VENTRALEX 0010303Recalls & reported problems

Summary

The FDA's MAUDE database contains 419 adverse event reports that list this exact device (DI 00801741016486), received between Apr 25, 2017 and Sep 1, 2026 — classified as 1 death, 414 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Defective Device” (380 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 419 reports, in the reporter's own words as published by the FDA.

• InjurySep 1, 2026Patient-Device Incompatibility

  Per Information provided:(b)(6) 2008 - Patient was diagnosed with recurrent ventral hernia thereby underwent open repair with implant of Ventralex Mesh (Device 1). Per op notes, "An incision was made in the previous scar. The hernia sac was encountered and was dissected away from the surrounding tissue. A Ventralex Mesh (Device 1) was placed into the peritoneal cavity using sutures.¿ (b)(6) 2008 - Patient was diagnosed with recurrent ventral hernia thereby underwent open repair with explant of Ventralex Mesh (Device 1) and implant of synthetic mesh. Per op notes, ¿An incision was made in the previous scar and extended down to the subcutaneous tissue. The Ventralex Mesh (Device1) was well incorporated and densely adherent to the fascia.The previous Ventralex Mesh (Device 1) was excised. Two synthetic meshes were placed at inner and outer layer and were secured with sutures.¿(b)(6) 2009 - Patient was diagnosed with recurrent ventral hernia thereby underwent open repair with explant of synthetic mesh and implant of Bard Flat Mesh (Device 2). Per op notes, ¿The synthetic meshes along with the tacks were removed. A Bard Flat Mesh (Device 2) was placed on the undersurface of the fascia u

  Patient problems: Adhesion(s); Hernia; Pain

  MAUDE report 50540247 ↗
• InjuryJul 3, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2013 - PATIENT WAS DIAGNOSED WITH VENTRAL HERNIA X 2 THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRALEX MESH (DEVICE 1 AND 2). PER OP NOTES, "AN INCISION WAS MADE OVER THE LARGE DEFECT. THE HERNIA SAC WAS DISSECTED AWAY AND AMPUTATED. A SINGLE DEFECT WAS IDENTIFIED ABOVE THE UMBILICUS AND IT WAS REDUCED. AN INCISION WAS MADE OVER THIS. THE HERNIA SAC WAS AMPUTATED AT THE FASCIAL LEVEL. DEFECT IN THE LOWER PORTION WAS IDENTIFIED AND AN VENTRALEX MESH (DEVICE 1) WAS PLACED INTO THE ABDOMEN AND SECURED WITH SUTURES. THE UPPER DEFECT WAS REPAIRED IN A SIMILAR FASHION WITH VENTRALEX MESH (DEVICE 2) AND THE WOUND WAS CLOSED WITH SUTURE." ON (B)(6) 2014 - PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRIO MESH (DEVICE 3). PER OP NOTES, "THE PREVIOUS LOWER MIDLINE INCISION WAS OPENED FROM THE UMBILICUS. HERNIA SAC WAS IDENTIFIED AND DISSECTED DOWN TO THE FASCIA AND REMOVED. INTRA-ABDOMINAL CONTENTS DISSECTED AWAY FROM THE FASCIAL DEFECT. THE EDGES OF THE FASCIAL DEFECT WERE APPROXIMATED WITH SUTURE. THIS LEFT A SMALL DEFECT. A VENTRIO MESH (DEVICE 3) WAS PLACED IN THE DEFECT AND TACKED ANTERI

  Patient problems: Adhesion(s); Hernia; Inflammation

  MAUDE report 25704358 ↗
• InjuryJun 4, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2008 - PATIENT WAS DIAGNOSED WITH VENTRAL EPIGASTRIC HERNIA AND UMBILICAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF VENTRALEX MESHES. PER OP NOTES, "A SUPRAUMBILICAL HERNIA DEFECT WAS PRESENT. THE UMBILICAL HERNIA WAS ALSO NOTED. THE UMBILICAL DEFECT WAS CLOSED WITH A SMALL VENTRALEX PATCH (DEVICE 1) WHICH WAS SECURED TO THE FASCIA USING SUTURES. THE LARGER SUPRAUMBILICAL DEFECT WAS CLOSED WITH A LARGE VENTRALEX MESH (DEVICE 2) WHICH WAS PLACED IN SUBFASCIAL POCKET USING SUTURES." (B)(6) 2018 - PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT OF VENTRALIGHT ST MESH USING ECHO PS (DEVICE 3). PER OP NOTES, "THERE WERE SIGNIFICANT ADHESIONS OF OMENTUM UP TO THE ANTERIOR ABDOMINAL WALL AND THE PREVIOUSLY PLACED MESH (DEVICE 1, 2) WAS TAKEN DOWN. TWO SMALL HERNIAS WERE IDENTIFIED IN THE PERIUMBILICAL AREA. AN ADDITIONAL HERNIA WAS IDENTIFIED IN THE LOWER ABDOMEN JUST TO THE LEFT OF THE MIDLINE. A PIECE OF VENTRALIGHT ST MESH USING ECHO PS (DEVICE 3) WAS PLACED AROUND THE DEFECT AND SECURED AROUND PERIPHERY USING SORBAFIX TACKS."

  Patient problems: Adhesion(s); Hernia

  MAUDE report 25390392 ↗
• MalfunctionMay 12, 2026Material Deformation

  AS REPORTED, DURING A PARAUMBILICAL HERNIA REPAIR AN VENTRALEX MESH (8 CM) WAS PLACED. AS REPORTED, "FORTUNATELY, THE HERNIA REPAIR WAS DONE AFTER LAPAROSCOPIC EXPLORATION, SO I HAD THE CHANCE TO SEE THE POSITION OF THE MESH INTRAABDOMINAL AFTER ITS PLACEMENT. SURPRISINGLY IT WAS CRUMBLED AND NOT FITTED WELL TO THE ABDOMINAL WALL SO I HAD TO REMOVE IT AND USE AN ALTERNATIVE METHOD FOR THE HERNIA REPAIR."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25153513 ↗
• InjuryApr 1, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2009, PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRALEX MESH (DEVICE 1). PER OP NOTES, ¿THE HERNIA SAC WAS ENCOUNTERED AND RESECTED. THE HERNIA CONTENTS WERE REDUCED. A VENTRALEX MESH (DEVICE 1) WAS PLACED IN THE DEFECT AND SECURED USING SUTURES.¿ ON (B)(6) 2010, PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF SYNTHETIC MESH. PER OP NOTES, ¿ALL THE ADHESIONS OF ABDOMINAL WALL WERE TAKEN DOWN. THE INCISIONAL HERNIA DEFECT WAS NOTED AND THE PRIOR PATCH (DEVICE 1) NOT COVERING THE DEFECT WELL CAUSED RECURRENCE. A SYNTHETIC MESH WAS PLACED IN THE DEFECT AND SUTURED. THE MESH WAS TACKED CIRCUMFERENTIALLY USING TACKS.¿ ON (B)(6) 2018, PATENT UNDERWENT REPAIR WITH IMPLANT OF VENTRALEX MESH (DEVICE 2) (NOTE: THERE IS NO OPERATIVE NOTES PROVIDED FOR THIS PROCEDURE IN PPF AND MEDICAL RECORDS)

  Patient problems: Adhesion(s); Hernia

  MAUDE report 24756075 ↗
• InjuryMar 26, 2026Patient-Device Incompatibility

  PER INFORMATION RECEIVED, (B)(6) 2009 ¿ PATIENT WAS DIAGNOSED WITH INCARCERATED RECURRENT INCISIONAL HERNIA AND PAIN THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH REMOVAL OF PRIOR UNKNOWN MESH AND IMPLANT OF VENTRALEX MESH (DEVICE 1). PER OPERATIVE NOTES, ¿IN THE LEFT UPPER QUADRANT, A RECURRENT INCARCERATED HERNIA WAS NOTED. THE PRIOR UNKNOWN MESH WAS REMOVED AND LARGE VENTRALEX MESH (DEVICE 1) WAS PLACED IN THE UMBILICUS AND TACKED INTO POSITION.¿ (NOTE: THE MESH REMOVED DURING THIS PROCEDURE IS UNKNOWN) (B)(6) 2010 - PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH REMOVAL OF OLD MESH (DEVICE 1) AND IMPLANT OF VENTRALEX MESH (DEVICE 2). PER OPERATIVE NOTES, ¿IN THE MIDLINE, A PALPABLE DEFECT CONTAINING HERNIA DEFECT WAS REDUCED AND ADHESIONS WERE FREED DOWN. THE OLD MESH (DEVICE 1) WAS REMOVED AND FLAPS WERE RAISED. A LARGE VENTRALEX MESH (DEVICE 2) WAS PLACED OVER THE DEFECT AND APPROXIMATED WITH SUTURES. THE FASCIA WAS CLOSED AND SECURED WITH SUTURES.¿ (B)(6) 2011 - PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH REMOVAL OF OLD MESH (DEVICE 2) AND IMPLANT OF ALLOMAX MESH (DEVICE 3). PER OPERATIVE N

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

  MAUDE report 24697883 ↗
• InjuryMar 26, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED. (B)(6) 2009 ¿ PATIENT WAS DIAGNOSED WITH INCARCERATED RECURRENT INCISIONAL HERNIA AND PAIN THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH REMOVAL OF PRIOR UNKNOWN MESH AND IMPLANT OF VENTRALEX MESH (DEVICE 1). PER OPERATIVE NOTES, ¿IN THE LEFT UPPER QUADRANT, A RECURRENT INCARCERATED HERNIA WAS NOTED. THE PRIOR UNKNOWN MESH WAS REMOVED AND LARGE VENTRALEX MESH (DEVICE 1) WAS PLACED IN THE UMBILICUS AND TACKED INTO POSITION.¿ (NOTE: THE MESH REMOVED DURING THIS PROCEDURE IS UNKNOWN) (B)(6) 2010 - PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH REMOVAL OF OLD MESH (DEVICE 1) AND IMPLANT OF VENTRALEX MESH (DEVICE 2). PER OPERATIVE NOTES, ¿IN THE MIDLINE, A PALPABLE DEFECT CONTAINING HERNIA DEFECT WAS REDUCED AND ADHESIONS WERE FREED DOWN. THE OLD MESH (DEVICE 1) WAS REMOVED AND FLAPS WERE RAISED. A LARGE VENTRALEX MESH (DEVICE 2) WAS PLACED OVER THE DEFECT AND APPROXIMATED WITH SUTURES. THE FASCIA WAS CLOSED AND SECURED WITH SUTURES.¿ (B)(6) 2011 - PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH REMOVAL OF OLD MESH (DEVICE 2) AND IMPLANT OF ALLOMAX MESH (DEVICE 3). PER OPERATIVE N

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

  MAUDE report 24697137 ↗
• InjuryMar 9, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2011 ¿ PATIENT WAS DIAGNOSED WITH VENTRAL INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF TWO VENTRALEX MESHES (DEVICE 1 AND 2). PER OPERATIVE NOTES, ¿IN THE MIDLINE, THE HERNIA SAC WAS NOTED, AND EXTENSIVE INTRA-ABDOMINAL ADHESIONS WERE REDUCED. THE MULTISEPTATED HERNIA WITH SMALLER AND LARGER DEFECT IN FASCIA JUST ABOVE THE UMBILICUS WAS NOTED. THE SEPTATION WAS LEFT INTACT AND SMALLER HERNIA WAS REPAIRED WITH SMALL CIRCLE VENTRALEX MESH (DEVICE 1) AND TO THE LARGE HERNIA ANOTHER LARGE CIRCLE VENTRALEX MESH (DEVICE 2) WAS PLACED AND SECURED WITH SUTURES.¿ (B)(6) 2017 - PATIENT WAS DIAGNOSED WITH INFECTED ABDOMINAL SOFT TISSUE WOUND WITH ABSCESS THEREBY UNDERWENT OPEN REPAIR WITH ABDOMINAL WALL WASHOUT AND WOUND VAC PLACEMENT. PER OPERATIVE NOTES, ¿THE SUPRAUMBILICAL MIDLINE WOUND WAS IRRIGATED. IN THE UPPER ASPECT OF THE WOUND, THE INFECTED MESHES (DEVICE 1 AND 2) WERE AS EXPOSED, WOUND WAS IRRIGATED AND WOUND VAC WAS PLACED.¿ (B)(6) 2017 - PATIENT WAS DIAGNOSED WITH INFECTED ABDOMINAL WALL MESH (DEVICE 1 AND 2) AND ENTEROCUTANEOUS FISTULA THEREBY UNDERWENT OPEN REPAIR WITH REMOVAL OF INFECTED MESHES (DEVICE 1 AND 2). PER OPERATIVE

  Patient problems: Abscess; Fistula; Unspecified Infection

  MAUDE report 24543411 ↗
• InjuryFeb 12, 2026Material Deformation

  PER INFORMATION PROVIDED: (B)(6) 2011 ¿ PATIENT WAS DIAGNOSED WITH FOUR VENTRAL HERNIAS THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF VENTRALEX MESHES (DEVICE 1, 2). PER OP NOTES, ¿TWO SEPARATE HERNIAS WERE ENCOUNTERED AT THE SUPERIOR END OF PREVIOUS MIDLINE INCISION. A VENTRALEX MESH (DEVICE 1) WAS PLACED THROUGH HERNIA AND SECURED UNDERSIDE TO THE MUSCLE USING SUTURE. ANOTHER TWO HERNIAS WERE FOUND INFERIOR END OF THE PREVIOUS INCISION. A VENTRALEX MESH (DEVICE 2) WAS PLACED INTO DEFECT AND SUTURED.¿ (B)(6) 2012 ¿ PATIENT UNDERWENT ESOPHAGOGASTRODUODENOSCOPY. (B)(6) 2013 ¿ PATIENT WAS DIAGNOSED WITH FOUR SEPARATE VENTRAL HERNIAS THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE REMOVAL OF MESHES (DEVICE 1, 2). PER OP NOTES, ¿SIGNIFICANTLY FOLDED AND CONVOLUTED MESH (DEVICE 2) AT THE MID PORTION OF THE ABDOMEN AND THE SECOND FOLDED AND CONVOLUTED SCARRED IN MESH (DEVICE 1) UP IN THE EPIGASTRIUM WITH SOME OBVIOUS HERNIAS IN CLOSE PROXIMITY TO MESHES WERE NOTED. THE MESH ITSELF HAD FOLDED AND WAS NOT COMPLETELY COVERING THE INITIAL INTENDED HERNIA SITES. BOTH THE MESHES (DEVICE 1, 2) WERE REMOVED. THE HERNIA WAS NOTED. A SYNTHETIC MESH WAS PLACED INTO ABDOMINAL CAVITY AND SUTURED.¿

  Patient problems: Hernia

  MAUDE report 24320472 ↗
• InjuryFeb 5, 2026Material Deformation

  PER INFORMATION PROVIDED: (B)(6) 2010 - PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF TWO VENTRALEX MESH (DEVICE 1 AND 2). PER OP NOTES, "TWO VENTRALEX MESH (DEVICE 1 AND 2) WERE PLACED TO THE ABDOMINAL WALL USING PROLENE SUTURES." (B)(6) 2012 - PATIENT WAS DIAGNOSED WITH INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF COMPOSIX KUGEL MESH (DEVICE 3). PER OP NOTES, "MIDLINE INCISIONAL SCAR WAS INCISED. A COMPOSIX KUGEL MESH (DEVICE 3) WAS PLACED TO THE INTRAPERITONEAL SPACE USING PROLENE SUTURES." (NOTE: THE PREVIOUSLY PLACED VENTRALEX MESH (DEVICE 1 AND 2) WERE NOT SEEN DURING THIS PROCEDURE). (B)(6) 2012 - PATIENT WAS DIAGNOSED WITH INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF VENTRIO MESH (DEVICE 4). PER OP NOTES, "THE PREVIOUS MIDLINE SCAR WAS INCISED. A VENTRIO PATCH (DEVICE 4) WAS PLACED TO THE INTRAPERITONEAL SPACE USING PROLENE SUTURES." (NOTE: THE PREVIOUSLY PLACED VENTRALEX MESH (DEVICE 1 AND 2) AND A COMPOSIX KUGEL MESH (DEVICE 3) WERE NOT SEEN DURING THIS PROCEDURE). (B)(6) 2014 - PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH

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

  MAUDE report 24266207 ↗
• InjuryNov 28, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2008 - PATIENT WAS DIAGNOSED WITH INCISIONAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT OF TWO VENTRALEX MESH (DEVICE 1 AND 2). PER OP NOTES, "TWO VENTRALEX MESH (DEVICE 1 AND 2) WERE PLACED TO THE ANTERIOR ABDOMINAL WALL USING SUTURES." ON (B)(6) 2009 - PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL HERNIA THEREBY UNDERWENT REPAIR WITH THE IMPLANT OF COMPOSIX KUGEL HERNIA PATCH (DEVICE 3). PER OP NOTES, "SCAR WAS CUT OF THE AREA. THE PREVIOUS MESH (DEVICE 1 AND 2) WERE NOTICED, A COMPOSIX KUGEL HERNIA PATCH (DEVICE 3) WAS PLACED INTO THE ABDOMINAL CAVITY USING SUTURES."

  Patient problems: Hernia; Scar Tissue

  MAUDE report 23670710 ↗
• InjuryNov 3, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2008: PATIENT WAS DIAGNOSED WITH INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRALEX MESH (DEVICE 1). PER OPERATIVE NOTES, ¿A SIZEABLE INCISIONAL HERNIA IN THE UPPER MIDLINE WAS REDUCED AND LARGE PIECE OF VENTRALEX MESH (DEVICE 1) WAS PLACED AND ANCHORED IT CIRCUMFERENTIALLY WITH SUTURES.¿ ON (B)(6) 2011: PATIENT WAS DIAGNOSED WITH RECURRENT UMBILICAL INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRALEX MESH (DEVICE 2). PER OPERATIVE NOTES, ¿AN UMBILICAL INCISIONAL HERNIA IN THE INFRAUMBILICAL AREA WAS DISSECTED AND SMALL PIECE OF VENTRALEX MESH (DEVICE 2) WAS PLACED AND ANCHORED CIRCUMFERENTIALLY.¿ ON (B)(6) 2012: PATIENT WAS DIAGNOSED WITH POSTOPERATIVE WOUND INFECTION WITH SEPSIS THEREBY UNDERWENT OPEN REPAIR. PER OPERATIVE NOTES, ¿THE PRIOR OLD MESHES (DEVICE 1 AND 2) WERE INTACT. A WELL INCAPSULATED CHRONIC SEROMA WAS DRAINED AND NECROTIC TISSUE WERE CLOSED WITH SUTURES.¿ ON (B)(6) 2012: PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA, CHRONIC SEROMA WITH CHRONIC ABDOMINAL PAIN THEREBY UNDERWENT OPEN REPAIR WITH REMOVAL OF OLD MESHES AND IMPLANT OF XENMATRIX MESH (DEVICE 3). PER OPERATIVE NOT

  Patient problems: Hernia; Necrosis; Post Operative Wound Infection; Sepsis; Seroma

  MAUDE report 23448778 ↗
• InjuryOct 31, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2013: PATIENT WAS DIAGNOSED WITH INCARCERATED UMBILICAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF TWO VENTRALEX MESH (DEVICE 1 AND 2). PER OP NOTES, "A SUPRAUMBILICAL INCISION WAS MADE, TWO VENTRALEX MESH (DEVICE 1 AND 2) WERE PLACED USING PROLENE SUTURES." ON (B)(6) 2016: PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE REMOVAL OF MESH (DEVICE 1 AND 2) AND IMPLANT OF VENTRALIGHT ST MESH USING ECHO PS (DEVICE 3). PER OP NOTES, "TAKEN DOWN THE ADHESIONS OFF THE MESH. THE OLD MESH (DEVICE 1 AND 2) WERE CUPPED FROM FIBROSIS AND WERE REMOVED FROM THE ABDOMINAL WALL. A VENTRALIGHT ST MESH USING ECHO PS (DEVICE 3) WAS PLACED THROUGH THE ABDOMINAL WALL USING SUTURES." ON (B)(6) 2017: PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT REPAIR WITH REMOVAL OF MESH (DEVICE 3). PER OP NOTES, "IDENTIFIED THE MESH (DEVICE 3) AND WAS REMOVED. A SEPRAMESH IP (DEVICE 4) WAS PLACED USING SUTURES."

  Patient problems: Adhesion(s); Fibrosis; Hernia

  MAUDE report 23439303 ↗
• InjuryAug 6, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2010 - PATIENT WAS DIAGNOSED WITH INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF TWO VENTRALEX MESH (DEVICE #1 & #2). PER OP NOTES, "TWO VENTRALEX MESH (DEVICE #1 & #2) WERE PLACED INTO THE FASCIA USING SUTURES." ON (B)(6) 2011 - PATIENT WAS DIAGNOSED WITH VENTRAL INCISIONAL HERNIA WITH INFECTED MESH THEREBY UNDERWENT REPAIR WITH REMOVAL OF MESH (DEVICE #1 & #2). PER OP NOTES, "ATTENTION TO THE MIDLINE, WHERE THE UMBILICUS WAS RESECTED. DISSECTION WAS CARRIED DOWN TO THE FASCIA, THE OLD MASS OF INFECTED TISSUE WAS RESECTED WHICH WAS DENSELY ADHERENT TO THE MESH. THE MESH (DEVICE #1 & #2) WAS COMPLETELY REMOVED. A SYNTHETIC MESH WAS PLACED."

  Patient problems: Adhesion(s); Unspecified Infection

  MAUDE report 22725210 ↗
• InjuryAug 1, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2006 - PATIENT WAS DIAGNOSED WITH INCARCERATED VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF BARD FLAT MESH (DEVICE #1). PER OP NOTES, "A MIDLINE INCISION WAS MADE ABOVE THE UMBILICUS, A BARD FLAT MESH (DEVICE #1) WAS PLACED USING TACKS." (B)(6) 2010 - PATIENT WAS DIAGNOSED WITH INCARCERATED SUPRAUMBILICAL HERNIA AND RECURRENT EPIGASTRIC HERNIA THEREBY UNDERWENT OPEN REPAIR WITH REMOVAL OF MESH (DEVICE #1) AND IMPLANT OF VENTRALEX MESH (DEVICE #2). PER OP NOTES, "A PORTION OF THE MESH (DEVICE #1) WAS REMOVED AND A VENTRALEX MESH (DEVICE #2) WAS PLACED INTO THE UMBILICUS USING SUTURES." (B)(6) 2011 - PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF COMPOSIX LP MESH (DEVICE #3). PER OP NOTES, "A MIDLINE INCISION WAS MADE JUST ABOVE THE UMBILICUS, A COMPOSIX LP MESH (DEVICE #3) WAS SECURED TO THE PERITONEUM."

  Patient problems: Hernia; Pain

  MAUDE report 22685401 ↗
• InjuryJul 21, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2011 - PATIENT WAS DIAGNOSED WITH INCARCERATED VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF TWO VENTRALEX MESH (DEVICE #1 AND #2). PER OPERATIVE NOTES, ¿IN THE UMBILICUS, SMALL HERNIA WAS NOTED AND A SEPARATE HERNIA COMING BENEATH THE SKIN OF UMBILICUS WAS ALSO NOTED. ALL DISTAL FASCIA WERE OPENED AND RESECTED AT THE LEVEL OF FASCIA. ALL THE HERNIA SACS WERE DISSECTED FREE AND ALL DEFECTS WERE COMBINED TOGETHER INTO SINGLE DEFECT. TWO OVERLAPPED VENTRALEX MESH (DEVICE #1 AND #2) WERE POSITIONED BENEATH FASCIAL DEFECT AND SUTURED.¿ ON (B)(6) 2019 ¿ PATIENT WAS DIAGNOSED WITH INFECTED MESH AND ENTEROCUTANEOUS FISTULA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH REMOVAL OF MESHES (DEVICE #1 AND #2). PER OPERATIVE NOTES, ¿SMALL BOWEL DENSELY ADHERENT TO THE ABDOMINAL WALL AND ABSCESS WAS NOTED. ADHESIONS WITH SOME BOWEL WAS RESECTED. THE OBVIOUS FISTULOUS TRACT WAS SEEN. THE MESH (DEVICE #1 AND #2) WAS REMOVED, AND MESENTERIC DEFECT WAS CLOSED WITH SUTURES.¿

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

  MAUDE report 22554915 ↗
• InjuryJun 11, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED, THE PATIENT PRESENTED WITH LOCALIZED DEHISCENCE AT THE UMBILICAL RING, EXTENDING ABOVE AND BELOW THE UMBILICUS THEREBY UNDERWENT UMBILICAL HERNIA REPAIR WITH IMPLANT OF VENTRALEX MESH USING PERMASORB FIXATION DEVICE ON (B)(6) 2012. IT WAS REPORTED THAT THE POSTOPERATIVE COURSE IS UNEVENTFUL, AND THE PATIENT WAS DISCHARGED. PER INFORMATION REPORTED POST IMPLANT THE PATIENT HAD ABDOMINAL CRAMPS WITH DEFORMATION, PAIN AFTER MEALS, IRREGULAR BOWEL MOVEMENTS, CONSTANT CONSTIPATION, DAILY PAIN, ESPECIALLY DURING ACTIVITY, PAIN IN THE NAVEL, RIBS, AND CAESAREAN SECTION SITE. PATIENT CAN NO LONGER RETURN TO WORK AS A CLEANER.

  Patient problems: Constipation; Pain

  MAUDE report 22186314 ↗
• InjuryMay 5, 2025Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  PER INFORMATION PROVIDED: ON (B)(6) 2003: PATIENT WAS DIAGNOSED WITH INCARCERATED VENTRAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT OF COMPOSIX E/X MESH (DEVICE #1). PER OPERATIVE NOTES, ¿THERE WAS A QUITE A BIT OF OMENTUM INCARCERATED WITHIN THE SYMPTOMATIC VENTRAL HERNIA. ADHESION FROM THE OMENTUM WAS EXCISED AND ALL PREVIOUS INCISION WERE TAKEN DOWN CAREFULLY. A COMPOSIX E/X MESH WAS PLACED AND SECURE IT WITH SUTURE.¿ ON (B)(6) 2008: PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF TWO SYNTHETIC MESH AND ONE LARGE VENTRALEX MESH (DEVICE #2). PER OPERATIVE NOTES, ¿THERE WAS MULTIPLE OMENTUM ADHESION WAS THERE. THERE WAS A RECURRENT HERNIA IN THE LOWER ABDOMEN WITH WHAT APPEARED TO BE COMPOSIX E/X (DEVICE #1) MESH AS THE HERNIA SAC. ADHESIONS WERE REMOVED. TWO SYNTHETIC MESH WAS THEN PLACED AND TACKED WITH SUTURE. LEFT UPPER QUADRANT A LARGE VENTRALEX MESH (DEVICE #2) WAS THEN PLACED AND SUTURED.¿ ON (B)(6) 2008: PATIENT WAS DIAGNOSED WITH INFECTED INTRAABDOMINAL CLOT THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH EXPLANT OF COMPOSIX E/X MESH (DEVICE #1) AND SYNTHETIC MESH. PER OPERATIVE NOTES, ¿THE BLOOD

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

  MAUDE report 21958438 ↗
• InjuryApr 25, 2025Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  PER INFORMATION PROVIDED: ON (B)(6) 2009: PATIENT WAS DIAGNOSED WITH INCARCERATED UMBILICAL AND INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRALEX MESH (DEVICE #1). PER OPERATIVE NOTES, ¿HERNIA SAC WAS DISSECTED FREE FROM THE UMBILICAL REGION. THEN A VENTRALEX MESH (DEVICE #1) WAS PLACED IN THE PREPERITONEAL SPACE AND TACKED BY SUTURES.¿ ON (B)(6) 2009: PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT OF VENTRIO MESH (DEVICE #2). PER OPERATIVE NOTES, ¿PREVIOUSLY PLACED VENTRALEX MESH (DEVICE #1) WAS IDENTIFIED IN GOOD POSITION, JUST RIGHT TO THIS RE-HERNIA IS NOTED. A VENTRIO MESH (DEVICE #2) WAS PLACED INTO ABDOMINAL CAVITY AND SUTURED. ON (B)96) 2009: PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF VENTRALEX MESH (DEVICE #3) AND EXPLANT OF VENTRALEX MESH (DEVICE #1) AND VENTRIO MESH (DEVICE #2). PER OPERATIVE NOTES, ¿PREVIOUSLY PLACED VENTRALEX MESH (DEVICE #1) WAS REMOVED AS IT FOUND TO BE TOTALLY UNATTACHED TO THE LEFT SIDE OF THE RECTUS AND THE ANOTHER PREVIOUSLY PLACED VENTRIO MESH (DEVICE #2) WAS UNINCORPORATED AND ONE AREA THERE WAS SO

  Patient problems: Adhesion(s); Unspecified Infection

  MAUDE report 21908081 ↗
• InjuryApr 25, 2025Defective Device; Patient Device Interaction Problem; Migration; Defective Device; Patient Device Interaction Problem; Migration

  PER INFORMATION PROVIDED: ON (B)(6) 2013: PATIENT WAS DIAGNOSED WITH RECURRENT UPPER MIDLINE HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRALEX MESH (DEVICE #1). PER OPERATIVE NOTES,¿ AT THE LEVEL OF FASCIA, THE HERNIA SAC WAS EXCISED. A VENTRALEX MESH (DEVICE #1) WAS INSERTED INTO THE SUBFASCIAL POSITION AND SUTURED." ON (B)(6) 2015: PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL MIDLINE VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF SEPRAMESH IP (DEVICE #2). PER OPERATIVE NOTES, "THE HERNIA SAC WAS SCARRED AND FIBROTIC. THE HERNIA CONTENTS WERE EXCISED FROM THE SAC. THE ADHESIONS IN THE ENTIRE LENGTH OF THE MESH AND LATERAL SIDEWALL WAS FREED. A SEPRAMESH IP (DEVICE #2) OF APPROXIMATE SIZE WAS PLACED AND SUTURED." ON (B)(6) 2016: PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA AND INTESTINAL OBSTRUCTION THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRIO ST MESH (DEVICE #3). AND REMOVAL OF MESH (DEVICE #1 AND #2). PER OPERATIVE NOTES, ¿TO THE HERNIA SAC TWO PIECE OF PREVIOUSLY PLACED MESH WAS DETACHED FROM THE LEFT SIDE OF THE FASCIA. THE SINGLE LOOP OF SMALL INTESTINE ADHERENT TO THE OLD MESH CAUSED SMALL BOWEL OBSTRUCTION. THE LYSIS OF ADHESI

  Patient problems: Adhesion(s); Fibrosis; Hernia; Obstruction/Occlusion; Scar Tissue

  MAUDE report 21906917 ↗
• InjuryApr 3, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2008 - PATIENT WAS DIAGNOSED WITH UMBILICAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF VENTRALEX MESH ON (B)(6) 2008. PER OPERATIVE NOTES, "THE HERNIA SAC WAS CIRCUMFERENTIALLY DISSECTED OUT. A SMALL DEFECT WAS MADE AND A VENTRALEX MESH WAS PLACED INSIDE THE DEFECT AND SUTURED." (B)(6) 2008 - PATIENT WAS DIAGNOSED WITH WOUND INFECTION AND ABSCESS THEREBY UNDERWENT INCISION AND DRAINAGE. (B)(6) 2008 - PATIENT WAS DIAGNOSED WITH INFECTED MESH THEREBY UNDERWENT OPEN REPAIR WITH EXPLANT OF MESH. PER OPERATIVE NOTES, "THE MESH WAS REMOVED, AND A LARGE COLLECTION OF PUS WAS NOTED AND SUCTIONED OUT. THE DEFECT WAS CLOSED WITH SUTURES." (B)(6) 2008 - PATIENT WAS DIAGNOSED WITH VENTRAL UMBILICAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF SYNTHETIC MESH. (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH RECURRENT UMBILICAL HERNIA THEREBY UNDERWENT EXCISION OF SUTURE GRANULOMA AND FASCIAL DEFECT REPAIR. ATTORNEY ALLEGES THAT THE PATIENT HAD ABSCESS, ADHESIONS, INFECTIONS, SCAR TISSUE, PAIN, HERNIA RECURRENCE AND EMOTIONAL INJURIES.

  Patient problems: Abscess; Bacterial Infection; Purulent Discharge

  MAUDE report 21761551 ↗
• InjuryMar 28, 2025Defective Device; Patient-Device Incompatibility; Defective Device; Patient-Device Incompatibility

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL VENTRALEX ON (B)(6) 2009. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE VENTRALEX. 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: Cellulitis; Insufficient Information; Pain; Unspecified Infection

  MAUDE report 21719948 ↗
• InjuryJan 20, 2025Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL VENTRALEX HERNIA PATCH ON (B)(6) 2011. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE VENTRALEX HERNIA PATCH. 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: Insufficient Information; Pain

  MAUDE report 21190169 ↗
• InjuryDec 9, 2024Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  PER INFORMATION PROVIDED: (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH INCISIONAL VENTRAL HERNIA THEREBY UNDERWENT REPAIR WITH IMPLANT OF TWO VENTRALEX MESHES (DEVICE #1 & DEVICE #2). (NOTE, NO OPERATIVE NOTES WERE PROVIDED IN THE MEDICAL RECORDS). (B)(6) 2016 - PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL VENTRAL HERNIA AND ADHESIONS THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH REMOVAL OF MESHES (DEVICE #1 & DEVICE #2). (NOTE, NO OPERATIVE NOTES WERE PROVIDED IN THE MEDICAL RECORDS). ATTORNEY ALLEGES THAT THE PATIENT HAD ADHESIONS, BOWEL PERFORATION, NERVE DAMAGE, PAIN AND EMOTIONAL INJURIES.

  Patient problems: Adhesion(s); Fibrosis; Hernia; Inflammation

  MAUDE report 20876058 ↗
• InjuryDec 6, 2024Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  PER INFORMATION PROVIDED: (B)(6) 2012 - PATIENT WAS DIAGNOSED WITH VENTRAL HERNIA THEREBY UNDERWENT REPAIR WITH THE IMPLANT OF SEPRAMESH IP (DEVICE #1). (NO OPERATIVE NOTES WERE PROVIDED). (B)(6) 2013 - PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRALEX MESH (DEVICE #2). PER OPERATIVE NOTES, ¿THE ANTERIOR WALL WAS CLEARED OF ADHESIONS. THE HERNIA SAC WAS EXCISED. THEN A VENTRALEX MESH (DEVICE #2) WAS PLACED FLAT AND UP AGAINST THE ABDOMINAL WALL USING SUTURES AND STAPLES.¿ (NOTE: THERE WAS NO VISUALIZATION/MENTION OF SEPRAMESH IP (DEVICE #1)). (B)(6) 2016 - PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL HERNIA AND ADHESIONS THEREBY UNDERWENT REPAIR WITH REMOVAL OF SEPRAMESH IP (DEVICE #1) AND VENTRALEX MESH (DEVICE #2) AND IMPLANT OF BARD FLAT MESH (DEVICE #3). (NO OPERATIVE NOTES WERE PROVIDED). (B)(6) 2018 - PATIENT WAS DIAGNOSED WITH SYMPTOMATIC VENTRAL HERNIA WITH INCARCERATION AND BOWEL OBSTRUCTION THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF POLYPROPYLENE MESH. PER OPERATIVE NOTES, ¿HERNIA DEFECT IDENTIFIED AT THE UMBILICUS AND LOOP OF BOWEL REMAINING INCARCERATED. BOWEL LOOP WAS DISSECTED FREE FROM PERITONEUM. SEROSAL T

  Patient problems: Adhesion(s); Hernia

  MAUDE report 20863199 ↗