VENTRIO 5950020Recalls & reported problems

Summary

The FDA's MAUDE database contains 52 adverse event reports that list this exact device (DI 00801741031519), received between Nov 17, 2017 and Dec 24, 2025 — classified as 52 injuries.

The most frequently reported specific device problem is “Defective Device” (48 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 52 reports, in the reporter's own words as published by the FDA.

• InjuryDec 24, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF THREE BARD/DAVOL VENTRIO ST MESH (CAT# 5950020, LOT# HUEW1693) ON (B)(6) 2021 AND (CAT# 5950020, LOT# HUGV0211) ON (B)(6) 2023 AND (CAT# 5950050, LOT# HUGW1573) ON (B)(6) 2024. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST ALL VENTRIO ST MESHES. 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 23887574 ↗
• InjuryDec 24, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF THREE BARD/DAVOL VENTRIO ST MESH (CAT# 5950020, LOT# HUEW1693) ON (B)(6) 2021 AND (CAT# 5950020, LOT# HUGV0211) ON (B)(6) 2023 AND (CAT# 5950050, LOT# HUGW1573) ON (B)(6) 2024. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST ALL VENTRIO ST MESHES. 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 23887571 ↗
• InjuryJun 10, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRALEX ST (DEVICE #1). PER OPERATIVE NOTES,¿ THE HERNIA SAC WAS IDENTIFIED AND EXCISED. THE HERNIA DEFECT WAS PLACED WITH VENTRALEX ST AND SUTURED.¿ ON (B)(6) 2016 - PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRIO ST (DEVICE #2). PER OPERATIVE NOTES, ¿THE HERNIA SAC WAS ENCOUNTERED AND DISSECTED AND VENTRIO ST MESH WAS PLACED AND SUTURED.¿ ON (B)(6) 2018 - PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT ROBOTIC ASSISTED LAPAROSCOPIC REPAIR WITH IMPLANT OF TWO VENTRALIGHT ST (DEVICE #3 AND #4). PER OPERATIVE NOTES, ¿THE ADHESIONS WERE REMOVED. THE HERNIA DEFECT WAS NOTED IN MIDDLE OF THE MESH IN THE LOWER HALF AND LARGER DEFECT IN UPPER HALF. THE MESH IN THE UPPER HALF (DEVICE #1) WAS FOLDED OVER ITSELF AND REMOVED IN PIECEMEAL FASHION AND LOWER MESH (DEVICE #2) WAS ADHERENT. THE VENTRALIGHT ST MESH (DEVICE #3) WAS PLACED IN UPPER DEFECT AND ANOTHER VENTRALIGHT ST MESH (DEVICE #4) WAS PLACED IN LOWER DEFECT AND SUTURED."

  Patient problems: Adhesion(s); Hernia

  MAUDE report 22177095 ↗
• InjuryJan 27, 2025Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  PER INFORMATION PROVIDED: (B)(6) 2013 - PATIENT WAS DIAGNOSED WITH EPIGASTRIC AND INCISIONAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC CONVERTED INTO OPEN REPAIR WITH THE IMPLANT OF KUGEL PATCH (DEVICE #1). PER OPERATIVE NOTES, ¿TWO HERNIAS IN THE EPIGASTRIC AREA WITH OMENTUM IN HERNIA SAC WAS REMOVED. THE PATIENT WAS FOUND TO HAVE ABOUT 3 DEFECTS AND SOME SMALL PIECES OF FASCIA IN BETWEEN LIKE BRIDGES, MADE INTO SINGLE DEFECT AND KUGEL PATCH (DEVICE #1) WAS PLACED AND SUTURED.¿ (B)(6) 2013 - PATIENT WAS DIAGNOSED WITH VENTRAL HERNIA IN EPIGASTRIUM THEREBY UNDERWENT REMOVAL OF KUGEL PATCH (DEVICE #1). PER OPERATIVE NOTES, ¿THE PATIENT WAS FOUND TO HAVE A VENTRAL HERNIA IN THE EPIGASTRIC AREA ON THE LEFT SIDE OF THE MIDLINE. THE HERNIA SAC WAS REPAIRED USING A PIECE OF SYNTHETIC MESH AND SECURED TO THE ABDOMINAL WALL USING INTERRUPTED SUTURES." (B)(6) 2017 - PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF VENTRIO ST MESH (DEVICE #2). PER OPERATIVE NOTES, ¿THE OLD SCAR IN THE EPIGASTRIC AREA AND CLOSE TO UMBILICUS WAS EXCISED. THE HERNIA IS MAINLY LOCALIZED MORE TO THE LEFT SIDE OF THE MIDLINE AND THE HERNIA SAC WAS RESECTED. PATIENT

  Patient problems: Abdominal Pain; Adhesion(s); Hernia; Inflammation; Scar Tissue

  MAUDE report 21239346 ↗
• InjuryApr 1, 2024Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  PER INFORMATION PROVIDED BY PATIENT'S ATTORNEY: (B)(6) 2011 - PATIENT WAS DIAGNOSED WITH UMBILICAL HERNIA AND MULTIPLE MIDLINE VENTRAL HERNIAS THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF COMPOSIX MESH (DEVICE #1). PER OPERATIVE NOTES, ¿AT THE DISTAL LOCATION BELOW THE UMBILICUS THERE WERE THREE SEPARATE DEFECTS AS WELL AS AN UMBILICAL DEFECT INFERIORLY. THERE WERE EXTENDING XIPHOID MULTIPLE SMALL DEFECTS ALMOST UP TO XIPHOID PROCESS. COMPOSIX MESH (DEVICE #1) WAS PLACED IN THE PREPERITONEAL SPACE AND TACKED.¿ (B)(6) 2011 - PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR. PER OPERATIVE NOTES, ¿THE FASCIA WAS GENTLY OPENED JUST IN FRONT OF THE MESH. THE COMPOSIX MESH (DEVICE #1) APPEARS TO BE ENTIRELY INTACT AND ATTACHED TO ITS LATERAL MARGINS SUPERIORLY AND INFERIORLY. THE RESULTANT DEFECT WAS FROM THE FRACTURED SUTURE IN THE MID-PORTION OF PREVIOUS REPAIR AND THIS WAS REMOVED. TWO PROLENE SUTURES USED TO REAPPROXIMATE THE FASCIA OVER THE MESH.¿ (B)(6) 2011 - PATIENT WAS DIAGNOSED WITH MINIMAL SEROUS FLUID ACCUMULATION ALONG THE ANTERIOR ABDOMINAL MIDLINE WHICH COULD NOT BE ASPIRATED DURING ULTRASOUND GUIDED ASPIRATION PROCEDURE. (B)(6) 201

  Patient problems: Abdominal Pain; Adhesion(s)

  MAUDE report 19012254 ↗
• InjuryMay 12, 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 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: Adhesion(s); Erosion; Insufficient Information; Unspecified Infection

  MAUDE report 16917401 ↗
• InjuryMay 10, 2023Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  PER LEGAL COURT FILE: ATTORNEY ALLEGES THAT THE PATIENT WAS IMPLANTED WITH A BARD/DAVOL VENTRIO ST HERNIA PATCH ON OR ABOUT (B)(6)2017. IT IS ALLEGED THAT THE VENTRIO ST MESH WAS INTERTWINED WITH INTESTINES, CAUSING INFECTION AND REQUIRING ANOTHER SURGICAL PROCEDURE IN (B)(6)2021 TO REMOVE THE MESH AND A PORTION OF INTESTINES. IT IS ALSO ALLEGED THAT THE PATIENT UNDERWENT SURGICAL OPERATIONS TO REMOVE THE ERODED SURGICAL MESH SPANNED CONSIDERABLE PERIODS OF TIME, AND IT IS UNCLEAR WHETHER ALL OF THE REMNANTS OF THE MESH DEVICES HAVE BEEN REMOVED. IT IS ALLEGED THAT THE PATIENT EXPERIENCED AND/OR CONTINUES TO EXPERIENCE SEVERE PAIN, REVISION SURGERY, INFECTION, ABSCESS, BOWEL RESECTION, HERNIA RECURRENCE, SCARRING AND DISFIGUREMENT. ATTORNEY ALSO ALLEGES PLAINTIFF HAS SUFFERED AND CONTINUES TO SUFFER BOTH INJURIES AND DAMAGES, INCLUDING, BUT NOT LIMITED TO: PAST, PRESENT AND FUTURE PHYSICAL AND MENTAL PAIN AND SUFFERING; PHYSICAL DISABILITY. IT IS ALLEGED THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

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

  MAUDE report 16903127 ↗
• InjuryNov 18, 2022Defective Device; Patient-Device Incompatibility; Defective Device; Patient-Device Incompatibility

  ATTORNEY ALLEGES THAT, "ON (B)(6) 2020, THE PATIENT WAS IMPLANTED WITH BARD/DAVOL VENTRIO ST IN THE COURSE OF AN INCISIONAL HERNIA REPAIR SURGERY." ATTORNEY ALLEGES THAT "FURTHER TO THE IMPLANTATION WITH THE PRODUCT, PATIENT SUFFERED THE DEVELOPMENT OF HERNIA RECURRENCE, GASTROINTESTINAL COMPLICATIONS AND CHRONIC PAIN." ATTORNEY ALLEGES THAT "ON (B)(6) 2020, THE PLAINTIFF UNDERWENT CORRECTIVE REVISION SURGERY AND WAS IMPLANTED WITH BARD/DAVOL VENTRALIGHT ST MESH WITH ECHO PS POSITIONING SYSTEM". IT IS ALSO ALLEGED THAT THE PLAINTIFF SUSTAINED INJURIES INCLUDING; HERNIA RECURRENCE, GASTROINTESTINAL COMPLICATIONS, CHRONIC PAIN, PSYCHOLOGICAL AND EMOTIONAL INJURIES. IT IS ALLEGED THAT THE PLAINTIFF "HAS SUFFERED INJURIES, LOSSES, AND DAMAGES RESULTING FROM NUMEROUS DEFECTS IN THE PRODUCT THAT CREATE AN UNREASONABLY HIGH RISK OF INJURY WITH SEVERE PERMANENT ADVERSE HEALTH CONSEQUENCES." ATTORNEY ALLEGES THE PLAINTIFF SUFFERED PERMANENT INJURIES INCLUDING SCARRING, DISFIGUREMENT, PAIN AND PHYSICAL DISABILITY." IT IS ALLEGED THAT THE PLAINTIFF CONTINUES TO UNDERGO MEDICAL CARE AND TREATMENT. IT IS ALSO ALLEGED THAT THE PATIENT SUSTAINED PERSONAL INJURY, EMOTIONAL DISTRESS AND THE DEVICE

  Patient problems: Deformity/ Disfigurement; Hernia; Pain; Scar Tissue

  MAUDE report 15822885 ↗
• InjuryAug 18, 2022Defective Device; Patient-Device Incompatibility; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF UNSPECIFIED BARD MESH (BARD FLAT MESH) ON (B)(6) 2010 AND BARD/DAVOL VENTRIO ST ON (B)(6) 2016. 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.

  Patient problems: Hernia; Insufficient Information; Pain; Scar Tissue; Seroma

  MAUDE report 15247172 ↗
• InjuryApr 1, 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 UNSPECIFIED BARD/DAVOL VENTRALEX AND VENTRIO ON (B)(6) 2011 AND/OR (B)(6) 2013. AS REPORTED THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST BOTH 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: Insufficient Information; Pain

  MAUDE report 13980101 ↗
• InjuryFeb 16, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED, DURING A RECURRENT INCISIONAL HERNIA REPAIR PROCEDURE ON (B)(6) 2019, THE PATIENT WAS IMPLANTED WITH A BARD/DAVOL VENTRIO ST MESH, WHICH WAS FIXATED USING AN OPTIFIX OPEN FIXATION DEVICE. IT WAS REPORTED THAT A FEW WEEKS POST-IMPLANT, THE PATIENT EXPERIENCED GENERALIZED ITCHING IN THE AREA OF MESH IMPLANT AND THE SURGEON SUSPECTS THAT THE PATIENT HAS AN ALLERGY TO THE MESH. AS REPORTED, THE SURGEON IS PLANNING TO PERFORM A REACTIVITY TEST WITH THE VENTRIO ST MESH SAMPLE.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 13542348 ↗
• InjuryJan 12, 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 UNSPECIFIED BARD/DAVOL VENTRALEX ST PATCH AND VENTRIO ST ON (B)(6) 2013. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST BOTH DEVICES. 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; Obstruction/Occlusion; Scar Tissue

  MAUDE report 13235217 ↗
• InjuryOct 1, 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 ST (X2) ON (B)(6) 2016 (X2) AND 3DMAX AND VENTRALIGHT ST (X3) ON (B)(6) 2018 AND/OR (B)(6) 2019 AND/OR (B)(6) 2019 AND/OR (B)(6) 2020. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE VENTRIO ST (X2) AND VENTRALIGHT ST (X3). 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 12562651 ↗
• InjurySep 24, 2020Device Appears to Trigger Rejection; Defective Device; Insufficient Device Problem Information; Device Appears to Trigger Rejection; Defective Device; Insufficient Device Problem Information

  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 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); Disability; Hernia; Injury; Pain

  MAUDE report 10578530 ↗
• InjurySep 20, 2020Defective 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 THE IMPLANT OF UNSPECIFIED BARD/DAVOL COMPOSIX E/X, VENTRALEX ST AND VENTRIO ST ON (B)(6) 2007 AND/OR (B)(6) 2014 AND/OR (B)(6) 2019. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST ALL 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); Disability; Hernia; Injury; Obstruction/Occlusion; Pain

  MAUDE report 10557904 ↗
• InjuryAug 13, 2020Defective 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 VENTRIO ST ON (B)(6) 2014. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE VENTRIO ST. ATTORNEY ALLEGES THAT THE MESH PRODUCT WAS EXPLANTED ON (B)(6) 2017 AND RECURRENT VENTRAL HERNIA REPAIRED WITH ABDOMINAL WALL RECONSTRUCTION ON (B)(6) 2019. 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); Disability; Hernia; Injury

  MAUDE report 10405820 ↗
• InjuryAug 13, 2020Defective 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 UNSPECIFIED BARD/DAVOL VENTRALEX HERNIA PATCH, VENTRIO PATCH AND VENTRIO ST ON (B)(6) 2010 AND/OR (B)(6) 2011 AND/OR (B)(6) 2012. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST ALL DEVICES. 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); Injury; Obstruction/Occlusion; Pain

  MAUDE report 10400850 ↗
• InjuryAug 10, 2020Defective 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 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 THAT THE PATIENT HAD SUBSEQUENT SURGICAL INTERVENTION DUE TO THE HERNIA MESH DEVICE. IT IS ALSO ALLEGED THAT PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Hernia; Injury; Pain

  MAUDE report 10383482 ↗
• InjuryJul 17, 2020Defective 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 UNSPECIFIED BARD/DAVOL PERFIX PLUG AND VENTRIO ST ON (B)(6) 2017 AND/OR (B)(6) 2018. 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. IT IS ALSO ALLEGED THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE. ADDENDUM PER ADDITIONAL INFORMATION PROVIDED: (B)(6) 2017 ¿ PATIENT UNDERWENT HERNIA REPAIR WITH THE IMPLANT OF PERFIX PLUG (DEVICE #1). (NOTE: THERE IS NO OP NOTES PROVIDED FOR THIS PROCEDURE IN MEDICAL RECORD) (B)(6) 2019 ¿ PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF VENTRIO ST MESH (DEVICE #2). PER OP NOTES, ¿ADHESIONS WERE TAKEN DOWN. AN UNDERLAY VENTRIO ST MESH (DEVICE #2) WAS PLACED BENEATH THE DEFECT AND SUTURED.¿

  Patient problems: Injury; Pain

  MAUDE report 10288470 ↗
• InjuryJun 23, 2020Defective 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 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 ALLEGED THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Adhesion(s); Disability; Hernia; Injury; Pain; Scar Tissue

  MAUDE report 10183785 ↗
• InjuryMay 25, 2020Defective Device; Insufficient Device Problem Information; Migration; Defective Device; Insufficient Device Problem Information; Migration

  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 ALLEGED THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Adhesion(s); Disability; Hernia; Injury; Pain

  MAUDE report 10085808 ↗
• InjuryFeb 18, 2020Defective Device; Material Deformation; Insufficient Device Problem Information; Defective Device; Material Deformation; Insufficient Device Problem Information

  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); Bowel Perforation; Disability; Hernia; Injury; Obstruction/Occlusion; Pain; Peritonitis; Unspecified Infection

  MAUDE report 9720040 ↗
• InjuryFeb 14, 2020Defective Device; Insufficient Device Problem Information; Migration; Defective Device; Insufficient Device Problem Information; Migration

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL VENTRIO ST ON (B)(6) 2018. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST 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); Disability; Hernia; Injury; Pain

  MAUDE report 9710957 ↗
• InjuryJan 30, 2020Defective 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 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 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); Disability; Hernia; Injury; Necrosis; Pain

  MAUDE report 9646611 ↗
• InjuryNov 22, 2019Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information; Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information

  ATTORNEY ALLEGES PER SHORT FORM (SEE ATTACHED) THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL VENTRALIGHT ST(DEVICE #1) OR AN UNSPECIFIED BARD/DAVOL VENTRIO PATCH(DEVICE #2) ON (B)(6) 2016 OR (B)(6) 2017. IT IS ALLEGED THAT THE PATIENT HAD SUBSEQUENT SURGICAL INTERVENTION DUE TO THE HERNIA MESH DEVICE(S). AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE BARD/DAVOL VENTRALIGHT ST(DEVICE #1) AND THE VENTRIO PATCH(DEVICE #2). AS REPORTED, THE ATTORNEY ALLEGES PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

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

  MAUDE report 9365452 ↗