VENTRIO 5950050Recalls & reported problems

Summary

The FDA's MAUDE database contains 92 adverse event reports that list this exact device (DI 00801741031540), received between Jul 27, 2017 and Mar 9, 2026 — classified as 87 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Defective Device” (77 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 92 reports, in the reporter's own words as published by the FDA.

• InjuryMar 9, 2026Device Appears to Trigger Rejection

  PER INFORMATION PROVIDED: (B)(6) 2008- PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL INCISIONAL HERNIA, THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF SEPRAMESH IP (DEVICE 1). PER OP NOTES, ¿A SMALL HERNIA DEFECT WAS IDENTIFIED IN THE ABDOMINAL REGION AND WAS DISSECTED. A SEPRAMESH IP (DEVICE 1) WAS PLACED ON THE PERITONEAL SPACE AND SUTURED¿. (B)(6) 2017- PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL HERNIA, THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH EXPLANT OF SEPRAMESH IP (DEVICE 1), IMPLANT OF VENTRIO ST MESH (DEVICE 2). PER OP NOTES, ¿MULTIPLE ADHESIONS OF THE SMALL BOWEL TO THE UNDERSIDE OF THE SEPRAMESH IP (DEVICE 1) IN ADDITION TO OMENTUM. ONCE THE ADHESIONS WERE LYSED. THE SEPRAMESH IP (DEVICE 1) WAS COMPLETELY EXPLANTED. A VENTRIO ST MESH (DEVICE 2) WAS PLACED AND TACKED CIRCUMFASCIALLY¿. (B)(6) 2017- PATIENT WAS DIAGNOSED WITH SMALL BOWEL OBSTRUCTION, THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF VENTRALIGHT ST USING ECHO PS (DEVICE 3). PER OP NOTES, ¿A PORTION OF OMENTUM FOUND ADHERED TO THE PREVIOUSLY PLACED MESH (DEVICE 2). A SMALL PORTION OF OMENTUM HAD HERNIATED UNDERNEATH AND A SMALL AREA OF OMENTUM FOUND PROTRUDING THROUGH THE MESH (DEVICE 2). A VENTR

  Patient problems: Adhesion(s); Obstruction/Occlusion

  MAUDE report 24543509 ↗
• 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 23887427 ↗
• InjuryDec 3, 2025Improper or Incorrect Procedure or Method; Patient-Device Incompatibility; Improper or Incorrect Procedure or Method; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: PATIENT WITH A HISTORY OF STABBING INJURY TO THE ABDOMEN (~10 YEARS AGO), WITH NO MEDICAL ATTENTION SOUGHT, DEVELOPED A LARGE ABDOMINAL HERNIA AND UNDERWENT IMPLANT OF A NON-BD SYNTHETIC MESH ON (B)(6) 2010. APPROXIMATELY 2 YEARS AND 9 MONTHS LATER, ON (B)(6) 2013, PATIENT PRESENTED WITH RECURRENT VENTRAL HERNIA AND A REDUCIBLE UMBILICAL HERNIA AND WAS SCHEDULED FOR REPAIR. PER OP NOTES, ¿THE UMBILICAL HERNIA SAC WAS ENCOUNTERED FIRST. THIS WAS DISSECTED FREE FROM THE UMBILICUS... FURTHER DISSECTION SUPERIORLY REVEALED THE VENTRAL HERNIA SAC... THE DEFECTS WERE COMBINED TO CREATE ONE CONTIGUOUS FASCIAL DEFECT." A VENTRIO ST (DEVICE #1) WAS PLACED AND TACKED USING SORBAFIX SUPERIORLY AND INFERIORLY; FASCIAL EDGES WERE SUTURED OVER THE MESH AND SKIN WAS STAPLED. BASED ON MEDICAL RECORDS PROVIDED, THE VENTRIO ST (DEVICE #1) WAS IMPLANTED ON (B)(6) 2013 WHICH WAS BEYOND THE LABELED EXPIRED DATE OF 28-MAR-2013. ON (B)(6) 2013 PATIENT PRESENTED TO THE HOSPITAL WITH WOUND DEHISCENCE AND HERNIA RECURRENCE. PER OP NOTES, ¿THE HERNIA SAC IN THE MIDLINE WAS DISSECTED FREE. THE PREVIOUS MESH WAS COMPLETELY EXCISED AND DISCARDED. A VENTRIO ST MESH (DEVICE #2) WAS DEPLO

  Patient problems: Hernia; Wound Dehiscence

  MAUDE report 23705108 ↗
• InjuryNov 5, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  ADDENDUM PER ADDITIONAL INFORMATION PROVIDED: (B)(6) 2010 - PATIENT WAS DIAGNOSED WITH INCISIONAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT OF SEPRAMESH IP (DEVICE 1). PER OPERATIVE NOTES, ¿AN INCISION WAS MADE IN THE LEFT UPPER QUADRANT IN THE ABDOMEN. HERNIA SAC WAS DISSECTED OUT. A SEPRAMESH IP (DEVICE 1) WAS PLACED IN THE ABDOMINAL CAVITY AND SECURE IT WITH SUTURES.¿ (B)(6) 2010 - PATIENT WAS DIAGNOSED WITH PARTIAL SMALL BOWEL OBSTRUCTION, ADHESIONS THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH LYSIS OF ADHESION, RESECTION OF SMALL BOWEL. (B)(6) 2016 - PATIENT WAS DIAGNOSED WITH ADHESION, RECURRENT SMALL BOWEL OBSTRUCTION, THEREBY UNDERWENT OPEN REPAIR WITH LYSIS OF ADHESIONS, REMOVAL OF FOREIGN BODY SEPRAMESH IP (DEVICE 1) MESH TACKS. (B)(6) 2020 - PATIENT WAS DIAGNOSED WITH RECURRENT INCARCERATED INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRIO ST MESH (DEVICE 2). PER OPERATIVE NOTES, ¿BELOW THE OLD MESH, HERNIA WAS THERE. HERNIA SAC WAS DISSECTED OUT. ALL ADHESIONS WERE TAKEN DOWN. A VENTRIO ST MESH (DEVICE 2) WAS PLACED IN SPACE UNDER THE PERITONEUM AND SECURE IT WITH SUTURES.¿ (B)(6) 2024 - PATIENT WAS DIAGNOSED WITH INFECTED MESH, F

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

  MAUDE report 23474165 ↗
• InjuryAug 5, 2025Material Deformation; Material Deformation

  PER INFORMATION PROVIDED: (B)(6) 2006 ¿ PATIENT WAS DIAGNOSED WITH INCARCERATED EPIGASTRIC HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF COMPOSIX MESH (DEVICE #1). PER OPERATIVE NOTES, "THE HERNIA WAS IDENTIFIED. A SMALL PATCH OF COMPOSIX MESH (DEVICE #1) WAS PLACED AND SUTURED." (B)(6) 2013 ¿ PATIENT WAS DIAGNOSED WITH VENTRAL HERNIA AND PAIN THEREBY UNDERWENT OPEN REPAIR WITH REMOVAL OF MESH (DEVICE #1) AND IMPLANT OF VENTRIO ST MESH (DEVICE #2). PER OPERATIVE NOTES, ¿THE PREVIOUS COMPOSIX MESH (DEVICE #1) WAS BALLED UP AND PULLED AWAY FROM THE WOUND WHICH CAUSED PAIN. THE PREVIOUSLY PLACED MESH (DEVICE #1) WAS REMOVED. THE VENTRIO ST MESH (DEVICE#2) WAS PLACED AND COVERED ALL THE AREAS.¿ (B)(6) 2019 ¿ PATIENT WAS DIAGNOSED WITH ABDOMINAL PAIN THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH REMOVAL OF VENTRIO ST MESH (DEVICE #2). PER OPERATIVE NOTES, ¿THE MESH WAS ADHERED TO THE ABDOMINAL WALL IN THE AREA THAT CAUSED PAIN. THE VENTRIO ST MESH (DEVICE #2) WAS FOLDED SLIGHTLY AND DENSELY INCORPORATED WAS REMOVED.¿

  Patient problems: Abdominal Pain; Adhesion(s)

  MAUDE report 22714539 ↗
• InjuryApr 23, 2025Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  PER INFORMATION PROVIDED: ON (B)(6) 2011: PATIENT WAS DIAGNOSED WITH PARTIAL SMALL BOWEL OBSTRUCTION AND VENTRAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT OF COMPOSIX KUGEL MESH (DEVICE #1). PER OPERATIVE NOTES, ¿THERE WAS CLEAR-CUT VENTRAL HERNIAS THAT HAD OMENTAL FAT AND THERE WERE SEVERAL IN THE UPPER INCISION. THESE WERE ALL REDUCED. THEN A COMPOSIX KUGEL MESH (DEVICE #1) WAS PLACED IN THE AREA OF THE HERNIA.¿ ON (B)(6) 2016: PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL HERNIA WITH ADHESIONS THEREBY UNDERWENT OPEN REPAIR WITH PARTIAL REMOVAL OF COMPOSIX KUGEL MESH (DEVICE #1) AND IMPLANT OF VENTRIO ST MESH (DEVICE #2). PER OPERATIVE NOTES, ¿THE ADHESIONS WERE IN THE UPPER ABDOMEN TO THE OLD MESH. THE PATIENT HAD DEVELOPED A RECURRENCE ALONG THE LEFT SIDE OF THE MESH, ALL THE ADHESIONS OF OMENTUM TO THE MESH WERE FREED UP. THEN A SMALL PART OF THE PREVIOUS MESH (DEVICE #1) WAS REMOVED AND THEN PLACED THE VENTRIO ST MESH (DEVICE #2) AS AN UNDERLAY UNDERNEATH THE PREVIOUS MESH AND COVERING UP THE DEFECT ON THE LEFT SIDE.¿ ON (B)(6) 2017: PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH PARTIAL REMOVAL OF COMPOSIX KUGEL MESH

  Patient problems: Adhesion(s); Hernia

  MAUDE report 21889091 ↗
• InjuryDec 5, 2024Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  PER INFORMATION PROVIDED: ON (B)(6) 2010 - PATIENT WAS DIAGNOSED WITH VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF COMPOSIX KUGEL MESH (DEVICE #1). PER OPERATIVE NOTES, ¿THERE WERE MULTIPLE DEFECTS. ALL THE DEFECTS WERE COMBINED INTO ONE DEFECT AND A COMPOSIX KUGEL MESH (DEVICE #1) WAS SEWN IN PLACE WITH SUTURES.¿ ON (B)(6) 2013 - PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL HERNIA AND BILATERAL INGUINAL HERNIAS THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF BARD FLAT MESH (RIGHT - DEVICE #2 & LEFT ¿ DEVICE #3) FOR BILATERAL INGUINAL HERNIAS, VENTRIO MESH (DEVICE #4) FOR RECURRENT VENTRAL HERNIA AND EXPLANT OF COMPOSIX KUGEL MESH (DEVICE #1). PER OPERATIVE NOTES, ¿THE DIRECT INGUINAL HERNIA WAS IDENTIFIED IN THE RIGHT GROIN AND A BARD FLAT MESH (RIGHT- DEVICE #2) WAS SEWN IN PLACE WITH SUTURES. THEN, DIRECT HERNIA IDENTIFIED IN THE LEFT INGUINAL REGION WAS REPAIRED USING BARD FLAT MESH (LEFT ¿ DEVICE #3) AND SUTURED. THE PREVIOUS MESH (DEVICE #1) WAS ENCOUNTERED, WHERE THE MESH HAD TORN FROM THE FASCIA. THE OLD MESH WAS REMOVED AND REPLACED WITH A VENTRIO MESH (DEVICE #4) AND SEWN IN PLACE WITH SUTURES.¿ ON (B)(6) 2016 - PATIENT WAS DIAGNOSED WITH RECURRENT INCIS

  Patient problems: Adhesion(s); Hernia

  MAUDE report 20850778 ↗
• MalfunctionNov 6, 2024Material Separation; Material Separation

  AS REPORTED, DURING OPEN VENTRAL HERNIA REPAIR PROCEDURE ON (B)(6) 2024, THE SURGEON FOLDED THE VENTRIO ST MESH AND WENT TO INSERT IT INTO THE PATIENT, BUT IT WAS NOTICED THAT PDO RING WAS EXPOSED FROM THE MESH LAYERS AND UNABLE TO ADHERE. IT WAS REPORTED THAT THE MESH WAS NOT USED AND ANOTHER ONE WAS USED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20620085 ↗
• InjuryOct 18, 2024Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  PER INFORMATION PROVIDED: (B)(6) 2006 - PATIENT WAS DIAGNOSED WITH EPIGASTRIC HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT OF COMPOSIX E/X MESH (DEVICE#1). PER OPERATIVE NOTES, ¿HERNIA WAS IDENTIFIED IN THE EPIGASTRIC REGION AND THE DISSECTION WAS CARRIED OUT. A COMPOSIX E/X MESH (DEVICE#1) WAS PLACED USING STAPLES. ¿ (B)(6) 2016 - PATIENT WAS DIAGNOSED WITH RECURRENT EPIGASTRIC HERNIA THEREBY UNDERWENT OPEN REPAIR WITH REMOVAL OF OLD COMPOSIX E/X MESH (DEVICE #1). PER OPERATIVE NOTES, ¿THE OLD MESH (DEVICE#1) WAS ENCOUNTERED, AND IT WAS CURLED UP. THIS WAS DISSECTED AND REMOVED. THE OMENTAL ADHESIONS WERE LYSED, AND THE HERNIA WAS REPAIRED BY USING SUTURES.¿ (B)(6) 2016, (B)(6) 2017 - PATIENT WAS DIAGNOSED WITH SMALL BOWEL OBSTRUCTION, INCARCERATED EPIGASTRIC HERNIA AND ADHESIONS THEREBY UNDERWENT REPAIR. (B)(6) 2018 - PATIENT WAS DIAGNOSED WITH RECURRENT EPIGASTRIC HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF VENTRIO ST MESH (DEVICE #2). PER OPERATIVE NOTES, ¿THE PREVIOUS SUTURES WERE GAPED INTO THE SCAR TISSUES, AND THERE WAS A LARGE HERNIA. A VENTRIO ST MESH (DEVICE #2) WAS PLACED INTO THE ABDOMEN USING SUTURES AND TACKERS.¿ (B)(6) 2018 - PATIENT WA

  Patient problems: Adhesion(s); Bowel Perforation; Unspecified Infection

  MAUDE report 20479319 ↗
• InjuryJun 26, 2024Defective Device; Patient Device Interaction Problem; Migration; Defective Device; Patient Device Interaction Problem; Migration

  PER PLAINTIFF PROFILE FORM (B)(4) : ATTORNEY ALLEGES THAT THE PATIENT HAD ADHESIONS, BOWEL/INTESTINAL REMOVAL, INFECTION, PAIN, HERNIA RECURRENCE, BOWEL ADHERENT TO MESH, MESH SEPARATION AND EMOTIONAL INJURIES. ADDENDUM PER ADDITIONAL INFORMATION PROVIDED: ON (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH UMBILICAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF VENTRALEX ST (DEVICE #1). PER OPERATIVE NOTES, ¿HERNIA WAS IDENTIFIED. A VENTRALEX MESH WAS PLACED UNDER THE FASCIA AND SUTURED.¿ ON (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF VENTRIO ST (DEVICE #2) AND REMOVAL OF VENTRALEX ST (DEVICE #1). PER OPERATIVE NOTES, ¿HERNIA SAC AND OLD MESH WERE ENCOUNTERED. A VENTRALEX ST MESH (DEVICE #1) AND LARGE HERNIA SAC WERE COMPLETELY REMOVED. A VENTRIO ST (DEVICE #2) WAS PLACED AND TACKED TO THE ANTERIOR ABDOMINAL WALL.¿ ON (B)(6) 2017 - PATIENT WAS DIAGNOSED WITH RECURRENT INCARCERATED VENTRAL INCISIONAL HERNIA AND PAIN THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF VENTRIO ST (DEVICE #3) AND EXPLANT OF VENTRIO ST (DEVICE #2). PER OPERATIVE NOTES, ¿AFTER REMOVAL OF HERNIA SAC, THE MESH WAS ENCOUNTERED WHICH W

  Patient problems: Adhesion(s); Hernia; Pain

  MAUDE report 19612657 ↗
• InjuryDec 11, 2023Defective 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 TWO UNSPECIFIED BARD/DAVOL VENTRIO ST ON (B)(6) 2019 AND (B)(6) 2020. 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. ADDENDUM PER ADDITIONAL INFORMATION PROVIDED: ADDENDUM PER PLAINTIFF PROFILE FORMAND MEDICAL RECORDS: (B)(6) 2019 ¿ PATIENT WAS DIAGNOSED WITH VENTRAL INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF VENTRIO ST PATCH (DEVICE 1). PER OP NOTES, ¿AN VENTRIO ST MESH (DEVICE 1) WAS PLACED IN PROPERITONEAL SPACE AND SECURED USING TACKS.¿ (B)(6) 2020 ¿ PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE REMOVAL OF MESH (DEVICE 1) AND IMPLANT OF VENTRIO ST MESH (DEVICE 2). PER OP NOTES, ¿THE PREVIOUS MESH (DEVICE 1) WHICH WAS SOMEWHAT PROTUBERANT WAS IDENTIFIED. THE MESH (DEVICE 1) ADHERENT TO

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

  MAUDE report 18299258 ↗
• InjuryMar 17, 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) 2015. 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.ADDENDUM PER ADDITIONAL INFORMATION PROVIDED:(B)(6) 2015 ¿ PATIENT WAS DIAGNOSED WITH INCISIONAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF VENTRIO ST MESH. PER OPERATIVE NOTES, ¿IN THE LEFT LOWER QUADRANT, A VENTRIO ST MESH WAS PLACED AND TACKED.¿ (B)(6) 2018 ¿ PATIENT WAS DIAGNOSED WITH INCARCERATED INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR. PER OPERATIVE NOTES, ¿THE HERNIA CONTENTS WERE DISSECTED. THE HERNIATED FAT WAS MEASURED AND WAS SUTURE LIGATED AT ITS BASE AND EXCESS FAT WAS REMOVED.¿

  Patient problems: Hernia; Insufficient Information

  MAUDE report 16564392 ↗
• InjuryNov 24, 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) 2013. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST BARD/DAVOL 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 15859860 ↗
• MalfunctionOct 18, 2022Expiration Date Error; Expiration Date Error

  AS REPORTED, DURING AN UNSPECIFIED PROCEDURE ON (B)(6) 2021, THE SURGEON IMPLANTED A BARD/DAVOL VENTRIO ST MESH WHICH WAS EXPIRED ON 28-FEB-2021. IT WAS REPORTED THAT THE MESH HAS BEEN LEFT IMPLANTED AND THE PATIENT HAS NOT RECEIVED ANY ADDITIONAL MEDICAL/SURGICAL TREATMENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15625296 ↗
• InjuryMay 26, 2022Defective Device; Patient Device Interaction Problem; Material Split, Cut or Torn; Defective Device; Patient Device Interaction Problem; Material Split, Cut or Torn

  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); Hernia; Insufficient Information; Pain

  MAUDE report 14508096 ↗
• InjuryMar 20, 2022Defective 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) 2012. 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: Hematoma; Insufficient Information

  MAUDE report 13828517 ↗
• InjuryJan 20, 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/DAVOL COMPOSIX L/P ON (B)(6) 2014 AND VENTRIO ST ON (B)(6) 2020. 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: Abscess; Insufficient Information; Pain; Unspecified Infection

  MAUDE report 13306929 ↗
• InjuryJan 8, 2022Defective Device; Material Deformation; Patient Device Interaction Problem; Migration; Defective Device; Material Deformation; Patient Device Interaction Problem; Migration

  ATTORNEY ALLEGES THAT ON OR ABOUT (B)(6) 2019, PATIENT WAS IMPLANTED WITH A BARD/DAVOL VENTRIO ST MESH. IT IS ALLEGED THAT THE DEVICE WAS DEFECTIVE, HAD THE PROPENSITY TO CONTRACT OR SHRINK INSIDE THE BODY, THAT IN TURN CAUSES SURROUNDING TISSUE TO BE INFLAMED, BECOME FIBROTIC, AND CONTRACT, RESULTING IN INJURY; HAD THE PROPENSITY TO "CREEP", OR TO GRADUALLY ELONGATE AND DEFORM WHEN SUBJECT TO PROLONGED TENSION INSIDE THE BODY; THE INELASTICITY OF THE MEDICAL DEVICE, CAUSING IT TO BE IMPROPERLY MATED TO THE DELICATE AND SENSITIVE AREAS OF THE VAGINA AND PELVIS WHERE THEY ARE IMPLANTED, AND CAUSING PAIN UPON NORMAL DAILY ACTIVITIES THAT INVOLVE MOVEMENT IN THE PELVIC REGION (E.G., INTERCOURSE, DEFECATION, WALKING); THE PROPENSITY OF THE MEDICAL DEVICE FOR DEGRADATION OR FRAGMENTATION OVER TIME, WHICH CAUSES A CHRONIC INFLAMMATORY AND FIBROTIC REACTION, AND RESULTS IN CONTINUING INJURY OVER TIME; AND THE CREATION OF NON-ANATOMIC CONDITION IN THE PELVIS LEADING TO CHRONIC PAIN AND FUNCTIONAL DISABILITIES WHEN THE MESH IS IMPLANTED. ATTORNEY ALLEGES THAT AS A DIRECT AND PROXIMATE RESULT OF THE ABOVE FOREGOING DEFECTIVE AND UNREASONABLY DANGEROUS CONDITIONS, THE PATIENT SUFFERED A MIGRA

  Patient problems: Fibrosis; Inflammation; Pain; Unspecified Infection

  MAUDE report 13200793 ↗
• InjuryNov 16, 2021Patient-Device Incompatibility; Patient-Device Incompatibility

  PER SYMPOSIUM PRESENTATION DURING HERNIA WEEK 2020 (B)(6)- "THREE CASES OF MESH INFECTION AFTER ABDOMINAL WALL HERNIA REQUIRING MESH REMOVAL" AS REPORTED THAT THE PATIENT UNDERWENT REPAIR OF AN UMBILICAL HERNIA AND A BARD/DAVOL VENTRIO ST MESH WAS IMPLANTED. IT WAS REPORTED THAT A MESH INFECTION OCCURRED APPROXIMATELY ONE AND A HALF MONTHS AFTER THE OPERATION. IT WAS REPORTED THE PATIENT WAS TREATED WITH CONSERVATIVE THERAPY (OPENING THE WOUND AND VAC) BUT THE INFECTION DID NOT RESOLVE. FOUR MONTHS LATER, THE PATIENT UNDERWENT MESH REMOVAL AND DIRECT SUTURING WAS PERFORMED. IT WAS ALSO REPORTED THAT THE PATIENT WAS DOING WELL AND DISCHARGED 72 DAYS AFTER THE OPERATION.

  Patient problems: Unspecified Infection

  MAUDE report 12822172 ↗
• InjurySep 12, 2021Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT ON (B)(6) 2018, THE PATIENT UNDERWENT SURGERY FOR AN INCISIONAL HERNIA REPAIR AND A BARD/DAVOL VENTRIO ST PATCH WAS IMPLANTED. ATTORNEY ALSO ALLEGES THAT FURTHER TO IMPLANTATION WITH THE PRODUCT, THE PATIENT SUFFERED THE DEVELOPMENT OF MESH INFECTION AND CHRONIC PAIN. IT IS ALLEGED THAT ON OR ABOUT (B)(6) 2018, (B)(6) 2019, THE PATIENT UNDERWENT ADDITIONAL SURGERIES DUE TO MESH COMPLICATIONS. IT IS ALLEGED THAT THE PATIENT 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 PATIENT SUFFERED PERMANENT INJURIES INCLUDING SCARRING, DISFIGUREMENT, SUFFERING AND PHYSICAL DISABILITY. IT IS ALLEGED THAT THE PATIENT CONTINUES TO UNDERGO MEDICAL CARE AND TREATMENT. IT IS ALSO ALLEGED THE DEVICE WAS DEFECTIVE.

  Patient problems: Deformity/ Disfigurement; Pain; Unspecified Infection

  MAUDE report 12457828 ↗
• InjurySep 7, 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 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.

  Patient problems: Insufficient Information; Unspecified Infection

  MAUDE report 12433167 ↗
• InjuryAug 10, 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 EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

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

  MAUDE report 12302245 ↗
• InjuryJul 20, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  AS REPORTED, THE PATIENT UNDERWENT AN ABDOMINAL WALL RECONSTRUCTION AND VENTRAL HERNIA REPAIR USING A BARD/DAVOL VENTRIO ST. POST IMPLANT, ABOUT TWO WEEKS LATER, THE PATIENT PRESENTED WITH BOWEL OBSTRUCTION WHICH REQUIRED SURGERY. DURING THE SURGERY, IT WAS FOUND THAT THE OMENTUM AND SEVERAL LOOPS OF SMALL BOWEL WERE DENSELY ADHERED TO THE MESH. THE SMALL BOWEL MESENTERY HAD VOLVULIZED AROUND THE ADHERENT LOOPS WHICH WAS INTERVENED QUICKLY WITHOUT ANY REQUIREMENT FOR BOWEL RESECTION. AS REPORTED, THE PATIENT REMAINED HOSPITALIZED WITH AN ILEUS AND HAS DEVELOPED A SUPERFICIAL SURGICAL SITE INFECTION.

  Patient problems: Adhesion(s); Obstruction/Occlusion; Post Operative Wound Infection

  MAUDE report 12195208 ↗
• InjuryJul 5, 2021Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT THE PATIENT DEVELOPED AN ABDOMINAL HERNIA THAT REQUIRED SURGICAL REPAIR. ON (B)(6) 2020, THE PATIENT WAS IMPLANTED WITH A BARD/DAVOL VENTRIO ST HERNIA PATCH DURING THE HERNIA REPAIR SURGERY. IT WAS ALLEGED THAT THE PATIENT DEVELOPED AN INFECTION AND ABSCESS INVOLVING THE VENTRIO ST HERNIA PATCH ALONG WITH CONSIDERABLE PAIN, FOLLOWING THE SURGERY. THE PATIENT REQUIRED A SECOND SURGERY TO DRAIN THE ABSCESS AND ALSO DEVELOPED FURTHER COMPLICATIONS, INCLUDING A SMALL BOWEL OBSTRUCTION THAT REQUIRED SURGICAL REPAIR. ATTORNEY ALLEGES THAT EVENTUALLY THE VENTRIO ST HERNIA PATCH WAS REMOVED AND REPLACED WITH A DIFFERENT MESH. IT IS ALLEGED THAT THE PATIENT UNDERWENT MULTIPLE SURGERIES FOR COMPLICATIONS ARISING FROM THE VENTRIO ST HERNIA PATCH, SUFFERED PAIN AND SUFFERING. IT IS ALSO ALLEGED THE DEVICE WAS DEFECTIVE.

  Patient problems: Abscess; Obstruction/Occlusion; Unspecified Infection

  MAUDE report 12114771 ↗
• InjuryApr 27, 2021Defective 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) AND BARD/DAVOL VENTRIO ST ON (B)(6) 2014 AND/OR (B)(6) 2020. 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: Adhesion(s); Hernia; Insufficient Information; Pain; Scar Tissue

  MAUDE report 11731389 ↗