VENTRIO 0010215Recalls & reported problems

Summary

The FDA's MAUDE database contains 82 adverse event reports that list this exact device (DI 00801741016424), received between Mar 23, 2017 and Sep 3, 2026 — classified as 80 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Defective Device” (69 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 82 reports, in the reporter's own words as published by the FDA.

• InjurySep 3, 2026Patient-Device Incompatibility

  Patient problems: Abscess; Wound Infection

  MAUDE report 50594859 ↗
• InjuryMay 29, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2017 - PATIENT WAS DIAGNOSED WITH INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF VENTRIO ST MESH (DEVICE 1) AND VENTRIO MESH (DEVICE 2). PER OP NOTES, "A VENTRIO ST MESH (DEVICE 1) AND VENTRIO MESH (DEVICE 2) WERE PLACED INTO THE ABDOMEN USING PROLENE SUTURES." ON (B)(6) 2018 - PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA AND INFECTED ABDOMINAL MESH THEREBY UNDERWENT REPAIR WITH REMOVAL OF OLD MESH (DEVICE 1 AND 2) AND LYSIS OF ADHESIONS. PER OP NOTES, "THE PATIENT'S UPPER AND LOWER ABDOMINAL WALL MESH (DEVICE 1 AND 2) WERE REMOVED. A XENMATRIX AB (DEVICE 3) WAS PLACED TO THE ABDOMINAL WALL USING PROLENE SUTURES."

  Patient problems: Adhesion(s); Hernia; Unspecified Infection

  MAUDE report 25334922 ↗
• InjuryApr 7, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2011 - PATIENT WAS DIAGNOSED WITH INCARCERATED UMBILICAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF VENTRIO MESH (DEVICE 1). PER OPERATIVE NOTES, ¿AN INCISION WAS MADE INTO THE UMBILICUS. THE HERNIA SAC WAS DISSECTED OUT. A VENTRIO MESH (DEVICE 1) WAS PLACED INTO THE ABDOMINAL CAVITY AND SECURE IT WITH SUTURES.¿ (B)(6) 2012 ¿ PATIENT WAS DIAGNOSED WITH RECURRENT UMBILICAL/VENTRAL HERNIA, THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRALEX ST MESH (DEVICE 2). PER OPERATIVE NOTES, ¿A SUPRAUMBILICAL CURVILINEAR INCISION WAS MADE OVER THE UMBILICUS. THE HERNIA SAC WAS DISSECTED OUT. A LARGE VENTRALEX ST MESH (DEVICE 2) WAS PLACED WITH PREVIOUSLY PLACED OLD (DEVICE 1) AND SECURED IT WITH SUTURES.¿ (B)(6) 2014 - PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL HERNIA, THEREBY UNDERWENT OPEN REPAIR WITH EXPLANT OF VENTRIO MESH (DEVICE 1) AND VENTRALEX ST MESH (DEVICE 2) AND IMPLANT OF BIOLOGICAL MESH. PER OPERATIVE NOTES, ¿AN INCISION WAS MADE VERTICALLY IN THE MIDLINE ABOVE THE UMBILICUS. THE HERNIA SAC WAS DISSECTED OUT. THE PREVIOUSLY PLACED MESHES WERE IDENTIFIED. BOTH (DEVICE 1) AND (DEVICE 2) WERE EXCISED ENTIRELY. A BIOLOGICAL MESH

  Patient problems: Hernia

  MAUDE report 24801208 ↗
• InjurySep 11, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2020 - PATIENT WAS DIAGNOSED WITH VENTRAL HERNIA THEREBY UNDERWENT ROBOTIC ASSISTED LAPAROSCOPIC REPAIR WITH IMPLANT OF VENTRIO MESH (DEVICE 1 AND 2). PER OP NOTES, "THE VENTRIO MESH (DEVICE 1 AND 2) WAS PLACED AND TACKED." (B)(6) 2020 - PATIENT WAS DIAGNOSED WITH VENTRAL HERNIA THEREBY UNDERWENT ROBOTIC ASSISTED LAPAROSCOPIC REPAIR. PER OP NOTES, "EXTENSIVE LYSIS OF ADHESIONS WAS PERFORMED. THE PREVIOUS MESH (DEVICE 1 AND 2) WAS FOUND WELL INCORPORATED ON PROLENE SIDE THAN THE GORTEX SIDE. THE UPPER PART OF MESH WAS LIFTED, AND A SMALL HERNIA WAS IDENTIFIED. A PRIMARY SUTURE REPAIR WAS DONE."

  Patient problems: Adhesion(s); Hernia

  MAUDE report 23024902 ↗
• InjuryDec 18, 2023Defective Device; Patient-Device Incompatibility; Material Deformation; Defective Device; Patient-Device Incompatibility; Material Deformation

  ALLEGED PER LEGAL CLAIM: (B)(6) 2017 - PATIENT WAS IMPLANTED WITH A VENTRIO HERNIA PATCH. (B)(6) 2022 - PATIENT EXPERIENCED SEVERE ABDOMINAL PAIN WHERE THE MESH WAS INSERTED, ACCOMPANIED BY A FEVER AND COULD BARELY WALK. IT IS ALSO ALLEGED THAT THE PATIENT'S GENERAL STATE OF HEALTH DETERIORATED NOTICEABLY. (B)(6) 2022 - "IT WAS DETERMINED THAT THE IMPLANTED MESH WAS NOT INTACT AND HAD TO BE SURGICALLY REMOVED. THE OPERATION REVEALED THE MESH HAD SHRUNK AND HAD GROWN TOGETHER WITH THE BODY'S OWN ABDOMINAL MESH." " THE MESH WAS THEN REMOVED DURING THE OPERATION. THE DOCTORS EXPLAINED TO MY CLIENT THAT PARTS OF THE IMPLANT COULD NOT BE REMOVED DUE TO THE ADHESION THAT HAD ALREADY OCCURRED AND THAT MY CLIENT WOULD NO LONGER BE FREE OF PAIN." ATTORNEY FOR THE PATIENT ALLEGES THE DEVICE WAS "FAULTY" AND THE PATIENT SUFFERS FROM RECURRING UNBEARABLE PAIN. PER LIMITED MEDICAL RECORDS (DOCTOR'S NOTES) PROVIDED: 2017 - PATIENT WAS DIAGNOSED WITH SUPRAUMBILICAL RECURRENT INCISIONAL HERNIA AND UNDERWENT IPOM SURGERY. (B)(6) 2022 - DURING HOSPITAL STAY, THE PATIENT RECEIVED ANTIBIOTIC THERAPY FOR SUSPECTED MESH INFECTION; AN INDICATION FOR REVISION SURGERY WAS MADE DUE TO PERSISTENT COMPLAINTS.

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

  MAUDE report 18345058 ↗
• InjuryMar 24, 2023Defective Device; Material Deformation; Patient Device Interaction Problem; Defective Device; Material Deformation; Patient Device Interaction Problem

  PER PROVIDED MEDICAL RECORDS: (B)(6) 2015 - PATIENT WHO HAD UNDERWENT CHOLECYSTECTOMY A YEAR BEFORE WAS DIAGNOSED WITH INCISIONAL HERNIA IN THE CHOLECYSTECTOMY SITE AND UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRIO MESH (DEVICE #1). PER THE OPERATIVE NOTES," HERNIA SAC WAS THEN IDENTIFIED. FASCIAL DEFECT WAS ABOUT 4 CM, SO A 3 INCH OR 7.6 CENTIMETER ROUND MESH (VENTRIO MESH DEVICE #1) WAS CHOSEN. THIS WAS INSERTED INTO THE DEFECT AND THEN SUTURED WITH #1 VICRYL TO THE FASCIAL EDGES." (B)(6) 2015 - PATIENT HAD SEVERE PERSISTENT PAIN IN PREVIOUS SURGERY AREA, WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA AND UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRIO MESH (DEVICE #2). PER THE OPERATIVE NOTES, ¿THE MESH WAS THEN REACHED, AND IT REALLY WAS NOT BUNCHED UP AS ANYTHING NOTICEABLE. OLD MESH (DEVICE #1) WAS REMOVED USING CAUTERY. AN 11 X 14 OVAL MESH (VENTRIO MESH DEVICE #2) WAS THEN CHOSEN AND SUTURED¿. (B)(6) 2016 - PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL HERNIA AND UNDERWENT OPEN REPAIR USING A COMPONENT SEPARATION. PER THE OPERATIVE NOTES, " THERE WERE A FEW ADHESIONS OF SMALL BOWEL TO THE ABDOMINAL WALL IN THIS AREA AND THERE WAS A MESH (VENTRIO MESH, DEVICE #2) FROM A PREVIOU

  Patient problems: Adhesion(s); Hernia

  MAUDE report 16613632 ↗
• InjuryJun 6, 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 MESH ON (B)(6) 2020. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE VENTRIO MESH. 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: Adhesion(s); Hernia; Insufficient Information; Pain; Scar Tissue; Seroma

  MAUDE report 14611415 ↗
• InjuryMay 26, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  REPORTED PER CLINICAL TRIAL (B)(6): ON (B)(6) 2016 - THE SUBJECT PATIENT UNDERWENT FIRST-TIME RECURRENT OPEN PERIUMBILICAL VENTRAL HERNIA REPAIR PROCEDURE, DURING WHICH A BARD/DAVOL VENTRIO MESH WAS PLACED IN UNDERLAY FASHION ON THE INTRA-PERITONEAL REGION USING A NON-BARD/DAVOL MECHANICAL FIXATION DEVICE AND SUTURES. FASCIA AND FULL CLOSURE WAS ACHIEVED WITH SUTURES AND ADHESIVE SKIN CLOSURE. THE PATIENT WAS DISCHARGED ON (B)(6) 2016. ON (B)(6) 2017, THE PATIENT WAS DIAGNOSED WITH "SUBCOSTAL INCISIONAL HERNIA UNRELATED TO INDEX PROCEDURE". REGARDING THIS DIAGNOSIS THE INFORMATION STATES "SUBJ. REQUIRED REOP DUE TO NEW HERNIA LOCATION BUT UNRELATED TO INDEX PROCEDURE". AS NOTED THE PATIENT WAS HOSPITALIZED FROM (B)(6) 2017. ON (B)(6) 2018 - CT SCAN WAS PERFORMED AND CONFIRMED WITH HERNIA RECURRENCE (SIZE 3CM X 1CM) ASSOCIATED WITH THE VENTRIO MESH IMPLANT. ON (B)(6) 2018 - SUBJECT PATIENT UNDERWENT AN OPEN VENTRAL PERIUMBILICAL RECURRENT HERNIA PROCEDURE FOR HERNIA RECURRENCE DUE TO 3CM OPENING OF MESH WHERE MECHANICAL FIXATION FAILED TO SECURE THE MESH IN THE ABDOMINAL WALL FROM PREVIOUS HERNIA PROCEDURE. FULL CLOSURE WAS ACHIEVED. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON T

  Patient problems: Hernia

  MAUDE report 14517071 ↗
• InjuryMay 25, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  REPORTED PER CLINICAL TRIAL (B)(4): (B)(6) 2013 - SUBJECT PATIENT UNDERWENT A PRIMARY OPEN MIDLINE UMBILICAL HERNIA REPAIR PROCEDURE. THE SIZE OF THE HERNIA DEFECT WAS 4CM X 1CM. A BARD/DAVOL VENTRIO HERNIA PATCH WAS PLACED MIDLINE IN AN UNDERLAY FASHION USING INTRA-PERITONEAL PLACEMENT USING NON-BARD/DAVOL MECHANICAL STAPLES AND SUTURES. FULL SKIN CLOSURE WAS ACHIEVED USING STAPLES. THE PATIENT WAS DISCHARGED ON SAME DAY. (B)(6) 2015 - A CT SCAN WAS PERFORMED AND DIAGNOSED THE PATIENT WITH A RECURRENT INCARCERATED INCISIONAL VENTRAL HERNIA. (B)(6) 2015 - SUBJECT PATIENT WAS CONFIRMED WITH RECURRENT HERNIA DURING PHYSICAL EXAMINATION. (B)(6) 2015 - SUBJECT PATIENT UNDERWENT A UPPER MIDLINE INCISIONAL HERNIA REPAIR FOR HERNIA RECURRENCE AND WAS IMPLANTED WITH A BARD/DAVOL VENTRALEX HERNIA PATCH. AN UPPER MIDLINE INCISION WAS MADE IN THE ABDOMINAL REGION AND THE SUTURING WAS MADE USING BOTH PROLENE AND IN A INTERRUPTED STITCH AND THE SKIN WAS FULLY CLOSED. PER THE STUDY CLINICIAN, THE REPORTED ADVERSE EVENT HAS BEEN ASSESSED AS SEVERE, POSSIBLY RELATED TO THE STUDY DEVICE AND POSSIBLY RELATED TO THE INDEX PROCEDURE. THE OUTCOME FOR THIS AE IS REPORTED AS RECOVERED/RESOLVED.

  Patient problems: Hernia

  MAUDE report 14496475 ↗
• InjuryMay 24, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  REPORTED PER CLINICAL TRIAL (B)(4): (B)(6) 2013 - SUBJECT PATIENT UNDERWENT FIRST TIME RECURRENT OPEN VENTRAL PERI-UMBILICAL HERNIA REPAIR, DURING WHICH A BARD/DAVOL VENTRALEX HERNIA PATCH (DEVICE #1) WAS IMPLANTED. FASCIA AND FULL SKIN CLOSURE WAS ACHIEVED USING STAPLES. THE PATIENT WAS DISCHARGED ON THE SAME DAY. B)(6) 2015 - SUBJECT PATIENT WAS DIAGNOSED WITH ¿RECURRENT INCISIONAL VENTRAL HERNIA (UPPER MIDLINE)¿. (THIS AE WAS ASSESSED AS NOT BEING RELATED TO THE PREVIOUSLY IMPLANTED MESH DEVICE). (B)(6) 2015 - SUBJECT PATIENT UNDERWENT OPEN MIDLINE PERI-UMBILICAL HERNIA REPAIR, DURING WHICH BARD/DAVOL VENTRIO MESH (DEVICE #2) WAS IMPLANTED; FASCIA AND FULL SKIN CLOSURE WAS ACHIEVED. THE PATIENT WAS DISCHARGED ON THE SAME DAY. (B)(6) 2018 - SUBJECT PATIENT WAS DIAGNOSED WITH ¿RECURRENT CHRONICALLY INCARCERATED VENTRAL HERNIA¿. (B)(6) 2018 - CT SCAN WAS PERFORMED AND CONFIRMED HERNIA RECURRENCE; PATIENT WAS ALSO DIAGNOSED WITH PARTIAL SMALL BOWEL OBSTRUCTION. (B)() 2018 - SUBJECT PATIENT UNDERWENT OPEN VENTRAL PERI-UMBILICAL REPAIR FOR HERNIA RECURRENCE AND PARTIAL SMALL BOWEL OBSTRUCTION, DURING WHICH BOTH THE MESHES WERE EXPLANTED. PATIENT DISCHARGED FROM THE HOSPITAL ON (B)(6)

  Patient problems: Hernia; Obstruction/Occlusion

  MAUDE report 14493002 ↗
• InjuryMay 24, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  REPORTED PER CLINICAL TRIAL (B)(6): ON (B)(6) 2016: THE SUBJECT PATIENT UNDERWENT PRIMARY LAPAROSCOPIC MIDLINE UMBILICAL HERNIA REPAIR PROCEDURE, DURING WHICH A BARD/DAVOL VENTRIO HERNIA PATCH WAS IMPLANTED. SKIN CLOSURE WAS ACHIEVED WITH STAPLES. THE PATIENT WAS DISCHARGED ON (B)(6) 2016. ON (B)(6) 2018: THE PATIENT WAS DIAGNOSED WITH SMALL BOWEL OBSTRUCTION SECONDARY TO BOWEL ADHESION OF THE MESH AND UNDERWENT SURGICAL PROCEDURE FOR MESH REMOVAL. THE PATIENT WAS DISCHARGED TO HOME ON (B)(6) 2018. PER THE STUDY CLINICIAN, THE REPORTED ADVERSE EVENT HAS BEEN ASSESSED AS SEVERE IN SEVERITY, DEFINITELY RELATED TO THE STUDY DEVICE AND DEFINITELY RELATED TO THE INDEX PROCEDURE. THE OUTCOME FOR THIS AE IS REPORTED AS RECOVERED/RESOLVED.

  Patient problems: Adhesion(s); Obstruction/Occlusion

  MAUDE report 14490184 ↗
• MalfunctionMay 24, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  REPORTED PER CLINICAL TRIAL DVL-HE-020: (B)(6) 2014 SUBJECT PATIENT UNDERWENT PRIMARY OPEN MIDLINE UMBILICAL HERNIA REPAIR PROCEDURE. A BARD/DAVOL VENTRIO HERNIA PATCH WAS PLACED INTRA-PERITONEAL IN AN UNDERLAY TECHNIQUE. NON-BARD/DAVOL MECHANICAL FIXATION AND SUTURES WERE USED. FULL SKIN CLOSURE WAS ACHIEVED USING SUTURES AND ADHESIVE SKIN CLOSURE. THE PATIENT WAS DISCHARGED TO HOME ON (B)(6) 2014. (B)(6) 2014 SUBJECT PATIENT WAS DIAGNOSED WITH SUBCUTANEOUS SEROMA; NO ACTION TAKEN. (B)(6) 2014 REPORTED END DATE FOR THE ADVERSE EVENT. 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. AS REPORTED, THE AE IS REPORTED AS RECOVERED/RESOLVED.

  Patient problems: Seroma

  MAUDE report 14488616 ↗
• InjuryMay 20, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  REPORTED PER CLINICAL TRIAL (B)(6): ON (B)(6) 2015: SUBJECT PATIENT UNDERWENT MULTIPLE RECURRENT OPEN MIDLINE HERNIA (3X1 CM) REPAIR PROCEDURE DURING WHICH A BARD/DAVOL VENTRIO HERNIA PATCH WAS IMPLANTED USING SUTURES. FASCIA AND FULL SKIN CLOSURE WAS ACHIEVED USING WITH SUTURE AND STAPLES. ON (B)(6) 2019: SUBJECT PATIENT WAS DIAGNOSED WITH RECURRENT SMALL MIDLINE HERNIA AT THE PERIUMBILICAL REGION. PER THE STUDY CLINICIAN, THE REPORTED ADVERSE EVENT HAS BEEN ASSESSED AS MILD 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 14462019 ↗
• InjuryFeb 26, 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 PATCH ON (B)(6) 2011. 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: Adhesion(s); Insufficient Information

  MAUDE report 13614871 ↗
• InjuryNov 30, 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 UNSPECIFIED BARD/DAVOL VENTRALEX HERNIA PATCH AND VENTRIO ST ON (B)(6) 2009. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE BOTH DEVICES. IT IS ALLEGED THAT THE PATIENT HAD SUBSEQUENT SURGICAL INTERVENTION DUE TO THE HERNIA MESH DEVICE. ATTORNEY ALLEGES THAT THE PATIENT SUSTAINED PERSONAL INJURY, EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Abdominal Pain; Abscess; Bowel Perforation; Fluid Discharge; Insufficient Information

  MAUDE report 12889439 ↗
• InjurySep 15, 2021Defective 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 MESH ON (B)(6) 2017. 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.

  Patient problems: Abscess; Insufficient Information; Pain; Purulent Discharge; Scar Tissue; Unspecified Infection

  MAUDE report 12472786 ↗
• InjuryJun 30, 2021Defective 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) 2015. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE VENTRIO. ATTORNEY ALLEGES GENERAL ALLEGATIONS FOR "PAST, PRESENT, AND FUTURE DAMAGES, INCLUDING BUT NOT LIMITED TO, MENTAL AND PHYSICAL PAIN AND SUFFERING FOR SEVERE AND PERMANENT PERSONAL INJURIES SUSTAINED BY THE PATIENT.¿ IT IS ALSO ALLEGED THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE. ADDENDUM PER ADDITIONAL INFORMATION PROVIDED: (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH INCARCERATED INCISIONAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC CONVERTED TO OPEN REPAIR WITH IMPLANT OF VENTRIO MESH. PER OPERATIVE NOTES, ¿THE ADHESIONS OF SMALL BOWEL TO HERNIA SAC WERE TAKEN DOWN. THE HERNIA SAC WAS IDENTIFIED WITH LOOPS OF SMALL BOWEL WERE RELEASED. THE HERNIA SAC WAS DISSECTED FREE. A VENTRIO MESH WAS PLACED USING PROLENE SUTURES.¿ (B)(6) 2017 - PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH SUTURES. PER OPERATIVE NOTES, ¿THE ADHESIONS OF MIDLINE WERE TAKEN DOWN. THE PREVIOUSLY PLACED MESH WAS IDENTIFIED, AND T

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

  MAUDE report 12090244 ↗
• InjuryMay 19, 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 UNSPECIFIED BARD/DAVOL VENTRALEX ST, VENTRIO AND VENTRALIGHT ST MESH ON (B)(6) 2015 AND/OR (B)(6) 2016 AND/OR (B)(6) 2020. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST ALL DEVICES. IT IS ALLEGED THAT THE PATIENT SUSTAINED UNSPECIFIED INJURIES ON (B)(6) 2016 AND (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. ADDENDUM PER ADDITIONAL INFORMATION PROVIDED: (B)(6) 2015 ¿ PATIENT WAS DIAGNOSED WITH INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF VENTRIO MESH (DEVICE #1). PER OPERATIVE NOTES, ¿A VENTRIO MESH (DEVICE #1) WAS PLACED INTO DEFECT AND SUTURED.¿ (B)(6) 2016 ¿ PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF VENTRALEX ST (DEVICE #2). PER OPERATIVE NOTES, ¿ADHESIONS WERE DIVIDED. THE VENTRALEX ST MESH (DEVICE #2) WAS PLACED B

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

  MAUDE report 11847935 ↗
• InjuryNov 26, 2020Defective Device; Insufficient Device Problem Information; Migration; Defective Device; Insufficient Device Problem Information; Migration

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR THE IMPLANT OF AN UNSPECIFIED BARD/DAVOL VENTRIO ON (B)(6) 2018. 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.

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

  MAUDE report 10910061 ↗
• InjuryNov 24, 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 TWO UNSPECIFIED BARD/DAVOL VENTRIO ST ON (B)(6) 2014 AND (B)(6) 2015. 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: Disability; Injury; Pain

  MAUDE report 10897087 ↗
• InjuryOct 24, 2020Defective Device; Insufficient Device Problem Information; Defective Device; Insufficient Device Problem Information

  ATTORNEY ALLEGES THAT ON OR ABOUT (B)(6) 2005, THE PATIENT UNDERWENT SURGERY FOR REPAIR OF A VENTRAL HERNIA. A BARD/DAVOL COMPOSIX KUGEL PATCH WAS IMPLANTED TO REPAIR THE HERNIA DEFECT. IT IS ALLEGED THAT ON OR ABOUT (B)(6) 2012, THE PATIENT UNDERWENT AN ADDITIONAL SURGERY TO REPAIR THE DEFECTED MESH. A BARD/DAVOL VENTRIO MESH WAS IMPLANTED. IT IS ALLEGED THAT THE PATIENT WAS INJURED SEVERELY AND PERMANENTLY. THE PATIENT SUFFERED PAIN, DISABILITY, HOSPITALIZATIONS AND ADDITIONAL SURGERIES. IT IS ALSO ALLEGED THAT THE PATIENT HAS SUFFERED AND WILL CONTINUE TO SUFFER PHYSICAL PAIN, CHRONIC PAIN, MENTAL ANGUISH, PSYCHOLOGICAL STRESS, DEPRESSION, HAS UNDERGONE AND WILL LIKELY REQUIRE MEDICAL TREATMENTS AND OTHER FORMS OF CARE. ATTORNEY ALSO ALLEGES THAT THE DEVICE WAS DEFECTIVE.

  Patient problems: Disability; Injury; Pain

  MAUDE report 10731785 ↗
• InjuryOct 7, 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 MESH (BARD FLAT MESH) AND BARD/DAVOL VENTRIO PATCH ON (B)(6) 2014 AND/OR (B)(6) 2019. 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); Injury; Seroma; Unspecified Infection

  MAUDE report 10641560 ↗
• InjurySep 14, 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 ON (B)(6) 2009. 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 ALLEGED THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

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

  MAUDE report 10526650 ↗
• InjurySep 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 THE IMPLANT OF AN UNSPECIFIED BARD/DAVOL VENTRIO PATCH ON (B)(6) 2015. 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: Adhesion(s); Hernia; Injury

  MAUDE report 10507357 ↗
• InjuryJun 20, 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) 2014. 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: Injury; Unspecified Infection

  MAUDE report 10177121 ↗