VENTRIO 0010211Recalls & reported problems

Summary

The FDA's MAUDE database contains 62 adverse event reports that list this exact device (DI 00801741016387), received between Dec 13, 2017 and Jul 28, 2026 — classified as 60 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Defective Device” (54 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 62 reports, in the reporter's own words as published by the FDA.

• InjuryJul 28, 2026Patient-Device Incompatibility

  Per information provided:(b)(6)2011 - Patient was diagnosed with incarcerated ventral hernia with partial small bowel obstruction thereby underwent open repair with implant of Ventralex Mesh (Device 1). Per op notes, "A semilunar infraumbilical incision was performed with identification of the hernia sac. The viable bowel was placed back within the abdomen. The incarcerated peritoneal fascia and the hernia sac was removed. The fascial defect was identified, dissected. A Ventralex Mesh (Device1) was placed within the defect and secured with sutures."(b)(6)2013 - Patient was diagnosed with moderate intraabdominal adhesions thereby underwent open repair with explant of Ventralex Mesh (Device1). Per op notes, "A midline laparotomy incision was made. The previous umbilical hernia was identified. The two thirds of the previously placed Ventralex Mesh (Device 1) was free floating within the abdomen was excised from the fascia and subcutaneous tissue. Multiple adhesions were excised from abdomen. The fascia was reapproximated with sutures. Splenectomy was performed."(b)(6)2013 - Patient was diagnosed with large incisional hernia, abdominal pain, adhesions thereby underwent open repair with

  Patient problems: Adhesion(s); Hernia

  MAUDE report 50050310 ↗
• InjuryMay 28, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT UMBILICAL HERNIA REPAIR WITH IMPLANT OF BARD/DAVOL VENTRALEX MESH ON (B)(6) 2019. POST IMPLANT PATIENT WAS DIAGNOSED WITH RECURRENT UMBILICAL HERNIA AS THE EDGE OF THE MESH WAS HERNIATED AND ALSO THE MESH WAS ADHERENT TO THE UNDERSIDE OF THE UMBILICAL STALK. LAPAROSCOPIC REVISION HIATAL HERNIA REPAIR WAS PERFORMED WITH EXCISION OF MESH. ALONG WITH IMPLANT OF BARD/DAVOL VENTRIO MESH ON (B)(6) 2025. PATIENT CONTINUED EXPERIENCING ABDOMINAL PAIN, TEARING SENSATIONS, AND SWELLING. ATTORNEYS ALLEGES THAT THE PATIENT EXPERIENCING RECURRENCE, CHRONIC PAIN, DISABILITY WHICH HAVE IMPAIRED DAILY ACTIVITIES AND UNDERWENT ADDITIONAL SURGICAL INTERVENTION. 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: Pain; Swelling/ Edema

  MAUDE report 25316635 ↗
• InjurySep 18, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2015 ¿ PATIENT WAS DIAGNOSED WITH LEFT INGUINAL HERNIA; EPIGASTRIC INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF PERFIX PLUG (DEVICE 1) IN LEFT INGUINAL REGION AND VENTRIO MESH (DEVICE 2) IN EPIGASTRIC REGION. PER OPERATIVE NOTES, ¿A LEFT INDIRECT INGUINAL HERNIA WAS NOTED. PERFIX PLUG (DEVICE 1) WAS PLACED THROUGH THE INTERNAL RING AND AN ONLAY PATCH WAS SECURED TO PUBIC TUBERCLE, SHELVING EDGE OF INGUINAL LIGAMENT USING SUTURES. ON EPIGASTRIC REGION. AN OVAL PIECE OF VENTRIO MESH (DEVICE 2) WAS PLACED INTO ABDOMINAL CAVITY USING TACKS.¿ (B)(6) 2017 ¿ PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF VENTRALIGHT ST MESH (DEVICE 3). PER OPERATIVE NOTES, ¿THE VENTRAL HERNIA WAS IDENTIFIED LATERAL AND SUPERIOR EDGE OF PREVIOUS MESH. ADHESIONS WERE LYSED. A VENTRALIGHT ST MESH (DEVICE 3) WAS PLACED TO COVER THE DEFECT USING SUTURES. THE PREVIOUSLY PLACED MESH (DEVICE 2) WAS INCORPORATED INTO CLOSURE FOR OVERLAP.¿ (B)(6) 2018 ¿ PATIENT WAS DIAGNOSED WITH RECURRENT LEFT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF PERFIX PLUG (DEVICE 4). PER OPERATIVE NOTES, ¿W

  Patient problems: Adhesion(s); Hernia

  MAUDE report 23083318 ↗
• InjuryMar 25, 2025Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  PER INFORMATION PROVIDED: (B)(6)2014 - PATIENT WAS DIAGNOSED WITH BILATERAL INGUINAL HERNIA WITH LEFT RECURRENT THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH TWO VENTRIO MESH (DEVICE #1 & #2). PER OPERATIVE NOTES, ¿DIRECT HERNIA WAS CLEARED AND THEN TWO OVAL VENTRIO (DEVICE #1 & #2) PATCHES WERE PLACED IN ABDOMEN ON EACH SIDE. EACH ONE WAS TACKED TO COVER UP THE INGUINAL REGION.¿ (B)(6)2014 - PATIENT WAS DIAGNOSED WITH SPERMATIC CORD ENTRAPMENT AND CHRONIC PAIN THEREBY UNDERWENT REPAIR WITH REMOVAL OF BOTH MESHES (DEVICE #1 & #2). PER OPERATIVE NOTES, ¿ADHESIONS WERE TAKEN DOWN. BOTH MESHES AND ALL TACKS WERE REMOVED.¿ ATTORNEY ALLEGES THAT THE PATIENT HAD ADHESIONS, HERNIA RECURRENCE, PAIN WITH URINATION, SPERMATIC CORD ENTRAPMENT AND EMOTIONAL INJURIES.

  Patient problems: Adhesion(s); Pain

  MAUDE report 21685342 ↗
• InjuryDec 9, 2024Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  PER INFORMATION PROVIDED: (B)(6)2002 - PATIENT WAS DIAGNOSED WITH LEFT INDIRECT INGUINAL HERNIA THEREBY UNDERWENT OPEN HERNIA REPAIR WITH THE IMPLANT OF PERFIX PLUG (DEVICE #1). PER OPERATIVE NOTES, "A LARGE INDIRECT HERNIA IDENTIFIED AND WAS DISSECTED FREE. A LARGE PLUG WAS SECURED WITH SUTURES. AN ON-LAY PATCH WAS PLACED ON THE FLOOR OF THE INGUINAL CANAL." (B)(6)2004 - PATIENT WAS DIAGNOSED WITH SUPRAUMBILICAL VENTRAL HERNIA THEREBY UNDERWENT OPEN HERNIA REPAIR. PER OPERATIVE NOTES, "THE HERNIA SAC WAS IDENTIFIED AND APPEARS TO BE LARGE. THE HERNIA SAC WAS FREED AND EXCISED FROM THE HERNIA DEFECT. THE HERNIA DEFECT WAS CLOSED TRANSVERSELY WITH SUTURES." (NOTES: NO MESH WAS IMPLANTED.) (B)(6)2006 - PATIENT WAS DIAGNOSED WITH RECURRENT LEFT INGUINAL HERNIA THEREBY UNDERWENT OPEN HERNIA REPAIR WITH THE REMOVAL OF PERFIX PLUG (DEVICE #1) AND IMPLANT OF SYNTHETIC MESH. PER OPERATIVE NOTES, "THE EXTERNAL OBLIQUE WAS DISSECTED FROM THE MASS, THE MESH (DEVICE #1) WAS BALLED UP AND WAS EXCISED. THE DEFECT IN THE FLOOR OF THE GROIN WAS NOTED. THE SYNTHETIC MESH WAS PLACED UNDERLAY AND SUTURED. THE OVERLAY WAS TACKED TO THE PUBIS." (B)(6)2010 - PATIENT WAS DIAGNOSED WITH MULTIFENUSTRATED V

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

  MAUDE report 20876057 ↗
• InjuryDec 6, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED, THE PATIENT WAS IMPLANTED WITH VENTRIO MESH DURING A LAPAROSCOPIC INGUINAL HERNIA REPAIR ABOUT 15 YEARS AGO. IT WAS REPORTED THAT THE MESH BECAME INFECTED DUE TO PERITONITIS AND WAS REMOVED IN MAY OF THIS YEAR.

  Patient problems: Peritonitis; Unspecified Infection

  MAUDE report 20863146 ↗
• InjurySep 24, 2024Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  ADDENDUM PER ADDITIONAL INFORMATION PROVIDED: (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH INCARCERATED VENTRAL INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF PERFIX PLUG (DEVICE #1). PER OPERATIVE NOTES, ¿AT THE LEVEL OF THE UMBILICUS, A LARGE VENTRAL HERNIA WAS IDENTIFIED, AND TWO SMALLER HERNIAS WERE IDENTIFIED SUPERIOR TO THIS. THE HERNIA WAS DISSECTED FREE, AND THE TWO UPPER HERNIAS WERE ALSO DISSECTED. A LARGE PERFIX PLUG (DEVICE #1) WAS PLACED AND SUTURED.¿ (B)(6) 2016 - PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH DIVISION OF ADHESIONS, REMOVAL OF PERFIX PLUG (DEVICE #1) AND IMPLANT OF VENTRIO MESH (DEVICE #2). PER OPERATIVE NOTES, ¿HERNIA JUST ABOVE THE UMBILICUS AND NON RECURRENT HERNIA WAS IDENTIFIED. BOTH WERE DISSECTED FREE. THE ENTIRE AREA OF THE MESH (DEVICE #1) AND PREVIOUSLY INVOLVED FASCIA WAS EXCISED. A VENTRIO MESH (DEVICE #2) WAS PLACED AND SUTURED.¿ (B)(6) 2016 - PATIENT WAS DIAGNOSED WITH MESH INFECTION THEREBY UNDERWENT OPEN REPAIR WITH THE REMOVAL OF VENTRIO MESH (DEVICE #2). PER OPERATIVE NOTES, ¿ON ENTERING THE WOUND, A SMALL AMOUNT OF SEROUS FLUID WAS ENCOUNTERED, AND THE MESH WAS IDEN

  Patient problems: Seroma; Unspecified Infection

  MAUDE report 20288692 ↗
• InjurySep 19, 2024Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  ADDENDUM PER ADDITIONAL INFORMATION PROVIDED: ON (B)(6) 2012 - PATIENT WAS DIAGNOSED WITH INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF VENTRALEX MESH (DEVICE #1). PER OPERATIVE NOTES, ¿THE HERNIA SAC WAS IDENTIFIED AND EXCESS SAC WAS REMOVED. THEN A VENTRALEX MESH WAS PLACED AND SEWN IN PLACE USING SUTURES.¿ ON (B)(6) 2013 - PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF VENTRIO MESH (DEVICE #2). PER OPERATIVE NOTES, ¿THE HERNIA SAC WAS CLEANED OFF AND THE OLD VENTRALEX MESH (DEVICE #1) WAS PART OF THE HERNIA SAC. THE EXCESS SAC WAS REMOVED AND A VENTRIO MESH WAS SEWN IN PLACE USING SUTURES.¿ ON (B)(6) 2013 - PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA, BOWEL OBSTRUCTION AND DEHISCENCE THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF VENTRALEX MESH (DEVICE #3) AND REMOVAL OF VENTRALEX MESH (DEVICE #1) AND VENTRIO MESH (DEVICE #2). PER OPERATIVE NOTES, ¿THE OLD VENTRALEX MESH AND VENTRIO MESH WERE REMOVED AND A NEW VENTRALEX MESH WAS SEWN IN PLACE USING SUTURES.¿ ON (B)(6) 2013 - PATIENT WAS DIAGNOSED WITH ENTEROCUTANEOUS FISTULA WITH ABDOMINAL WALL CELLULITIS, ABDOMINAL PAIN AND DRAINAGE HA

  Patient problems: Hernia; Obstruction/Occlusion; Wound Dehiscence

  MAUDE report 20254894 ↗
• InjuryJun 5, 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 VENTRIO MESH AND BIOLG AB MESH (UNSPECIFIED) 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 MESH. 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) 2014 - PATIENT WAS DIAGNOSED WITH INCARCERATED INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF VENTRIO MESH (DEVICE 1). PER OPERATIVE NOTES, ¿HERNIA SAC WAS REMOVED. AN OVAL VENTRIO MESH (DEVICE 1) WAS PLACED INTO THE ABDOMEN AND SECURE IT WITH SUTURE.¿ (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL HERNIA, ADHESION, PAIN THEREBY UNDERWENT OPEN REPAIR WITH EXPLANT OF VENTRIO MESH (DEVICE 1) AND IMPLANT OF XENMATRIX AB MESH (DEVICE 2). PER OPERATIVE NOTES, ¿HERNIA SAC WAS DISSECTED OUT. ALL ADHESIONS WERE REMOVED. PREVIOUSLY PLA

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

  MAUDE report 17057005 ↗
• InjuryMay 12, 2023Defective Device; Material Deformation; Patient Device Interaction Problem; Defective Device; Material Deformation; Patient Device Interaction Problem

  PER INFORMATION PROVIDED BY PATIENT'S ATTORNEY: (B)(6) 2008 - PATIENT WAS DIAGNOSED WITH INCARCERATED EPIGASTRIC HERNIA AND UNDERWENT OPEN REPAIR WITH COMPOSIX KUGEL MESH (DEVICE #1). PER THE OPERATIVE NOTES, "THE HERNIA CONTENTS WERE IDENTIFIED AND CIRCUMFERENTIALLY DISSECTED. THE PREPERITONEAL SPACE WAS THEN FURTHER BLUNTLY DISSECTED TO ACCOMMODATE PLACEMENT OF A COMPOSIX KUGEL MESH (DEVICE #1)." (B)(6) 2008 - PATIENT HAD POST-OPERATIVE SEROMA. (B)(6) 2013 - PATIENT WAS DIAGNOSED WITH RECURRENT EPIGASTRIC HERNIA, UNDERWENT LAPAROSCOPIC REPAIR AND COMPOSIX KUGEL MESH REMOVAL (DEVICE #1). PER THE OPERATIVE NOTES, "I ELECTED TO REMOVE THE PIECE OF INTRAPERITONEAL MESH (DEVICE #1) USING ELECTROCAUTERY. ONCE THIS HAD BEEN FREED, THE PREVIOUS OPEN INCISION OF THE PRIOR HERNIA REPAIR WAS OPENED AND THE OLD MESH WAS PULLED THROUGH THIS OPENING. A VENTRALEX PATCH (DEVICE #2) WAS THEN PLACED AND SEWN IN 4 QUADRANTS." (NOTE: THERE WERE NO PRODUCT IDENTIFIERS PROVIDED FOR DEVICE #2) (B)(6) 2013 - PATIENT VISITED HOSPITAL FOR ABDOMINAL PAIN AND WAS DIAGNOSED WITH VENTRAL HERNIA. (B)(6) 2013 - PATIENT UNDERWENT LAPAROSCOPIC CONVERTED TO OPEN HERNIA REPAIR WITH VENTRIO MESH (DEVICE #3) AND REMO

  Patient problems: Hernia

  MAUDE report 16919552 ↗
• InjuryNov 17, 2022Defective Device; Patient-Device Incompatibility; Defective Device; Patient-Device Incompatibility

  ATTORNEY ALLEGES THAT THE PLAINTIFF UNDERWENT INCISIONAL HERNIA REPAIR SURGERY AND WAS IMPLANTED WITH BARD/DAVOL VENTRALEX ON (B)(6) 2010. IT IS ALLEGED THAT THE PATIENT SUFFERED THE DEVELOPMENT OF HERNIA RECURRENCE, ADHESIONS AND CHRONIC PAIN. IT IS ALSO ALLEGED THAT THE PATIENT UNDERWENT A CORRECTIVE REVISION SURGERY ON OR ABOUT (B)(6) 2013 AND WAS IMPLANTED WITH BARD/DAVOL VENTRIO. IT IS ALLEGED THAT THE PLAINTIFF "HAS SUFFERED INJURIES, LOSSES, AND DAMAGES RESULTING FROM NUMEROUS DEFECTS IN THE PRODUCT THAT CREATE AN UNREASONABLY HIGH RISK OF INJURY WITH SEVERE PERMANENT ADVERSE HEALTH CONSEQUENCES." ATTORNEY ALLEGES THE PLAINTIFF SUFFERED PERMANENT INJURIES INCLUDING SCARRING, DISFIGUREMENT..." ATTORNEY ALLEGES THE PLAINTIFF'S ADVERSE REACTION, COMPLICATIONS, AND FURTHER SURGERY DIRECTLY AND PROXIMATELY RESULTED FROM THE DEFECTIVE AND DANGEROUS CONDITION OF THE PRODUCT"; THE PLAINTIFF SUSTAINED INJURIES INCLUDING HERNIA RECURRENCE, MESH ADHESIONS, CHRONIC PAIN AND PERMANENT PHYSICAL DISABILITY DUE TO THE PRODUCT. IT IS ALLEGED THAT THE PLAINTIFF CONTINUES TO UNDERGO MEDICAL CARE AND TREATMENT. IT IS ALSO ALLEGED THAT THE PATIENT SUSTAINED PERSONAL INJURY AND THE DEVICE WAS DEF

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

  MAUDE report 15812853 ↗
• InjuryJun 9, 2022Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF BARD/DAVOL VENTRIO ON (B)(6) 2010. 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: Adhesion(s); Hernia; Insufficient Information; Pain

  MAUDE report 14641065 ↗
• MalfunctionMay 23, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  REPORTED PER CLINICAL TRIAL (B)(6) : ON (B)(6) 2017 - SUBJECT PATIENT UNDERWENT PRIMARY OPEN MIDLINE INCISIONAL HERNIA REPAIR AT THE RIGHT UPPER QUADRANT (RUQ). A BARD/DAVOL VENTRIO HERNIA PATCH WAS IMPLANTED USING MECHANICAL FIXATION AND SUTURES. THE PATIENT WAS DISCHARGED TO HOME ON (B)(6) 2017. ON (B)(6) 2017 - SUBJECT PATIENT DEVELOPED SMALL COLLECTION POSSIBLY REPRESENTING HEMATOMA AND SEROMA. PER THE STUDY CLINICIAN, THE REPORTED ADVERSE EVENT HAS BEEN ASSESSED AS MILD IN SEVERITY, DEFINITELY RELATED TO THE STUDY DEVICE AND DEFINITELY RELATED TO THE PROCEDURE. THERE HAS BEEN NO ACTION TAKEN AT THIS TIME AND THE OUTCOME FOR THIS AE IS REPORTED AS RECOVERED/RESOLVED.

  Patient problems: Hematoma; Seroma

  MAUDE report 14468984 ↗
• InjuryMay 7, 2022Defective Device; Patient-Device Incompatibility; Patient Device Interaction Problem; Defective Device; Patient-Device Incompatibility; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF UNSPECIFIED BARD/DAVOL VENTRALEX ON (B)(6) 2013 AND VENTRIO ON (B)(6) 2014. 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

  MAUDE report 14321650 ↗
• InjuryApr 19, 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 ON (B)(6) 2014. 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: Abscess; Adhesion(s); Bacterial Infection; Cellulitis; Hernia; Insufficient Information; Pain

  MAUDE report 14139996 ↗
• InjuryFeb 15, 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 PATCH ON (B)(6) 2016. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE VENTRIO PATCH. 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; Insufficient Information; Unspecified Infection

  MAUDE report 13536089 ↗
• InjuryDec 15, 2021Defective 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 UNSPECIFIED BARD/DAVOL VENTRIO ON (B)(6) 2011 AND VENTRIO ST ON (B)(6) 2017. 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: Adhesion(s); Bowel Perforation; Fistula; Hernia; Insufficient Information; Pain

  MAUDE report 13009887 ↗
• InjuryOct 27, 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 THE IMPLANT OF AN UNSPECIFIED BARD/DAVOL VENTRIO ON (B)(6) 2010. 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: Adhesion(s); Hematoma; Hernia; Insufficient Information; Pain

  MAUDE report 12702376 ↗
• InjuryMay 13, 2021Patient-Device Incompatibility; Material Split, Cut or Torn; Patient-Device Incompatibility; Material Split, Cut or Torn

  AS REPORTED, THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF A BARD/DAVOL VENTRIO MESH ON (B)(6) 2015, BUT THE MESH HAD TORN LOOSE AFTER A CAR ACCIDENT AND SEVERAL FALLS. POST-IMPLANT, THE PATIENT HAD REPEATED COMPLAINTS OF SEVERE PAIN THAT LED TO A REVISION SURGERY. AS REPORTED, THE PATIENT DIED ON (B)(6) 2021 DUE TO COVID-19, SEPTIC SHOCK, AND CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD).

  Patient problems: Pain

  MAUDE report 11819248 ↗
• InjuryApr 27, 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 THE IMPLANT OF AN UNSPECIFIED BARD/DAVOL VENTRIO PATCH ON (B)(6) 2016. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST VENTRIO PATCH. ATTORNEY ALLEGES THAT THE PATIENT HAD SUBSEQUENT SURGICAL INTERVENTION DUE TO THE HERNIA MESH DEVICE. ATTORNEY ALLEGES GENERAL ALLEGATIONS FOR "PAST, PRESENT, AND FUTURE DAMAGES, INCLUDING BUT NOT LIMITED TO, MENTAL AND PHYSICAL PAIN AND SUFFERING FOR SEVERE AND PERMANENT PERSONAL INJURIES SUSTAINED BY THE PATIENT." IT IS ALSO ALLEGED THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

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

  MAUDE report 11731474 ↗
• InjuryFeb 25, 2021Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information; Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information

  ATTORNEY ALLEGES THAT, ON OR ABOUT (B)(6) 2016, THE PATIENT UNDERWENT REPAIR OF AN ABDOMINAL HERNIA AND WAS IMPLANTED WITH A NON-BARD/DAVOL MESH. ON OR ABOUT (B)(6) 2017, THE PATIENT UNDERWENT REVISION OF THE NON- BARD/DAVOL MESH FOR THE REPAIR OF AN ABDOMINAL HERNIA AND WAS IMPLANTED WITH A BARD/DAVOL VENTRIO MESH PATCH DURING THIS REPAIR. ON OR ABOUT (B)(6) 2019, THE PATIENT UNDERWENT REMOVAL OF THE MESH PRODUCTS. THE PATIENT EXPERIENCED AND/OR CONTINUES TO EXPERIENCE SEVERE AND CHRONIC PAIN/DISCOMFORT, INFLAMMATION, SIGNIFICANT ADHESIONS, RECURRENCE AND SURGERY TO REMOVE THE MESH. ATTORNEY ALSO 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 FURTHER ALLEGED THAT THE DEVICE WAS DEFECTIVE.

  Patient problems: Adhesion(s); Disability; Hernia; Inflammation

  MAUDE report 11379035 ↗
• InjuryJan 18, 2021Defective 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 UNSPECIFIED BARD/DAVOL 3DMAX AND VENTRIO. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE VENTRIO WHICH WAS IMPLANTED ON (B)(6) 2016. IT IS ALLEGED THAT THE PATIENT'S MESH REMOVAL OCCURRED IN 2017. ATTORNEY ALSO 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; Injury; Pain; Purulent Discharge; Unspecified Infection

  MAUDE report 11191074 ↗
• InjuryDec 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 VENTRIO PATCH (X2) ON (B)(6) 2012 (X2) AND BARD MESH (BARD FLAT MESH) ON (B)(6) 2019. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST VENTRIO PATCH. 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 10926294 ↗
• InjuryDec 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 VENTRIO PATCH (X2) ON (B)(6) 2012 (X2) AND BARD MESH (BARD FLAT MESH) ON (B)(6) 2019. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST VENTRIO PATCH. 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 10926234 ↗
• InjuryOct 21, 2020Defective Device; 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 on (b)(6)2015. As reported, the patient is making a claim for an adverse patient outcome against 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.Addendum per additional information provided:(b)(6)2015 ¿ Patient was diagnosed with recurrent incisional ventral hernia thereby underwent open repair with the implant of Ventrio Mesh. Per op notes, ¿The hernia sac was encountered and was dissected free from the edges of the fascia. A small oval Ventrio mesh was inserted into the abdominal cavity and secured using sutures.¿ (b)(6)2018 ¿ Patient was diagnosed with incarcerated recurrent incisional ventral hernia thereby underwent open repair with the implant of synthetic mesh. Per op notes, ¿The hernia sac contained a bowel and fatty material. Previous onlay of mesh repair was noted just inferior and the edge of this de

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

  MAUDE report 10709888 ↗