VENTRIO 5950030Recalls & reported problems

Summary

The FDA's MAUDE database contains 71 adverse event reports that list this exact device (DI 00801741031526), received between Jan 18, 2018 and Mar 13, 2026 — classified as 1 death, 69 injuries, 1 malfunction.

The most frequently reported specific device problem is “Defective Device” (64 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 71 reports, in the reporter's own words as published by the FDA.

• InjuryMar 13, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2010 ¿ PATIENT WAS DIAGNOSED WITH VENTRAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF DULEX MESH (DEVICE 1). PER OP NOTES, ¿EPIGASTRIC INCISION IN THE MIDLINE WAS MADE. THE HERNIA DEFECT WAS NOTED. A DULEX MESH (DEVICE 1) WAS PLACED AND SECURED WITH SUTURES AND ABSORBABLE TACKER. (B)(6) 2011 ¿ PATIENT WAS DIAGNOSED WITH SUBXIPHOID PORT SITE INCISIONAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF SYNTHETIC MESH. PER OP NOTES, ¿ADHESIONS TO THE PREVIOUS MESH REPAIR TO THE PERIUMBILICAL AREA WAS TAKEN DOWN. THE HERNIA DEFECT WAS IDENTIFIED AND APPROXIMATED WITH SUTURES. A SYNTHETIC MESH WAS PLACED INTO THE PERITONEAL CAVITY AND SECURED WITH SUTURES AND TACKS.¿ (B)(6) 2012 ¿ PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL PORT SITE HERNIA, RECURRENT SUBXIPHOID RIGHT MID QUADRANT THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF COMPOSIX L/P MESH (DEVICE 2) FOR SUBXIPHOID DEFECT AND SYNTHETIC MESH FOR RIGHT MID QUADRANT DEFECT. PER OP NOTES, ¿ADHESIONS IN THE SUBXIPHOID AREA WERE TAKEN DOWN AND FREE UP THE LOOP OF BOWEL AND EDGE OF THE LIVER, WHICH WAS ATTACHED TO THE EDGE OF THE MESH, WHICH WAS AT THE SUPERIOR EDG

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

  MAUDE report 24590391 ↗
• DeathFeb 18, 2026Patient Device Interaction Problem

  PER INFORMATION PROVIDED: ON (B)(6) 2014 - PATIENT WAS DIAGNOSED WITH VENTRAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF VENTRIO ST PATCH (DEVICE 1 AND 2). PER OP NOTES, ¿AN INCISION WAS MADE IN THE RIGHT UPPER QUADRANT. ADHESIONS FROM PREVIOUS SURGERY WERE NOTED AND LYSED. A COMPLEX HERNIA WAS IDENTIFIED WITH MULTIPLE FASCIAL DEFECTS. A VENTRIO ST PATCH (DEVICE 1) WAS PLACED INTO THE ABDOMEN AND SECURED WITH TACKING SUTURE. APPROXIMATELY 1 CM APART, VENTRIO ST PATCH (DEVICE 2) WAS PLACED IN THE SAME FASHION AND TACKED ON THE INNER AND OUTER ASPECT OF THE MESH.¿ (PPF/MRR) 8, 23. ON (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH SMALL BOWEL OBSTRUCTION AND HERNIA THEREBY UNDERWENT LAPAROSCOPIC CONVERTED TO OPEN REPAIR WITH EXCISION OF VENTRIO ST PATCH (DEVICE 1 AND 2) AND IMPLANT OF BIOLOGICAL MESH. PER OP NOTES, ¿AN INCISION WAS MADE ON THE RIGHT SIDE OF PREVIOUS INSERTION SITE. A LARGE AMOUNT OF SCARRING AND DILATED BOWEL ADHERENT TO THE MESH IN THE MIDLINE WAS NOTED. AN INCISION WAS MADE IN THE MIDLINE AND THE MESH (DEVICE 1 AND 2) WAS IDENTIFIED. THE SMALL BOWEL WAS DISSECTED FROM THE MESH AND NOTED AN INJURY IN THE SMALL BOWEL WITH A LARGE AMOUNT OF ENTERIC FLUID DR

  Patient problems: Bowel Perforation; Hernia; Unspecified Infection

  MAUDE report 24380811 ↗
• InjuryAug 6, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2013: PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL INCARCERATED HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRALIGHT ST (DEVICE #1). PER OPERATIVE NOTES, ¿A VENTRALIGHT ST (DEVICE #1) WAS PLACED IN UPPER ABDOMINAL WALL AND SUTURED.¿ ON (B)(6) 2013: PATIENT WAS DIAGNOSED WITH LARGE LEFT ABDOMINAL WALL MASS, SEROMA AND RECURRENT INCARCERATED INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRIO ST (DEVICE #2). PER OPERATIVE NOTES, ¿ADHESIONS WERE TAKEN DOWN. SCAR TISSUE WAS NOTED AND THE CAPSULE WAS RESECTED. THE PRIOR HERNIA MESH WAS ENCOUNTERED (DEVICE #1). A VENTRIO ST MESH (DEVICE #2) WAS PLACED AND SUTURED.¿ ON (B)(6) 2015: PATIENT WAS DIAGNOSED WITH ABDOMINAL MASS THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF PHASIX FLAT MESH (DEVICE #3). PER OPERATIVE NOTES, ¿A LARGE VOLUME OF FLUID WAS DRAINED. THE SEROMA CAPSULE WAS REMOVED. A PHASIX FLAT MESH (DEVICE #3) WAS PLACED IN THE ABDOMINAL WALL AND ILIAC CREST USING PROTACKS.¿

  Patient problems: Seroma

  MAUDE report 22725212 ↗
• InjuryJul 14, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2007- PATIENT WAS DIAGNOSED WITH INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF BARD FLAT MESH (DEVICE #1). PER OPERATIVE NOTES, ¿A BARD FLAT MESH (DEVICE #1) WAS PLACED AND SUTURED.¿ (B)(6) 2012 - PATIENT WAS DIAGNOSED WITH INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH EXPLANT OF BARD FLAT MESH (DEVICE #1) AND IMPLANT OF VENTRALIGHT ST MESH (DEVICE #2) AND BARD SOFT MESH (DEVICE #3). PER OPERATIVE NOTES, ¿OLD BARD FLAT MESH (DEVICE #1) WAS EXCISED. ONE VENTRALIGHT ST MESH (DEVICE #2) AND ONE BARD SOFT MESH (DEVICE #3) WAS PLACED AND SUTURED.¿ (B)(6) 2013 - PATIENT WAS DIAGNOSED WITH INTESTINAL PERFORATION, ADHESION, ABSCESS, MESH INFECTION, INFLAMMATION THEREBY UNDERWENT OPEN REPAIR WITH EXPLANT OF VENTRALIGHT ST MESH (DEVICE #2) AND BARD SOFT MESH (DEVICE #3), LYSIS OF ADHESION, ABSCESS, AND IMPLANT ONE SYNTHETIC MESH. PER OPERATIVE NOTES, ¿ABSCESS WERE DRAINED FROM INTRA-ABDOMINAL AREA. INFECTED VENTRALIGHT ST MESH (DEVICE #2) AND BARD SOFT MESH (DEVICE #3) WAS EXCISED COMPLETELY.¿ (B)(6) 2014 - PATIENT WAS DIAGNOSED WITH VENTRAL INCISIONAL HERNIA, ADHESION THEREBY UNDERWENT OPEN REPAIR WITH EXPLANT OLD BIOLOGICAL MESH

  Patient problems: Adhesion(s); Obstruction/Occlusion

  MAUDE report 22492568 ↗
• InjuryJun 2, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2012: PATIENT WAS DIAGNOSED WITH PARASTOMAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF PARASTOMAL PATCH (DEVICE #1). PER OPERATIVE NOTES, ¿MULTIPLE INTRA-ABDOMINAL ADHESIONS WERE TAKEN DOWN. THE PARASTOMAL HERNIA WAS NOTED AND REPAIRED WITH PARASTOMAL PATCH (DEVICE #1) WITHIN THE ABDOMEN AND SUTURED.¿ ON (B)(6) 2013: PATIENT WAS DIAGNOSED WITH RECURRENT INCARCERATED PARASTOMAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRIO ST (DEVICE #2). PER OPERATIVE NOTES, ¿THE EXTENSIVE INTRAABDOMINAL ADHESIONS WERE DISSECTED. THE PARASTOMAL HERNIA WAS NOTED AROUND PREVIOUSLY PLACED MESH (DEVICE #1). THE HERNIA WAS REPAIRED AND PLACED WITH VENTRIO ST (DEVICE #2). ON (B)(6) 2018: PATIENT WAS DIAGNOSED WITH RECURRENT PARASTOMAL HERNIA AND VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH REMOVAL OF MESH. PER OPERATIVE NOTES, ¿MULTIPLE VENTRAL HERNIA WERE ENCOUNTERED AND DENSE ADHESIONS IN THE ABDOMEN AND MESH WERE REMOVED. (DEVICE #1 AND DEVICE #2). THE PARASTOMAL HERNIA AND VENTRAL HERNIA WERE CLOSED WITH SUTURES.¿ ON (B)(6) 2019: PATIENT WAS DIAGNOSED WITH VENTRAL HERNIA AND INCISIONAL HERNIA AND ABDOMINAL PAIN THEREBY UNDERWENT OPEN R

  Patient problems: Adhesion(s); Hernia

  MAUDE report 22122041 ↗
• InjuryMar 29, 2024Defective Device; Patient-Device Incompatibility; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL VENTRIO ST ON (B)(6) 2017. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE VENTRIO ST. ATTORNEY ALLEGES THAT THE PATIENT HAD SUBSEQUENT SURGICAL INTERVENTION DUE TO THE HERNIA MESH DEVICE. IT IS ALSO ALLEGED THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Hernia; Insufficient Information; Pain

  MAUDE report 19001755 ↗
• InjuryAug 11, 2023Defective Device; Patient-Device Incompatibility; Patient Device Interaction Problem; Defective Device; Patient-Device Incompatibility; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF UNSPECIFIED BARD/DAVOL VENTRALEX ST (X2) ON (B)(6) 2018 AND (B)(6) 2018 AND VENTRIO ST ON (B)(6) 2019. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST ALL THE DEVICES. 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); Hernia; Insufficient Information; Pain

  MAUDE report 17509075 ↗
• InjuryMay 3, 2022Defective Device; Patient Device Interaction Problem; Migration; Defective Device; Patient Device Interaction Problem; Migration

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL VENTRIO ST ON (B)(6) 2013. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE VENTRIO ST. 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); Hernia; Insufficient Information; Pain

  MAUDE report 14270135 ↗
• InjuryApr 25, 2022Defective Device; Patient-Device Incompatibility; Patient Device Interaction Problem; Defective Device; Patient-Device Incompatibility; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL VENTRIO ST ON (B)(6) 2012. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE VENTRIO ST. 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 14191571 ↗
• InjuryMar 8, 2022Defective Device; Material Deformation; Patient Device Interaction Problem; Defective Device; Material Deformation; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL VENTRIO ST ON(B)(6) 2015. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE VENTRIO ST. 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; Obstruction/Occlusion; Pain

  MAUDE report 13693700 ↗
• InjuryFeb 15, 2022Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem; Migration

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL VENTRIO ST ON (B)(6) 2016. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE VENTRIO ST. 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); Hernia; Insufficient Information; Pain; Scar Tissue

  MAUDE report 13536087 ↗
• InjuryDec 15, 2021Defective Device; Patient-Device Incompatibility; Patient Device Interaction Problem; Defective Device; Patient-Device Incompatibility; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF UNSPECIFIED BARD/DAVOL VENTRIO ON (B)(6) 2011 AND VENTRIO ST ON (B)(6) 2017. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE BOTH DEVICES. 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. ADDENDUM PER ADDITIONAL INFORMATION PROVIDED: (B)(6) 2011 - PATIENT WAS DIAGNOSED WITH RECURRENT 2 INCISIONAL HERNIAS THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF VENTRIO MESH (DEVICE #1). PER OPERATIVE NOTES, ¿HERNIA SAC WAS DISSECTED. A VENTRIO MESH (DEVICE #1) WAS PLACED JUST ABOVE THE UMBILICUS AND SECURE IT WITH SUTURE.¿ (B)(6) 2017 - PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL INCISIONAL HERNIA, ADHESION, SCAR TISSUE THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF THE BARD VENTRIO ST MESH (DEVICE #2). PER OPERATIVE NOTES, ¿HERNIA SAC WAS DISSECTED. THE OLD MESH WAS FOLDED. BARD VENTRIO ST MESH (DEVICE #1) WAS PLACED AND SUTUR

  Patient problems: Adhesion(s); Bowel Perforation; Fistula; Hernia; Insufficient Information; Pain

  MAUDE report 13009894 ↗
• InjuryNov 8, 2021Defective 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 VENTRIO ST ON (B)(6) 2017. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE VENTRIO ST. 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; Obstruction/Occlusion; Pain

  MAUDE report 12776343 ↗
• InjuryOct 19, 2021Defective Device; Detachment of Device or Device Component; Patient Device Interaction Problem; Material Split, Cut or Torn; Defective Device; Detachment of Device or Device Component; Patient Device Interaction Problem; Material Split, Cut or Torn

  ATTORNEY ALLEGES THAT ON OR ABOUT (B)(6) 2012, THE PATIENT UNDERWENT REPAIR OF AN ABDOMINAL HERNIA AND WAS IMPLANTED WITH A BARD/DAVOL VENTRIO ST MESH. IT IS ALLEGED THAT ON OR ABOUT (B)(6) 2013 AND (B)(6) 2014, THE PATIENT UNDERWENT ADDITIONAL SURGERIES TO REVISE THE VENTRIO ST MESH. ATTORNEY ALLEGES THAT ON OR ABOUT (B)(6) 2015, THE PATIENT UNDERWENT SURGERY TO REVISE THE VENTRIO ST MESH AND A NON-BARD/DAVOL MESH WAS IMPLANTED DURING THIS PROCEDURE. IT IS ALLEGED THAT ON OR ABOUT (B)(6) 2019, THE PATIENT UNDERWENT ADDITIONAL SURGERIES TO PARTIALLY REMOVE THE MESH PRODUCTS. IT IS ALLEGED THAT THE PATIENT EXPERIENCED AND/OR CONTINUES TO EXPERIENCE SEVERE AND CHRONIC PAIN/DISCOMFORT, INFLAMMATION, TORN MESH, DENSE ADHESIONS, MESH DETACHMENT, INFECTION, ULCERATION, DENSE SCARRING, OPEN DRAINING WOUND, ABDOMINAL WALL RECONSTRUCTION, NECROSIS, ABSCESS, AND RECURRENCE. IT IS ALLEGED THAT THE PATIENT IS AT A HIGHER RISK OF SEVERE COMPLICATIONS DURING AN ABDOMINAL SURGERY, TO THE EXTENT THAT FUTURE ABDOMINAL OPERATIONS MIGHT NOT BE FEASIBLE. ATTORNEY ALLEGES THAT THE VENTRIO ST MESH IMPLANTED IN PATIENT FAILED TO REASONABLY PERFORM AS INTENDED, CAUSED SERIOUS INJURY AND HAD TO BE SURGICAL

  Patient problems: Abscess; Hernia; Necrosis; Unspecified Infection

  MAUDE report 12661821 ↗
• InjurySep 24, 2021Defective Device; Patient Device Interaction Problem; Migration; Defective Device; Patient Device Interaction Problem; Migration

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL VENTRIO ST ON (B)(6) 2020. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE VENTRIO ST. ATTORNEY ALLEGES THAT THE PATIENT HAD SUBSEQUENT SURGICAL INTERVENTION DUE TO THE HERNIA MESH DEVICE. IT IS ALSO ALLEGED THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Hernia; Insufficient Information

  MAUDE report 12527176 ↗
• InjurySep 23, 2021Defective Device; Patient-Device Incompatibility; Patient Device Interaction Problem; Defective Device; Patient-Device Incompatibility; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL VENTRIO ST ON (B)(6) 2020. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE VENTRIO ST. ATTORNEY ALLEGES THAT THE PATIENT HAD SUBSEQUENT SURGICAL INTERVENTION DUE TO THE HERNIA MESH DEVICE. IT IS ALSO ALLEGED THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Insufficient Information; Seroma

  MAUDE report 12518071 ↗
• InjuryAug 27, 2021Defective Device; Patient-Device Incompatibility; Patient Device Interaction Problem; Defective Device; Patient-Device Incompatibility; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL VENTRIO ST ON (B)(6) 2016. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE VENTRIO ST. 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: Abscess; Insufficient Information; Pain; Scar Tissue; Unspecified Infection

  MAUDE report 12376242 ↗
• InjuryAug 6, 2021Defective Device; Patient-Device Incompatibility; Patient Device Interaction Problem; Defective Device; Patient-Device Incompatibility; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF UNSPECIFIED BARD/DAVOL VENTRALEX HERNIA PATCH AND VENTRIO ST ON (B)(6) 2017 AND/OR (B)(6) 2019. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST BOTH DEVICES. IT IS ALLEGED THAT THE PATIENT HAD SUBSEQUENT SURGICAL INTERVENTION DUE TO THE HERNIA MESH DEVICE. ATTORNEY ALSO ALLEGES THAT THE PATIENT SUSTAINED PERSONAL INJURY, EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Insufficient Information; Pain

  MAUDE report 12291230 ↗
• InjuryJul 6, 2021Defective Device; Patient Device Interaction Problem; Migration; Defective Device; Patient Device Interaction Problem; Migration

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL VENTRIO ST ON (B)(6) 2017. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE VENTRIO ST. ATTORNEY ALLEGES THAT THE PATIENT HAD SUBSEQUENT SURGICAL INTERVENTION DUE TO THE HERNIA MESH DEVICE. IT IS ALSO ALLEGED THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Adhesion(s); Hernia; Insufficient Information

  MAUDE report 12121293 ↗
• InjuryJul 1, 2021Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF UNSPECIFIED BARD/DAVOL SEPRAMESH COMPOSITE IP ON (B)(6) 2010, VENTRALEX ST AND VENTRIO ST ON (B)(6) 2014, PHASIX MESH AND XENMATRIX AB ON (B)(6) 2016. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST ALL DEVICES. IT IS ALLEGED THAT THE PATIENT SUSTAINED INJURIES ON (B)(6) 2016. 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. ADDENDUM PER ADDITIONAL INFORMATION PROVIDED: (B)(6) 2010 - PATIENT WAS DIAGNOSED WITH LARGE RECURRENT VENTRAL UMBILICAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF SEPRAMESH IP (DEVICE #1). PER OPERATIVE NOTES, ¿THE LIPOMA OF THE CORD WAS EXCISED. A SEPRAMESH IP (DEVICE #1) WAS PLACED AND SECURED TO THE FASCIA USING SUTURES.¿ (B)(6) 2014 - PATIENT WAS DIAGNOSED WITH RECURRENT COMPLEX VENTRAL HERNIA AND PAIN THEREBY UNDERWENT OPEN REPAIR WITH EXPLANT OF SEPRAMESH IP (DEVICE #1) AND IMPLANT

  Patient problems: Abdominal Pain; Adhesion(s); Fibrosis; Granuloma; Insufficient Information; Pain; Purulent Discharge; Unspecified Infection

  MAUDE report 12097829 ↗
• InjuryJun 9, 2021Defective Device; Patient-Device Incompatibility; Patient Device Interaction Problem; Defective Device; Patient-Device Incompatibility; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL VENTRIO ST ON (B)(6) 2019. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE VENTRIO ST. ATTORNEY ALLEGES THAT THE PATIENT HAD SUBSEQUENT SURGICAL INTERVENTION DUE TO THE HERNIA MESH DEVICE. IT IS ALSO ALLEGED THAT THE PATIENT SUSTAINED PERSONAL INJURY, EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE. ADDENDUM PER ADDITIONAL INFORMATION PROVIDED: (B)(6) 2019 - PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL AND PARASTOMAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF VENTRIO ST MESH. PER OPERATIVE NOTES, ¿A BARD VENTRIO MESH WAS PLACED AND SUTURED.¿ (B)(6) 2020 - PATIENT WAS DIAGNOSED WITH PARASTOMAL HERNIA WITH OBSTRUCTION WITHOUT GANGRENE, ADHESION THEREBY UNDERWENT ROBOTIC ASSISTED REPAIR WITH THE EXPLANT OF VENTRIO ST MESH AND IMPLANT OF ONE BIOLOGICAL MESH. PER OPERATIVE NOTES, ¿VENTRIO ST MESH WAS REMOVED. ONE BIOLOGICAL MESH WAS PLACED AND SUTURED.¿

  Patient problems: Adhesion(s); Hernia; Insufficient Information

  MAUDE report 11970270 ↗
• InjuryMar 31, 2021Defective Device; Patient-Device Incompatibility; Patient Device Interaction Problem; Defective Device; Patient-Device Incompatibility; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF UNSPECIFIED BARD MESH (BARD FLAT MESH) ON (B)(6) 2005 AND BARD/DAVOL VENTRIO ST ON (B)(6) 2017. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST BOTH DEVICES. 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: Hernia; Insufficient Information; Pain

  MAUDE report 11598958 ↗
• InjuryMar 19, 2021Defective Device; Patient-Device Incompatibility; Patient Device Interaction Problem; Defective Device; Patient-Device Incompatibility; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL VENTRIO ST ON (B)(6) 2016. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST VENTRIO ST. ATTORNEY ALLEGES THAT THE PATIENT HAD SUBSEQUENT SURGICAL INTERVENTION DUE TO THE HERNIA MESH DEVICE. IT IS ALSO ALLEGED THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Adhesion(s); Hernia; Insufficient Information

  MAUDE report 11526896 ↗
• InjuryMar 11, 2021Defective Device; Patient-Device Incompatibility; Patient Device Interaction Problem; Defective Device; Patient-Device Incompatibility; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL VENTRIO ST ON (B)(6) 2016. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE VENTRIO ST. 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: Hernia; Insufficient Information; Pain

  MAUDE report 11464764 ↗
• InjuryJan 22, 2021Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information; Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL VENTRALEX HERNIA PATCH. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST VENTRALEX HERNIA PATCH (DATE OF IMPLANT NOT PROVIDED). ATTORNEY ALLEGES THAT THE PATIENT HAD SUBSEQUENT SURGICAL INTERVENTION DUE TO THE HERNIA MESH DEVICE. IT IS ALSO ALLEGED THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Abdominal Pain; Adhesion(s); Injury; Obstruction/Occlusion

  MAUDE report 11214900 ↗