VENTRIO 5950060Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00801741031557), received between Jul 7, 2017 and Sep 30, 2026 — classified as 22 injuries, 1 malfunction.

The most frequently reported specific device problem is “Defective Device” (18 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Patient-Device Incompatibility

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

  MAUDE report 50948304 ↗
• InjurySep 3, 2026Patient-Device Incompatibility

  Per information provided:(b)(6)2012 - Patient was diagnosed with incarcerated umbilical hernia thereby underwent open repair with implant of Ventralex ST (Device 1). Per op notes, "A incision was made in the area of hernia to the fascia. The hernia sac was identified and the contents were reduced. Adhesions were taken down to free up the preperitoneal space. A Ventralex ST (Device 1) was placed in the preperitoneal space and sutured."(b)(6)2017 - Patient was diagnosed with recurrent incarcerated umbilical hernia and abdominal pain thereby underwent open repair with excision of Ventralex ST (Device 1) and implant of Ventrio ST (Device 2). Per op notes, "A midline incision was made below the umbilicus. The fascia was incised and fat was lifted up. The hernia defect was noted superior to the incision, The old mesh (Device 1) was noted. Adhesions were lysed. The umbilicus was excised and removed. The hernia sac was opened, and the prior mesh (Device 1) was excised and removed entirely. The hernia contents were released. A Ventrio ST (Device 2) was placed and sutured."(b)(6)2017 - Patient was diagnosed with wound dehiscence thereby underwent open repair. Per op notes, "The staples from

  Patient problems: Adhesion(s); Obstruction/Occlusion; Wound Dehiscence

  MAUDE report 50582079 ↗
• InjuryMay 25, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  ALLEGED PER CLINICAL TRIAL (B)(4): (B)(6) 2018, THE PATIENT UNDERWENT PRIMARY OPEN VENTRAL INCISIONAL HERNIA REPAIR, DURING WHICH A BARD/DAVOL VENTRIO ST (DEVICE 1) WAS PLACED IN UNDERLAY FASHION INTRA-PERITONEALLY USING ANTERIOR CST METHOD, FIXATED USING NON-BARD/DAVOL MAXON SUTURES WITH 8 FIXATION POINTS. FASCIA AND FULL SKIN CLOSURE WAS ACHIEVED USING NON-BARD/DAVOL MAXON INTERRUPTED STITCHES AND STAPLES. THE PATIENT WAS DISCHARGED TO HOME ON (B)(6) 2018. (B)(6) 2019 ¿ PATIENT DIAGNOSED WITH A ¿RECURRENT, REDUCIBLE, INCISIONAL VENTRAL HERNIA¿ (THERE IS NO DETERMINATION THIS EVENT IS RELATED TO THE PREVIOUSLY IMPLANTED MESH (DEVICE 1)). (B)(6) 2020, THE PATIENT UNDERWENT PRIMARY OPEN VENTRAL INCISIONAL HERNIA REPAIR, DURING WHICH A BARD/DAVOL VENTRIO (DEVICE 2) WAS PLACED IN UNDERLAY FASHION, FIXATED USING NON-BARD/DAVOL SILK SUTURES. FASCIA AND FULL SKIN CLOSURE WAS ACHIEVED USING NON-BARD/DAVOL SILK INTERRUPTED STITCHES AND RUNNING STITCHES. THE PATIENT WAS DISCHARGED TO HOME ON (B)(6) 2020. (B)(6) 2020, PATIENT EXPERIENCED ABDOMINAL WALL SEROMA WITH OVERLYING ERYTHEMA. (B)(6) 2020, THE PATIENT WAS DIAGNOSED WITH SURGICAL SITE INFECTION. THE PATIENT UNDERWENT AN REOPERATION AND

  Patient problems: Bacterial Infection; Erythema; Post Operative Wound Infection; Seroma

  MAUDE report 14498445 ↗
• InjuryAug 30, 2021Defective Device; Patient Device Interaction Problem; Defective Device; Patient-Device Incompatibility; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF TWO UNSPECIFIED BARD/DAVOL VENTRIO ON (B)(6) 2010 AND (B)(6) 2013. 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: Insufficient Information; Pain

  MAUDE report 12382505 ↗
• InjuryOct 1, 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 AND VENTRIO ST ON (B)(6) 2012 AND/OR (B)(6) 2019. 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 SUSTAINED PERSONAL INJURY, EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Injury; Pain

  MAUDE report 10611388 ↗
• InjurySep 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 VENTRALIGHT ST AND VENTRIO ST ON (B)(6) 2016 AND/OR (B)(6) 2018. 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: Injury; Pain

  MAUDE report 10546428 ↗
• InjuryApr 21, 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 AN UNSPECIFIED BARD/DAVOL VENTRIO ST ON (B)(6) 2014. 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: Abscess; Adhesion(s); Hernia; Injury; Unspecified Infection

  MAUDE report 9980957 ↗
• InjuryApr 8, 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 VENTRALEX ST AND BARD/DAVOL VENTRIO ON (B)(6) 2014 AND/OR (B)(6) 2015. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE VENTRIO. 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: Disability; Hernia; Injury; Pain

  MAUDE report 9933998 ↗
• MalfunctionApr 1, 2020Expiration Date Error; Expiration Date Error

  AS REPORTED ON (B)(6) 2020 THE PATIENT UNDERWENT OPEN HERNIA REPAIR SURGERY AND WAS IMPLANTED WITH A BARD VENTRIO ST MESH. IT WAS LATER NOTED THAT THE LABELED EXPIRATION DATE OF THE IMPLANT WAS (B)(6) 2020. AS REPORTED THE MESH WAS TAKEN FROM THE HOSPITAL INVENTORY. THERE WAS NO PATIENT INJURY AND NO ADDITIONAL MEDICAL OR SURGICAL INTERVENTION WAS PROVIDED TO THE PATIENT AS A RESULT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9913954 ↗
• InjuryMar 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 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: Disability; Hernia; Injury; Pain

  MAUDE report 9810372 ↗
• 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 VENTRALIGHT ST ON (B)(6) 2017. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE VENTRALIGHT 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: Abscess; Adhesion(s); Bacterial Infection; Fistula; Injury; Necrosis

  MAUDE report 9710965 ↗
• InjuryNov 26, 2019Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information; Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information

  ATTORNEY ALLEGES THAT ON (B)(6) 2011, THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL VENTRALEX (DEVICE #1). IT IS ALLEGED THAT ON (B)(6) 2013, THE PATIENT HAD UNSPECIFIED INJURIES RELATED TO A DEFECT IN THE VENTRALEX (DEVICE #1), UNDERWENT REVISION SURGERY, AND IMPLANT OF AN UNSPECIFIED BARD/DAVOL VENTRIO ST (DEVICE #2). IT IS ALLEGED THAT ON (B)(6) 2016, THE PATIENT HAD UNSPECIFIED INJURIES RELATED TO A DEFECT IN THE VENTRALEX (DEVICE #1) AND VENTRIO ST (DEVICE #2), AND UNDERWENT REVISION SURGERY. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE VENTRALEX (DEVICE #1) AND VENTRIO ST (DEVICE #2). AS REPORTED, THE 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."

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

  MAUDE report 9379409 ↗
• InjurySep 17, 2019Defective Device; Material Deformation; Insufficient Device Problem Information; Migration; Defective Device; Material Deformation; Insufficient Device Problem Information; Migration

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL BARD MESH (DEVICE #1) ON (B)(6) 2016 AND AN UNSPECIFIED BARD/DAVOL VENTRIO ST (DEVICE #2) ON (B)(6) 2017. IT IS ALSO ALLEGED BY PATIENT'S ATTORNEY THAT THE PATIENT HAD UNSPECIFIED INJURIES RELATED TO A DEFECT IN THE BARD MESH (DEVICE #1) AND VENTRIO ST (DEVICE #2), AND UNDERWENT REVISION SURGERY ON (B)(6) 2017 AND (B)(6) 2017. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE BARD MESH (DEVICE #1) AND THE VENTRIO ST (DEVICE #2). AS REPORTED, THE 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."

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

  MAUDE report 9079078 ↗
• InjuryAug 22, 2019Defective Device; Insufficient Device Problem Information; Patient Device Interaction Problem; Defective Device; Insufficient Device Problem Information; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF TWO (2) UNSPECIFIED BARD/DAVOL VENTRIO ST(DEVICE #1 AND DEVICE #2 )ON (B)(6) 2012. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE TWO (2) VENTRIO ST(DEVICE #1 AND DEVICE #2). AS REPORTED, THE 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."

  Patient problems: Abscess; Adhesion(s); Bowel Perforation; Disability; Fibrosis; Fistula; Inflammation; Injury; Pain; Unspecified Infection

  MAUDE report 8919955 ↗
• InjuryNov 21, 2018Defective Device; Insufficient Device Problem Information; Defective Device; Insufficient Device Problem Information

  THE FOLLOWING WAS ALLEGED BY THE PATIENT'S ATTORNEY: (B)(6) 2014: THE PATIENT UNDERWENT REPAIR OF AN INCISIONAL HERNIA. A BARD/DAVOL VENTRIO ST (DEVICE #1) WAS IMPLANTED IN THE PATIENT DURING THIS REPAIR. ON (B)(6) 2015: THE PATIENT UNDERWENT SURGERY FOR RECURRENT INCISIONAL HERNIA REPAIR. THE PHYSICIAN PERFORMED EXTENSIVE LYSIS OF ADHESIONS WHICH WERE DENSELY ADHERENT TO THE MESH. THE PHYSICIAN FURTHER NOTED THAT THE SMALL BOWEL WAS ALSO DENSELY ADHERENT TO THE MESH. ALTHOUGH MOST OF THE SMALL BOWEL WAS TAKEN DOWN (OFF THE MESH), A PORTION STILL REMAINED DENSELY ADHERENT TO THE MESH, AND FURTHER DISSECTION WAS NOT PERFORMED TO AVOID THE RISK OF ENTEROTOMY. THE PATIENT WAS IMPLANTED WITH A BARD/DAVOL VENTRIO ST (DEVICE #2) ON (B)(6) 2015: THE PATIENT ONCE AGAIN UNDERWENT SURGERY, WHEREBY DUE TO PNEUMOPERITONEUM, A PORTION OF THE MESH INITIALLY IMPLANTED ON (B)(6) 2014 ("OLD MESH") WAS REMOVED. THE MESH IMPLANTED ON (B)(6) 2015 WAS COMPLETELY REMOVED. THE PHYSICIAN NOTED THAT PORTIONS OF THE SMALL BOWEL HAD REMAINED ADHERENT TO THE OLD MESH. SEROUS FLUID WAS EVACUATED. THE PATIENT IS AT HIGH RISK OF MESH INFECTION FROM THE REMAINING PIECE OF THE OLD MESH, AND AT SIGNIFICANT RISK OF

  Patient problems: Adhesion(s); Disability; Hernia

  MAUDE report 8097276 ↗
• InjurySep 17, 2018Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information; Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information

  THE FOLLOWING WAS ALLEGED BY THE PATIENT'S ATTORNEY: ON (B)(6) 2016:THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL VENTRIO ST. THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE BARD/DAVOL VENTRIO ST. THE 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."

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

  MAUDE report 7882130 ↗
• InjuryJul 12, 2018Defective Device; Insufficient Device Problem Information; Patient Device Interaction Problem; Migration; Defective Device; Insufficient Device Problem Information; Patient Device Interaction Problem; Migration

  THE FOLLOWING WAS ALLEGED BY THE PATIENT'S ATTORNEY: ON (B)(6) 2015 - THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL VENTRIO ST (DEVICE 1). ON (B)(6) 2015 - THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL PHASIX MESH. AS ALLEGED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE VENTRIO ST (DEVICE 1) ONLY. AS REPORTED, THE PATIENT'S ATTORNEY ALLEGES A GENERAL CLAIM RELATED TO THE VENTRIO ST (DEVICE 1) "FOR PAST, PRESENT, AND FUTURE DAMAGES, INCLUDING BUT NOT LIMITED TO, MENTAL AND PHYSICAL PAIN AND SUFFERING FOR SEVERE AND PERMANENT PERSONAL INJURIES SUSTAINED."

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

  MAUDE report 7683278 ↗
• InjuryJul 10, 2018Defective Device; Insufficient Device Problem Information; Patient Device Interaction Problem; Defective Device; Insufficient Device Problem Information; Patient Device Interaction Problem

  THE FOLLOWING WAS ALLEGED BY THE PATIENT'S ATTORNEY: ON (B)(6) 2013: THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL VENTRIO ST. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE BARD/DAVOL VENTRIO ST. AS REPORTED, THE 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.¿

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

  MAUDE report 7674619 ↗
• InjuryMay 22, 2018Defective Device; Insufficient Device Problem Information; Patient Device Interaction Problem; Defective Device; Insufficient Device Problem Information; Patient Device Interaction Problem

  THE FOLLOWING WAS ALLEGED BY THE PATIENT'S ATTORNEY: ON (B)(6) 2016: THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL VENTRIO ST. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE BARD/DAVOL VENTRIO ST. AS REPORTED, THE 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.¿

  Patient problems: Abscess; Adhesion(s); Bacterial Infection; Disability; Fistula; Fungal Infection; Inflammation; Injury; Pain; Purulent Discharge

  MAUDE report 7532844 ↗
• InjuryApr 13, 2018Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information; Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information

  THE FOLLOWING WAS ALLEGED BY THE PATIENT'S ATTORNEY: ON (B)(6) 2015 AND (B)(6) 2015 THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL BARD FLAT MESH OR AN UNSPECIFIED BARD/DAVOL VENTRIO ST (DEVICE #1). AS REPORTED, THE PATIENT IS ONLY MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE VENTRIO ST (DEVICE #1). AS REPORTED, THE ATTORNEY ALLEGES GENERAL ALLEGATIONS AGAINST THE VENTRIO ST 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.¿

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

  MAUDE report 7428646 ↗
• InjuryApr 10, 2018Defective Device; Insufficient Device Problem Information; Patient Device Interaction Problem; Migration; Defective Device; Insufficient Device Problem Information; Patient Device Interaction Problem; Migration

  THE FOLLOWING WAS ALLEGED BY THE PATIENT'S ATTORNEY: ON (B)(6) 2013 - THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL VENTRIO. AS REPORTED, THE PATIENT'S ATTORNEY ALLEGES A GENERAL CLAIM "FOR PAST, PRESENT, AND FUTURE DAMAGES, INCLUDING BUT NOT LIMITED TO, MENTAL AND PHYSICAL PAIN AND SUFFERING FOR SEVERE AND PERMANENT PERSONAL INJURIES SUSTAINED".

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

  MAUDE report 7412705 ↗
• InjuryMar 20, 2018Defective Device; Insufficient Device Problem Information; Patient Device Interaction Problem; Defective Device; Insufficient Device Problem Information; Patient Device Interaction Problem

  THE FOLLOWING WAS ALLEGED BY THE PATIENT'S ATTORNEY: ON (B)(6) 2016 - THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL VENTRIO ST. ON (B)(6) 2017 - THE PATIENT WAS INJURED. AS REPORTED, THE PATIENT'S ATTORNEY ALLEGES A GENERAL CLAIM "FOR PAST, PRESENT, AND FUTURE DAMAGES, INCLUDING BUT NOT LIMITED TO, MENTAL AND PHYSICAL PAIN AND SUFFERING FOR SEVERE AND PERMANENT PERSONAL INJURIES SUSTAINED".

  Patient problems: Disability; Fistula; Impaired Healing; Injury; Pain; Seroma; Unspecified Infection

  MAUDE report 7355847 ↗
• InjuryJul 7, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  THE FOLLOWING WAS REPORTED TO DAVOL: ON (B)(6) 2015 - THE PATIENT UNDERWENT REPAIR OF THE LARGE RECURRENT HERNIA. DURING THIS PROCEDURE IT IS REPORTED THAT THE PATIENT WAS IMPLANTED WITH A BARD VENTRIO ST HERNIA PATCH. AS REPORTED, POSTOPERATIVELY THE PATIENT EXPERIENCED ABDOMINAL WOUND DEHISCENCE AND WOUND HEALING COMPLICATIONS. THE PATIENT UNDERWENT EXTENSIVE WOUND CARE TREATMENTS TO HEAL HER ABDOMINAL WOUND. AS REPORTED THE PATIENT HAS BEEN EXPERIENCING CHRONIC ABDOMINAL PAIN SINCE THE 2015 HERNIA REPAIR. THE PAIN IS REPORTED TO BE INTERMITTENT AND THE PATIENT CAN FEEL "IN FOUR CORNERS OF HER STOMACH SHARP PAIN." ALSO REPORTED IS LABORED BREATHING, NAUSEA AND FREQUENT BOWEL ISSUES (DIARRHEA). THE PATIENT HAS TO FREQUENTLY CALL OUT SICK FROM WORK DUE TO HER SYMPTOMS. THE PATIENT HAS SEEN MULTIPLE DOCTORS REGARDING THE REPORTED ISSUES. SHE HAD 2 CT SCANS PERFORMED WHICH HAD NO FINDINGS. THE PATIENT HAS BEEN EVALUATED FOR INFECTIONS AND THOSE REPORTS ARE NEGATIVE AS WELL. AS REPORTED THE DOCTORS DO NOT KNOW WHAT IS CONTRIBUTING TO THE REPORTED ISSUES. THE CONTACT STATED THAT THE PATIENT IS VERY DEPRESSED FROM EXPERIENCING ALL THESE ISSUES AND HAS BEEN PUT ON AN ANTIDEPRESSANT FROM

  Patient problems: Impaired Healing; Pain; Wound Dehiscence

  MAUDE report 6692830 ↗