PerFix 0112760Recalls & reported problems

Summary

The FDA's MAUDE database contains 339 adverse event reports that list this exact device (DI 00801741016608), received between Feb 7, 2017 and Sep 25, 2026 — classified as 1 death, 335 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Defective Device” (290 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 339 reports, in the reporter's own words as published by the FDA.

• InjurySep 25, 2026Patient-Device Incompatibility

  Patient problems: Ambulation or Postural Difficulties; Fatigue; Muscle Weakness/Atrophy; Pain

  MAUDE report 50900126 ↗
• InjurySep 25, 2026Patient-Device Incompatibility

  Patient problems: Adhesion(s); Hernia

  MAUDE report 50898523 ↗
• InjuryAug 26, 2026Patient-Device Incompatibility

  Per information provided:(b)(6) 2015 - Patient was diagnosed with right inguinal hernia thereby underwent open repair with implant of PerFix Plug (Device 1 and 2). (b)(6) 2016 - Patient was diagnosed with right ilioinguinal neuralgia and right groin pain thereby underwent ilioinguinal nerve block on the right inguinal region. (b)(6) 2016 - Patient was diagnosed with ilioinguinal neuralgia thereby underwent ilioinguinal nerve block was performed. (b)(6) 2016 - Patient was diagnosed with right groin/ inguinal pain. Patient has since developed recurrent of his pain at the site.

  Patient problems: Neuralgia

  MAUDE report 50459858 ↗
• InjuryAug 17, 2026Migration

  Per information provided: On (b)(6) 2017- Patient was diagnosed with right femoral hernia thereby underwent open repair with implant of PerFix Plug (Device 1 and Device 2). Per op notes, "A skin incision was made on the previous C-section incision. External oblique was opened. A femoral hernia was identified. It was dissected out of the canal. A PerFix Plug (Device 1) was placed into the canal in the location of the defect and secured with sutures. The proximal defect ends another PerFix Plug (Device 2) were placed into the opening and anchored in place with sutures together for better coverage." On (b)(6) 2021- Patient was diagnosed with left inguinal hernia, recurrent right inguinal hernia, umbilical hernia and pain in right groin thereby underwent robotic assisted laparoscopic repair and open repair for umbilical hernia with partial explant of PerFix Plug (Device 1 and Device 2) and implant of Bard Flat Mesh (Device 3 and Device 4). Per op notes, "In the left groin a small indirect defect was identified. On the left a peritoneal incision was made in a transverse direction. The peritoneum was dissected and the hernia sac was reduced. A large lipoma which was adherent to the round

  Patient problems: Adhesion(s); Hernia; Pain

  MAUDE report 50272594 ↗
• InjuryJun 29, 2026Material Deformation

  PER INFORMATION PROVIDED: ON (B)(6) 2006 - PATIENT WAS DIAGNOSED WITH VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF TWO PERFIX PLUGS (DEVICE 1 AND 2). PER OP NOTES, "A PERFIX PLUG (DEVICE 1) WAS PLACED TO THE FASCIA USING PROLENE SUTURES. ATTENTION TO JUST ABOVE UMBILICAL REGION. TWO LARGE HERNIAS WERE THERE; A PERFIX PLUG (DEVICE 2) WAS PLACED INTO THE FASCIA USING PROLENE SUTURES." ON 1(B)(6) 2012 - PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA AND HAD ABDOMINAL PAIN THEREBY UNDERWENT REPAIR WITH THE REMOVAL OF OLD MESH (DEVICE 1 AND 2) AND IMPLANT OF BARD FLAT MESH (DEVICE 3). PER OP NOTES, "AN INCISION WAS MADE AROUND THE FASCIA. THERE WAS TWO SEPARATE HERNIAS, THERE WAS A PIECE OF MESH PRESENT AS WELL, WHICH HAD BALLED UP. THE MESH (DEVICE 1 AND 2) WERE EXCISED. A BARD FLAT MESH (DEVICE 3) WAS PLACED TO THE UNDERLYING FASCIA USING SUTURES."

  Patient problems: Abdominal Pain; Hernia

  MAUDE report 25654350 ↗
• InjuryJun 29, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2016 - PATIENT WAS DIAGNOSED WITH RECURRENT RIGHT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF PERFIX PLUG AND PATCH (DEVICE 1). PER OP NOTES, "AN INDIRECT HERNIA SAC WAS DISSECTED AWAY FROM THE CORD AND REDUCED INTO THE ABDOMEN. A MEDIUM PERFIX PLUG (DEVICE 1) WAS PLACED AND HELD THE HERNIA FIRMLY IN REDUCTION. THE FLOOR OF CANAL WAS IMBRICATED OVER THE PLUG WITH SUTURES. THE PATCH WAS PLACED OVER THE FLOOR AND SECURED LATERAL TO CORD USING SUTURES." (B)(6) 2016 - PATIENT WAS DIAGNOSED WITH RECURRENT LEFT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF PERFIX PLUG AND PATCH (DEVICE 2). PER OP NOTES, "A DIRECT HERNIA SAC AND A SMALL INDIRECT SAC WAS IDENTIFIED AND REDUCED INTO ABDOMEN. A MEDIUM PERFIX PLUG (DEVICE 2) WAS PLACED OVER THE DEFECT AND THE PATCH WAS TAILORED TO CONFORM TO THE FLOOR OF CANAL USING SUTURES." (B)(6) 2017 - PATIENT WAS DIAGNOSED WITH RIGHT GROIN PAIN THEREBY UNDERWENT OPEN REPAIR WITH THE REMOVAL OF MESH (DEVICE 1). PER OP NOTES, "THE PATCH WAS IDENTIFIED AND SEPARATED FROM SCAR TISSUE. THE MESH WAS REMOVED. AT THE LEVEL OF THE INTERNAL RING, THE PERFIX PLUG WAS PALPABLE. THE PLUG (DEVI

  Patient problems: Pain; Scar Tissue

  MAUDE report 25651113 ↗
• InjuryJun 3, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2013 - PATIENT WAS DIAGNOSED WITH RECURRENT FEMORAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH EXCISION OF MESH AND IMPLANT OF PERFIX PLUG (DEVICE 1). PER OP NOTES, "AN INCISION WAS MADE THROUGH THE PREVIOUS INCISION. A VERY LARGE FIRM MASS IN THE AREA CONSISTENT WITH A PIECE OF MESH WITHIN THE SUBCUTANEOUS TISSUE WAS NOTED. THE UNKNOWN MESH WAS COMPLETELY REMOVED WHICH EXPOSED THE FEMORAL CANAL. A LARGE HERNIA SAC WAS IDENTIFIED AND DISSECTED FREE. A LARGE PIECE OF OMENTUM INCARCERATED WITH THE HERNIA WAS NOTED AND REDUCED. IT WAS THEN CLOSED WITH SUTURE. A VERY LARGE FEMORAL HERNIA WAS IDENTIFIED. A PERFIX PLUG (DEVICE 1) WAS PLACED AND SECURED WITH SUTURE." (NOTE: THE PRIOR MESH VISUALIZED DURING THIS PROCEDURE WAS UNKNOWN). ON (B)(6) 2014 - PATIENT WAS DIAGNOSED WITH RECURRENT LEFT FEMORAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC CONVERTED TO OPEN REPAIR WITH EXCISION OF PERFIX PLUG (DEVICE 1) AND IMPLANT OF PERFIX PLUG (DEVICE 2). PER OP NOTES, "A SKIN INCISION WAS MADE BELOW THE UMBILICUS. A LOT OF FILMY ADHESIONS WERE NOTED. FEMORAL HERNIA WAS IDENTIFIED. AN INCISION WAS MADE THROUGH HER PREVIOUS INGUINAL INCISION FOR OPEN REPAIR. A VERY CONTR

  Patient problems: Hernia; Scar Tissue

  MAUDE report 25371607 ↗
• InjuryMay 21, 2026Material Deformation

  PER INFORMATION PROVIDED: ON (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, "AN INCISION WAS MADE IN THE RIGHT INGUINAL REGION. AN INDIRECT HERNIA SAC WAS IDENTIFIED AND REDUCED. A PERFIX PLUG (DEVICE 1) WAS PLACED INTO THE DEFECT AND SECURED WITH SUTURE. A LARGE PATCH WAS THEN SECURED TO THE PUBIC TUBERCLE WITH SUTURE. THE LEFT INGUINAL HERNIA WAS REPAIRED WITH A PERFIX PLUG (DEVICE 2) AND SECURED WITH SUTURE." ON (B)(6) 2013 - PATIENT WAS DIAGNOSED WITH RECURRENT RIGHT AND LEFT INDIRECT INGUINAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH EXCISION OF PERFIX PLUG (DEVICE 1 AND 2) AND IMPLANT OF 3DMAX LIGHT (DEVICE 3 AND 4). PER OP NOTES, "A PERIUMBILICAL INCISION WAS MADE. A RECURRENT RIGHT INDIRECT INGUINAL HERNIA WAS IDENTIFIED. A PERFIX PLUG (DEVICE 1) WAS NOTED TO BE TORN AWAY FROM THE LATERAL ABDOMINAL WALL AND BALLED UP NEAR THE INTERNAL RING. THE PERFIX PLUG (DEVICE 1) WAS REMOVED COMPLETELY. THE HERNIA SAC WAS REDUCED AND SEPARATED ALONG WITH CORD LIPOMA. A 3DMAX LIGHT (DEVICE 3) WAS PLACED INTO THE PREPERITONEAL SPACE AND SECURED TO COOPER'S LIGAMENT WITH T

  Patient problems: Hernia

  MAUDE report 25240955 ↗
• InjuryApr 9, 2026Material Deformation

  PER INFORMATION PROVIDED: (B)(6) 2005 - PATIENT WAS DIAGNOSED WITH INDIRECT AND DIRECT RIGHT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF PERFIX PLUGS (DEVICE 1, 2. 3). PER OP NOTES, ¿DIRECT AND INDIRECT INGUINAL HERNIA WAS IDENTIFIED IN THE RIGHT INGUINAL REGION AND WAS DISSECTED. A LARGE PERFIX PLUG (DEVICE 1) WAS PLACED FOR THE INDIRECT HERNIA COMPONENT. TWO MEDIUM SIZED PERFIX PLUGS (DEVICE 2 AND 3) WERE PLACED IN THE LATERAL AND MEDIAL ASPECT OF THE LARGE DIRECT HERNIA COMPONENT AND SUTURED. ONLAY PATCH WAS PLACED TO REINFORCE THE REPAIR AND SUTURED¿. (B)(6) 2005- PATIENT WAS DIAGNOSED WITH LEFT INDIRECT AND DIRECT INGUINAL HERNIA, THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF PERFIX PLUGS (DEVICE 4, 5). PER OP NOTES, ¿A SMALL HERNIA SAC WAS IDENTIFIED IN THE LEFT INGUINAL REGION AND WAS DISSECTED. A PERFIX PLUG (DEVICE 4) WAS PLACED AND SUTURED. A HERNIA SAC WAS IDENTIFIED IN THE AREA OF DIRECT INGUINAL REGION AND WAS DISSECTED. A PERFIX PLUG (DEVICE 5) WAS PLACED DEEP INTO THE PERITONEAL SPACE AND SUTURED. AN ONLAY PATCH WAS THEN PLACED TO REINFORCE WITH TAILS OF PATCH AND SUTURED¿. (B)(6) 2009- PATIENT WAS DIAGNOSED WITH RECURRENT RIGHT INGUINAL HERNIA AND

  Patient problems: Adhesion(s); Hernia; Pain

  MAUDE report 24828181 ↗
• InjuryApr 7, 2026Material Deformation

  PER INFORMATION PROVIDED: ON (B)(6) 2005 - PATIENT WAS DIAGNOSED WITH INDIRECT AND DIRECT RIGHT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF PERFIX PLUGS (DEVICE 1, 2. 3). PER OPERATION NOTES, "DIRECT AND INDIRECT INGUINAL HERNIA WAS IDENTIFIED IN THE RIGHT INGUINAL REGION AND WAS DISSECTED. A LARGE PERFIX PLUG (DEVICE 1) WAS PLACED FOR THE INDIRECT HERNIA COMPONENT. TWO MEDIUM SIZED PERFIX PLUGS (DEVICE 2 AND 3) WERE PLACED IN THE LATERAL AND MEDIAL ASPECT OF THE LARGE DIRECT HERNIA COMPONENT AND SUTURED. ONLAY PATCH WAS PLACED TO REINFORCE THE REPAIR AND SUTURED". ON (B)(6) 2005- PATIENT WAS DIAGNOSED WITH LEFT INDIRECT AND DIRECT INGUINAL HERNIA, THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF PERFIX PLUGS (DEVICE 4, 5). PER OPERATION NOTES, "A SMALL HERNIA SAC WAS IDENTIFIED IN THE LEFT INGUINAL REGION AND WAS DISSECTED. A PERFIX PLUG (DEVICE 4) WAS PLACED AND SUTURED. A HERNIA SAC WAS IDENTIFIED IN THE AREA OF DIRECT INGUINAL REGION AND WAS DISSECTED. A PERFIX PLUG (DEVICE 5) WAS PLACED DEEP INTO THE PERITONEAL SPACE AND SUTURED. AN ONLAY PATCH WAS THEN PLACED TO REINFORCE WITH TAILS OF PATCH AND SUTURED". ON (B)(6) 2009- PATIENT WAS DIAGNOSED WITH RECURRENT RIG

  Patient problems: Adhesion(s); Hernia; Pain

  MAUDE report 24799533 ↗
• InjuryFeb 27, 2026Patient-Device Incompatibility

  AS PER ANSM REPORT ((B)(4)) IN SUMMARY: DATE OF OCCURRENCE: (B)(6) 2019. DESCRIPTION OF THE INCIDENT: (B)(6) 2019 "SINCE WAKING UP FOLLOWING OUTPATIENT SURGERY TO REPAIR A BILATERAL INGUINAL HERNIA USING PLUGS (PERFIX PLUG DEVICES LOT NUMBERS HUCY1469/HUDP0501), MY SON HAS BEEN SUFFERING FROM SEVERE PAIN IN HIS GROIN AND TESTICLES, WHICH IS WHY HE REMAINED IN HOSPITAL FOR A DAY." CLINICAL CONSEQUENCES AND CURRENT CONDITION: "SINCE THEN, THE PAIN HAS NEVER STOPPED, PARTICULARLY ON THE LEFT SIDE, BUT TODAY IT IS GETTING WORSE ON THE RIGHT SIDE (LIKE ELECTRIC SHOCKS OR STABBING PAINS) IN MY LOWER ABDOMEN, GROIN, PRIVATE PARTS, AND THIGH. OVER THE YEARS, I HAVE HAD SEVERAL SCANS AND ULTRASOUNDS, OFTEN WITH CONFLICTING RESULTS. OVER THE YEARS, OTHER SYMPTOMS HAVE DEVELOPED, SOME OF WHICH HAVE BEEN PRESENT SINCE THE BEGINNING, INCLUDING INSOMNIA, EXHAUSTION, LOW MOOD, AND DIFFUSE PAIN THROUGHOUT THE BODY. SO, NORMAL BIOLOGICAL TESTS, NORMAL RHEUMATOLOGICAL TESTS (MULTIPLE X-RAYS, ETC., WITH NO CLEAR CONCLUSIONS). HE SAW THREE OTHER SURGEONS WHO EXPLAINED THAT THE PLUGS COULD NOT BE REMOVED BECAUSE IT WAS TOO DANGEROUS. THE LAST SCAN IN 2024 SHOWED A SMALL RECURRENCE ON THE LEFT SIDE. CON

  Patient problems: Ambulation or Postural Difficulties; Depression; Dyspareunia; Hernia; Neuralgia; Pain

  MAUDE report 24469920 ↗
• InjuryFeb 27, 2026Patient-Device Incompatibility

  AS PER ANSM REPORT (B)(4) IN SUMMARY: DATE OF OCCURRENCE: (B)(6) 2019. DESCRIPTION OF THE INCIDENT: (B)(6) 2019 "SINCE WAKING UP FOLLOWING OUTPATIENT SURGERY TO REPAIR A BILATERAL INGUINAL HERNIA USING PLUGS (PERFIX PLUG DEVICES LOT NUMBERS HUCY1469/HUDP0501), MY SON HAS BEEN SUFFERING FROM SEVERE PAIN IN HIS GROIN AND TESTICLES, WHICH IS WHY HE REMAINED IN HOSPITAL FOR A DAY." CLINICAL CONSEQUENCES AND CURRENT CONDITION: "SINCE THEN, THE PAIN HAS NEVER STOPPED, PARTICULARLY ON THE LEFT SIDE, BUT TODAY IT IS GETTING WORSE ON THE RIGHT SIDE (LIKE ELECTRIC SHOCKS OR STABBING PAINS) IN MY LOWER ABDOMEN, GROIN, PRIVATE PARTS, AND THIGH. OVER THE YEARS, I HAVE HAD SEVERAL SCANS AND ULTRASOUNDS, OFTEN WITH CONFLICTING RESULTS. OVER THE YEARS, OTHER SYMPTOMS HAVE DEVELOPED, SOME OF WHICH HAVE BEEN PRESENT SINCE THE BEGINNING, INCLUDING INSOMNIA, EXHAUSTION, LOW MOOD, AND DIFFUSE PAIN THROUGHOUT THE BODY. SO, NORMAL BIOLOGICAL TESTS, NORMAL RHEUMATOLOGICAL TESTS (MULTIPLE X-RAYS, ETC., WITH NO CLEAR CONCLUSIONS). HE SAW THREE OTHER SURGEONS WHO EXPLAINED THAT THE PLUGS COULD NOT BE REMOVED BECAUSE IT WAS TOO DANGEROUS. THE LAST SCAN IN 2024 SHOWED A SMALL RECURRENCE ON THE LEFT SIDE. CONSE

  Patient problems: Ambulation or Postural Difficulties; Depression; Dyspareunia; Hernia; Neuralgia; Pain

  MAUDE report 24469911 ↗
• InjuryFeb 25, 2026Material Deformation

  PER INFORMATION PROVIDED: (B)(6) 2011- PATIENT WAS DIAGNOSED WITH RECURRENT RIGHT INGUINAL HERNIA, PRIMARY LEFT INGUINAL HERNIA, THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF PERFIX PLUG (DEVICE 1), VENTRIO ST MESH (DEVICE 2). PER OP NOTES, ¿THERE WAS A DIRECT WEAKNESS LATERAL TO THE EXTERNAL RING IN RIGHT INGUINAL REGION. A PERFIX PLUG (DEVICE 1) WAS PLACED AND SUTURED. ON THE LEFT INGUINAL REGION, LARGE VENTRAL HERNIA SAC WAS FOUND. A VENTRIO ST MESH (DEVICE 2) WAS PLACED AND SUTURED¿. (B)(6) 2013- PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA, THEREBY UNDERWENT OPEN REPAIR WITH EXPLANT OF PERFIX PLUG (DEVICE 1), VENTRIO ST MESH (DEVICE 2) AND IMPLANT OF 3DMAX MESHES (DEVICE 3 AND 4).PER OP NOTES, ¿INCISION THROUGH THE PREVIOUS SCAR, HERNIA SAC WAS IDENTIFIED AND IT CONTAINED A WADED UP PIECE OF MESH WHICH WAS REMOVED (PERFIX PLUG- DEVICE 1, VENTRIO ST MESH- DEVICE 2). BILATERAL PLACEMENT OF 3DMAX MESHES (DEVICE 3 AND 4) IN THE EXTRAPERITONEAL SPACE AND THERE WAS A SIGNIFICANT OVERLAP IN THE MIDDLE. THESE MESH WERE TRIMMED AND SUTURED¿.

  Patient problems: Hernia; Scar Tissue

  MAUDE report 24444434 ↗
• InjuryFeb 18, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2007 - PATIENT WAS DIAGNOSED WITH INCISIONAL HERNIA, RECURRENT RIGHT INGUINAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF COMPOSIX KUGEL PATCH (DEVICE 1). PER OPERATIVE NOTES, ¿AN INCISION WAS MADE INTO THE RIGHT INGUINAL SIDE. THE HERNIA SAC WAS DISSECTED OUT. A COMPOSIX KUGEL PATCH (DEVICE 1) WAS PLACED INTO THE INGUINAL FLOOR AND SECURE IT WITH SUTURES.¿ ON (B)(6) 2014 - PATIENT WAS DIAGNOSED WITH EPIGASTRIC/VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH PRIMARY HERNIA REPAIR. ON (B)(6) 2016 - PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL HERNIA THEREBY UNDERWENT OPEN HERNIA REPAIR WITH IMPLANT OF PERFIX PLUG (DEVICE 2). PER OPERATIVE NOTES, ¿AN INCISION WAS MADE THROUGH PREVIOUS SCAR. ALL SCAR TISSUE WERE TAKEN DOWN. THE HERNIA SAC WAS DISSECTED OUT FROM ABDOMEN. A PERFIX PLUG (DEVICE 2) WAS PLACED INTO THE SUBFASCIAL LOCATION AND TACKED IN CIRCUMFERENTIALLY USING SUTURES.¿ ON (B)(6) 2018 - PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL INCISIONAL HERNIA, SCAR TISSUE THEREBY UNDERWENT OPEN REPAIR WITH EXPLANT OF PERFIX PLUG (DEVICE 2) AND IMPLANT OF SEPRAMESH IP (DEVICE 3). PER OPERATIVE NOTES, ¿AN INCISION WAS MADE THROUGH P

  Patient problems: Hernia; Scar Tissue

  MAUDE report 24378829 ↗
• InjuryJan 9, 2026Device Appears to Trigger Rejection

  PER INFORMATION PROVIDED: (B)(6) 2009 - PATIENT WAS DIAGNOSED WITH RECURRENT LEFT INGUINAL HERNIA 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 SECURED TO THE PUBIC TUBERCLE." (B)(6) 2012 - PATIENT WAS DIAGNOSED WITH RECURRENT LEFT INGUINAL HERNIA THEREBY UNDERWENT REPAIR WITH REMOVAL OF EXTRUDED PLUGS (DEVICE 1 AND 2). PER OP NOTES, "SCAR INCISED DOWN TO THE EXTERNAL OBLIQUE. A SYNTHETIC MESH WAS PLACED BENEATH THE FASCIA." (B)(6) 2016 - PATIENT WAS DIAGNOSED WITH RECURRENT LEFT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF PERFIX PLUG (DEVICE 3) AND BARD FLAT MESH (DEVICE 4). PER OP NOTES, "PROTRUSION HAD BEEN PREVIOUSLY NOTED WITH THE PATIENT'S TRANSVERSE INCISION, THE SYNTHETIC MESH WAS DENSELY ADHERENT TO THE INFERIOR FLAP OF THE EXTERNAL OBLIQUE. A PERFIX PLUG (DEVICE 3) WAS SECURED AND A BARD FLAT MESH (DEVICE 4) WAS PLACED UNDER THE EXTERNAL OBLIQUE."

  Patient problems: Hernia; Scar Tissue

  MAUDE report 24019079 ↗
• InjuryNov 6, 2025Material Deformation; Material Deformation

  PER INFORMATION PROVIDED: (B)(6) 2011 - PATIENT WAS DIAGNOSED WITH RIGHT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF PERFIX PLUG (DEVICE 1). PER OP NOTES, "A MEDIUM PERFIX PLUG AND PATCH (DEVICE 1) WAS PLACED OVER THE INGUINAL FLOOR USING PROLENE SUTURES." (B)(6) 2013 - PATIENT WAS DIAGNOSED WITH RECURRENT LEFT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF PERFIX PLUG (DEVICE 2). PER OP NOTES, "A MEDIUM PERFIX PLUG (DEVICE 2) WAS PLACED AT THE PUBIC TUBERCLE OF POUPART'S LIGAMENT USING PROLENE SUTURES." (B)(6) 2017 - PATIENT WAS DIAGNOSED WITH RECURRENT RIGHT INGUINAL HERNIA THEREBY UNDERWENT REPAIR. PER OP NOTES, "AN INCISION WAS MADE THROUGH THE EXISTING SCAR. THERE WAS MESH (DEVICE 1) ON THE FLOOR OF THE INGUINAL CANAL THAT WAS CRUMPLED UP. BETWEEN 2 FOLDS OF THE MESH AS THE HERNIA DEFECT." (B)(6) 2019 - PATIENT HAD RIGHT GROIN PAIN AND WAS DIAGNOSED WITH RECURRENT LEFT INGUINAL HERNIA THEREBY UNDERWENT REPAIR WIT REMOVAL OF MESH (DEVICE 1 AND 2). PER OP NOTES, "ATTENTION TO THE LEFT SIDE, THE PERFIX PLUG (DEVICE 2) WAS REMOVED AND PLACED A 3DMAX MESH (DEVICE 3) INTO THE PREPERITONEAL SPACE USING TACKS. ATTENTION THE RIGHT SIDE, PERFIX P

  Patient problems: Hernia; Pain; Scar Tissue

  MAUDE report 23484863 ↗
• InjuryNov 6, 2025Migration; Migration

  PER INFORMATION PROVIDED: (B)(6) 2006 - PATIENT WAS DIAGNOSED WITH RECURRENT LEFT 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 ON THE FLOOR OF THE INGUINAL CANAL USING SUTURES." (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH INFECTED MESH WITH SMALL BOWEL FISTULA TO ABSCESS THEREBY UNDERWENT REPAIR WITH REMOVAL OF PREVESICAL ABSCESS AND MESH (DEVICE 1 AND 2) AND SMALL BOWEL RESECTION. PER OP NOTES, "A LARGE ABSCESS CAVITY WAS IDENTIFIED. A PORTION OF MESH FROM PRIOR INGUINAL HERNIA HAD PULLED FREE, THIS MESH HAD ERODED. ALL MESH HAD BEEN EXCISED."

  Patient problems: Erosion; Fistula; Unspecified Infection

  MAUDE report 23484554 ↗
• InjuryOct 31, 2025Migration; Migration

  PER ADDITIONAL INFORMATION PROVIDED: ON (B)(6) 2006 ¿ PATIENT WAS DIAGNOSED WITH LEFT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF BARD FLAT MESH (DEVICE 1). PER OP NOTES, ¿A INDIRECT COMPONENT OF HERNIA SAC WAS FOUND ON ANTEROMEDIAL ASPECT OF CORD. A PIECE OF BARD FLAT MESH (DEVICE 1) WAS PLACED IN REGION OF PUBIC TUBERCLE USING SUTURES.¿ ON (B)(6) 2007 ¿ PATIENT WAS DIAGNOSED WITH LEFT GROIN PAIN THEREBY UNDERWENT OPEN REPAIR WITH THE PARTIAL REMOVAL OF MESH (DEVICE 1) AND IMPLANT OF PERFIX PLUG (DEVICE 2). PER OP NOTES, ¿THE CORD WAS ADHESED DOWN TO INGUINAL FLOOR AND MESH. A LARGE SUTURE AND REDUNDANT MESH AT PUBIC TUBERCLE WERE IDENTIFIED. THERE REMAINED A SIGNIFICANT DEFECT BETWEEN THE REMAINING MESH (DEVICE 1) AND PUBIC TUBERCLE. A MEDIUM SIZED PERFIX PLUG (DEVICE 2) WAS PLACED IN PREPERITONEAL SPACE AND POSITIONED BENEATH PUBIC TUBERCLE USING SUTURES.¿ ON (B)(6) 2009 ¿ PATIENT WAS DIAGNOSED WITH RIGHT INGUINAL HERNIA, RECURRENT LEFT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE REMOVAL OF MESH (DEVICE 1, 2). PER OP NOTES, ¿ON RIGHT SIDE, A LARGE SIZED DIRECT INGUINAL HERNIA WAS FOUND. A LARGE SYNTHETIC MESH WAS PLACED TO COVER THE DEFECT USING

  Patient problems: Hernia; Scar Tissue

  MAUDE report 23441361 ↗
• InjuryOct 16, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2004 - PATIENT WAS DIAGNOSED WITH LARGE RIGHT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF PERFIX PLUG (DEVICE 1) AND PERFIX PLUG (DEVICE 2). PER OPERATIVE NOTES, ¿A LARGE INDIRECT INGUINAL HERNIA SAC WAS DISSECTED OUT. A LARGE PERFIX PLUG (DEVICE 1) WAS PLACED THROUGH THE INTERNAL RING, AND A SECOND PIECE OF PERFIX PLUG (DEVICE 2) WAS INSERTED ON THE FLOOR OF THE INGUINAL CANAL AND SECURE IT WITH SUTURES.¿ (B)(6) 2010 - PATIENT WAS DIAGNOSED WITH BILATERAL INCARCERATED INGUINAL HERNIAS, ABDOMINAL PAIN, THEREBY UNDERWENT OPEN REPAIR WITH EXPLANT OF PERFIX PLUG (DEVICE 1 AND DEVICE 2) AND IMPLANT OF SYNTHETIC MESH. PER OPERATIVE NOTES, ¿AN INCISION WAS MADE JUST LEVEL OF THE EXTERNAL OBLIQUE FASCIA. PREVIOUSLY PLACED PERFIX PLUG (DEVICE 1 & DEVICE 2) WAS PARTIALLY REMOVED FROM THE RIGHT SIDE. IN LEFT SIDE HERNIA SAC WAS DISSECTED OUT. A SYNTHETIC MESH WAS PLACED AND SUTURED.¿

  Patient problems: Abdominal Pain; Hernia

  MAUDE report 23308324 ↗
• InjuryJul 30, 2025Material Deformation; Material Deformation

  PER INFORMATION PROVIDED: (B)(6) 2008 ¿ PATIENT WAS DIAGNOSED WITH RECURRENT INCARCERATED SPIGELIAN /ABDOMINAL WALL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF SEPRAMESH IP (DEVICE #1). PER OP NOTES, ¿THE HERNIA SAC WAS IDENTIFIED WITH INCARCERATED BOWEL. ALL THE BOWEL WAS REDUCED. A SEPRAMESH IP (DEVICE #1) WAS PLACED AND TACKED.¿ (B)(6) 2014 - PATIENT WAS DIAGNOSED WITH RECURRENT SPIGELIAN/LATERAL ABDOMINAL WALL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF PERFIX PLUG (DEVICE #2 & #3) AND SEPRAMESH IP (DEVICE #4). PER OP NOTES, ¿A LARGE HERNIA SAC IN THE RIGHT UPPER QUADRANT WAS IDENTIFIED WITH INCARCERATED BOWEL. THE BOWEL WAS REDUCED. THE SAC WAS EXCISED. TWO PERFIX PLUGS (DEVICE #2 & #3) WERE PLACED NEXT TO EACH OTHER AND TACKED. A SEPRAMESH IP (DEVICE #4) WAS PLACED AS AN OVERLAY MESH AND TACKED.¿ (B)(6) 2019 - PATIENT WAS DIAGNOSED WITH RECURRENT INCARCERATED RIGHT LOWER QUADRANT SPIGELIAN HERNIA WITH ABSCESS THEREBY UNDERWENT REPAIR WITH DRAINAGE OF ABSCESS. PER OP NOTES, ¿THE HERNIA SAC WAS IDENTIFIED AND NOT REDUCIBLE CONTAINS BOWEL. THE BOWEL WAS REDUCED HARDLY. THE SAC WAS EXCISED. THE PRIOR MESHES (DEVICE #1, #2, #3 & #4) WERE IDENTIFIE

  Patient problems: Fistula; Hernia; Unspecified Infection

  MAUDE report 22663380 ↗
• InjuryJul 3, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2013 ¿ PATIENT WAS DIAGNOSED WITH BILATERAL INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF MODIFIED KUGEL PATCH (DEVICE #1 ¿ RIGHT), PERFIX PLUG (DEVICE #2 - LEFT), BARD MESH (DEVICE #3 - LEFT). PER OP NOTES, ¿ON RIGHT, THE ENTIRE INGUINAL FLOOR WAS REINFORCED BY A PIECE OF MODIFIED KUGEL PATCH (DEVICE #1) AND SUTURED FROM THE SHELVING EDGE OF THE INGUINAL LIGAMENT TO THE INTERNAL OBLIQUE FASCIA. ON LEFT, SIMILAR PROCEDURE WAS CARRIED OUT AS RIGHT SIDE WITH THE IMPLANT OF PERFIX PLUG (DEVICE #2) AND BARD FLAT MESH (DEVICE #3).¿ (B)(6) 2019 ¿ PATIENT WAS DIAGNOSED WITH RECURRENT RIGHT INGUINAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT OF BARD SOFT MESH (DEVICE #4). PER OP NOTES, ¿ON THE LEFT SIDE, THE PATIENT WAS NOTED TO HAVE MESH (DEVICE #2, #3) WITH PRIOR OPEN HERNIA REPAIR EXTRUDING THROUGH THE INTERNAL RING. ON THE RIGHT SIDE, PATIENT HAD SMALL DEFECT. A BARD SOFT MESH (DEVICE #4) WAS PLACED IN A U FORMATION AROUND THE VESSELS IN VAS DEFERENS USING A SORBAFIX TACKER.¿ (B)(6) 2019 ¿ PATIENT UNDERWENT REMOVAL OF LEFT INGUINAL NERVE. (NOTE: THERE IS NO OP NOTES PROVIDED IN MEDICAL RECORD).

  Patient problems: Nerve Damage

  MAUDE report 22396261 ↗
• InjuryJun 23, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2011 - PATIENT WAS DIAGNOSED WITH BILATERAL INGUINAL HERNIAS THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF THREE PERFIX PLUGS (DEVICE #1, #2 & #3). PER OP NOTES, ¿ON THE RIGHT SIDE A MEDIUM SIZED PERFIX PLUG (DEVICE #1) AND EXTRA-LARGE PERFIX PLUG (DEVICE #2) WERE PLACED WITH PROLENE SUTURES. ON THE LEFT SIDE, A LARGE PERFIX PLUG (DEVICE #3) WAS PLACED WITH PROLENE SUTURES.¿ (B)(6) 2016 - PATIENT WAS DIAGNOSED WITH RECURRENT RIGHT INGUINAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE REMOVAL OF TWO PERFIX PLUGS (DEVICE #1 & #2). PER OP NOTES, ¿THERE WAS A MESH PLUG THAT WAS PROTRUDING INTO THE PREPERITONEAL SPACE AT THE INDIRECT SPACE AND THERE WAS ALSO ONE ON THE DIRECT SPACE AS WELL. ADHESIONS IN THE RIGHT UPPER ABDOMEN. THE MESH PLUGS (DEVICE #1 & #2) WERE EXCISED. A VENTRALIGHT ST MESH (DEVICE #4) WAS PLACED.¿

  Patient problems: Adhesion(s); Hernia

  MAUDE report 22305523 ↗
• InjuryJun 6, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2016 - PATIENT WAS DIAGNOSED WITH RIGHT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF PERFIX PLUG (DEVICE #1). PER OP NOTES, ¿A PERFIX PLUG (DEVICE #1) WAS PLACED INTO THE INGUINAL HERNIA DEFECT AND WAS SECURED WITH PROLENE SUTURES." (B)(6) 2017 - PATIENT WAS DIAGNOSED WITH RECURRENT LEFT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF PERFIX PLUG (DEVICE #2). PER OP NOTES, ¿THERE WAS A DIRECT INGUINAL HERNIA NOTED AND WAS REDUCED. A PERFIX PLUG (DEVICE #2) WAS PLACED INTO THE HERNIA DEFECT AND A PATCH WAS ALSO PLACED OVER THE PLUG USING PROLENE SUTURES.¿ (NOTE: A PERFIX PLUG (DEVICE #1) WAS NOT SEEN DURING THIS PROCEDURE). (B)(6) 2017 - PATIENT WAS DIAGNOSED WITH RECURRENT LEFT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF PERFIX PLUG (DEVICE #3). PER OP NOTES, ¿A SMALL PERFIX PLUG (DEVICE #3) WAS PLACED OVERLYING THE INGUINAL CANAL USING PROLENE SUTURE & A PATCH WAS PLACED OVER THE PLUG.¿ (NOTE: A PERFIX PLUG (DEVICE #2) WAS NOT SEEN DURING THIS PROCEDURE). (B)(6) 2018 - PATIENT WAS DIAGNOSED WITH RECURRENT LEFT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE REMOVAL OF MESH (DEVICE

  Patient problems: Hernia

  MAUDE report 22158407 ↗
• InjuryJun 3, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2007 - PATIENT WAS DIAGNOSED WITH LEFT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF PERFIX PLUG (DEVICE #1 & #2). PER OPERATIVE NOTES, ¿THE DIRECT HERNIA SAC WAS IDENTIFIED AND DISSECTED. A LARGE PERFIX PLUG (DEVICE #1) WAS PLACED AND TACKED. THE PROLAPSING CORD LIPOMA WAS DISSECTED. A MEDIUM SIZE PERFIX PLUG (DEVICE #2) WAS PLACED AND TACKED.¿ (B)(6) 2009 - PATIENT WAS DIAGNOSED WITH RECURRENT LEFT INGUINAL HERNIA WITH PAIN THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT PERFIX PLUG (DEVICE #3). PER OPERATIVE NOTES, ¿MODERATE AMOUNT OF SCAR TISSUE WAS EXCISED. THE DEFECT WAS IDENTIFIED AND DISSECTED. A PERFIX PLUG (DEVICE #3) WAS PLACED WITH ONLAY MESH AND TACKED TO PUBIC TUBERCLE.¿ (B)(6) 2016 - PATIENT WAS DIAGNOSED WITH RECURRENT LEFT INGUINAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF BARD FLAT MESH (DEVICE #4). PER OPERATIVE NOTES, ¿THE HERNIA SAC WAS IDENTIFIED AND REDUCED. A BARD FLAT MESH (DEVICE #4) WAS PLACED AND TACKED."

  Patient problems: Hernia

  MAUDE report 22129959 ↗
• InjuryJun 2, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2007 - PATIENT WAS DIAGNOSED WITH LEFT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF PERFIX PLUG (DEVICE #1 & #2). PER OPERATIVE NOTES, ¿THE DIRECT HERNIA SAC WAS IDENTIFIED AND DISSECTED. A LARGE PERFIX PLUG (DEVICE #1) WAS PLACED AND TACKED. THE PROLAPSING CORD LIPOMA WAS DISSECTED. A MEDIUM SIZE PERFIX PLUG (DEVICE #2) WAS PLACED AND TACKED. ¿ ON (B)(6) 2009 - PATIENT WAS DIAGNOSED WITH RECURRENT LEFT INGUINAL HERNIA WITH PAIN THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT PERFIX PLUG (DEVICE #3). PER OPERATIVE NOTES, ¿MODERATE AMOUNT OF SCAR TISSUE WAS EXCISED. THE DEFECT WAS IDENTIFIED AND DISSECTED. A PERFIX PLUG (DEVICE #3) WAS PLACED WITH ONLAY MESH AND TACKED TO PUBIC TUBERCLE. ¿ ON (B)(6) 2016 - PATIENT WAS DIAGNOSED WITH RECURRENT LEFT INGUINAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF BARD FLAT MESH (DEVICE #4). PER OPERATIVE NOTES, ¿THE HERNIA SAC WAS IDENTIFIED AND REDUCED. A BARD FLAT MESH (DEVICE #4) WAS PLACED AND TACKED."

  Patient problems: Hernia; Pain; Scar Tissue

  MAUDE report 22123652 ↗