VENTRIO 5950070Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 00801741031564), received between Feb 13, 2018 and Mar 2, 2026 — classified as 28 injuries, 1 malfunction.

The most frequently reported specific device problem is “Defective Device” (24 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 29 reports, in the reporter's own words as published by the FDA.

• InjuryMar 2, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2018 - PATIENT WAS DIAGNOSED WITH INCARCERATED INCISIONAL HERNIA, ADHESIONS THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRIO ST MESH (DEVICE 1 AND DEVICE 2). PER OPERATIVE NOTES, ¿A MIDLINE INCISION WAS MADE FROM JUST ABOVE THE UMBILICUS. THERE WERE ADHESIONS INTO THE ABDOMINAL WALL WHICH WERE DISSECTED OUT. TWO VENTRIO ST MESH (DEVICE 1 AND DEVICE 2) WAS PLACED TOGETHER FOR BETTER COVERAGE AND CLOSED WITH SUTURES.¿ (B)(6) 2018 - PATIENT WAS DIAGNOSED WITH INCARCERATED RECURRENT VENTRAL HERNIA, SCAR TISSUE, THEREBY UNDERWENT OPEN PRIMARY HERNIA REPAIR, RESECTION OF PORTION OF SMALL BOWEL, ABDOMINAL WASHOUT. PER OPERATIVE NOTES, ¿AN INCISION WAS MADE THROUGH PREVIOUS INCISION. PRIOR SCAR TISSUES WERE REMOVED. PREVIOUSLY PLACED VENTRIO ST MESH (DEVICE 1 AND DEVICE 2) HAD INCORPORATED INTO THE FASCIA. WOUND WAS IRRIGATED AND VAC PLACEMENT WAS DONE.¿ (B)(6) 2019 - PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA, SEROMA THEREBY UNDERWENT OPEN PRIMARY HERNIA REPAIR. PER OPERATIVE NOTES, ¿A MIDLINE INCISION WAS MADE OVER THE PREVIOUS SCAR. THE VENTRAL HERNIA SAC WAS DISSECTED OUT. DENSE AMOUNT OF SEROSAL FLUID WAS PRESENT INTO THE ABDOMINAL WAL

  Patient problems: Adhesion(s); Hernia; Seroma

  MAUDE report 24485034 ↗
• InjuryMay 5, 2025Defective Device; Material Deformation; Patient Device Interaction Problem; Defective Device; Material Deformation; Patient Device Interaction Problem

  PER INFORMATION PROVIDED: (B)(6) 2003 - PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF COMPOSIX KUGEL MESH (DEVICE #1). PER OPERATIVE NOTES, ¿THE PATIENT NOTED TO HAVE OMENTAL ADHESIONS IN THE HERNIA SAC WAS REDUCED. A FASCIAL DEFECT WAS ENCOUNTERED. A MEDIUM COMPOSIX KUGEL PATCH (DEVICE #1) WAS PLACED ON TOP OF THE OMENTUM AND SECURED TO THE ANTERIOR ABDOMINAL WALL USING SPIRAL TACKING DEVICE.¿ (B)(6) 2012 - PATIENT WAS DIAGNOSED WITH VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE REMOVAL OF MESH (DEVICE #1) AND IMPLANT OF VENTRIO ST MESH (DEVICE #2). PER OPERATIVE NOTES, ¿EXTENSIVE ADHESIOLYSIS WAS PERFORMED. A UPPER VENTRAL INCISION REVEALED DISTORTED PRIOR MESH (DEVICE #2) WAS EXCISED. A OVAL VENTRIO ST HERNIA PATCH (DEVICE #2) WAS PLACED AND SECURED TO THE OVERLYING PERITONEUM AND FASCIA USING SUTURES.¿ (B)(6) 2017 - PATIENT WAS DIAGNOSED WITH PARAESOPHAGEAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT OF SYNTHETIC MESH. (B)(6) 2019 - PATIENT WAS DIAGNOSED WITH EVENTRATION OF ANTERIOR ABDOMINAL WALL THEREBY UNDERWENT ROBOTIC ASSISTED REPAIR. PER OPERATIVE NOTES, ¿ADHESIONS TO THE ANTERIOR ABDOMIN

  Patient problems: Adhesion(s)

  MAUDE report 21959006 ↗
• InjuryJul 22, 2024Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF VENTRIO ST MESH (LOT #HUBY1616 AND CAT #5950070) ON 20-JUN-2019. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE VENTRIO ST MESH. ATTORNEY ALLEGES THAT THE PATIENT HAD SUBSEQUENT SURGICAL INTERVENTION DUE TO THE HERNIA MESH DEVICE. IT IS ALSO ALLEGED THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Insufficient Information

  MAUDE report 19791437 ↗
• InjuryApr 23, 2024Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  PER INFORMATION PROVIDED BY THE ATTORNEY: ON (B)(6) 2012 - PATIENT WITH THE HISTORY OF PRIMARY UMBILICAL HERNIA REPAIR DEVELOPED RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF COMPOSIX KUGEL (DEVICE #1). PER OPERATIVE NOTES, "THE HERNIA SAC WAS IDENTIFIED JUST INFERIOR TO THE UMBILICUS AND AMPUTATED. A PIECE OF COMPOSIX KUGEL MESH (DEVICE #1) WAS IRRIGATED IN ANTIBIOTIC SOLUTION AND SECURED IN PLACE WITH SUTURE." 07-APR-2014 - PATIENT DEVELOPED ABDOMINAL PAIN, ABDOMINAL DISTENTION, LIGHTHEADED, NAUSEA AND VOMITING THEREBY UNDERWENT CT SCAN. ON (B)(6) 2014 - PATIENT WAS DIAGNOSED WITH LARGE INCISIONAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH VENTRIO ST MESH (DEVICE #2), IYSIS OF ADHESIONS AND REMOVAL OF MESH (DEVICE #1). PER OPERATIVE NOTES, ¿THERE WAS A LARGE INCISIONAL HERNIA AND A LARGE HERNIA SAC WHICH CONTAINED OLD MESH. THERE WAS A DENSE ADHESION OF THE OMENTUM TO THE MESH, AND A SEGMENT OF THE SMALL BOWEL WAS ALSO ADHERED TO THE MESH WHICH WERE TAKEN DOWN WITH SHARP DISSECTION. THE SMALL BOWEL WAS FREED AND HERNIA SAC WAS THEN EXCISED. A VENTRIO ST MESH (DEVICE #2) WAS THEN PLACED INTO THE ABDOMINAL CAVITY AND TACKED.¿ 29-JUL-2014 - PAT

  Patient problems: Abdominal Pain; Hematoma; Seroma

  MAUDE report 19166707 ↗
• InjuryOct 10, 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 UNSPECIFIED BARD/DAVOL VENTRALEX ST PATCH AND VENTRIO ST ON (B)(6) 2012 AND/OR (B)(6) 2015. 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: Insufficient Information; Pain

  MAUDE report 17905473 ↗
• InjuryMay 18, 2023Defective Device; Patient-Device Incompatibility; Patient Device Interaction Problem; Defective Device; Patient-Device Incompatibility; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF UNSPECIFIED BARD/DAVOL COMPOSIX KUGEL HERNIA PATCH AND VENTRIO ST ON (B)(6) 2011 AND/OR (B)(6) 2015 AND/OR (B)(6) 2019. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST ALL THE DEVICES. IT IS ALLEGED THAT THE PATIENT SUSTAINED INJURIES ON (B)(6) 2014, (B)(6) 2015 AND (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. ADDENDUM PER ADDITIONAL INFORMATION PROVIDED: (B)(6) 2011 - PATIENT WAS DIAGNOSED WITH INCARCERATED INCISIONAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT OF COMPOSIX KUGEL MESH (DEVICE 1). PER OP NOTES, "A COMPOSIX KUGEL MESH (DEVICE 1) WAS PLACED INTO THE ABDOMEN USING TACKS." (B)(6) 2014 - PATIENT WAS DIAGNOSED WITH INCISIONAL HERNIA THEREBY UNDERWENT REPAIR WITH PARTIAL REMOVAL OF MESH (DEVICE 1). PER OP NOTES, "THE SMALL BOWEL WAS DENSELY ADHERENT TO THE MESH AND THE MESH WAS SE

  Patient problems: Insufficient Information; Pain

  MAUDE report 16951269 ↗
• InjuryJun 3, 2022Defective Device; Patient Device Interaction Problem; Migration; Defective Device; Patient Device Interaction Problem; Migration

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL VENTRIO ON (B)(6) 2013. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE VENTRIO. IT IS ALLEGED THAT THE PATIENT SUSTAINED INJURIES ON (B)(6) 2020. 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; Fistula; Insufficient Information; Pain; Unspecified Infection

  MAUDE report 14593188 ↗
• InjuryMay 24, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  REPORTED PER CLINICAL TRIAL (B)(6): ON (B)(6) 2016 - SUBJECT PATIENT UNDERWENT OPEN FIRST-TIME RECURRENT MIDLINE UMBILICAL HERNIA REPAIR PROCEDURE DURING WHICH A BARD/DAVOL VENTRIO ST MESH WAS IMPLANTED USING A NON-BARD/DAVOL FIXATION DEVICE. THE FASCIA WAS COMPLETELY CLOSED USING SUTURE AND FULL SKIN CLOSURE WAS ACHIEVED USING STAPLES. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON THE SAME DAY. ON (B)(6) 2018 - CT SCAN REVEALED INCISIONAL HERNIA RECURRENCE OF SIZE 1CM X 7.9CM. THE PATIENT WAS NOT MEDICALLY CLEARED FOR SURGERY AT THAT TIME. PER THE STUDY CLINICIAN, THE REPORTED ADVERSE EVENT HAS BEEN ASSESSED AS MODERATE IN SEVERITY, POSSIBLY RELATED TO THE STUDY DEVICE AND DEFINITELY RELATED TO THE INDEX PROCEDURE. THE OUTCOME FOR THIS AE IS REPORTED AS RECOVERING/RESOLVING.

  Patient problems: Hernia

  MAUDE report 14488211 ↗
• InjuryApr 21, 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) 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); Insufficient Information; Obstruction/Occlusion

  MAUDE report 14166368 ↗
• InjuryJan 23, 2022Defective Device; Material Deformation; Patient Device Interaction Problem; Defective Device; Material Deformation; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL VENTRIO ST ON (B)(6) 2015. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE VENTRIO ST. ATTORNEY ALLEGES THAT THE PATIENT HAD SUBSEQUENT SURGICAL INTERVENTION DUE TO THE HERNIA MESH DEVICE. IT IS ALSO ALLEGED THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

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

  MAUDE report 13330496 ↗
• InjuryDec 7, 2021Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED, DURING IMPLANT OF THE BARD/DAVOL VENTRIO ST MESH, THE ADHESION BARRIER (ST) SIDE OF THE MESH ADHERED TO THE MESOCOLON. AS REPORTED, IT WAS DIFFICULT TO REMOVE THE MESH, RESULTING IN TEARING THE MESOCOLON. THIS REQUIRED HEMOSTASIS AND THE PROCEDURE WAS STOPPED TO ADDRESS THE CONDITION. IT WAS REPORTED THAT THERE WAS A RISK OF COLON ISCHEMIA FOR THE PATIENT.

  Patient problems: Adhesion(s); Laceration(s)

  MAUDE report 12955105 ↗
• InjuryJul 3, 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) 2017. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE VENTRIO ST. THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2018. 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; Insufficient Information; Pain; Unspecified Infection

  MAUDE report 12112770 ↗
• InjuryMar 31, 2021Defective Device; Patient-Device Incompatibility; Patient Device Interaction Problem; Defective Device; Patient-Device Incompatibility; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL VENTRIO ST ON (B)(6) 2018. 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 11599067 ↗
• InjuryDec 6, 2020Defective Device; Insufficient Device Problem Information; Migration; Defective Device; Insufficient Device Problem Information; Migration

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF TWO UNSPECIFIED BARD/DAVOL VENTRIO ST ON (B)(6) 2015 AND (B)(6) 2017. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE BOTH DEVICES. IT IS ALSO ALLEGED THAT THE PATIENT HAD REVISION SURGERIES ON (B)(6) 2016 AND (B)(6) 2017. 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 10955671 ↗
• InjuryJun 25, 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) 2014. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE VENTRIO ST. ATTORNEY ALLEGES THAT THE PATIENT HAD SUBSEQUENT SURGICAL INTERVENTION DUE TO THE HERNIA MESH DEVICE. IT IS ALSO ALLEGED THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

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

  MAUDE report 10193517 ↗
• MalfunctionMay 18, 2020Expiration Date Error; Expiration Date Error

  IT WAS REPORTED THAT THE PATIENT UNDERWENT IMPLANT OF A VENTRIO ST MESH ON (B)(6) 2020. 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 CONSIGNMENT INVENTORY. THERE WAS NO PATIENT INJURY AND NO PATIENT INTERVENTION WAS REQUIRED AS A RESULT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10065769 ↗
• InjuryMay 14, 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) 2015. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE VENTRIO ST. ATTORNEY ALSO ALLEGES THAT THE PATIENT HAD REVISION SURGERY 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: Abscess; Disability; Injury; Pain; Unspecified Infection

  MAUDE report 10055153 ↗
• InjuryApr 29, 2020Defective Device; Insufficient Device Problem Information; Defective Device; Insufficient Device Problem Information

  ATTORNEY ALLEGES THAT THE PATIENT WAS IMPLANTED WITH A NON-BARD/DAVOL PRODUCT ON (B)(6) 2013 TO REPAIR A LOW MIDLINE ABDOMEN HERNIA. THE PATIENT UNDERWENT REVISION OF THE NON-BARD/DAVOL PRODUCT ON OR ABOUT (B)(6) 2014 AND WAS IMPLANTED WITH A SECOND NON-BARD/DAVOL PRODUCT IN THE LEFT LOWER QUADRANT. THE PATIENT UNDERWENT PARTIAL REMOVAL OF NON-BARD/DAVOL PRODUCT ON OR ABOUT (B)(6) 2015. THE PATIENT WAS IMPLANTED WITH A BARD/DAVOL VENTRIO ST HERNIA PATCH ON OR ABOUT (B)(6) 2016 TO REPAIR A MIDLINE HERNIA. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST VENTRIO ST HERNIA PATCH. THE PATIENT UNDERWENT OPEN SURGERY TO REVISE THE BARD/DAVOL VENTRIO ST HERNIA PATCH ON OR ABOUT (B)(6) 2017. IT IS ALLEGED THE VENTRIO ST CAUSED SERIOUS INJURY AND HAD TO BE SURGICALLY REMOVED VIA INVASIVE SURGERY, NECESSITATING ADDITIONAL INVASIVE SURGERY TO REPAIR THE HERNIA THAT THE PRODUCT HAD INITIALLY BEEN IMPLANTED TO TREAT. THE PATIENT WAS IMPLANTED WITH A THIRD NON-BARD/DAVOL PRODUCT ON OR ABOUT (B)(6) 2017 IN LEFT LOWER QUADRANT TO REPAIR A HERNIA. THE PATIENT UNDERWENT REVISION OF THE NON-BARD/DAVOL PRODUCT HERNIA SYSTEM ON OR ABOUT (B)(6) 2019. IT IS ALLEGED THAT T

  Patient problems: Disability; Hernia; Obstruction/Occlusion

  MAUDE report 10010000 ↗
• InjuryApr 27, 2020Defective Device; Material Deformation; Insufficient Device Problem Information; Patient Device Interaction Problem; Defective Device; Material Deformation; Insufficient Device Problem Information; 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 THE VENTRIO ST. IT IS ALLEGED THAT THE PATIENT HAD SUBSEQUENT SURGICAL INTERVENTION DUE TO THE HERNIA MESH DEVICE. ATTORNEY ALSO ALLEGES THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Adhesion(s); Hernia; Injury

  MAUDE report 10000482 ↗
• InjuryDec 17, 2019Defective 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 COMPOSIX E/X (DEVICE #1) ON (B)(6) 2006. AN UNSPECIFIED BARD/DAVOL VENTRALIGHT ST (DEVICE #2) ON (B)(6) 2012. AN UNSPECIFIED BARD/DAVOL VENTRIO ST (DEVICE #3, DEVICE #4 AND DEVICE #5) ON (B)(6) 2017, (B)(6) 2017 AND (B)(6) 2018. IT IS ALSO ALLEGED BY PATIENT ATTORNEY THAT THE PATIENT HAD UNSPECIFIED INJURIES AND ON OR ABOUT (B)(6) 2017 UNDERWENT SURGERY FOR THE PARTIAL REMOVAL OF THE MESH PRODUCTS IMPLANTED ON (B)(6) 2006 AND (B)(6) 2012. (DEVICES #1 AND #2). IT IS ALSO ALLEGED BY THE PATIENT'S ATTORNEY THAT THE PATIENT UNDERWENT ADDITIONAL SURGERIES TO REVISE THE MESH IMPLANTS ON OR ABOUT (B)(6) 2017, (B)(6) 2017 AND (B)(6) 2018. (DEVICES #3,#4 AND #5). AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE COMPOSIX E/X (DEVICE #1), THE VENTRALIGHT ST (DEVICE #2) AND THE THREE (3) VENTRIO ST (DEVICES#3,#4, AND #5). 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 9484158 ↗
• InjuryDec 3, 2019Defective 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 TWO UNSPECIFIED BARD/DAVOL VENTRIO ST MESHES ON (B)(6) 2015 AND (B)(6) 2016. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST BOTH THE VENTRIO ST MESHES. THE ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR THE REMOVAL OF HERNIA MESH PRODUCT ON (B)(6) 2016 WHICH WAS IMPLANTED ON (B)(6) 2015. 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." ATTORNEY ALLEGES THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

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

  MAUDE report 9404678 ↗
• InjuryNov 8, 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 AN UNSPECIFIED BARD/DAVOL COMPOSIX E/X (DEVICE #1) ON (B)(6) 2008 AND UNSPECIFIED BARD/DAVOL VENTRIO ST (DEVICE #2) ON (B)(6) 2012. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE COMPOSIX E/X (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: Abscess; Adhesion(s); Bacterial Infection; Cellulitis; Disability; Fistula; Injury; Pain; Scar Tissue

  MAUDE report 9298692 ↗
• InjuryNov 7, 2019Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED VIA AN EMAIL MESSAGE THAT THE PATIENT DEVELOPED AN ALLERGIC REACTION (RASH) FOLLOWING IMPLANT OF A BARD VENTRIO ST MESH. AS REPORTED THE PATIENT IS QUESTIONING IF THE CAUSE OF THEIR POSSIBLE LUPUS AND OR VASCULITIS IS LINKED TO THE MESH. AS REPORTED THE PATIENT HAS NO KNOWN ALLERGIES.

  Patient problems: Rash; Reaction

  MAUDE report 9293283 ↗
• InjuryMay 24, 2019Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information; Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information

  ATTORNEY ALLEGES THAT ON (B)(6) 2013, THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL VENTRIO ST (DEVICE #1) AND AN UNSPECIFIED BARD/DAVOL BARD MESH. IT IS ALLEGED THAT ON (B)(6) 2017, THE PATIENT HAD UNSPECIFIED INJURIES. AS REPORTED, THE PATIENT IS ONLY MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE VENTRIO ST (DEVICE #1). AS REPORTED, THE PATIENT 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 8642335 ↗
• InjuryApr 24, 2019Defective 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 COMPOSIX E/X (DEVICE #1) AND AN UNSPECIFIED BARD/DAVOL VENTRIO ST (DEVICE #2) ON (B)(6) 2009 AND/OR (B)(6) 2012. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE COMPOSIX E/X (DEVICE#1) AND VENTRIO ST (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: Adhesion(s); Disability; Hernia; Injury; Pain; Scar Tissue

  MAUDE report 8546959 ↗