VENTRIO 5950090Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00801741031588), received between May 14, 2018 and Apr 1, 2026 — classified as 1 death, 18 injuries.

The most frequently reported specific device problem is “Defective Device” (11 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• InjuryApr 1, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2016 - PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF TWO VENTRIO ST MESH (DEVICE 1 AND 2). PER OP NOTES, "THE PATIENT HAD A VERTICAL MIDLINE INCISION, TWO VENTRIO ST MESH (DEVICE 1 AND 2) WERE PLACED TOGETHER TO THE ABDOMEN USING PROLENE SUTURES." ON (B)(6) 2016 - PATIENT HAD ABSCESS THEREBY UNDERWENT INCISION AND DRAINAGE OF ABSCESS ABDOMINAL WALL. PER OP NOTES, "THE PATIENT HAD A PREVIOUS INCISIONAL HERNIA REPAIR WITH MESH. THERE WAS A SIGNIFICANT AMOUNT OF PURULENCE IN THE ABSCESS CAVITY AND IT WAS DRAINED." ON (B)(6) 2017 - PATIENT HAD STATUS POST ABDOMINAL HERNIA REPAIR WITH EXPOSED MESH THEREBY UNDERWENT REPAIR WITH REMOVAL OF EXPOSED MESH (DEVICE 1 AND 2). PER OP NOTES, "THE PATIENT HAD EXPOSED MESH THAT WAS REMOVED.

  Patient problems: Abscess; Purulent Discharge

  MAUDE report 24752337 ↗
• InjuryMar 3, 2026Patient-Device Incompatibility

  AS REPORTED PER MEDWATCH FORM (MW5182185): "THE PATIENT HAS DEVELOPED A MESH-ASSOCIATED ENTEROCUTANEOUS FISTULA FROM IMPLANTED MESH DURING VENTRAL HERNIA REPAIR". AS REPORTED PER ADDITIONAL INFORMATION RECEIVED: AS REPORTED, THE PATIENT UNDERWENT VENTRAL HERNIA REPAIR WITH THE IMPLANT OF VENTRIO ST MESH ON (B)(6) 2023. ON (B)(6) 2025 THE PATIENT HAD FECULENT/SUCCUS OUTPUT FROM ABDOMINAL WALL. THE PATIENT UNDERWENT VENTRAL HERNIA REPAIR ON (B)(6) 2026 WITH THE FISTULA TAKEDOWN, SMALL BOWEL RESECTION AND EXPLANT OF THE VENTRIO ST MESH.

  Patient problems: Fistula

  MAUDE report 24496251 ↗
• InjuryFeb 5, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2014 - PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF VENTRALIGHT ST MESH (DEVICE 1) AND A PHASIX MESH (DEVICE 2). PER OP NOTES, "AN UNKNOWN MESH WAS REMOVED. A VENTRALIGHT ST MESH (DEVICE 1) WAS PLACED TO COOPER'S LIGAMENT AND SECURED INSIDE THE FASCIA OF THE RECTUS MUSCLES DOWN INTO THE PELVIS. IN THE ABDOMINAL WALL PLACED A PHASIX MESH (DEVICE 2) TO THE FASCIA." (B)(6) 2016 - PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH REMOVAL OF MESH (DEVICE 1 AND 2) AND IMPLANT OF VENTRIO ST MESH (DEVICE 3). PER OP NOTES, "SEVERE ADHESIONS NOTED. THE OLD MESH WAS ATTACHED TO THE FASCIA, AND THE MESH WAS SPLIT IN HALF. ONCE THIS WAS DONE, REMOVED A PIECE OF THE MESH (DEVICE 1 AND 2). A VENTRIO ST MESH (DEVICE 3) WAS PLACED TO THE SUPRAPUBIC AND COOPER'S LIGAMENT ON BOTH SIDES." (B)(6) 2018 - PATIENT HAD RIGHT LOWER QUADRANT PAIN THEREBY UNDERWENT REPAIR WITH THE REMOVAL OF MESH (DEVICE 3) AND IMPLANT OF PHASIX ST MESH (DEVICE 4) AND ADHESIOLYSIS. PER OP NOTES, "ADHESIONS WERE SEVERE. DETACHED THE MESH (DEVICE 3) FROM THE SMALL BOWEL. PUBIS, COOPER'S LIGAMENT AND THE

  Patient problems: Adhesion(s); Pain

  MAUDE report 24266055 ↗
• InjuryJul 14, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2007- PATIENT WAS DIAGNOSED WITH INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF BARD FLAT MESH (DEVICE #1). PER OPERATIVE NOTES, ¿A BARD FLAT MESH (DEVICE #1) WAS PLACED AND SUTURED.¿ (B)(6) 2012 - PATIENT WAS DIAGNOSED WITH INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH EXPLANT OF BARD FLAT MESH (DEVICE #1) AND IMPLANT OF VENTRALIGHT ST MESH (DEVICE #2) AND BARD SOFT MESH (DEVICE #3). PER OPERATIVE NOTES, ¿OLD BARD FLAT MESH (DEVICE #1) WAS EXCISED. ONE VENTRALIGHT ST MESH (DEVICE #2) AND ONE BARD SOFT MESH (DEVICE #3) WAS PLACED AND SUTURED.¿ (B)(6) 2013 - PATIENT WAS DIAGNOSED WITH INTESTINAL PERFORATION, ADHESION, ABSCESS, MESH INFECTION, INFLAMMATION THEREBY UNDERWENT OPEN REPAIR WITH EXPLANT OF VENTRALIGHT ST MESH (DEVICE #2) AND BARD SOFT MESH (DEVICE #3), LYSIS OF ADHESION, ABSCESS, AND IMPLANT ONE SYNTHETIC MESH. PER OPERATIVE NOTES, ¿ABSCESS WERE DRAINED FROM INTRA-ABDOMINAL AREA. INFECTED VENTRALIGHT ST MESH (DEVICE #2) AND BARD SOFT MESH (DEVICE #3) WAS EXCISED COMPLETELY.¿ (B)(6)2014 - PATIENT WAS DIAGNOSED WITH VENTRAL INCISIONAL HERNIA, ADHESION THEREBY UNDERWENT OPEN REPAIR WITH EXPLANT OLD BIOLOGICAL MESH

  Patient problems: Adhesion(s); Obstruction/Occlusion

  MAUDE report 22492806 ↗
• InjuryMar 22, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED THE CASE WAS A WOMAN IN HER 80S. THIRTEEN (13) YEARS AGO SHE UNDERWENT AN OPEN SIGMOID COLON RESECTION FOR SIGMOID COLON CANCER AND FIVE (5) YEARS AGO, PRESENTED WITH AN ABDOMINAL WALL SCAR HERNIA. OPEN ABDOMINAL WALL SCAR HERNIA REPAIR WAS PERFORMED, AND THE PATIENT WAS IMPLANTED WITH A VENTRIO ST MESH. FOUR (4) MONTHS LATER REDNESS, PAIN, AND LEAKAGE OF INTESTINAL FLUID FROM THE WOUND WERE OBSERVED. CONSERVATIVE TREATMENT, INCLUDING ANTIMICROBIALS, FAILED TO IMPROVE THE SITUATION. ABDOMINAL WALL RESECTION INCLUDING MESH WAS PERFORMED. REPORTEDLY THE MESH WAS ADHERENT TO THE SMALL INTESTINE AND FORMED A FISTULA.

  Patient problems: Adhesion(s); Erythema; Fistula; Purulent Discharge

  MAUDE report 18958631 ↗
• InjuryMay 24, 2023Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  PER ADDITIONAL INFORMATION RECEIVED: (B)(6) 2017 - PATIENT WITH INCISIONAL VENTRAL HERNIA UNDERWENT REPAIR WITH VENTRALEX ST MESH (DEVICE #1). PER THE OPERATIVE NOTES,¿ I OPENED THE OLD INCISION AND DISSECTED THE HERNIA SAC. I PUT VENTRALEX ST MESH (DEVICE #1) AND SUTURED." (B)(6) 2017 - PATIENT WAS DIAGNOSED WITH CELLULITIS. (B)(6) 2017 - PATIENT DEVELOPED SEROMA, FISTULA AND INFECTION AROUND THE MESH AND UNDERWENT EXCISION OF MESH AND PRIMARY FASCIAL CLOSURE. PER THE OPERATIVE NOTES, " I MAKE AN OPENING IN THE OLD INCISION. THERE WAS A FISTULOUS TRACK FROM THE MESH TO THE SKIN WHICH WAS DISSECTED. THERE WAS LOT OF SCAR TISSUE IN THE AREA AND ALSO GRANULATION TISSUE THAT IS INFECTED IN THIS AREA AROUND THE MESH. I PULLED THE MESH OUT." (B)(6) 2017 - PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL HERNIA AND UNDERWENT LAPAROSCOPIC REPAIR WITH MESH. PER THE OPERATIVE NOTES," THERE WERE ADHESIONS AND VENTRAL HERNIA. I OPENED A MIDLINE INCISION AND DISSECTED THE HERNIA SAC. VENTRALIGHT ST MESH (DEVICE #2) WAS PLAVED UNDERLAY BEHIND THE MUSCLE AND SUTURED." (B)(6) 2017 - PATIENT DEVELOPED ABDOMINAL PAIN. (B)(6) 2017 - PATIENT VISITED THE HOSPITAL FOR ABDOMINAL PAIN AND DIAGNOSED WITH RECU

  Patient problems: Fluid Discharge; Granuloma; Hernia

  MAUDE report 16994578 ↗
• InjuryMar 24, 2023Defective 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 ST ON (B)(6) 2020. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST VENTRIO ST. IT IS ALLEGED THAT THE PATIENT UNDERWENT REMOVAL OF THE VENTRIO ST AND IMPLANT OF AN UNKNOWN MESH ON (B)(6) 2021. 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

  MAUDE report 16609174 ↗
• InjuryMar 11, 2022Defective 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) 2015. 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); Insufficient Information; Pain

  MAUDE report 13737720 ↗
• InjuryNov 16, 2021Patient-Device Incompatibility; Patient-Device Incompatibility

  PER SYMPOSIUM PRESENTATION DURING (B)(6) - "THREE CASES OF MESH INFECTION AFTER ABDOMINAL WALL HERNIA REQUIRING MESH REMOVAL" AS REPORTED, THE PATIENT UNDERWENT REPAIR OF A VENTRAL INCISIONAL HERNIA AND A BARD/DAVOL VENTRIO ST MESH WAS IMPLANTED. IT WAS REPORTED THAT MESH INFECTION OCCURRED APPROXIMATELY 4 MONTHS AFTER THE OPERATION. WOUND OPENING AND CONSERVATIVE TREATMENT OF VAC THERAPY DID NOT IMPROVE, AND ONE MONTH LATER, MESH REMOVAL AND DIRECT SUTURING WERE PERFORMED. IT WAS ALSO REPORTED THAT THE PATIENT WAS DOING WELL AND DISCHARGED 10 DAYS AFTER THE OPERATION.

  Patient problems: Unspecified Infection

  MAUDE report 12822216 ↗
• InjuryNov 16, 2021Patient-Device Incompatibility; Patient-Device Incompatibility

  PER SYMPOSIUM PRESENTATION DURING HERNIA WEEK 2020 TOKYO - "THREE CASES OF MESH INFECTION AFTER ABDOMINAL WALL HERNIA REQUIRING MESH REMOVAL" THE PATIENT UNDERWENT A VENTRAL INCISIONAL HERNIA REPAIR PROCEDURE WITH IMPLANT OF A BARD/DAVOL VENTRIO ST MESH. ABOUT ONE MONTH POST-OPERATIVE, THE PATIENT DEVELOPED A MESH INFECTION. THE PATIENT UNDERWENT SURGERY AND THE MESH WAS REMOVED AND DIRECT SUTURING WERE PERFORMED EARLY. THE PATIENT WAS REPORTED TO BE DOING WELL AND DISCHARGED 10 DAYS AFTER THE OPERATION. AS REPORTED, THERE WAS NO RECURRENCE OF INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 12822186 ↗
• InjuryJun 14, 2021Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT ON OR ABOUT (B)(6) 2017, THE PATIENT UNDERWENT SURGERY FOR THE REPAIR OF TWO INCISIONAL HERNIAS. A BARD/DAVOL VENTRIO ST WAS IMPLANTED TO REPAIR THE HERNIA DEFECT. IT IS ALLEGED THAT THE PATIENT UNDERWENT AN ADDITIONAL OPERATION TO REPAIR AND/OR REMOVE THE DEFECTED MESH ON OR ABOUT (B)(6) 2018. FURTHER, ANOTHER BARD/DAVOL VENTRIO ST MESH WAS IMPLANTED. THE PATIENT INJURED SEVERELY AND PERMANENTLY. ATTORNEY ALSO ALLEGES THAT THE PATIENT HAS SUFFERED AND WILL CONTINUE TO SUFFER CHRONIC PHYSICAL PAIN, DISABILITY, HOSPITALIZATIONS, ADDITIONAL SURGERIES, HAS UNDERGONE AND WILL LIKELY REQUIRE IN THE FURTHER OTHER FORMS OF CARE AND MEDICAL TREATMENTS. ATTORNEY ALSO ALLEGES THAT THE DEVICE WAS DEFECTIVE.

  Patient problems: Insufficient Information; Pain

  MAUDE report 11995430 ↗
• InjuryDec 6, 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) 2015 AND (B)(6) 2017. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE BOTH DEVICES. IT IS ALSO ALLEGED THAT THE PATIENT HAD REVISION SURGERIES ON (B)(6) 2016 AND (B)(6) 2017. 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 10955667 ↗
• DeathMar 26, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT ON (B)(6) 2019 THE PATIENT WAS IMPLANTED WITH BARD VENTRIO ST MESH AND A NON BARD MESH. AS REPORTED THE PATIENT LATER PASSED AWAY (DATE OF DEATH NOT PROVIDED). AS REPORTED THE BOWEL HAD ADHERED TO A MESH HOWEVER THE CONTACT WAS UNABLE TO SAY IF THE MESH ADHESIONS HAD CAUSED OR CONTRIBUTED TO THE PATIENT'S DEATH. THE PATIENT'S DOCTOR IS UNAVAILABLE AT THIS TIME TO PROVIDE FURTHER DETAILS. ADDENDUM BASED ON ADDITIONAL INFORMATION PROVIDED BY SURGEON ON (B)(6) 2019 ¿ THE PATIENT HAD A ¿6 X 6CM HERNIA, WELL DEFINED NECK OF DENSE SCAR TISSUE. NO SURGICAL PLANES SO NOVEL ONES CREATED. RIVES STOPPA BUT DUE TO INFLEXIBILITY WOULDN¿T COME TOGETHER. THEREFORE, RIGHT ANTERIOR COMPARTMENT SEPARATION. INADEQUATE POSTERIOR SHEATH NOT CLOSED. BARD VENTRIO ST 35 X 24 MESH PLACED AS SUBLAY (RETRO MUSCULAR). ON CLOSING MIDLINE THE SCAR TISSUE LATERAL TO THE RECTUS ON THE RIGHT TORE OPEN. MIDLINE CLOSURE COMPLETED AND VENTRIO ST AUGMENTED WITH (ONLAY NON-BARD 20 X 15). POST OPERATIVELY HAD A SLOW RECOVERY WITH LOTS OF FLUID COMING INTO THE DRAINS AS WOULD BE EXPECTED AS THERE WAS NO SEAL BETWEEN ABDOMEN AND SUBCUTANEOUS FAT EXCEPT BRIDGED MESH SANDWICH. POST OPERATIVE ILEUS. PROL

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

  MAUDE report 9882447 ↗
• InjuryFeb 21, 2020Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information; Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF UNSPECIFIED BARD/DAVOL COMPOSIX KUGEL HERNIA PATCH ON (B)(6) 2009 AND VENTRIO ST ON (B)(6) 2012. 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); Disability; Injury; Pain

  MAUDE report 9737618 ↗
• InjuryNov 22, 2019Defective Device; Insufficient Device Problem Information; Patient Device Interaction Problem; Defective Device; Insufficient Device Problem Information; Patient Device Interaction Problem

  ATTORNEY ALLEGES THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL VENTRIO ST ON (B)(6) 2016. IT IS ALLEGED THAT THE PATIENT HAD SUBSEQUENT SURGICAL INTERVENTION DUE TO THE HERNIA MESH DEVICE(S). AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE BARD/DAVOL VENTRIO ST. AS REPORTED, THE ATTORNEY ALLEGES PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Abscess; Fistula; Injury; Unspecified Infection

  MAUDE report 9363941 ↗
• InjuryApr 2, 2019Defective Device; Insufficient Device Problem Information; Patient Device Interaction Problem; Defective Device; Insufficient Device Problem Information; Patient Device Interaction Problem

  ATTORNEY ALLEGES PER SHORT FORM THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL COMPOSIX KUGEL PATCH (DEVICE #1) ON (B)(6) 2008. IT IS ALSO ALLEGED BY THE PATIENT'S ATTORNEY 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 COMPOSIX KUGEL PATCH (DEVICE #1) AND THE VENTRIO ST(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: Adhesion(s); Disability; Hernia; Injury; Obstruction/Occlusion; Pain; Unspecified Infection

  MAUDE report 8472904 ↗
• InjuryDec 4, 2018Defective Device; Insufficient Device Problem Information; Defective Device; Insufficient Device Problem Information

  THE PATIENT'S ATTORNEY HAS ALLEGED THE FOLLOWING: (B)(6) 2016 - THE PATIENT UNDERWENT REPAIR OF ABDOMINAL HERNIA AND A BARD/DAVOL VENTRIO ST MESH WAS IMPLANTED IN THE PATIENT DURING THIS REPAIR. ON (B)(6) 2017 - THE PATIENT UNDERWENT SURGERY TO EXPLANT AN INFECTED HERNIA MESH. DURING THE SURGERY, A MASSIVE INFECTION WAS FOUND, AT THE LOCATION WHERE THE MESH WAS LOCATED AND REMOVED. THE BOTTOM SURFACE OF THE MESH WAS SEPARATED FROM THE OMENTUM AND PORTIONS WERE DENSELY ADHERED TO THE SMALL BOWEL. ADHESIONS HAD TO BE REMOVED BEFORE THE MESH COULD BE COMPLETELY EXCISED. AS ALLEGED, THE PATIENT CONTINUES TO EXPERIENCE COMPLICATIONS RELATED TO THE BARD/DAVOL VENTRIO ST MESH AND THAT THE PATIENT HAS BEEN INJURED. ATTORNEY ALLEGES THAT THE PATIENT HAS SUSTAINED SEVERE AND PERMANENT PAIN, SUFFERING, ANXIETY, DEPRESSION, DISABILITY, AND IMPAIRMENT AND THAT THE VENTRIO ST IMPLANTED IN THE PATIENT WAS DEFECTIVE.

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

  MAUDE report 8131197 ↗
• InjuryJul 10, 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: ON (B)(6) 2016: THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL VENTRIO ST. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE BARD/DAVOL VENTRIO ST. 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; Obstruction/Occlusion; Pain

  MAUDE report 7674000 ↗
• InjuryMay 14, 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: ON (B)(6) 2013: THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL VENTRIO ST. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE BARD/DAVOL VENTRIO ST. 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; Erosion; Injury; Pain; Unspecified Infection

  MAUDE report 7512443 ↗