VENTRIO 5950080Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00801741031571), received between Oct 18, 2017 and Mar 26, 2026 — classified as 20 injuries, 1 malfunction.

The most frequently reported specific device problem is “Defective Device” (14 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• InjuryMar 26, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2012 - PATIENT WAS DIAGNOSED WITH INCISIONAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT OF VENTRALIGHT ST MESH USING ECHO PS (DEVICE 1). PER OP NOTES, "A VENTRALIGHT ST MESH USING ECHO PS (DEVICE 1) WAS PLACED TO THE UMBILICUS USING TACKS." ON (B)(6) 2012 - PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH REMOVAL OF MESH (DEVICE 1) AND IMPLANT OF VENTRIO ST (DEVICE 2). PER OP NOTES, "AN UPPER MIDLINE INCISION WAS THEN MADE. THE MESH WAS THEN OPENED AND THERE WAS ADHESIONS UNDERLYING THE MESH, THESE ADHESIONS WERE TAKEN DOWN AND THE MESH (DEVICE 1) WAS REMOVED. A VENTRIO ST MESH (DEVICE 2) WAS PLACED TO THE ABDOMINAL WALL AND A SYNTHETIC MESH ALSO PLACED." ON (B)(6) 2014 - PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA AND UMBILICAL HERNIA THEREBY UNDERWENT REPAIR. PER OP NOTES, "UMBILICAL HERNIA WAS NOTED AND ABOVE THIS THE INCISIONAL HERNIA WAS ALSO ENTERED. THE PANNUS WAS THEN REMOVED OFF OF THE ABDOMINAL WALL. THE PREVIOUS MESH WAS NOTED."

  Patient problems: Hernia

  MAUDE report 24696337 ↗
• InjuryDec 12, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2007 ¿ PATIENT WAS DIAGNOSED WITH INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF COMPOSIX E/X MESH (DEVICE 1). PER OPERATIVE NOTES, ¿ IN THE MIDLINE, THE HERNIA DEFECT WITH SAC WAS RESECTED. THE ADHESIONS WERE REMOVED, AND COMPOSIX E/X MESH (DEVICE 1) WAS PLACED OVER THE HERNIA DEFECT AND SECURED WITH SUTURES CIRCUMFERENTIALLY.¿ ON (B)(6) 2008 ¿ PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA (X2) THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF COMPOSIX MESH (DEVICE 2) AND COMPOSIX E/X MESH (DEVICE 3). PER OPERATIVE NOTES, ¿THE HERNIA DEFECTS SUPERIOR AND INFERIOR TO THE PRIOR INCISIONAL HERNIA WAS NOTED. TWO HERNIA DEFECT WITH SACS WERE REDUCED. THE UPPER HERNIA WAS REPAIRED AND COMPOSIX MESH (DEVICE 2) WAS PLACED AND TO THE INFERIOR DEFECT, COMPOSIX E/X MESH (DEVICE 3) WAS PLACED AND SECURED AND IRRIGATED.¿ ON (B)(6) 2018 - PATIENT WAS DIAGNOSED WITH SMALL BOWEL OBSTRUCTION AND ADHESIONS TO PRIOR MESH THEREBY UNDERWENT OPEN REPAIR WITH REMOVAL OF MESHES (DEVICE 1, 2 AND 3) AND IMPLANT OF VENTRIO ST MESH (DEVICE 4). PER OPERATIVE NOTES, ¿THE DENSE SCAR TISSUES WERE EXCISED. THE SEROMA CAVITY OVERLYING MESH WAS DRAINED. THRE

  Patient problems: Adhesion(s); Bowel Perforation

  MAUDE report 23787957 ↗
• InjurySep 12, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2014 - PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF VENTRALIGHT ST (DEVICE 1). PER OP NOTES, ¿THE OMENTUM AND BOWEL ADHESIONS WERE LYSED. TWO HERNIA DEFECTS WERE IDENTIFIED AND REDUCED. A VENTRALIGHT ST (DEVICE 1) WAS PLACED AND TACKED USING SUTURES.¿ (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH INCARCERATED RECURRENT VENTRAL HERNIA WITH PAIN THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH EXCISION OF VENTRALIGHT ST (DEVICE 1) AND IMPLANT OF VENTRIO ST (DEVICE 2). PER OP NOTES, ¿LARGE AMOUNT OF ADHESIONS WAS LYSED. ADHESIOLYSIS AND ENTEROLYSIS WERE PERFORMED. THE COLON ADHERENT TO MESH WAS LYSED. THE PRIOR MESH (DEVICE 1) WAS EXCISED. LARGE HERNIA SACS WERE IDENTIFIED AND EXCISED. A VENTRIO ST (DEVICE 2) WAS PLACED AND SUTURED.¿ (B)(6) 2020 - PATIENT WAS DIAGNOSED WITH MULTIPLE RECURRENT INCARCERATED VENTRAL HERNIA AND SMALL BOWEL OBSTRUCTION THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRIO ST (DEVICE 3). PER OP NOTES, ¿LARGE HERNIA SACS WERE IDENTIFIED AND OPENED. THE LOOPS OF SMALL BOWEL WERE NOTED AND RELEASED. THE BOWEL WAS REDUCED. THE SAC WAS RESECTED. THE BOWEL ADHERENT TO ABDOMINAL WAL

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

  MAUDE report 23035523 ↗
• InjuryMar 1, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED, DURING ELECTIVE LAPAROSCOPIC AND OPEN REPAIR OF INCISIONAL HERNIA ON (B)(6) 2021, THE PATIENT WAS IMPLANTED WITH A VENTRIO ST MESH (DEVICE #1). A VENTRALIGHT ST MESH (DEVICE #2) WAS USED TO EXTEND THE MIDLINE COVERAGE. IT WAS REPORTED THAT, 9-MONTHS POST-IMPLANT, THE PATIENT WAS DIAGNOSED WITH AN INFECTION. AS REPORTED, DURING (B)(6) 2022, THE PATIENT WAS DIAGNOSED WITH A COLO-CUTANEOUS FISTULA THROUGH THE MESH, WHICH WAS MANAGED WITH IVABS, SKIN MANAGEMENT AND NUTRITION. IN (B)(6) 2023, THE PATIENT UNDERWENT A LAPAROTOMY, EXCISION OF COLO-CUTANEOUS FISTULA, MESH AND MIDLINE REPAIR.

  Patient problems: Fistula; Unspecified Infection

  MAUDE report 16460534 ↗
• InjuryJan 20, 2023Defective 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) 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.

  Patient problems: Fistula; Insufficient Information; Unspecified Infection

  MAUDE report 16213833 ↗
• MalfunctionNov 2, 2022Expiration Date Error; Expiration Date Error

  AS REPORTED, DURING AN OPEN VENTRAL HERNIA REPAIR PROCEDURE ON (B)(6) 2022, THE PATIENT WAS IMPLANTED WITH AN EXPIRED BARD/DAVOL VENTRIO ST MESH WHICH HAD EXPIRED ON (B)(6) 2022. AS REPORTED, THERE WAS NO MEDICAL INTERVENTION POST IMPLANT AND THERE IS NO PATIENT HARM OR INJURY AS A RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15713673 ↗
• InjuryJun 3, 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), BARD/DAVOL COMPOSIX KUGEL HERNIA PATCH AND VENTRIO ST ON (B)(6) 2005 AND/OR (B)(6) 2010 AND/OR (B)(6) 2012. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST ALL THE DEVICES. ATTORNEY ALSO ALLEGES THAT THE PATIENT SUSTAINED INJURIES ON (B)(6) 2009, (B)(6) 2010, (B)(6) 2011, (B)(6) 2012 AND ON (B)(6) 2014. 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 14593858 ↗
• InjuryOct 29, 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 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; Seroma

  MAUDE report 12721859 ↗
• InjuryMar 16, 2021Device Appears to Trigger Rejection; Defective 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) C2016. 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: Abscess; Adhesion(s); Impaired Healing; Insufficient Information; Unspecified Infection

  MAUDE report 11494607 ↗
• InjuryFeb 25, 2021Defective Device; Insufficient Device Problem Information; Defective Device; Insufficient Device Problem Information

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR A REPAIR OF A MIDLINE INCISIONAL HERNIA AND A BARD/DAVOL VENTRIO ST HERNIA PATCH WAS IMPLANTED ON OR ABOUT (B)(6) 2015. THE PATIENT UNDERWENT REVISION SURGERY OF THE VENTRIO ST AND WAS IMPLANTED WITH NON-BARD/DAVOL MESH TO REPAIR A RECURRENT HERNIA ON OR ABOUT (B)(6) 2018. THE PATIENT UNDERWENT REVISION SURGERY OF THE MESH PRODUCTS ON OR ABOUT (B)(6) 2018. IT IS ALLEGED THAT THE PATIENT CONTINUES TO EXPERIENCE COMPLICATIONS RELATED TO THE MESH PRODUCTS, INCLUDING SEVERE AND CHRONIC PAIN/DISCOMFORT, ADHESIONS TO THE BOWEL, BOWEL BLOCKAGE, HEMATOMA, AND RECURRENCE, AND WILL LIKELY REQUIRE ADDITIONAL SURGERIES TO REPAIR THE DAMAGE FROM THE MESH PRODUCTS IF THE COMPLICATIONS CONTINUE. 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 DEVICE WAS DEFECTIVE.

  Patient problems: Disability; Hernia; Obstruction/Occlusion

  MAUDE report 11380657 ↗
• InjurySep 9, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A PATIENT WHO HAD PREVIOUSLY BEEN IMPLANTED WITH A PHASIX MESH PRESENTED WITH A RECURRENCE OF THE HERNIA. ON (B)(6) 2020 THE PATIENT UNDERWENT A REVISION PROCEDURE TO REPAIR THE RECURRENCE. AS REPORTED, A VENTRIO ST MESH WAS PULLED FROM THE HOSPITAL SHELF AND USED FOR REINFORCEMENT OF THE RECURRENT HERNIA. THE SURGEON PLACED THE VENTRIO ST MESH IN THE PATIENT AND THEN USED A NON-BARD/DAVOL FIXATION SYSTEM TO PLACE 33 TACKS THROUGH THE OUTER POCKET AND INTO THE PATIENT. WHILE SUTURING THE FASCIA TO THE INNER POCKET, THE SURGEON SAW SOMETHING AND USED PICK-UPS TO PULL OUT A (APPROXIMATELY) 7¿ LONG DARK HAIR FROM THE INNER POCKET OF THE MESH. AFTER DISCUSSION WITH SEVERAL INDIVIDUALS, IT WAS ASSUMED THAT THE HAIR WAS IN BETWEEN THE POSTERIOR AND ANTERIOR MESH ON THE VENTRIO ST, AND WAS THEREFORE STERILIZED. THE HAIR WAS REMOVED, MESH WASHED OUT, AND A DRAIN WAS PLACED IN THE PATIENT TO MONITOR OUTPUT.

  Patient problems: Injury

  MAUDE report 10507787 ↗
• InjuryJul 22, 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 VENTRIO ST (X2) ON (B)(6) 2019 AND (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 EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Hernia; Injury

  MAUDE report 10306531 ↗
• InjuryDec 20, 2019Defective 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) 2012. 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: Abscess; Disability; Injury; Obstruction/Occlusion; Pain; Unspecified Infection

  MAUDE report 9504353 ↗
• InjuryNov 4, 2019Defective Device; Insufficient Device Problem Information; Patient Device Interaction Problem; Defective Device; Insufficient Device Problem Information; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT ON (B)(6) 2014, THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL VENTRIO ST. IT IS ALLEGED THAT THE PATIENT HAD SUBSEQUENT SURGICAL INTERVENTION DUE TO THE HERNIA MESH DEVICE. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE VENTRIO ST. AS REPORTED, THE ATTORNEY ALLEGES PRODUCT IS DEFECTIVE AND THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS. ADDENDUM PER ADDITIONAL INFORMATION PROVIDED: ON (B)(6) 2014 - PATIENT WAS DIAGNOSED WITH MULTIPLE ABDOMINAL WALL VENTRAL HERNIAS THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRIO ST MESH. PER OPERATIVE NOTES, "DISSECTED THE HERNIA SAC FREE DOWN TO THE FASCIAL EDGES. A 20X15 CM PIECE OF VENTRIO ST PATCH WAS PLACED AND SUTURED." ON (B)(6) 2016 - PATIENT WAS DIAGNOSED WITH INTERNAL HERNIA AND BOWEL OBSTRUCTION THEREBY UNDERWENT OPEN REPAIR WITH REMOVAL OF MESH. PER OPERATIVE NOTES, "FOUND VERY DENSE ADHESIONS FROM THE BOWEL TO THE UNDERSURFACE OF THE PREVIOUSLY PLACED SYNTHETIC MESH. DETACHED THE SMALL BOWEL AND LARGE BOWEL WHICH WAS DENSELY ADHERENT TO THE MESH AND A PIECE OF BIOLOGICAL MESH WAS PLACED." ATTORNEY ALLEGED THAT THE PATIENT HAD ADHESIONS, BOWEL OB

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

  MAUDE report 9274581 ↗
• InjurySep 27, 2019Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information; Defective Device; Insufficient Device Problem Information

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL COMPOSIX (DEVICE #1) OR AN UNSPECIFIED BARD/DAVOL VENTRIO ST (DEVICE #2) AND AN UNSPECIFIED BARD/DAVOL UNKNOWN BARD HERNIA MESH (DEVICE #3) SOMETIME IN 2012. 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 COMPOSIX (DEVICE #1), THE VENTRIO ST (DEVICE #2) AND AN UNKNOWN BARD HERNIA MESH (DEVICE #3). AS REPORTED, THE ATTORNEY ALLEGES PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Abscess; Adhesion(s); Injury; Scar Tissue; Unspecified Infection

  MAUDE report 9131537 ↗
• InjurySep 26, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT ON (B)(6) 2019 THE PATIENT UNDERWENT THE REPAIR OF A VENTRAL INCISIONAL HERNIA AND WAS IMPLANTED WITH A BARD VENTRIO ST MESH. ON (B)(6) 2019, THE PATIENT PRESENTED WITH ABDOMINAL PAIN. CONTRAST CT REVEALED THAT THERE WAS PERFORATION OF THE SMALL BOWEL. ON (B)(6) 2019, THE PATIENT UNDERWENT SURGERY FOR THE REPAIR OF THE PERFORATED BOWEL AND MESH REMOVAL. THE PERFORATION WAS CLOSED BY SUTURING. DURING THE SURGERY, THE DOCTOR DID NOT FIND THAT THE MESH WAS ADHERED TO THE SMALL BOWEL. NO OTHER PATIENT INJURY WAS REPORTED.

  Patient problems: Bowel Perforation; Pain

  MAUDE report 9125360 ↗
• InjuryJun 18, 2019Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information; Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information

  ATTORNEY ALLEGES THAT ON (B)(6) 2016, THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL VENTRIO ST. IT IS ALLEGED THAT ON (B)(6) 2016, THE PATIENT HAD UNSPECIFIED INJURIES RELATED TO A DEFECT IN THE BARD DAVOL VENTRIO ST, AND UNDERWENT REVISION SURGERY. 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; Seroma; Unspecified Infection

  MAUDE report 8707709 ↗
• InjuryApr 17, 2019Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information; Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information

  IT IS ALLEGED BY THE PATIENT'S ATTORNEY THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL VENTRIO ST (DEVICE 1 AND DEVICE 2) ON (B)(6) 2012 AND (B)(6) 2014. IT IS ALSO ALLEGED BY PATIENT ATTORNEY THAT ON (B)(6) /2017, THE PATIENT HAD UNSPECIFIED INJURIES. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE TWO VENTRIO ST DEVICES. 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; Scar Tissue

  MAUDE report 8524428 ↗
• InjuryApr 5, 2019Defective Device; Insufficient Device Problem Information; Patient Device Interaction Problem; Defective Device; Insufficient Device Problem Information; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT ON (B)(6) 2011, THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL COMPOSIX L/P. IT IS ALLEGED THAT ON (B)(6) 2013, THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL VENTRIO (DEVICE #1). AS ALLEGED, ON (B)(6) /2014, THE PATIENT HAD UNSPECIFIED INJURIES RELATED TO A DEFECT IN THE VENTRIO (DEVICE #1), AND UNDERWENT REVISION SURGERY. AS REPORTED, THE PATIENT IS ONLY MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE VENTRIO (DEVICE #1). 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; Erosion; Fistula; Hernia; Inflammation; Injury; Pain; Unspecified Infection

  MAUDE report 8488546 ↗
• InjuryNov 15, 2018Defective Device; No Apparent Adverse Event; Insufficient Device Problem Information; Defective Device; No Apparent Adverse Event; Insufficient Device Problem Information

  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) 2016 : THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL VENTRIO ST(DEVICE #2). THE PATIENT HAD UNSPECIFIED INJURIES. THE PATIENT IS ONLY MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE TWO(2) VENTRIO ST(DEVICE #1 AND DEVICE #2). 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: Disability; Injury; No Clinical Signs, Symptoms or Conditions; Pain

  MAUDE report 8075738 ↗
• InjuryOct 18, 2017Defective Device; Insufficient Device Problem Information; Patient Device Interaction Problem; Defective Device; Insufficient Device Problem Information; Patient Device Interaction Problem

  THE FOLLOWING WAS REPORTED TO DAVOL BY THE PATIENT'S ATTORNEY: ON (B)(6) 2014 - THE PATIENT HAD A VENTRIO ST HERNIA PATCH IMPLANTED TO REPAIR A INCISIONAL HERNIA DEFECT. ON (B)(6) 2015 - THE PATIENT UNDERWENT AN ADDITIONAL SURGERY TO REPAIR THE HERNIA DEFECT AND REMOVE THE INFECTED SYNTHETIC MESH WITH ABSCESS CAVITY. THE ATTORNEY ALLEGES THE PATIENT WAS INJURED SEVERELY AND PERMANENTLY AND HAS SUFFERED AND WILL CONTINUE TO SUFFER PHYSICAL PAIN.

  Patient problems: Abdominal Pain; Abscess; Disability; Hernia; Unspecified Infection

  MAUDE report 6957484 ↗