COMPOSIXRecalls & reported problems across all models

We found 18 models of COMPOSIX by Davol Inc. in the FDA's device registry (GUDID). Together they are named in 510 adverse event reports in the FDA's MAUDE database, received between Apr 28, 2016 and Aug 21, 2026 — classified as 1 death, 507 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Defective Device” (455 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported COMPOSIX problems

COMPOSIX models

18 models, most reported first. Each model has its own page with its reports, recalls and device details.

• COMPOSIX 0123460

  Mesh, surgical, polymeric
  1 death115 reports
• COMPOSIX 0123680

  Mesh, surgical, polymeric
  93 reports
• COMPOSIX 0123810

  Mesh, surgical, polymeric
  63 reports
• COMPOSIX 0134460

  Mesh, surgical, polymeric
  49 reports
• COMPOSIX 0134450

  Mesh, surgical, polymeric
  44 reports
• COMPOSIX 0134680

  Mesh, surgical, polymeric
  37 reports
• COMPOSIX 0123790

  Mesh, surgical, polymeric
  30 reports
• COMPOSIX 0123113

  Mesh, surgical, polymeric
  22 reports
• COMPOSIX 0134810

  Mesh, surgical, polymeric
  18 reports
• COMPOSIX 0123114

  Mesh, surgical, polymeric
  11 reports
• COMPOSIX 0144680

  Laparoscope, general & plastic surgery
  7 reports
• COMPOSIX 0134113

  Mesh, surgical, polymeric
  6 reports
• COMPOSIX 0134790

  Mesh, surgical, polymeric
  6 reports
• COMPOSIX 0134610

  Mesh, surgical, polymeric
  4 reports
• COMPOSIX 0144790

  Mesh, surgical, polymeric
  2 reports
• COMPOSIX 0134114

  Mesh, surgical, polymeric
  1 report
• COMPOSIX 0144113

  Laparoscope, general & plastic surgery
  1 report
• COMPOSIX 0144810

  Mesh, surgical, polymeric
  1 report

Recent COMPOSIX adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryAug 21, 2026Patient-Device Incompatibility

  Per information provided:(b)(6)2008 - Patient was diagnosed with recurrent umbilical hernia thereby underwent open repair with implant of Ventralex Mesh (Device 1). Per operative notes, "A semicircular incision was made in the skin superior to the umbilicus. The hernia sac was identified and was dissected free from the deep tissue. A Ventralex Mesh (Device 1) was placed into the abdominal fascia in a tension free repair and secured it with sutures."(b)(6)2011 - Patient was diagnosed with recurrent incarcerated umbilical hernia, adhesion thereby underwent laparoscopic repair with implant of Composix LP Mesh (Device 2) and explant of Ventralex Mesh (Device 1). Per operative notes, "An incision was made around the umbilicus. The hernia sac was dissected out. There were multiple adhesions to the abdominal wall around the previous Ventralex Mesh (Device 1). Extensive lysis of adhesions was performed. The Ventralex Mesh (Device 1) was excised entirely. A Composix LP Mesh (Device 2) was placed into the abdominal wall and secured it with sutures."(b)(6)2011 - Patient was diagnosed with recurrent umbilical hernia thereby underwent open repair with implant of biological mesh. (Note: No opera

  Patient problems: Hernia; Pain

  MAUDE report 50382861 ↗
• InjuryJul 30, 2026Patient-Device Incompatibility

  Per information provided:26-Nov-2001 - Patient was diagnosed with recurrent ventral hernia thereby underwent open repair with the implant of Composix Mesh (Device 1). Per op notes, "The underlying hernia defect was dissected free. A piece of Composix Mesh (Device 1) was placed into defect and secured to fascia using sutures."11-Apr-2002 - Patient was diagnosed with recurrent ventral hernia, adhesion thereby underwent laparoscopic repair with the implant of Composix E/X Mesh. Per op notes, "There were massive adhesions up into the old hernia area and stuck to previously placed mesh. The defect was noted. An Composix E/X Mesh was placed as marlex portion up against the abdominal wall and secured circumferentially using tacks."10-Mar-2004 - Patient was diagnosed with recurrent ventral hernia thereby underwent open repair. Per op notes, "An infraumbilical cutdown was made in the middle where the hernia was noted. There were some adhesions. A mesh was sutured peripherally." (Note: The mesh implanted in this procedure was unknown)

  Patient problems: Adhesion(s); Hernia

  MAUDE report 50089799 ↗
• InjuryJul 3, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2011 - PATIENT WAS DIAGNOSED WITH VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF COMPOSIX E/X MESH (DEVICE 1). PER OP NOTES, ¿THE HERNIA SAC WAS IDENTIFIED IN ABDOMINAL REGION. A COMPOSIX E/X MESH WAS PLACED ON THE INTRAPERITONEAL SURFACE OF THE FASCIA AND SUTURED¿. ON (B)(6) 2019- PATIENT WAS DIAGNOSED WITH VENTRAL INCISIONAL HERNIA REPAIR WITH MESH. ON (B)(6) 2019 - PATIENT WAS DIAGNOSED WITH VENTRAL INCISIONAL HERNIA, EPIGASTRIC HERNIA, THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRALEX ST MESH (DEVICE 2). PER OP NOTES, ¿THE PREVIOUS SCAR WAS EXCISED. THE HERNIA DEFECT WAS REPAIRED BY PLACING A VENTRALEX ST MESH (DEVICE 2) AND SUTURED¿.

  Patient problems: Hernia; Scar Tissue

  MAUDE report 25707240 ↗
• InjuryJun 30, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2007 - PATIENT WAS DIAGNOSED WITH INCISIONAL HERNIA, THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRALEX MESH (DEVICE 1). PER OPERATIVE NOTES, "AN INCISION WAS MADE INTO THE UPPER MIDLINE. THE HERNIA SAC WAS DISSECTED OUT. A LARGE VENTRALEX MESH (DEVICE 1) WAS PLACED INTO THE ABDOMEN AND SECURED IT WITH SUTURES." ON (B)(6) 2008 - PATIENT WAS DIAGNOSED WITH ADHESION, RECURRENT VENTRAL INCISIONAL HERNIA, THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF COMPOSIX L/P MESH (DEVICE 2). PER OPERATIVE NOTES, "A MIDLINE INCISION WAS MADE INTO THE ABDOMEN. THE HERNIA SAC WAS DISSECTED OUT. THERE WERE DENSE ADHESIONS PRESENT INTO THE ABDOMEN. ALL ADHESIONS WERE TAKEN DOWN SHARPLY. A COMPOSIX L/P MESH (DEVICE 2) WAS PLACED INTO THE ANTERIOR ABDOMINAL WALL AND SECURED IT WITH SUTURES." ON (B)(6) 2010 - PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL HERNIA, ADHESION, THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH REINFORCEMENT OF EXISTING MESH. PER OPERATIVE NOTES, "MULTIPLE LOOPS OF SMALL BOWEL WERE ADHERENT TO THE EPIGASTRIC AREA. ALL ADHESIONS WERE TAKEN DOWN SHARPLY. THE PREVIOUS DEFECT ITSELF HAD BEEN ADEQUATELY COVERED AND REINFORCED WITH PREVIOUSLY P

  Patient problems: Adhesion(s); Hernia

  MAUDE report 25666782 ↗
• InjuryJun 18, 2026Material Deformation; Migration

  PER INFORMATION PROVIDED: ON (B)(6) 2011 - PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL ABDOMINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF COMPOSIX E/X MESHES (DEVICE 1, 2). PER OP NOTES, "A LARGE HERNIA SAC WAS NOTED FASCIAL RENT IN MIDLINE. TWO COMPOSIX MESHES WERE USED ON EACH SIDE OF DEFECT DUE TO LARGE RENT. THE FIRST COMPOSIX E/X MESH (DEVICE 1) WAS PLACED AS SUBLAY ON LEFT SIDE OF DEFECT AND ANOTHER COMPOSIX E/X MESH (DEVICE 2) WAS PLACED ON RIGHT SIDE OF DEFECT USING SUTURES." ON (B)(6) 2013 - PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR. PER OP NOTES, "THE ADHESIONS WERE FREED UP. THE HERNIA SAC AND CONTENTS WERE REMOVED. THE DEFECT WAS NOTED. THE PREVIOUSLY PLACED MESH (DEVICE 1, 2) HAD COLLAPSED AND AVULSED INTO SOME OF HERNIA SAC, COLON, LIVER. A MESH WAS PLACED TO OVERLAP THE HERNIA DEFECT INTO ABDOMINAL CAVITY USING TACKS." NOTE: THE MESH IMPLANTED IN THIS PROCEDURE WILL BE CONSIDERED AS UNKNOWN).

  Patient problems: Abscess; Adhesion(s); Hernia

  MAUDE report 25551991 ↗
• InjuryApr 21, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2020 - PATIENT WAS DIAGNOSED WITH INCISIONAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF COMPOSIX L/P USING ECHO MESH (DEVICE 1). PER OP NOTES, ¿OMENTAL ADHESIONS WERE TAKEN DOWN. THE HERNIA DEFECT WAS NOTED AND REDUCED. A COMPOSIX L/P USING ECHO MESH (DEVICE 1) WAS PLACED AND TACKED CIRCUMFERENTIALLY USING SPIRAL TACKS.¿ ON (B)(6) 2020 - PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF COMPOSIX L/P MESH (DEVICE 2). PER OP NOTES, ¿OMENTAL ADHESIONS WERE TAKEN DOWN. THE PRIOR MESH (DEVICE 1) WAS NOTED TO BE JUST BELOW THE FASCIAL DEFECT. THE HERNIA DEFECT WAS REDUCED. A COMPOSIX L/P MESH (DEVICE 2) WAS PLACED AND TACKED CIRCUMFERENTIALLY.¿ ON (B)(6) 2021 - PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA AND DIVERTICULOSIS THEREBY UNDERWENT LAPAROSCOPIC CONVERTED TO OPEN REPAIR WITH EXCISION OF COMPOSIX L/P USING ECHO MESH (DEVICE 1) AND COMPOSIX L/P (DEVICE 2). PER OP NOTES, ¿DENSE ADHESIONS BETWEEN OMENTUM AND PRIOR MESHES (DEVICE 1 AND 2) WERE LYSED. THERE WAS A RECURRENT HERNIA AND REDUCED. ALL THE PRIOR ABDOMINAL MESHES (DEVICE 1 AND 2) WERE EXCISED END REMOVED

  Patient problems: Adhesion(s); Hernia

  MAUDE report 24939503 ↗
• InjuryApr 7, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2011 - PATIENT WAS DIAGNOSED WITH LEFT LUMBAR HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF VENTRALEX MESH (DEVICE 1). PER OP NOTES, "A VENTRALEX MESH (DEVICE 1) WAS PLACED TO THE ABDOMINAL WALL USING PROLENE SUTURES." (B)(6) 2012 - PATIENT WAS DIAGNOSED WITH RECURRENT LEFT FLANK HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE REMOVAL OF PREVIOUS MESH (DEVICE 1) AND IMPLANT OF COMPOSIX L/P MESH (DEVICE 2). PER OP NOTES, "THERE WAS A HERNIA SAC AND THE MESH (DEVICE 1) WAS PULLED AWAY FROM THE INFERIOR ATTACHMENTS AND JUST WAS A LITTLE POSTERIOR, THE MESH WAS EXCISED. A COMPOSIX L/P MESH (DEVICE 2) WAS PLACED TO THE FASCIA USING PROLENE SUTURES." (B)(6) 2013 - PATIENT WAS DIAGNOSED WITH RECURRENT LEFT FLANK HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE REMOVAL OF PREVIOUS MESH (DEVICE 2) AND IMPLANT OF VENTRIO MESH (DEVICE 3). PER OP NOTES, "THERE WAS A HERNIA AND PART OF THIS WENT THROUGH THE MESH AND PULLED OUT SUPERIORLY AND FOLDED IN ON ITSELF, THEREFORE EXCISED THE OLD MESH (DEVICE 2). A VENTRIO MESH (DEVICE 3) WAS SECURED USING PROLENE SUTURES THROUGH MID FASCIA AROUND THE EDGES."

  Patient problems: Hernia

  MAUDE report 24801215 ↗
• InjuryMar 30, 2026Material Deformation; Migration

  PER INFORMATION PROVIDED: (B)(6) 2003 - PATIENT WAS DIAGNOSED WITH VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF COMPOSIX E/X MESH (DEVICE 2 AND 3). PER OP NOTES, ¿AN INCISION WAS MADE OVER THE UPPER ABDOMEN PREVIOUS INCISION SITE. ADHESIONS TO THE ABDOMINAL WALL WERE TAKEN DOWN. TWO COMPOSIX E/X MESH (DEVICE 2 AND 3) WERE PLACED INTO THE ABDOMEN AND SECURED WITH SUTURES TIED ON EACH OF THE OVAL ENDS TO THE ANTERIOR ABDOMINAL WALL AND TACKED INTO POSITION.¿ (B)(6) 2004 - PATIENT WAS DIAGNOSED WITH UPPER ABDOMEN VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF COMPOSIX E/X MESH (DEVICE 4 AND 5). PER OP NOTES, ¿AN INCISION WAS MADE THROUGH THE OLD CHEVRON INCISION. THE HERNIA WAS IDENTIFIED UNDER THE OLD SCAR. THE HERNIA SAC WAS NOTED TO BE VERY THIN. DISSECTION WAS MADE DOWN TO THE FLANK SIDE ON LEFT LATERAL SIDE AND THEN ANTERIORLY TO ABOVE THE UMBILICUS. TWO COMPOSIX E/X MESH (DEVICE 4 AND 5) WERE PLACED ON TOP OF EACH OTHER AND SECURED TOGETHER WITH SUTURES. THE OVERLAP WAS THEN EXCISED AND THE MESH WAS PLACED UNDER THE ABDOMEN AND SECURED WITH SUTURES AND TACKED TO ANTERIOR ABDOMINAL WALL.¿ (B)(6) 2007 ¿ PATIENT WAS DIAGNOSED WITH ABSCESS ABDOMINAL WAL

  Patient problems: Abscess; Fistula; Hernia; Necrosis; Unspecified Infection

  MAUDE report 24714032 ↗
• InjuryMar 26, 2026Migration

  PER INFORMATION PROVIDED: (B)(6) 2003 - PATIENT WAS DIAGNOSED WITH VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF COMPOSIX E/X MESH (DEVICE 2 AND 3). PER OP NOTES, ¿AN INCISION WAS MADE OVER THE UPPER ABDOMEN PREVIOUS INCISION SITE. ADHESIONS TO THE ABDOMINAL WALL WERE TAKEN DOWN. TWO COMPOSIX E/X MESH (DEVICE 2 AND 3) WERE PLACED INTO THE ABDOMEN AND SECURED WITH SUTURES TIED ON EACH OF THE OVAL ENDS TO THE ANTERIOR ABDOMINAL WALL AND TACKED INTO POSITION.¿ (B)(6) 2004 - PATIENT WAS DIAGNOSED WITH UPPER ABDOMEN VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF COMPOSIX E/X MESH (DEVICE 4 AND 5). PER OP NOTES, ¿AN INCISION WAS MADE THROUGH THE OLD CHEVRON INCISION. THE HERNIA WAS IDENTIFIED UNDER THE OLD SCAR. THE HERNIA SAC WAS NOTED TO BE VERY THIN. DISSECTION WAS MADE DOWN TO THE FLANK SIDE ON LEFT LATERAL SIDE AND THEN ANTERIORLY TO ABOVE THE UMBILICUS. TWO COMPOSIX E/X MESH (DEVICE 4 AND 5) WERE PLACED ON TOP OF EACH OTHER AND SECURED TOGETHER WITH SUTURES. THE OVERLAP WAS THEN EXCISED AND THE MESH WAS PLACED UNDER THE ABDOMEN AND SECURED WITH SUTURES AND TACKED TO ANTERIOR ABDOMINAL WALL.¿ (B)(6) 2007 ¿ PATIENT WAS DIAGNOSED WITH ABSCESS ABDOMINAL WAL

  Patient problems: Abscess; Fistula; Necrosis; Unspecified Infection

  MAUDE report 24700338 ↗
• InjuryMar 26, 2026Device Appears to Trigger Rejection; Migration

  PER INFORMATION PROVIDED: (B)(6) 2019- PATIENT WAS DIAGNOSED WITH INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF COMPOSIX L/P MESH (DEVICE 1). PER OP NOTES, ¿THE HERNIA SAC WAS IDENTIFIED IN THE UMBILICAL REGION AND DISSECTED. A COMPOSIX L/P MESH (DEVICE 1) WAS PLACED AND SUTURED¿. (B)(6) 2019 - PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA, THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH ADHESIOLYSIS, EXPLANT OF COMPOSIX L/P MESH (DEVICE 1), IMPLANT OF COMPOSIX L/P MESH (DEVICE 2). PER OP NOTES, ¿RECURRENT HERNIA WAS IDENTIFIED IN UMBILICAL REGION AND THE PRIOR MESH (DEVICE 1) WAS EXCISED. A NEW COMPOSIX L/P MESH (DEVICE 2) WAS PLACED AND SUTURED CIRCUMFERENTIALLY¿. (B)(6) 2020- PATIENT WAS DIAGNOSED WITH INCISIONAL HERNIA WITH DENSE INTRA-ABDOMINAL ADHESIONS, THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF SYNTHETIC MESH. PER OP NOTES,¿ DENSE ADHESIONS WERE TAKEN DOWN. THE PRIOR MESH (DEVICE 2) WAS FOUND TO BE PULLED AWAY FROM LEFT SIDE. EVENTRATION OF MESH WAS NOTED. A SYNTHETIC MESH WAS PLACED IN THE ABDOMINAL CAVITY AND TACKED.¿

  Patient problems: Adhesion(s); Hernia

  MAUDE report 24698699 ↗
• InjuryMar 26, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2004 ¿ PATIENT WAS DIAGNOSED WITH UMBILICAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF MODIFIED KUGEL PATCH (DEVICE 1). PER OP NOTES, ¿HERNIA WAS NOTED. A MODIFIED KUGEL PATCH (DEVICE 1) WAS PLACED AND FLATTENED OUT AGAINST PREPERITONEAL SPACE. THE TAILS SUTURED DOWN TO SURROUNDING FASCIA.¿ (B)(6) 2007 - PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL HERNIA, EPIGASTRIC HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT OF COMPOSIX L/P MESH (DEVICE 2). PER OP NOTES, ¿ADHESIONS WERE LYSED. THE ORIGINAL MESH (DEVICE 1) WAS IDENTIFIED, AND A DEFECT WAS NOTED TO ONE SIDE AND SECOND HERNIA DEFECT WAS ALSO NOTED. A ROUND PIECE OF COMPOSIX L/P MESH (DEVICE 2) WAS PLACED LATERALLY IN LEFT FLANK AND SECURED USING PROTACKS.¿ (B)(6) 2012 ¿ PATIENT WAS DIAGNOSED WITH INCARCERATED VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE REMOVAL OF MESHES (DEVICE 1, 2). PER OP NOTES, ¿THE HERNIA SAC WAS FREED UP FROM THE SUBCUTANEOUS TISSUES. ADHESIONS OF SMALL BOWEL WERE FREED UP. ALL THE MESH (DEVICE 1, 2) AND TACKS WERE REMOVED. THE FASCIAL LAYER WAS IDENTIFIED AND A PIECE OF SYNTHETIC MESH WAS PLACED AS UNDERLAY TYPE REPAIR USING SUTURES.¿

  Patient problems: Adhesion(s); Hernia

  MAUDE report 24697901 ↗
• InjuryFeb 25, 2026Material Deformation

  PER INFORMATION PROVIDED: (B)(6) 2010 - PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA WITH PAIN THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF COMPOSIX E/X MESH (DEVICE 1). PER OPERATIVE NOTES, ¿MULTIPLE ANTERIOR ABDOMINAL WALL ADHESIONS WITH A LARGE, HERNIATED DEFECT IN FROM PRIOR PFANNENSTIEL INCISION WAS NOTED. THE ADHESIONS WERE TAKEN DOWN, AND LARGE DEFECT WAS REDUCED AND COMPOSIX E/X MESH (DEVICE 1) WAS PLACED AND OVER THE DEFECT IN THE RIGHT LOWER QUADRANT AND TACKED IN PLACE. THE FASCIA WAS CLOSED AND SECURED WITH SUTURES AND TACKS.¿ (B)(6) 2011 ¿ PATIENT HAD RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF COMPOSIX E/X MESH (DEVICE 2) AND REMOVAL OF TACKS. (NOTE: THERE IS NO OPERATIVE NOTE PROVIDED FOR THIS PROCEDURE IN MEDICAL RECORDS). (B)(6) 2018 ¿ PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA, SMALL BOWEL OBSTRUCTION WITH ABDOMINAL PAIN THEREBY UNDERWENT OPEN REPAIR WITH REMOVAL OF PRIOR MESHES (DEVICE 1 AND 2) AND PRIMARY REPAIR OF RECURRENT HERNIA. PER OPERATIVE NOTES, ¿MINOR OMENTAL ADHESIONS WERE TAKEN DOWN AND WRINKLED MESHES (DEVICE 1 AND 2) IN LOWER ABDOMEN IN MIDLINE WAS NOTED. THE DILATED BOWEL AND DECO

  Patient problems: Abdominal Pain; Adhesion(s); Fibrosis; Hernia; Obstruction/Occlusion; Wrinkling

  MAUDE report 24444449 ↗
• InjuryFeb 12, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2009 ¿ PATIENT WAS DIAGNOSED WITH LEFT LOWER QUADRANT INCISIONAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF TWO COMPOSIX L/P MESHES (DEVICE 1 AND 2). PER OPERATIVE NOTES, ¿ IN THE LEFT LOWER QUADRANT, A LARGE HERNIA WITH SCAR WAS NOTED. ADHESIONS WERE LYSED AND OVAL COMPOSIX L/P MESH (DEVICE 1) WAS PLACED, AND ANOTHER CIRCULAR COMPOSIX L/P MESH (DEVICE 2) WAS PLACED AS AN ADEQUATE COVERAGE AND CONNECTED TOGETHER WITH SUTURES AND TACKS." ON (B)(6) 2009 ¿ PATIENT WAS DIAGNOSED WITH RECURRENT LEFT LOWER QUADRANT INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH REMOVAL OF PRIOR MESHES (DEVICE 1 AND 2) IMPLANT OF BIOLOGICAL GRAFT. PER OPERATIVE NOTES, ¿ A SMALL HERNIA SAC WAS IDENTIFIED INFERIOR TO THE MESHES (DEVICE 1 AND 2). THE MESHES (DEVICE 1 AND 2) WERE SEPARATED FROM THE ANTERIOR ABDOMINAL WALL AND COMPLETELY REMOVED. SEVERAL AREAS OF ADHESIONS WERE LYSED. THE BIOLOGICAL GRAFT WAS PLACED IN AN UNDERLAY FASHION AND SECURED TO ANTERIOR ABDOMINAL WALL WITH SUTURES.¿

  Patient problems: Adhesion(s); Hernia

  MAUDE report 24326890 ↗
• InjuryFeb 12, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2009 - PATIENT WAS DIAGNOSED WITH UMBILICAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF VENTRALEX MESH (DEVICE 1). PER OP NOTES, "INCISION WAS MADE TO THE INFRAUMBILICALLY, A VENTRALEX MESH (DEVICE 1) WAS PLACED INTO THE DEFECT USING SUTURES." (B)(6) 2010 - PATIENT WAS DIAGNOSED WITH INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE REMOVAL OF INFECTED MESH (DEVICE 1) AND IMPLANT OF COMPOSIX L/P MESH (DEVICE 2). PER OP NOTES, "A COMPOSIX L/P MESH (DEVICE 2) WAS PLACED INTO THE ABDOMINAL CAVITY USING SUTURES." (B)(6) 2010 - PATIENT HAD ABSCESS. PER OP NOTES, "DISSECTION WAS CARRIED DOWN THROUGH THE SKIN AND SUBCUTANEOUS TISSUE TO THE UNDERLYING STITCH ABSCESS AND SINUS TRACT, THIS WAS EXCISED. THE PREVIOUSLY HEALED SCAR AND TISSUE ARRANGEMENT WAS DONE."

  Patient problems: Abscess; Scar Tissue

  MAUDE report 24321202 ↗
• InjuryJan 29, 2026Migration

  PER INFORMATION PROVIDED: (B)(6) 2024 - PATIENT WAS DIAGNOSED WITH INCARCERATED INCISIONAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF COMPOSIX E/X MESH (DEVICE 1 AND 2). PER OP NOTES, ¿THE HERNIA WAS IDENTIFIED IN THE EPIGASTRIC AREA AND THE OMENTUM WAS PARTIALLY REDUCED. ADHESIONS BETWEEN THE SMALL BOWEL AND HERNIA SAC WERE LYSED. SMALL BOWEL ADHERENT TO THE ANTERIOR ABDOMINAL WALL WERE LYSED. A COMPOSIX E/X MESH (DEVICE 1) WAS PLACED ALONG THE ANTERIOR ABDOMINAL WALL AND SECURED WITH TACKER. A COMPOSIX E/X MESH (DEVICE 2) WAS PLACED INTO THE PERITONEAL CAVITY IN THE IDENTICAL CONFIGURATION AND SECURED TO THE ANTERIOR ABDOMINAL WALL WITH TACKER.¿ (B)(6) 2008 - PATIENT WAS DIAGNOSED WITH INFECTED MESH AND RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH EXCISION OF COMPOSIX E/X MESH (DEVICE 1 AND 2) AND IMPLANT OF BIOLOGICAL PATCH. PER OP NOTES, ¿DENSE ADHESIONS AND THE BORDER OF THE MESH WERE IDENTIFIED IN THE LEFT SIDE OF THE ABDOMEN. THE ABSCESS CAVITY BETWEEN THE FASCIA AND THE MESH WAS NOTED. A LARGE AMOUNT OF FECULENT AND FOUL-SMELLING FLUID AS WELL AS BLOOD WAS OBTAINED AND THE AREA WAS IRRIGATED OUT. A LARGE MESH WAS IDENTIFIED ON THE RIGHT S

  Patient problems: Fistula; Hernia; Unspecified Infection

  MAUDE report 24207872 ↗

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