VENTRIO 5950040Recalls & reported problems

Summary

The FDA's MAUDE database contains 109 adverse event reports that list this exact device (DI 00801741031533), received between Dec 18, 2017 and Jul 27, 2026 — classified as 107 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Defective Device” (93 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 109 reports, in the reporter's own words as published by the FDA.

• InjuryJul 27, 2026Patient-Device Incompatibility

  As reported, the patient underwent an umbilical hernia repair procedure on (b)(6) 2025 with the implant of a Ventrio ST Mesh. About 1 week later, the patient developed an infection on the right side of her incision. An MRI was performed and she was provided antibiotics. The following week, the patient continued with the symptoms of infection, she consulted with a new surgeon who ordered another MRI of her abdomen and determined she was still infected and the mesh needed to be removed. the patient was injected with Botox to help loosen the muscles around her abdominal wall before having the mesh removed. As reported, on (b)(6) 2026 patient underwent removal of the Ventrio ST Mesh. Contact alleges the mesh was infected. No further issues have presented since the removal of the mesh other than some tenderness with bending but no further treatment or recommendations have been provided.

  Patient problems: Medical device site infection

  MAUDE report 50021659 ↗
• MalfunctionJul 27, 2026Use of Device Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50021501 ↗
• InjuryMay 7, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2007 ¿ PATIENT WAS DIAGNOSED WITH UMBILICAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF PERFIX PLUG (DEVICE 1). PER OPERATIVE NOTES, ¿IN THE INFRAUMBILICAL AREA, THE HERNIA SAC IN UMBILICUS WAS FREED AND EXCISED CIRCUMFERENTIALLY. AN EXTRA-LARGE PERFIX PLUG (DEVICE 1) WAS PLACED IN THE HERNIA DEFECT AND SECURED WITH SUTURES IN CIRCUMFERENTIAL FASHION AROUND THE UMBILICUS. THE WOUND WAS IRRIGATED AND SUBCUTANEOUS TISSUES WERE APPROXIMATED USING SUTURES.¿ ON (B)(6) 2014 ¿ PATIENT WAS DIAGNOSED WITH RECURRENT ABDOMINAL WALL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRALEX ST MESH (DEVICE 2). PER OPERATIVE NOTES, ¿THE HERNIA RIGHT TO THE UMBILICUS WAS NOTED. THE PRIOR UMBILICAL REPAIR WITH MESH (DEVICE 1) WAS NOTED AND HERNIA WAS DISSECTED FREE AND REDUCED INTO PREPERITONEAL SPACE. THE PRIOR OLD MESH (DEVICE 1) WAS NOTED AND LEFT IN-SITU. A MEDIUM ROUND VENTRALEX ST MESH (DEVICE 1) WAS PLACED IN PREPERITONEAL SPACE AND SECURED IT WITH SUTURES. THE WOUND WAS IRRIGATED AND CLOSED WITH SUTURES.¿ ON (B)(6) 2020 ¿ PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL HERNIA WITH PAIN THEREBY UNDERWENT ROBOTIC ASSISTED LAPAROSCOPIC REPAIR WIT

  Patient problems: Hematoma; Seroma

  MAUDE report 25109859 ↗
• InjuryApr 29, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2013- PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA AND SPIGELIAN HERNIA, THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF VENTRALEX ST MESH (DEVICE 1), VENTRIO ST MESH (DEVICE 2). PER OP NOTES, ¿HERNIA SAC WITH OMENTUM WAS IDENTIFIED IN THE ABDOMINAL REGION AND THE OMENTUM WAS REDUCED. PREVIOUS MESH AND TACKS WERE FOUND IN LOWER MIDLINE HERNIA REPAIR. A VENTRALEX ST MESH (DEVICE 1) WAS PLACED OVER THE DEFECT IN LOWER MIDLINE AND TACKED. A VENTRIO ST MESH (DEVICE 2) WAS PLACED OVER THE RECURRENT INCISIONAL HERNIA ON THE LEFT UPPER QUADRANT AND TACKED¿. (NOTE: THE PREVIOUS MESH NOTICED IN THIS PROCEDURE WAS UNKNOWN). (B)(6) 2014- PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA, THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH EXPLANT OF VENTRIO ST MESH (DEVICE 2), IMPLANT VENTRALIGHT ST MESH (DEVICE 3). PER OP NOTES, ¿MIDLINE HERNIA HEALED WELL. MIDLINE HERNIA REPAIR MESH (DEVICE 1) WAS IN GOOD POSITION. ADHESIONS WERE TAKEN DOWN AND LEFT FLANK HERNIA WAS IDENTIFIED AND THE OLD MESH (DEVICE 2) WAS EXCISED. A VENTRALIGHT ST MESH (DEVICE 3) WAS PLACED IN THE ABDOMEN COVERING THE ENTIRE DEFECT AND SUTURED¿.

  Patient problems: Adhesion(s); Hernia

  MAUDE report 25025883 ↗
• InjuryFeb 18, 2026Patient-Device Incompatibility

  AS REPORTED PER ANSM REPORT PROVIDED (B)(4). AS REPORTED, ON (B)(6) 2022 THE PATIENT WAS IMPLANTED WITH A VENTRIO ST MESH AND ON (B)(6) 2022 THE MESH WAS EXPLANTED. DESCRIPTION OF INCIDENT: AFTER IMPLANTATION, VARIOUS SYMPTOMS APPEARED: ENORMOUS SWELLING IN THE ABDOMEN, FEVER, VOMITING, DISCOMFORT. AN ULTRASOUND SCAN REVEALED A LARGE COLLECTION OF FLUID AROUND THE PROSTHESIS. CURRENT PATIENT STATUS: SURGERY TO REMOVE THE PROSTHESIS, WHICH WAS STUCK TO THE INTESTINES. SUTURING OF THE HERNIA. SIGNIFICANT ABDOMINAL PAIN AND INTESTINAL DISORDERS SINCE THAT DAY. CLEAR DECREASE IN PHYSICAL ACTIVITY. ACTIONS TAKEN IN THE HEALTHCARE FACILITY TO TREAT THE PATIENT: NR.

  Patient problems: Adhesion(s); Discomfort; Fever; Swelling/ Edema; Vomiting

  MAUDE report 24380536 ↗
• InjurySep 11, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: NI-NI-NI ¿ PATIENT HAD A VENTRAL HERNIA THEREBY UNDERWENT REPAIR WITH BARD FLAT MESH (DEVICE 1). (NOTE: THERE IS NO OPERATIVE NOTES PROVIDED FOR THIS PROCEDURE IN PPF AND MEDICAL RECORDS). (B)(6) 1997 ¿ PATIENT WAS DIAGNOSED WITH RECURRENT INCARCERATED VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH SUTURES. PER OPERATIVE NOTES, ¿THE HERNIA AT THE EDGE OF THE PREVIOUS MESH (DEVICE 1) WAS IDENTIFIED. MULTIPLE ADHESIONS OF SMALL BOWEL TO ANTERIOR ABDOMINAL WALL WAS LYSED. THE HERNIA DEFECT BETWEEN FASCIA AND MESH (DEVICE 1) WAS NOTED. THE HERNIA DEFECT WITH MESH (DEVICE 1) WAS CLOSED WITH SUTURES. ¿(NOTE: THERE IS NO IMPLANT OF ANY MESH DURING THIS PROCEDURE). (B)(6) 2000 ¿ PATIENT WAS DIAGNOSED WITH LARGE VENTRAL HERNIA, ABDOMINAL PAIN AND PARTIAL SMALL BOWEL OBSTRUCTION THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF COMPOSIX MESH (DEVICE 2). PER OPERATIVE NOTES, ¿A LARGE VENTRAL HERNIA SAC WAS DISSECTED, AND AREA OF OBSTRUCTION WAS ENCOUNTERED WITH EXTENSIVE SCAR TISSUE FORMING ADHESION TO THE PERITONEUM OF HERNIA SAC. ADHESIONS WERE LYSED BOWEL WAS RELIEVED AND COMPOSIX MESH (DEVICE 2) WAS PLACED AND SUTURED.¿ (B)(6) 2000 ¿ PATIENT HAD ABDOMINAL WOUND EX

  Patient problems: Adhesion(s); Hernia

  MAUDE report 23024803 ↗
• InjuryApr 28, 2025Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  PER INFORMATION PROVIDED: (B)(6) 2012 - PATIENT WAS DIAGNOSED WITH VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF VENTRIO ST MESH (DEVICE #1) PER OPERATIVE NOTES, ¿ADHESIONS FROM OMENTUM WERE REMOVED. A VENTRIO ST MESH (DEVICE #1) WAS PLACED SUBFASCIAL, SUTURED AND SECURED.¿ (B)(6) 2012 - PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF VENTRIO ST MESH (DEVICE #2) AND EXPLANT OF VENTRIO ST MESH (DEVICE #1). PER OPERATIVE NOTES, ¿THE PREVIOUSLY PLACED VENTRIO ST MESH (DEVICE #1) WAS NOTED TO BE LIFTED FROM LEFT SIDE OF THE FASCIA, AND IT WAS REMOVED OUT COMPLETELY. THE ADHESIONS WERE REMOVED, AND VENTRIO ST MESH (DEVICE #2) WAS PLACED INTRAABDOMINALLY AND SUTURED". (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH LARGE VENTRAL RECURRENT HERNIA IN THE RIGHT ABDOMINAL WALL THEREBY UNDERWENT OPEN REPAIR. PER OPERATIVE NOTES, ¿SCARRING WAS NOTED IN THE RIGHT UPPER QUADRANT. HERNIA WAS NOTED ABOVE THE UMBILICUS TO THE LEFT OF THE MIDLINE AND ALL ADHESIONS WERE REMOVED. A PIECE OF MESH (DEVICE #2) WAS NOTED IN THE RIGHT LOWER ABDOMEN. A SYNTHETIC MESH WAS PLACED AND SECURED BY SUTURES.¿ ATTORNEY ALLEGED THAT THE PAT

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

  MAUDE report 21917105 ↗
• InjuryMar 27, 2025Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  PER INFORMATION PROVIDED BY PATIENT¿S ATTORNEY AND REVIEW OF PATIENT MEDICAL RECORDS: ON (B)(6) 2009: PATIENT WAS DIAGNOSED WITH VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF SEPRAMESH IP (DEVICE #1). PER OPERATIVE NOTES, ¿THERE WAS A MIDLINE HERNIA AND THEN AT THE INFERIOR ASPECT OF THE WOUND WAS ANOTHER LARGE HERNIA. ADHESIONS WERE TAKEN DOWN. A SEPRAMESH IP (DEVICE #1) WAS THEN PLACED POSTERIOR TO THE ABDOMINAL WALL USING SUTURES.¿ ON (B)(6) 2011: PATIENT WAS DIAGNOSED WITH LARGE RECURRENT VENTRAL HERNIA THEREBY UNDERWENT REPAIR WITH PARTIAL REMOVAL OF MESH (DEVICE #1) & IMPLANT OF VENTRALIGHT ST MESH (DEVICE #2). PER OPERATIVE NOTES, ¿IDENTIFIED THE HERNIA SAC AND WAS EXCISED. THERE WAS ONE LOOP OF BOWEL WHICH WAS MORE DENSELY ADHERENT TO THE MESH. THIS WAS TAKEN DOWN. EXCISING A SMALL PORTION OF THE OLD MESH (DEVICE #1), WHICH HAD BEEN SHRUNKEN AND CRUMPLED UP IN THE INFERIOR ASPECT OF THE INCISION, WHERE IT HAD PULLED AWAY FROM THE FASCIA FROM HER PREVIOUS REPAIR. THE DEFECT WAS REPAIRED WITH A VENTRALIGHT ST MESH (DEVICE #2) USING PROLENE SUTURES.¿ ON (B)(6) 2015: PATIENT WAS DIAGNOSED WITH LEFT FLANK INCISIONAL HERNIA THEREBY UNDERWENT REPAIR WITH THE IMP

  Patient problems: Abdominal Pain; Fibrosis; Unspecified Infection

  MAUDE report 21705989 ↗
• InjuryFeb 21, 2025Defective Device; Material Deformation; Patient Device Interaction Problem; Defective Device; Material Deformation; Patient Device Interaction Problem

  PER INFORMATION PROVIDED: ON (B)(6) 2014 - PATIENT WAS DIAGNOSED WITH VENTRAL HERNIA THEREBY UNDERWENT REPAIR WITH THE IMPLANT OF VENTRALEX MESH (DEVICE#1), RIGHT INGUINAL HERNIA WITH THE IMPLANT OF VENTRIO ST MESH (DEVICE #2) AND LEFT INGUINAL HERNIA WITH THE IMPLANT OF VENTRIO ST (DEVICE #3). NI-NI-2014 - PATIENT HAD PAIN. NI-NI-2015 TO NI-NI-2016 - PATIENT HAD GROIN PAIN, NERVE DISSECTION, REVISION OF MESH. ON (B)(6) 2016 - PATIENT WAS DIAGNOSED WITH LEFT INGUINAL HERNIA WITH THE IMPLANT OF PERFIX PLUG (DEVICE #4) AND HAD REVISION OF CRUMPLED MESH, DISSECTION OF ILIOINGUINAL NERVE. NI-NI-2017 TO NI-NI-2018 - PATIENT HAD UROLOGY AND PAIN. ATTORNEY ALLEGED THAT THE PATIENT HAD HERNIA RECURRENCE, MESH SHRINKAGE, NERVE DAMAGE, PAIN & SUFFERING. DIFFICULTY AND PAIN WITH URINATION, URINARY INCONTINENCE, KIDNEY PAIN, SEXUAL DYSFUNCTION, SPORADIC AND SEVERE CRAMPS. PATIENT SUFFERED SEVERE DAMAGE TO HIS SPERMATIC CORD, LEFT TESTICLE, AND LEFT GROIN AREA.

  Patient problems: Hernia; Nerve Damage; Pain

  MAUDE report 21437033 ↗
• InjuryFeb 12, 2025Defective Device; Material Deformation; Patient Device Interaction Problem; Defective Device; Material Deformation; Patient Device Interaction Problem

  PER INFORMATION PROVIDED: ON (B)(6) 2012 - PATIENT WAS DIAGNOSED WITH INCARCERATED VENTRAL INCISIONAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT OF TWO VENTRIO ST (DEVICE #1 & DEVICE #2). PER OPERATIVE NOTES, ¿A LARGE AMOUNT OF ADHESIONS WERE TAKEN DOWN FROM THE ABDOMINAL WALL. A VENTRIO ST (DEVICE #1) WAS PLACED AND SECURED USING SUTURES. THEN A VENTRIO ST (DEVICE #2) WAS PLACED AT THE LOWER POINT OF THE HERNIA DEFECT AND SECURED BY SUTURES.¿ ON (B)(6) 2018 - PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL INCISIONAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT OF VENTRIO ST (DEVICE #3) AND REMOVAL OF VENTRIO ST (DEVICE #1 & DEVICE #2). PER OPERATIVE NOTES, ¿NUMEROUS DENSE ADHESIONS IN THE RIGHT UPPER QUADRANT WERE TAKEN DOWN. THERE WAS A SMALL HERNIA DEFECT IDENTIFIED IN AN AREA WHERE THE VENTRIO ST (DEVICE #1 & DEVICE #2) HAD CURLED INWARD AWAY FROM THE ABDOMINAL WALL WAS REMOVED. THEN A VENTRIO ST (DEVICE #3) WAS PLACED AND SECURED BY SUTURES.¿ ATTORNEY ALLEGES THAT THE PATIENT HAD ADHESIONS, PAIN, HERNIA RECURRENCE, INFECTION AND EMOTIONAL INJURIES. IT WAS ALSO ALLEGED THAT THE PATIENT HAD MESH HAD CURLED INWARD AWAY FROM THE ABDOMINAL WALL.

  Patient problems: Adhesion(s); Fibrosis; Hernia

  MAUDE report 21363282 ↗
• InjuryMay 8, 2024Defective 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 ST ON (B)(6) 2022. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE VENTRIO ST. ATTORNEY ALLEGES THAT THE PATIENT HAD SUBSEQUENT SURGICAL INTERVENTION DUE TO THE HERNIA MESH DEVICE. IT IS ALSO ALLEGED THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

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

  MAUDE report 19266519 ↗
• InjuryMar 29, 2024Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  PER INFORMATION PROVIDED BY PATIENT'S ATTORNEY: (B)(6) 2010 - PATIENT WITH THE HISTORY OF PRIMARY HERNIA REPAIR DEVELOPED RECURRENT INCISIONAL HERNIA AND UNDERWENT OPEN REPAIR WITH THE IMPLANT OF VENTRIO PATCH (DEVICE #1). PER OPERATIVE NOTES, "THE HERNIA SAC AND ADHESIONS OF THE SMALL BOWEL TO THE ANTERIOR ABDOMEN WERE TAKEN DOWN. A MEDIUM OVAL VENTRIO PATCH (DEVICE #1) WAS TRIFOLDED, PLACED IN THE MID PORTION OF THE DEFECT AND SECURED TO THE ANTERIOR ABDOMINAL WALL, POSTERIOR SHEATH AND PERITONEUM USING TACKERS". (B)(6) 2010 - DURING POST OP VISIT PATIENT HAD A SUTURE PROTRUDING THROUGH THE UPPER END OF THE WOUND WHICH WAS REMOVED WITH FORCEPS. (B)(6) 2015 - DURING HOSPITAL VISIT, PATIENT HAD A SLIGHT PAIN IN THE RIGHT LOWER QUADRANT OF THE ABDOMEN. ON EXAMINATION, THE PATIENT HAD A MIDLINE SCAR SKIRTING THE UMBILICUS TO THE RIGHT BUT THERE WAS NO RECURRENCE. (B)(6) 2015 - DURING VISIT PATIENT HAD A PERIUMBILICAL ABDOMINAL PAIN AND RECENTLY NOTED WITH SOME REDNESS OF THE SKIN TO THE RIGHT UMBILICUS WHICH HAS IMPROVED. ON EXAMINATION, THE PATIENT HAD SOME MILD DIASTASIS OF CENTRAL ABDOMEN AND MILD CELLULITIS JUST TO THE RIGHT AND ABOVE UMBILICUS. THERE WAS SOME INDURATION IN THIS

  Patient problems: Adhesion(s); Drug Resistant Bacterial Infection; Purulent Discharge; Seroma

  MAUDE report 19003038 ↗
• InjuryJan 17, 2024Defective 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 ST (X2) ON (B)(6) 2019 AND (B)(6) 2020. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST BOTH THE 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); Insufficient Information; Pain

  MAUDE report 18524356 ↗
• InjuryJan 12, 2024Defective 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 MESH VENTRIO ST (X2) ON (B)(6) 2019 AND (B)(6) 2020. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST BOTH THE 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 18501458 ↗
• InjuryDec 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 VENTRIO ST ON (B)(6) 2021. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE VENTRIO ST. ATTORNEY ALLEGES THAT THE PATIENT HAD SUBSEQUENT SURGICAL INTERVENTION DUE TO THE HERNIA MESH DEVICE. IT IS ALSO ALLEGED THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Abscess; Adhesion(s); Fistula; Hernia; Insufficient Information; Pain; Unspecified Infection

  MAUDE report 18342852 ↗
• InjurySep 28, 2023Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  PER INFORMATION PROVIDED BY PATIENT'S ATTORNEY: ON (B)(6) 2012 - PATIENT WAS DIAGNOSED WITH LARGE INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF SEPRAMESH IP (DEVICE #1). PER OPERATIVE NOTES, "THERE WERE A FEW ADHESIONS BETWEEN THE BOWEL AND THE HERNIA SAC WHICH WERE REDUCED. A SEPRAMESH IP (DEVICE #1) WAS CUT FOR THE DEFECT, PLACED BELOW THE LEVEL OF THE FASCIA AND SUTURED.¿ ON (B)(6) 2014 - PATIENT VISITED HOSPITAL FOR ABDOMINAL WALL HERNIA. ON (B)(6) 2014 - PATIENT WAS DIAGNOSED WITH PAIN, RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE EXPLANT OF MESH (DEVICE #1). PER OPERATIVE NOTES, "HERNIA SAC WAS PROTRUDING, APPEARED TO BE LATERALLY FROM MESH THAT HAD PULLED AWAY. LYSIS OF ADHESIONS TO FREE UP THE SEGMENT OF THE SMALL BOWEL WAS PERFORMED. ONCE IT WAS FREED UP, UNDERSURFACE OF THE OLD MESH (DEVICE #1) WAS REMOVED OR PORTION THEREOF IT REMOVED. SOME OTHER CREASE OF MESH THAT WAS LEFT BEHIND. A PIECE OF VENTRIO ST HERNIA PATCH (DEVICE #2) WAS PLACED INTO THE DEFECT.¿ ON (B)(6) 2015 - PATIENT HAD SMALL RECURRENCE OF HERNIA, REDUCES EASILY AND POPS BACK OUT A LITTLE BIT. PATIENT WILL BE RECONSIDERED FOR ANOTHER REPAIR IF HERNIA STARTS TO BE BI

  Patient problems: Hernia

  MAUDE report 17836016 ↗
• InjuryMay 19, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED PER PATIENT MEDICAL RECORDS: ON (B)(6) 2023, THE PATIENT UNDERWENT ROBOTIC ASSISTED, CONVERTED TO OPEN REPAIR OF A RECURRENT VENTRAL INCISIONAL HERNIA WITH VENTRIO ST MESH. THE PATIENT HAD PAIN AND ERYTHEMA IN THE RUQ INCISION AND UNDERWENT AN EXPLORATORY PROCEDURE ON (B)(6) 2023. DURING THIS PROCEDURE, THE PATIENT UNDERWENT DRAINAGE OF AN ABSCESS AND REMOVAL OF INFECTED MESH. PER THE OPERATIVE NOTES," HER PREVIOUS RIGHT UPPER QUADRANT INCISION WAS RE-INCISED. THIS WAS CARRIED DOWN TO THE MESH WHICH WAS IN A POCKET OF FLUID AND FIBRIN EXUDATE. THIS WAS CULTURED. THE MESH WAS REMOVED.".

  Patient problems: Abscess; Erythema; Seroma; Unspecified Infection

  MAUDE report 16963500 ↗
• InjuryMar 27, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  PER LEGAL CLAIM: ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT LAPAROSCOPIC VENTRAL HERNIA REPAIR AND IMPLANTED WITH THE BARD/DAVOL VENTRIO ST ON (B)(6) 2018. IT IS ALLEGED THAT DURING POST OPERATIVE VISITS FROM (B)(6)( 2018 TO (B)(6) 2018, THE PATIENT CONTINUED TO HAVE POSTOPERATIVE PAIN AND DISCOMFORT. IN (B)(6) 2020, THE PATIENT CONTINUED TO EXPERIENCE WORSENING SYMPTOMS WITH PROGRESSIVE EPIGASTRIC PAIN, NAUSEA, CONSTIPATION, FOOD AND LIQUID INTOLERANCE, ANXIETY, AND DEPRESSION. ON (B)(6) 2020, ESOPHAGOGASTRODUODENOSCOPY WAS THEN PERFORMED, WHICH CONFIRMED ¿GASTRIC BYPASS WITH A SMALL-SIZED POUCH AND INTACT STAPLE LINE". ON (B)(6) 2022, EXPLORATORY LAPAROSCOPY WAS PERFORMED WHICH FINDS FOR SIGNIFICANT ABDOMINAL ADHESIONS ¿RELATED TO HER UPPER MESH¿ INVOLVING THE ROUX LIMB, WHICH WAS KINKED AND BALLED, REQUIRING SURGICAL LYSIS. BARIATRIC SURGERY HAS BEEN CONSULTED. IT IS ALLEGED THAT DURING FURTHER EXPLORATION SURGEON REALIZED THAT THE MESH WAS IMPLANTED BACKWARDS AND FOUND CATASTROPHICALLY FORMED SEVERELY DENSE ADHESIONS. THE PATHOLOGIC FINDINGS SHOWN THAT THE ¿SEVERE ADHESIONS OF THE ROUX LIMB AND LIVER TO THE MESH CAUSING SUBSTANTIAL DISTORTION. IT APPEARED THAT THE MESH WAS PLA

  Patient problems: Abdominal Pain; Adhesion(s); Liver Laceration(s)

  MAUDE report 16619101 ↗
• InjuryDec 1, 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 VENTRIO PATCH AND PHASIX ON (B)(6) 2019 AND/OR (B)(6) 2020. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST BOTH THE 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: Hernia; Insufficient Information

  MAUDE report 15894992 ↗
• 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 MESH ON (B)(6) 2016. 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: Insufficient Information; Necrosis; Obstruction/Occlusion; Pain; Sepsis; Strangulation; Unspecified Infection

  MAUDE report 14514862 ↗
• InjuryMay 20, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED, A BARD/DAVOL VENTRIO ST MESH WAS IMPLANTED DURING JULY 2021 AND THE PATIENT HAS SINCE DEVELOPED A RASH. AS REPORTED, THE PATIENT IS BEING TREATED BY THE PATIENT'S ALLERGIST; SPECIFIC TREATMENT IS UNKNOWN. AS REPORTED, THE SURGEON AND ALLERGIST WOULD LIKE TO PERFORM A REACTIVITY TEST, HOWEVER THE TEST HAS YET TO BE PERFORMED.

  Patient problems: Rash

  MAUDE report 14461993 ↗
• InjuryDec 14, 2021Defective Device; Patient-Device Incompatibility; Patient Device Interaction Problem; Defective Device; Patient-Device Incompatibility; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL VENTRIO ST ON (B)(6) 2020. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST VENTRIO ST. ATTORNEY ALLEGES THAT THE PATIENT HAD SUBSEQUENT SURGICAL INTERVENTION DUE TO THE HERNIA MESH DEVICE. IT IS ALSO ALLEGED THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

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

  MAUDE report 13003195 ↗
• InjuryNov 19, 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 ST ON (B)(6) 2019. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE VENTRIO ST. ATTORNEY ALLEGES THAT THE PATIENT HAD SUBSEQUENT SURGICAL INTERVENTION DUE TO THE HERNIA MESH DEVICE. IT IS ALSO ALLEGED THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

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

  MAUDE report 12848221 ↗
• InjuryOct 8, 2021Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT ON (B)(6) 2019, THE PATIENT WAS IMPLANTED WITH A BARD/DAVOL VENTRIO ST IN THE COURSE OF A VENTRAL HERNIA REPAIR SURGERY. IT IS ALLEGED THAT FURTHER TO THE IMPLANTATION WITH THE PRODUCT, THE PATIENT SUFFERED THE DEVELOPMENT OF CHRONIC PAIN, INFLAMMATION, SWELLING, BOWEL OBSTRUCTION, GASTROINTESTINAL MALFUNCTION, HERNIA RECURRENCE AND NECESSITATING FURTHER REPARATIVE SURGERY WHICH OCCURRED ON (B)(6) 2019. ATTORNEY ALLEGES THAT SUBSEQUENT TO THE LATTER SURGERY, THE PATIENT HAS CONTINUED TO SUFFER FROM CHRONIC PAIN, INFLAMMATION, SWELLING, BOWEL OBSTRUCTION, GASTROINTESTINAL MALFUNCTION, AND HERNIA RECURRENCE. 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 THAT THE PATIENT EXPERIENCED SEVERE PAIN AND SUFFERING, INCLUDING CHRONIC PAIN. IT IS ALSO ALLEGED THE PATIENT WAS TREATED WITH A COURSE OF HOSPITALIZATION, DIAGNOSTIC IMAGING, REVISION SURGERY, SERUM TESTING, ANTIBIOTICS, ANALGESICS AND REST. ATTORNEY ALLEGES THAT THE PATIENT WILL REQUIRE FURTHER INVASIVE REPAIR SURGERY, PHYS

  Patient problems: Hernia; Obstruction/Occlusion; Pain

  MAUDE report 12596731 ↗
• InjurySep 23, 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 AN UNSPECIFIED BARD/DAVOL VENTRIO ST ON (B)(6) 2016. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE VENTRIO ST. ATTORNEY ALLEGES THAT THE PATIENT HAD SUBSEQUENT SURGICAL INTERVENTION DUE TO THE HERNIA MESH DEVICE. IT IS ALSO ALLEGED THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

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

  MAUDE report 12517692 ↗