VENTRIO 0010214Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 00801741016417), received between Nov 16, 2017 and Jun 30, 2026 — classified as 1 death, 32 injuries.

The most frequently reported specific device problem is “Defective Device” (30 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 33 reports, in the reporter's own words as published by the FDA.

• InjuryJun 30, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2009 - PATIENT WAS DIAGNOSED WITH VENTRAL INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF BARD FLAT MESH (DEVICE 1). PER OP NOTES, "THE HERNIA DEFECT WAS IDENTIFIED AND DISSECTED FREE. THE PREVIOUS MESH WAS PLACED FROM PRIOR REPAIR WAS NOTED. THE HERNIA SAC WAS OPENED AND THE CONTENTS WERE REDUCED. A BARD FLAT MESH (DEVICE 1) WAS PLACED AND SUTURED." (NOTE: THE OLD MESH VISUALIZED IN THIS PROCEDURE WAS UNKNOWN) ON (B)(6) 2013 - PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRIO MESH (DEVICE 2). PER OP NOTES, "LOWER MIDLINE INCISION WAS OPENED. THE HERNIA SAC WAS IDENTIFIED AND THE CONTENTS SHOWED THAT THERE WAS SMALL BOWEL HERNIATING THROUGH THE SAC WAS REDUCED. THE HERNIA SAC WAS EXCISED. THE OLD MESH (DEVICE 1) WAS NOTED INTACT. A VENTRIO MESH (DEVICE 2) WAS PLACED AS AN UNDERLAY AND TACKED TO THE OLD MESH (DEVICE 1) USING ABSORBABLE TACKS." ON (B)(6) 2013 - PATIENT WAS DIAGNOSED WITH ABDOMINAL WOUND INFECTION THEREBY UNDERWENT REPAIR WITH DRAINAGE OF THE FOUL-SMELLING FLUID, DEBRIDEMENT OF NECROTIC TISSUES AND PACKED WITH DRESSING. MULTIPLE HERNIA REPAIRS WERE PERFORMED

  Patient problems: Post Operative Wound Infection

  MAUDE report 25666785 ↗
• DeathOct 28, 2024Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  PER INFORMATION PROVIDED:(B)(6) 2012 - PATIENT WAS DIAGNOSED WITH INCARCERATED INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF VENTRALEX ST MESH (DEVICE #1). PER OPERATIVE NOTES, "THE HERNIA SAC ATTACHED TO THE SMALL INTESTINE WERE TAKEN DOWN AND REDUCED INTO THE PERITONEUM CAVITY. THE DEFECT WAS MEASURED AND A VENTRALEX MESH (DEVICE #1) WAS FIXED WITH BOTH ENDS AWAY FROM THE HERNIA SAC BY SUTURING TO THE FASCIA." (B)(6) 2014 PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA WITH SMALL BOWEL INCARCERATION THEREBY UNDERWENT EXPLORATORY LAPAROSCOPY WITH LYSIS OF ADHESIONS. PER OPERATIVE NOTES, "IDENTIFIED AND REMOVED THE HERNIA SAC, THE INFERIOR BORDER OF THE VENTRALEX MESH (DEVICE #1) AND THE LOWER PART OF THE FASCIA. THERE WERE SIGNIFICANT NUMBER OF ADHESIONS FROM THE FASCIA WHICH WERE CLEANED AND THE SMALL BOWEL WAS REPAIRED WITH TWO LAYERS OF SUTURES. THERE IS PROBABLY TISSUE COVERING THE MESH ITSELF, SO CHOOSE TO NOT REMOVE IT." (B)(6) 2014 TO (B)(6) 2016 - PATIENT HAD MULTIPLE HOSPITAL VISITS FOR ABDOMINAL WALL WOUND INFECTION, UMBILICAL ABSCESS AND DRAINING SEROSANGUINEOUS FLUID THEREBY PROVIDED ANTIBIOTICS. (B)(6) 2016 - PATIENT WAS DIAGNOSED WITH LAR

  Patient problems: Bowel Perforation; Peritonitis; Sepsis

  MAUDE report 20543709 ↗
• InjuryFeb 14, 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 AND VENTRALEX PATCH ON (B)(6) 2019. 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: Insufficient Information; Pain

  MAUDE report 16371895 ↗
• InjuryJun 14, 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 AND VENTRIO ON (B)(6) 2010 AND/OR (B)(6) 2011. 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 14685431 ↗
• InjuryMay 24, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  REPORTED PER CLINICAL TRIAL (B)(6): ON (B)(6) 2016 - SUBJECT PATIENT UNDERWENT A PRIMARY OPEN MIDLINE EPIGASTRIC HERNIA REPAIR PROCEDURE DURING WHICH A BARD/DAVOL VENTRIO HERNIA PATCH WAS IMPLANTED USING SUTURE. FULL SKIN CLOSURE WAS ACHIEVED WITH SUTURE USING INTERRUPTED STITCH TECHNIQUE AND STAPLES. ON (B)(6) 2017 - THE PATIENT WAS DIAGNOSED WITH RECURRENT MIDLINE EPIGASTRIC HERNIA AT THE RIGHT INFERIOR LATERAL MARGINS OF ABDOMEN. NO ACTION TAKEN. PER THE STUDY CLINICIAN, THE REPORTED ADVERSE EVENT HAS BEEN ASSESSED AS MODERATE IN SEVERITY, POSSIBLY RELATED TO THE STUDY DEVICE AND POSSIBLY RELATED TO THE INDEX PROCEDURE. THE OUTCOME FOR THIS AE IS REPORTED AS NOT RECOVERED/NOT RESOLVED.

  Patient problems: Hernia

  MAUDE report 14488776 ↗
• InjuryAug 30, 2021Defective Device; Patient Device Interaction Problem; Defective Device; Patient-Device Incompatibility; Patient Device Interaction Problem

  ATTORNEY ALLEGESTHAT 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: Abscess; Insufficient Information; Pain; Unspecified Infection

  MAUDE report 12382501 ↗
• InjuryFeb 8, 2021Defective 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 AND PHASIX ON (B)(6) 2015 AND/OR (B)(6) 2020. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE VENTRIO. ATTORNEY ALLEGES THAT THE PATIENT SUSTAINED UNSPECIFIED INJURIES ON (B)(6) 2020 (HENCE THE DATE OF IMPLANT FOR VENTRIO IS CONSIDERED AS (B)(6) 2015). 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; Fibrosis; Injury; Pain; Unspecified Infection

  MAUDE report 11293076 ↗
• InjuryOct 9, 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 ON (B)(6) 2012. 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); Disability; Hernia; Injury; Pain

  MAUDE report 10654470 ↗
• InjuryOct 7, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED TO DAVOL THAT A PATIENT WHO IS PART OF A CLINICAL STUDY EXPERIENCED HERNIA RECURRENCE. (B)(6) 2015: THE SUBJECT MALE PATIENT UNDERWENT REPAIR OF AN PRIMARY VENTRAL EPIGASTRIC HERNIA USING VENTRIO, LARGE CIRCLE, 4.5 CM WITH EPTFE MESH, PERFORMED IN AN OPEN FASHION. THE MESH WAS PLACED PRE-PERITONEALLY. THE MESH WAS SUTURED IN POSITION USING NON-BARD/DAVOL SUTURES. INTERRUPTED SUTURES WERE USED TO CLOSE THE FASCIA. THE SKIN WAS COMPLETELY CLOSED USING SUTURES. THE SUBJECT PATIENT WAS ALSO ADMINISTERED WITH PROPHYLACTIC ANTIBIOTICS. THE PATIENT WAS DISCHARGED TO HOME. (B)(6) 2018: THE SUBJECT PATIENT WAS DIAGNOSED WITH AN EPIGASTRIC RECURRENT HERNIA OF LENGTH 9CM AND WIDTH 10CM. THE HERNIA RECURRENCE WAS ASSESSED BY THE CLINICIAN AS MODERATE IN SEVERITY AND NOT A SERIOUS ADVERSE EVENT (SAE) AND REQUIRED REOPERATION AND HAD RESOLVED. THE AE HAS BEEN ASSESSED PER CLINICIAN AS DEFINITELY RELATED TO THE STUDY DEVICE AND INDETERMINATE IN RELATION TO THE INDEX PROCEDURE.

  Patient problems: Hernia

  MAUDE report 10642270 ↗
• InjuryAug 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 ON (B)(6) 2012. 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) 2012 ¿ PATIENT WAS DIAGNOSED WITH VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF VENTRIO MESH. PER OP NOTES, ¿A PIECE OF ONLAY VENTRIO MESH WAS PLACED UNDERNEATH THE FASCIA AND ANCHORED USING SUTURES.¿ (B)(6) 2019 ¿ PATIENT WAS DIAGNOSED WITH SMALL BOWEL OBSTRUCTION AND ADHESIONS THEREBY UNDERWENT OPEN REPAIR. PER OP NOTES, ¿DENSE ADHESIONS OF SMALL BOWEL TO THE ANTERIOR ABDOMINAL WALL WERE LYSED AND BOWEL WAS FREED FROM LIGAMENT OF TREITZ.¿ (B)(6) 2019 ¿ PATIENT WAS DIAGNOSED WITH PERFORATED SMALL BOWEL, OBSTRUCTION, ADHESIONS THEREBY UNDERWENT OPEN REPAIR WITH THE PARTIAL REMOVAL OF MESH. PER OP NOT

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

  MAUDE report 10407683 ↗
• InjuryMay 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 PATCH ON (B)(6) 2009. 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 ALLEGED THAT THE PATIENT SUSTAINED UNSPECIFIED INJURIES ON (B)(6) 2010. IT IS ALSO ALLEGED THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Abscess; Hernia; Injury

  MAUDE report 10041590 ↗
• InjuryMar 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 AN UNSPECIFIED BARD/DAVOL VENTRIO ON (B)(6) 2011. 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: Abdominal Pain; Adhesion(s); Disability; Hernia; Injury; Pain

  MAUDE report 9841157 ↗
• InjuryFeb 19, 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 ON (B)(6) 2012. 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); Disability; Fistula; Injury; Pain; Unspecified Infection

  MAUDE report 9726807 ↗
• InjuryNov 14, 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 IMPLANT OF AN UNSPECIFIED BARD/DAVOL VENTRIO ON (B)(6) 2010. IT IS ALSO ALLEGED BY PATIENT'S ATTORNEY THAT ON 01/18/2017, THE PATIENT HAD UNSPECIFIED INJURIES RELATED TO A DEFECT IN THE VENTRIO, AND UNDERWENT REVISION SURGERY. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE VENTRIO. 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); Bacterial Infection; Disability; Fistula; Hernia; Impaired Healing; Injury; Pain; Purulent Discharge

  MAUDE report 9324739 ↗
• InjuryOct 30, 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 VENTRIO ON (B)(6) 2019. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE VENTRIO. 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 9257490 ↗
• InjuryOct 22, 2019Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information; Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information

  ATTORNEY ALLEGES THAT ON (B)(6) 2010, THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL VENTRIO PATCH. 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 PATCH. AS REPORTED, THE ATTORNEY ALLEGES PRODUCT IS DEFECTIVE AND THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS.

  Patient problems: Abscess; Hernia; Injury; Seroma; Unspecified Infection

  MAUDE report 9220790 ↗
• InjuryOct 2, 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 IMPLANT OF AN UNSPECIFIED BARD/DAVOL VENTRALEX HERNIA PATCH (DEVICE #1) OR AN UNSPECIFIED BARD/DAVOL VENTRIO ST (DEVICE #2) ON (B)(6) 2009 OR (B)(6) 2009. ATTORNEY ALLEGES UNSPECIFIED INJURIES. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE BARD/DAVOL VENTRALEX HERNIA PATCH (DEVICE #1) AND THE BARD/DAVOL VENTRIO ST (DEVICE #2). IT IS ALLEGED THAT THE PATIENT HAD SUBSEQUENT SURGICAL INTERVENTION DUE TO THE HERNIA MESH DEVICE. AS REPORTED, THE ATTORNEY ALLEGES PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

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

  MAUDE report 9147091 ↗
• InjurySep 17, 2019Defective Device; Insufficient Device Problem Information; Patient Device Interaction Problem; Migration; Defective Device; Insufficient Device Problem Information; Patient Device Interaction Problem; Migration

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL VENTRIO ON (B)(6) 2017. IT IS ALSO ALLEGED BY PATIENT'S ATTORNEY THAT THE PATIENT HAD UNSPECIFIED INJURIES RELATED TO A DEFECT IN THE VENTRIO, AND UNDERWENT REVISION SURGERY ON (B)(6) 2018. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE VENTRIO. 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; Disability; Hernia; Injury; Pain

  MAUDE report 9077354 ↗
• InjuryJul 16, 2019Defective Device; Insufficient Device Problem Information; Patient Device Interaction Problem; Defective Device; Insufficient Device Problem Information; Patient Device Interaction Problem

  ATTORNEY ALLEGES PER SHORT THAT ON (B)(6) 2010, THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL VENTRIO. IT IS ALLEGED THAT THE PATIENT HAD UNSPECIFIED INJURIES. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE VENTRIO. 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); Disability; Fistula; Injury; Pain; Sepsis

  MAUDE report 8796102 ↗
• InjuryJul 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 VENTRIO ON (B)(6) 2009. IT IS ALLEGED BY PATIENT¿S ATTORNEY THAT ON (B)(6) 2012, PATIENT HAD UNSPECIFIED INJURIES RELATED A DEFECT IN THE VENTRIO AND UNDERWENT REVISION SURGERY. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE VENTRIO. 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 8769225 ↗
• InjuryJun 25, 2019Defective Device; Insufficient Device Problem Information; Migration; Defective Device; Insufficient Device Problem Information

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL VENTRIO (DEVICE #1) ON (B)(6) 2010 AND AN UNSPECIFIED BARD/DAVOL COMPOSIX KUGEL HERNIA PATCH (DEVICE #2) ON (B)(6) 2011. IT IS ALSO ALLEGED BY PATIENT'S ATTORNEY THAT THE PATIENT HAD UNSPECIFIED INJURIES RELATED TO A DEFECT IN THE VENTRIO (DEVICE #1) AND THE COMPOSIX KUGEL MESH (DEVICE #2), AND UNDERWENT REVISION SURGERIES ON (B)(6) 2011 AND (B)(6) 2017. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE VENTRIO (DEVICE #1) AND THE COMPOSIX KUGEL HERNIA PATCH (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: Disability; Fistula; Inflammation; Injury; Pain; Purulent Discharge; Unspecified Infection

  MAUDE report 8732724 ↗
• InjuryMar 29, 2019Defective Device; Insufficient Device Problem Information; Patient Device Interaction Problem; Defective Device; Insufficient Device Problem Information; Patient Device Interaction Problem

  PER LEGAL COMPLAINT: (B)(6) 2016 - PATIENT UNDERWENT SURGERY DURING WHICH THE PATIENT WAS IMPLANTED WITH AN UNSPECIFIED BARD/DAVOL VENTRIO. 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."

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

  MAUDE report 8465832 ↗
• InjuryMar 13, 2019Defective Device; Material Deformation; Insufficient Device Problem Information; Patient Device Interaction Problem; Defective Device; Material Deformation; Insufficient Device Problem Information; Patient Device Interaction Problem

  THE PATIENT UNDERWENT SURGERY FOR 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. 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); Disability; Fistula; Hernia; Injury; Obstruction/Occlusion; Pain

  MAUDE report 8418439 ↗
• InjuryDec 3, 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: (B)(6) 2011: THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL VENTRIO. (B)(6) 2016: THE PATIENT HAD UNSPECIFIED INJURIES AND UNDERWENT REVISION SURGERY. THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE VENTRIO. THE PATIENT'S 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." ADDENDUM PER ADDITIONAL INFORMATION PROVIDED: (B)(6) 2011 - PATIENT WAS DIAGNOSED WITH INCARCERATED VENTRAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF VENTRIO MESH. PER OPERATIVE NOTES, ¿THE INCARCERATED VENTRAL HERNIA SAC WAS IDENTIFIED AND EXCISED. A VENTRIO MESH WAS PLACED AND TACKED. ¿ (B)(6) 2016 - PATIENT WAS DIAGNOSED WITH RECURRENT UMBILICAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH EXCISION OF VENTRIO MESH AND IMPLANT OF SYNTHETIC MESH. PER OPERATIVE NOTES, ¿THE ADHESIONS WERE TAKEN DOWN. A SECTION OF SMALL BOWEL STUCK AND ATTACHED FIRMLY UP TO THE PRIOR MESH WAS DISSECTED. THE VENTRIO MESH WAS REMOVED COMPLETELY. THE

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

  MAUDE report 8125927 ↗
• InjurySep 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: (B)(6) 2010: THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL VENTRIO (DEVICE #1). (B)(6) 2012: THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL COMPOSIX E/X(DEVICE #2). (B)(6) 2013: THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL VENTRALEX(DEVICE #3). AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE VENTRIO (DEVICE #1), COMPOSIX E/X (DEVICE#2) AND VENTRALEX (DEVICE #3). 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; Injury; Pain

  MAUDE report 7895307 ↗