURGEON IN 2019 AND REQUIRED PELVIC FLOOR THERAPY FROM 2021-2022, SPANNING EIGHT VISITS... I ENDURE AGGRAVATED PAIN... DAILY STRUGGLE AFFECTING BASIC COMFORT. IT WAS ALLEGED THAT THE "THE PERFIX PLUGS¿ DESIGN OR MATERIAL IS DEFECTIVE, CAUSING CHRONIC PAIN, NERVE DAMAGE, AND RELATED COMPLICATIONS."

  Patient problems: Nerve Damage; Pain

  MAUDE report 21967527 ↗
• InjuryMay 6, 2025Defective Device; Patient-Device Incompatibility; Defective Device; Patient-Device Incompatibility

  AS ALLEGED PER PATIENT (PRO SE): IT WAS ALLEGED THAT THE PATIENT WAS DIAGNOSED WITH DIRECT AND INDIRECT RIGHT INGUINAL HERNIA THEREBY UNDERWENT REPAIR WITH THE IMPLANT OF TWO PREFIX PLUGS (DEVICE #1 AND #2) ON (B)(6) 2011. IT WAS ALLEGED THAT "PATIENT SUFFERED PERSISTENT SYMPTOMS, CONSTANT DULL PAIN AND NUMBNESS IN THE MESH AREA EVEN WHEN STILL, SHARP PAINS WHEN LEANING AGAINST OBJECTS, AND POSSIBLE SEXUAL SIDE EFFECTS. THESE ISSUES LED TO A REFERRAL FROM MY ORIGINAL SURGEON IN 2019 AND REQUIRED PELVIC FLOOR THERAPY FROM 2021-2022, SPANNING EIGHT VISITS... I ENDURE AGGRAVATED PAIN... DAILY STRUGGLE AFFECTING BASIC COMFORT. IT WAS ALLEGED THAT THE "THE PERFIX PLUGS' DESIGN OR MATERIAL IS DEFECTIVE, CAUSING CHRONIC PAIN, NERVE DAMAGE, AND RELATED COMPLICATIONS."

  Patient problems: Nerve Damage; Pain

  MAUDE report 21967517 ↗
• InjuryMay 5, 2025Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  PER INFORMATION PROVIDED: (B)(6) 2001 - PATIENT WAS DIAGNOSED WITH BILATERAL INGUINAL HERNIAS THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF TWO PERFIX PLUG (RIGHT - DEVICE #1 & LEFT - DEVICE #2). PER OPERATIVE NOTES, ¿AN INDIRECT SAC IDENTIFIED ON THE RIGHT GROIN WAS REDUCED AND A PERFIX PLUG (DEVICE #1) WAS PLACED AND SUTURED. A SMALL INDIRECT SAC IDENTIFIED ON THE LEFT SIDE WAS RETURNED INTO THE PERITONEAL CAVITY AND A PERFIX PLUG (DEVICE #2) WAS PLACED AND SUTURED." (B)(6) 2004 - PATIENT WAS DIAGNOSED WITH RECURRENT BILATERAL INGUINAL HERNIAS THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF KUGEL PATCH (LEFT - DEVICE #3 & RIGHT - DEVICE #4). PER OPERATIVE NOTES, ¿THE SCARRING WAS NOTED. A DIRECT HERNIA WAS IDENTIFIED ON THE LEFT AND A KUGEL PATCH (DEVICE #3) WAS PLACED AD SUTURED. ON THE RIGHT SIDE, SCARRING WAS NOTED, HERNIA SAC WAS COMPLETELY REDUCED, AND A KUGEL PATCH (DEVICE #4) WAS PLACED AND SUTURED." (B)(6) 2012 - PATIENT WAS DIAGNOSED WITH RECURRENT LEFT INGUINAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT OF SYNTHETIC MESH. PER OPERATIVE NOTES, ¿DENSE ADHESIONS WERE NOTED TO THE PREVIOUSLY PLACED KUGEL PATCH (DEVICE #3) IN THE LEFT GROIN. HERNIA S

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

  MAUDE report 21958291 ↗
• InjuryMar 28, 2025Defective Device; Patient-Device Incompatibility; Migration; Defective Device; Patient-Device Incompatibility; Migration

  ATTORNEY ALLEGES PER THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL PERFIX PLUG ON (B)(6) 2008. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE 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: Adhesion(s); Insufficient Information; Pain

  MAUDE report 21718116 ↗
• InjuryMar 14, 2025Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  PER INFORMATION PROVIDED BY PATIENT¿S ATTORNEY AND REVIEW OF PATIENT MEDICAL RECORDS: (B)(6)2015 - PATIENT WAS DIAGNOSED WITH RIGHT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF PERFIX PLUG (DEVICE #1) ON (B)(6)2015. PER OPERATIVE NOTES, ¿THE HERNIA SAC WAS DISSECTED FREE OF THE SURROUNDING STRUCTURES AND REDUCED. A PERFIX PLUG (DEVICE #1) WAS PLACED AND SECURED WITH SUTURES. THE FLOOR WAS REINFORCED USING THE ONLAY PATCH.¿ (B)(6)2017 - PATIENT WAS DIAGNOSED WITH LEFT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF PERFIX PLUG (DEVICE #2). PER OPERATIVE NOTES, ¿THE HERNIA SAC WAS DISSECTED FREE OF THE SURROUNDING STRUCTURES AND REDUCED. A PERFIX PLUG (DEVICE #2) WAS PLACED AND SECURED WITH SUTURES. THE FLOOR WAS REINFORCED USING THE ONLAY PATCH.¿ (B)(6)2018 - PATIENT WAS DIAGNOSED WITH RIGHT INGUINAL HERNIA, NEURALGIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF PERFIX PLUG (DEVICE #3), LYSIS OF ADHESION AND EXPLANT OF PERFIX PLUG (DEVICE #1). PER OPERATIVE NOTES, ¿OLD MESH (DEVICE #1) WAS ENCOUNTERED, SIGNIFICANT CONTRACTION OF THE MESH WAS NOTED. DEEPER SCAR TISSUE APPEARED ILIOINGUINAL NERVE AND THIS WAS DIVIDED LATERALLY. THE PATCH AND

  Patient problems: Adhesion(s); Hernia

  MAUDE report 21603708 ↗
• InjuryDec 9, 2024Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  PER INFORMATION PROVIDED: (B)(6) 2007- PATIENT WAS DIAGNOSED WITH LEFT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF PERFIX PLUG (DEVICE #1). PER OPERATIVE NOTES, ¿THE DEFECT AT THE BASE OF THE INGUINAL FLOOR WAS IDENTIFIED AND A PERFIX PLUG (DEVICE #1) PLACED AND SECURED USING SUTURES, THEN A PATCH WAS PLACED OVER THE TOP OF THE PLUG AND TACKED.¿ (B)(6) 2012 - PATIENT WAS DIAGNOSED WITH SYMPTOMATIC DIRECT RIGHT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF PERFIX PLUG (DEVICE #2). PER OPERATIVE NOTES, ¿THE HERNIA SAC WAS DISSECTED AND A PERFIX PLUG (DEVICE #2) PLACED IN THE INGUINAL FLOOR AND SUTURED. THEN, A PRECUT PATCH WAS SECURED OVER THE TOP OF THE PLUG USING SUTURES.¿ (B)(6) 2014 - PATIENT WAS DIAGNOSED WITH RECURRENT LEFT INGUINAL HERNIA AND RIGHT LOWER QUADRANT INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF PERFIX PLUG (DEVICE #3 & DEVICE #4) AND EXPLANT OF PERFIX PLUG (DEVICE #2). PER OPERATIVE NOTES, ¿THE DIRECT HERNIA IN THE MEDIAL PORTION OF THE LEFT INGUINAL FLOOR WAS FOUND AND A PERFIX PLUG (DEVICE #3) WAS PLACED AND SECURED USING SUTURES. IN THE RIGHT LOWER QUADRANT, HERNIA WAS IDENTIFIED AFTER REMOVING PE

  Patient problems: Hernia

  MAUDE report 20876078 ↗
• InjuryJul 17, 2024Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  PER ADDITIONAL INFORMATION PROVIDED: (B)(6) 2012 - PATIENT WAS DIAGNOSED WITH LEFT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF PERFIX PLUG (DEVICE #1). PER OPERATIVE NOTES, ¿A LARGE INDIRECT HERNIA SAC WAS SEPARATED FROM THE CORD AND WAS REPAIRED WITH A SMALL PERFIX PLUG (DEVICE #1) WITHIN THE INTERNAL RING AND A PERFIX PLUG (PERFIX PLUG ONLAY) TO REPAIR POSTERIOR WALL. THIS WAS ANCHORED TO THE BASE OF THE INGUINAL LIGAMENT LATERALLY AND TO THE CONJOINED TENDON MEDIALLY." (B)(6) 2013 - PATIENT WAS DIAGNOSED WITH RIGHT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF PERFIX PLUG (DEVICE #2). PER OPERATIVE NOTES, "A LARGE POSTERIOR DEFECT WAS FOUND. A MEDIUM PERFIX PLUG (DEVICE #2) WAS PLACED WITHIN THE DEFECT AND THE BASE OF THE INGUINAL LIGAMENT APPROXIMATED TO THE CONJOINED TENDON TO REPAIR THE POSTERIOR WALL, ANCHORING THE MESH PLUG (PERFIX PLUG ONLAY)." (B)(6) 2016 - PATIENT WAS DIAGNOSED WITH RECURRENT RIGHT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF PERFIX PLUG (DEVICE #3). PER OPERATIVE NOTES, "A LARGE INDIRECT HERNIA SAC WAS FOUND AND WAS DISSECTED UP TO THE INTERNAL RING AND LIGATED. A SMALL PERFIX PLUG (DEVICE #

  Patient problems: Hernia; Inflammation

  MAUDE report 19759937 ↗
• InjuryApr 30, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  ATTORNEY ALLEGES MULTIPLE PATIENTS HE REPRESENTS HAVE EXPERIENCE UNSPECIFIED INJURY AND ALLEGE THEY MAY HAVE REQUIRED ADDITIONAL MEDICAL/SURGICAL TREATMENT. ATTORNEY ALLEGES THIS PATIENT WAS TREATED WITH A PERFIX PLUG. CASE-SPECIFIC DETAILS NOT PROVIDED. ADDENDUM PER INFORMATION PROVIDED BY PATIENT'S ATTORNEY: (B)(6)2006 - PATIENT WAS DIAGNOSED WITH LEFT INDIRECT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF PERFIX PLUG ON (B)(6) 2006. PER OPERATIVE NOTES, ¿CONGENITAL SAC IDENTIFIED AND EXCISED IN THE FORM OF HERNIOTOMY. A PERFIX PLUG WAS USED TO REPAIR THE POSTERIOR WALL.¿ (B)(6)-2016 - PATIENT REPORTS GROIN PAIN.

  Patient problems: Abdominal Pain; Insufficient Information

  MAUDE report 19214442 ↗