VENTRIO 0010212Recalls & reported problems

Summary

The FDA's MAUDE database contains 81 adverse event reports that list this exact device (DI 00801741016394), received between Sep 13, 2017 and Feb 27, 2026 — classified as 78 injuries, 3 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 81 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 27, 2026Migration

  PER INFORMATION PROVIDED: ON (B)(6) 2015 ¿ PATIENT WAS DIAGNOSED WITH VENTRAL INCISIONAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT OF VENTRALIGHT ST MESH USING ECHO PS (DEVICE 1). PER OP NOTES, ¿THE PATIENT WAS NOTED TO HAVE OMENTAL ADHESION INTO THE INFRAUMBILICAL MIDLINE HERNIA. AN VENTRALIGHT ST MESH ECHO PS (DEVICE 1) WAS PLACED INTO ABDOMINAL CAVITY AND TACKED.¿ ON (B)(6) 2015 ¿ PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE PARTIAL REMOVAL OF MESH (DEVICE 1). PER OP NOTES, ¿THE HERNIA SAC AND WAS FREED UP FROM THE SURROUNDING TISSUES AT LOWER MIDLINE INCISION. PRIOR LAPAROSCOPIC MESH (DEVICE 1) WAS TRIMMED. A VENTRIO MESH (DEVICE 2) WAS PLACED INTO ABDOMINAL CAVITY USING TACKS.¿ ON (B)(6) 2019 ¿ PATIENT WAS DIAGNOSED WITH INCISIONAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR. PER OP NOTES, ¿ADHESIONS OF OMENTUM AND SMALL BOWEL UP TO ABDOMINAL WALL AND PREVIOUS HERNIA MESH. TWO PIECES OF MESH (DEVICE 1, 2) WERE NOTED IN LOWER MIDLINE AND RIGHT LOWER QUADRANT. THE SMALL BOWEL HERNIATED BETWEEN THE MESHES. THE ILEOSTOMY SITE HERNIA MESH (DEVICE 1) HAD EVENTRATED SOMEWHAT UP INTO HERNIA SAC AND LOWER MID

  Patient problems: Adhesion(s); Hernia

  MAUDE report 24466602 ↗
• MalfunctionSep 5, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  PER INFORMATION PROVIDED: ON (B)(6) 2009 ¿ PATIENT WAS DIAGNOSED WITH INCARCERATED RECURRENT UMBILICAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC TO OPEN REPAIR WITH THE IMPLANT OF VENTRIO MESH (DEVICE # 2). PER OPERATIVE NOTES, ¿A VENTRIO MESH (DEVICE 1) WAS ROLLED AND ATTEMPTED TO BE PLACED THROUGH A 12 MM TROCAR. WITH STAY SUTURES AND USAGE OF THE ENDOSTAPLER, THERE WAS DIFFICULTY IN POSITIONING THE MESH, AT THIS TIME CREATED A TEAR IN THE MESH EXPOSING POLYPROPYLENE. AT THIS TIME, THE LAPAROSCOPIC PROCEDURE WAS TERMINATED, FEELING THAT THE EXPOSED MESH HAS POSSIBILITIES OF ADHESION, FISTULA FORMATION, AS SUCH MESH (DEVICE #1) WAS REMOVED. THE PROCEDURE WAS CONVERTED TO AN OPEN PROCEDURE, GOING THROUGH THE MIDLINE. THEN ANOTHER VENTRIO MESH (DEVICE 2) WAS PLACED TO THE DEFECT AND TACKED CIRCUMFERENTIALLY.¿ ON (B)(6) 2017 ¿ PATIENT WAS DIAGNOSED WITH THE ENTEROCUTANEOUS FISTULA THEREBY UNDERWENT REMOVAL OF INFECTED MESH (DEVICE 2). PER OPERATIVE NOTES, ¿A BOWEL WITH INFECTED MESH (DEVICE 2) AND FISTULA SITE WAS IDENTIFIED. ADHESIONS WERE LYSED. THE MESH (DEVICE 2) WAS EXCISED AND THE SMALL BOWEL RESECTION PERFORMED.¿ NOTE: THIS FILE REPRESENTS DEVICE 1 WHICH, PER THE MEDICAL RECORDS,

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22975578 ↗
• MalfunctionDec 6, 2024Expiration Date Error; Expiration Date Error

  AS REPORTED, DURING A PROCEDURE, A VENTRIO MESH WHICH HAD A LABELED EXPIRATION DATE OF 28-OCT-2024 WAS IMPLANTED IN THE PATIENT ON (B)(6)2024. THERE WAS NO PATIENT INJURY, CHANGE IN COURSE OF TREATMENT, OR ANY MEDICAL/SURGICAL INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20862939 ↗
• InjuryApr 1, 2024Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  PER INFORMATION PROVIDED BY PATIENT'S ATTORNEY: ON (B)(6) 2011 - PATIENT WAS DIAGNOSED WITH UMBILICAL HERNIA AND MULTIPLE MIDLINE VENTRAL HERNIAS THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF COMPOSIX MESH (DEVICE #1). PER OPERATIVE NOTES, ¿AT THE DISTAL LOCATION BELOW THE UMBILICUS THERE WERE THREE SEPARATE DEFECTS AS WELL AS AN UMBILICAL DEFECT INFERIORLY. THERE WERE EXTENDING XIPHOID MULTIPLE SMALL DEFECTS ALMOST UP TO XIPHOID PROCESS. COMPOSIX MESH (DEVICE #1) WAS PLACED IN THE PREPERITONEAL SPACE AND TACKED.¿ ON (B)(6) 2011 - PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR. PER OPERATIVE NOTES, ¿THE FASCIA WAS GENTLY OPENED JUST IN FRONT OF THE MESH. THE COMPOSIX MESH (DEVICE #1) APPEARS TO BE ENTIRELY INTACT AND ATTACHED TO ITS LATERAL MARGINS SUPERIORLY AND INFERIORLY. THE RESULTANT DEFECT WAS FROM THE FRACTURED SUTURE IN THE MID-PORTION OF PREVIOUS REPAIR AND THIS WAS REMOVED. TWO PROLENE SUTURES USED TO REAPPROXIMATE THE FASCIA OVER THE MESH.¿ ON (B)(6) 2011 - PATIENT WAS DIAGNOSED WITH MINIMAL SEROUS FLUID ACCUMULATION ALONG THE ANTERIOR ABDOMINAL MIDLINE WHICH COULD NOT BE ASPIRATED DURING ULTRASOUND GUIDED ASPIRATION PROCEDURE. O

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

  MAUDE report 19012227 ↗
• InjuryJan 13, 2024Defective Device; Patient Device Interaction Problem; Migration; Defective Device; Patient Device Interaction Problem; Migration

  PER INFORMATION PROVIDED BY PATIENT'S ATTORNEY: (B)(6) 2011 - PATIENT WAS DIAGNOSED WITH INCISIONAL VENTRAL HERNIA (X2) THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF VENTRALEX MESH (DEVICE #1) AND VENTRIO MESH (DEVICE #2). PER OPERATIVE NOTES, ¿THE COMPOUND HERNIA SAC WAS FOUND AND FREED FROM ATTACHMENTS. FOUND ADDITIONAL DEFECT INFERIORLY AND ANTERIORLY. PREVIOUS MESH THAT HAD BEEN STAPLED HAD PULLED APART. EXPOSED THE FASCIAL DEFECT AND PUT A LARGE PIECE OF VENTRALEX OVAL MESH (DEVICE #1) CIRCUMFERENTIALLY. THE INFERIOR VENTRAL DEFECT WITH INCARCERATED BOWEL AND OMENTUM WERE DISSECTED. THE FASCIAL DEFECT IN THE SUBXIPHOID WAS MUCH SMALLER, IT WAS ABLE TO FULLY BE OCCLUDED WITH A LARGE VENTRALEX KUGEL PATCH (VENTRIO - DEVICE #2) AND SEWED.¿ (NOTE, NO PRODUCT IDENTIFIERS PROVIDED FOR PREVIOUS MESH). (B)(6) 2014 - DURING HOSPITAL VISIT PATIENT WAS DIAGNOSED WITH HERNIA RECURRENCE. (B)(6) 2014 - PATIENT WAS DIAGNOSED WITH INCARCERATED RECURRENT VENTRAL HERNIA (X2) AND ABDOMINAL PANNUS THEREBY UNDERWENT REPAIR WITH EXPLANT OF THE DISLODGED MESH (DEVICE #2), LYSIS OF ADHESIONS AND PANNICULECTOMY. PER OPERATIVE NOTES. ¿FAIR AMOUNT OF SMALL AND LARGE BOWEL INCARCERATED VENTRAL HERNIA

  Patient problems: Adhesion(s); Hernia

  MAUDE report 18509414 ↗
• 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.

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

  MAUDE report 16951263 ↗
• 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 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 16372270 ↗
• InjuryMay 26, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  REPORTED PER CLINICAL TRIAL (B)(6): ON (B)(6) 2016 - SUBJECT PATIENT UNDERWENT PRIMARY OPEN VENTRAL PERIUMBILICAL HERNIA REPAIR PROCEDURE, DURING WHICH A BARD/DAVOL VENTRIO HERNIA PATCH WAS PLACED IN UNDERLAY FASHION INTRA-PERITONEALLY USING ANTERIOR CST METHOD, USING NON-BARD/DAVOL MECHANICAL FIXATION DEVICE AND SUTURES. FASCIA AND FULL SKIN CLOSURE WAS ACHIEVED USING SUTURES AND STAPLES. THE PATIENT WAS DISCHARGED ON (B)(6) 2016. ON (B)(6) 2018 - SUBJECT PATIENT WAS DIAGNOSED WITH SURGICAL SITE INFECTION, WAS TREATED WITH ORAL ANTIBIOTICS, AND UNDERWENT WOUND DEBRIDEMENT. THE SSI WAS DEEP LAYER AND THE CULTURE TESTED POSITIVE FOR METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS (MRSA). THE SUBJECT PATIENT WAS ALSO DIAGNOSED WITH CHRONIC WOUND DRAINING AT THE SINUS TRACT, WHICH IS LIKELY SECONDARY TO SUTURE ABSCESS. ON (B)(6) 2018 - SUBJECT PATIENT UNDERWENT VENTRAL PERIUMBILICAL REPAIR FOR SSI AND CHRONIC WOUND DRAINING. FASCIA AND FULL SKIN CLOSURE WAS ACHIEVED USING SUTURES. THE PATIENT WAS DISCHARGED ON (B)(6) 2018. ON (B)(6) 2018 - SUBJECT PATIENT WAS DIAGNOSED WITH MESH INFECTION. ON (B)(6) 2018 - SUBJECT PATIENT UNDERWENT LAPAROTOMY VENTRAL PERIUMBILICAL REPAIR FOR MESH INFECTIO

  Patient problems: Abscess; Drug Resistant Bacterial Infection; Impaired Healing

  MAUDE report 14517690 ↗
• InjuryMay 26, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  REPORTED PER CLINICAL TRIAL (B)(6): ON (B)(6) 2016 - SUBJECT PATIENT UNDERWENT MULTIPLE RECURRENT VENTRAL HERNIA REPAIR IN THE LEFT LOWER QUADRANT (LLQ) USING A BARD/DAVOL VENTRIO HERNIA PATCH. FASCIA CLOSURE WAS PERFORMED AND SKIN CLOSURE WAS ACHIEVED USING STAPLES. THE PATIENT WAS DISCHARGED ON THE SAME DAY. ON (B)(6) 2018 - SUBJECT PATIENT WAS DIAGNOSED WITH A RECURRENT INCISIONAL HERNIA DURING A PHYSICAL EXAM. ON (B)(6) 2018 - SUBJECT PATIENT UNDERWENT VENTRAL HERNIA (LLQ) REPAIR PROCEDURE FOR HERNIA RECURRENCE. THE PATIENT WAS DISCHARGED ON SAME DAY. 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 RECOVERED/RESOLVED. ON (B)(6) 2019 - SUBJECT PATIENT WAS DIAGNOSED WITH A RECURRENT INCISIONAL HERNIA. ON (B)(6) 2019 - SUBJECT PATIENT UNDERWENT VENTRAL HERNIA REPAIR PROCEDURE IN THE LEFT LOWER QUADRANT (LLQ), DURING WHICH THE MESH WAS EXPLANTED. THE PATIENT WAS DISCHARGED ON (B)(6) 2019. PER THE STUDY CLINICIAN, THE REPORTED ADVERSE EVENT HAS BEEN ASSESSED AS MODERATE IN SEVERITY, POSSIBLY RELATED TO THE STUDY DEVIC

  Patient problems: Hernia

  MAUDE report 14515355 ↗
• InjuryMay 26, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  REPORTED PER CLINICAL TRIAL (B)(6): ON (B)(6) 2016 - SUBJECT PATIENT UNDERWENT MULTIPLE RECURRENT VENTRAL HERNIA REPAIR IN THE LEFT LOWER QUADRANT (LLQ) USING A BARD/DAVOL VENTRIO HERNIA PATCH. FASCIA CLOSURE WAS PERFORMED AND SKIN CLOSURE WAS ACHIEVED USING STAPLES. THE PATIENT WAS DISCHARGED ON THE SAME DAY. ON (B)(6) 2018 - SUBJECT PATIENT WAS DIAGNOSED WITH A RECURRENT INCISIONAL HERNIA DURING A PHYSICAL EXAM. ON (B)(6) 2018 - SUBJECT PATIENT UNDERWENT VENTRAL HERNIA (LLQ) REPAIR PROCEDURE FOR HERNIA RECURRENCE. THE PATIENT WAS DISCHARGED ON SAME DAY. 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 RECOVERED/RESOLVED. ON (B)(6) 2019 - SUBJECT PATIENT WAS DIAGNOSED WITH A RECURRENT INCISIONAL HERNIA. ON (B)(6) 2019 - SUBJECT PATIENT UNDERWENT VENTRAL HERNIA REPAIR PROCEDURE IN THE LEFT LOWER QUADRANT (LLQ), DURING WHICH THE MESH WAS EXPLANTED. THE PATIENT WAS DISCHARGED ON (B)(6) 2019. PER THE STUDY CLINICIAN, THE REPORTED ADVERSE EVENT HAS BEEN ASSESSED AS MODERATE IN SEVERITY, POSSIBLY RELATED TO THE STUDY DEVIC

  Patient problems: Hernia

  MAUDE report 14515166 ↗
• InjuryMay 26, 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 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: Insufficient Information; Pain

  MAUDE report 14509879 ↗
• InjuryMay 25, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  ALLEGED PER CLINICAL TRIAL (B)(4): (B)(6) 2018, THE PATIENT UNDERWENT PRIMARY OPEN VENTRAL INCISIONAL HERNIA REPAIR, DURING WHICH A BARD/DAVOL VENTRIO ST (DEVICE 1) WAS PLACED IN UNDERLAY FASHION INTRA-PERITONEALLY USING ANTERIOR CST METHOD, FIXATED USING NON-BARD/DAVOL MAXON SUTURES WITH 8 FIXATION POINTS. FASCIA AND FULL SKIN CLOSURE WAS ACHIEVED USING NON-BARD/DAVOL MAXON INTERRUPTED STITCHES AND STAPLES. THE PATIENT WAS DISCHARGED TO HOME ON (B)(6) 2018. (B)(6) 2019 ¿ PATIENT DIAGNOSED WITH A ¿RECURRENT, REDUCIBLE, INCISIONAL VENTRAL HERNIA¿ (THERE IS NO DETERMINATION THIS EVENT IS RELATED TO THE PREVIOUSLY IMPLANTED MESH (DEVICE 1)) (B)(6) 2020, THE PATIENT UNDERWENT PRIMARY OPEN VENTRAL INCISIONAL HERNIA REPAIR, DURING WHICH A BARD/DAVOL VENTRIO (DEVICE 2) WAS PLACED IN UNDERLAY FASHION, FIXATED USING NON-BARD/DAVOL SILK SUTURES. FASCIA AND FULL SKIN CLOSURE WAS ACHIEVED USING NON-BARD/DAVOL SILK INTERRUPTED STITCHES AND RUNNING STITCHES. THE PATIENT WAS DISCHARGED TO HOME ON (B)(6) 2020. (B)(6) 2020, PATIENT EXPERIENCED ABDOMINAL WALL SEROMA WITH OVERLYING ERYTHEMA. (B)(6) 2020, THE PATIENT WAS DIAGNOSED WITH SURGICAL SITE INFECTION. THE PATIENT UNDERWENT AN REOPERATION AND

  Patient problems: Bacterial Infection; Erythema; Post Operative Wound Infection; Seroma

  MAUDE report 14498765 ↗
• InjuryMay 25, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  ALLEGED PER CLINICAL TRIAL (B)(6): ON (B)(6) 2013, THE PATIENT UNDERWENT MULTI-RECURRENT OPEN VENTRAL INCISIONAL HERNIA REPAIR, DURING WHICH A BARD/DAVOL VENTRIO HERNIA PATCH (DEVICE #1) WAS PLACED. FASCIA AND FULL SKIN CLOSURE WAS ACHIEVED. ON (B)(6) 2015, PATIENT EXPERIENCED INCARCERATED RECURRENT INCISIONAL HERNIA. ON (B)(6) 2015 PATIENT ADMITTED TO THE HOSPITAL. THE RECURRENCE RESULTED IN REOPERATION. PATIENT UNDERWENT OPEN VENTRAL INCISIONAL HERNIA REPAIR, DURING WHICH A BARD/DAVOL VENTRIO HERNIA PATCH (DEVICE 2) WAS PLACED . AS REPORTED, NO ACTION WAS TAKEN RELATED TO THE PREVIOUSLY IMPLANTED MESH (DEVICE 1). THE PATIENT WAS DISCHARGED TO HOME ON (B)(6) 2015. THE AE (RECURRENCE ¿ DEVICE 1) IS CLINICALLY ASSESSED TO BE SERIOUS AND POSSIBLY RELATED TO THE STUDY DEVICE AND POSSIBLY RELATED TO THE PROCEDURE. (B)(6) 2019, A CULTURE WAS OBTAINED THE CULTURE TESTED POSITIVE FOR BACTERIAL INFECTION AS GORDONIA. ON (B)(6) 2020, PATIENT DEVELOPED CHRONIC NONHEALING ABDOMINAL WALL WITH SOFT TISSUE NECROSIS AND SEROMA (AE 2). THE REPORTED AE RESULTED IN REOPERATION AND PARTIALLY REMOVAL OF BOTH MESH. ON (B)(6) 2020, PATIENT UNDERWENT ADDITIONAL SURGICAL INTERVENTION, WHICH INCLUDED ADDIT

  Patient problems: Bacterial Infection; Necrosis; Seroma

  MAUDE report 14497373 ↗
• InjuryMay 25, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  REPORTED PER CLINICAL TRIAL (B)(4): (B)(6) 2015 - SUBJECT PATIENT UNDERWENT AN OPEN FIRST-TIME RECURRENT VENTRAL HERNIA REPAIR PROCEDURE IN THE LEFT LOWER QUADRANT. A BARD/DAVOL VENTRIO HERNIA PATCH WAS PLACED IN UNDERLAY FASHION INTRA-PERITONEALLY AND WAS FIXATED USING NON-BARD/DAVOL MECHANICAL FIXATION DEVICE AND SUTURES. FASCIA AND SKIN CLOSURE WAS ACHIEVED USING SUTURES AND STAPLES. THE PATIENT WAS DISCHARGED ON (B)(6) 2015. (B)(6) 2016 - SUBJECT PATIENT WAS DIAGNOSED WITH SMALL ENTEROCUTANEOUS FISTULA, INFECTED ABDOMINAL WALL/MESH INFECTION. (B)(6) 2016 - SUBJECT PATIENT WAS ADMITTED TO THE HOSPITAL. (B)(6) 2016 - THE ENTIRE MESH WAS MOBILIZED AND EXPLANTED, LARGE PENROSE DRAIN PLACED AND THE PATIENT WAS DISCHARGED ON 22-NOV-2016. IT WAS NOTED THAT THE "FISTULA MAY NEVER HEAL" DURING THE LAST OFFICE VISIT. PER THE STUDY CLINICIAN, THE REPORTED ADVERSE EVENT HAS BEEN ASSESSED AS SEVERE IN SEVERITY, DEFINITELY RELATED TO THE STUDY DEVICE AND POSSIBLY RELATED TO THE INDEX PROCEDURE. THE OUTCOME FOR THIS AE IS REPORTED AS RECOVERED/RESOLVED WITH SEQUELAE.

  Patient problems: Fistula; Unspecified Infection

  MAUDE report 14495322 ↗
• InjuryMay 21, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  REPORTED PER CLINICAL TRIAL (B)(4): (B)(6) 2019 - SUBJECT PATIENT UNDERWENT FIRST TIME RECURRENT OPEN MIDLINE INCISIONAL HERNIA (6X1 CM) REPAIR PROCEDURE DURING WHICH A BARD/DAVOL VENTRIO HERNIA PATCH WAS IMPLANTED. FASCIA AND FULL SKIN CLOSURE WAS ACHIEVED WITH NON-BARD/DAVOL MAXON SUTURE AND STAPLES. (B)(6) 2019 - SUBJECT PATIENT WAS DIAGNOSED WITH AN INFECTED WOUND SEROMA. (B)(6) 2019 - SUBJECT PATIENT WAS ADMITTED FOR SUPERFICIAL SURGICAL SITE INFECTION (SSI). (B)(6) 2019 - SUBJECT PATIENT UNDERWENT INCISION AND DRAINAGE OF THE WOUND SEROMA AT THE INFECTION SITE WITH A LITER OF SALINE AND BETADINE. CULTURE WAS POSITIVE FOR STAPHYLOCOCCUS AUREUS. THE PATIENT WAS HOSPITALIZED UNTIL (B)(6) 2019. PER THE STUDY CLINICIAN, THE REPORTED ADVERSE EVENT HAS BEEN ASSESSED AS SEVERE IN SEVERITY, POSSIBLY RELATED TO STUDY DEVICE AND DEFINITELY RELATED TO THE INDEX PROCEDURE. THE OUTCOME FOR THIS AE IS REPORTED AS RESOLVED.

  Patient problems: Bacterial Infection; Seroma

  MAUDE report 14465052 ↗
• InjuryMar 30, 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) 2020. 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); Fistula; Insufficient Information; Unspecified Infection

  MAUDE report 13956584 ↗
• InjuryJan 10, 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 THE IMPLANT OF UNSPECIFIED BARD MESH (BARD FLAT MESH) AND BARD/DAVOL VENTRIO ON (B)(6) 2018 AND/OR (B)(6) 2019. 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; Scar Tissue; Seroma

  MAUDE report 13204844 ↗
• InjuryNov 10, 2021Defective Device; Material Deformation; Patient Device Interaction Problem; Migration; Defective Device; Material Deformation; Patient Device Interaction Problem; Migration

  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 ALLEGED THAT THE PATIENT SUSTAINED PERSONAL INJURY, EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

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

  MAUDE report 12785283 ↗
• InjuryOct 21, 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 ON (B)(6) 2018 AND VENTRIO PATCH ON (B)(6) 2020. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST BOTH DEVICES. ATTORNEY ALLEGES THAT THE PATIENT HAD SUBSEQUENT SURGICAL INTERVENTION DUE TO THE HERNIA MESH DEVICE. IT IS ALSO ALLEGED THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Insufficient Information; Pain

  MAUDE report 12671195 ↗
• InjurySep 12, 2021Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT ON (B)(6) 2015, THE PATIENT UNDERWENT SURGERY FOR A VENTRAL HERNIA REPAIR AND A BARD/DAVOL VENTRIO HERNIA PATCH WAS IMPLANTED. ATTORNEY ALSO ALLEGES THAT FURTHER TO IMPLANTATION WITH THE PRODUCT, THE PATIENT SUFFERED THE DEVELOPMENT OF MESH INFECTION AND CHRONIC PAIN. IT IS ALLEGED THAT ON OR ABOUT (B)(6) 2015 AND (B)(6) 2016, THE PATIENT UNDERWENT ADDITIONAL CORRECTIVE REVISION SURGERIES. IT IS ALLEGED THAT THE PATIENT 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 PATIENT SUFFERED PERMANENT INJURIES INCLUDING SCARRING, DISFIGUREMENT, SUFFERING AND PHYSICAL DISABILITY. IT IS ALLEGED THAT THE PATIENT CONTINUES TO UNDERGO MEDICAL CARE AND TREATMENT. IT IS ALSO ALLEGED THAT THE DEVICE WAS DEFECTIVE.

  Patient problems: Deformity/ Disfigurement; Pain; Unspecified Infection

  MAUDE report 12457803 ↗
• InjurySep 9, 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 TWO UNSPECIFIED BARD/DAVOL VENTRIO PATCHES ON (B)(6) 2014 AND (B)(6) 2016. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST BOTH DEVICES. ATTORNEY ALLEGES THAT THE PATIENT HAD SUBSEQUENT SURGICAL INTERVENTION DUE TO THE HERNIA MESH DEVICE. IT IS ALSO ALLEGED THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS, SUSTAINED PERSONAL INJURY AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Insufficient Information; Pain

  MAUDE report 12445067 ↗
• InjuryJul 1, 2021Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF UNSPECIFIED BARD/DAVOL MARLEX MESH AND VENTRIO ON (B)(6) 2013 AND/OR (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: Abscess; Adhesion(s); Fistula; Insufficient Information; Pain; Scar Tissue; Unspecified Infection

  MAUDE report 12105299 ↗
• InjuryJun 7, 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 PATCH ON (B)(6) 2015. 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 SUSTAINED PERSONAL INJURY, EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Insufficient Information; Seroma

  MAUDE report 11946484 ↗
• InjuryFeb 24, 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 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: Adhesion(s); Disability; Hernia; Injury; Pain

  MAUDE report 11371589 ↗
• InjuryFeb 2, 2021Defective 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 TWO UNSPECIFIED BARD/DAVOL VENTRIO ON (B)(6) 2013 AND (B)(6) 2014. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST BOTH DEVICES. IT IS ALLEGED THAT THE PATIENT'S BOWEL OBSTRUCTION WAS DIAGNOSED IN 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: Adhesion(s); Disability; Hernia; Obstruction/Occlusion; Pain

  MAUDE report 11267366 ↗