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VENTRALIGHT 5954610Recalls & reported problems

Davol Inc. · Ventralight ST Mesh, 6" x 10" (15.2 cm x 25.4 cm), Oval · Class 2 · Implant

Adverse event reports
18
Deaths reported
0
Injuries reported
18
Recalls naming it
0

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00801741031649), received between Apr 1, 2019 and Mar 17, 2026 — classified as 18 injuries.

The most frequently reported specific device problem is “Defective Device” (15 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.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 1 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 1 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 1 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Defective Device15
  • Patient-Device Incompatibility10
  • Insufficient Device Problem Information9
  • Patient Device Interaction Problem7
  • Migration2
  • Biocompatibility1
  • No Apparent Adverse Event1

Patient problems

  • Adhesion(s)8
  • Hernia8
  • Injury8
  • Pain7
  • Insufficient Information5
  • Disability4
  • Seroma4
  • Abscess3

Recent adverse event reports

The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

  • InjuryMar 17, 2026Patient-Device Incompatibility

    PER INFORMATION PROVIDED: ON (B)(6) 2005 - PATIENT WAS DIAGNOSED WITH VENTRAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF COMPOSIX E/X MESH (DEVICE 1). PER OPERATIVE NOTES, ¿THE HERNIA DEFECT IN THE MIDLINE WAS IDENTIFIED AND OMENTAL ADHESIONS WERE TAKEN DOWN. A PIECE OF COMPOSIX E/X MESH (DEVICE 1) WAS PLACED OVER THE DEFECT AND SECURED WITH SUTURES. THE FASCIA WAS CLOSED AND SECURED WITH SUTURES.¿ ON (B)(6) 2021 - PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH REMOVAL OF PRIOR MESH AND IMPLANT OF VENTRALIGHT ST MESH (DEVICE 2). PER OPERATIVE NOTES, ¿IN THE INTRA-ABDOMINAL CAVITY, AT THE CEPHALAD PORTION OF THE INCISION, RECURRENT VENTRAL HERNIA WITH PRIOR MESH WAS NOTED. ADHESIONS OF ANTERIOR ABDOMINAL WALL AND SMALL BOWEL WAS LYSED. THE PRIOR MESH (DEVICE 1) WAS REMOVED AND VENTRALIGHT ST MESH (DEVICE 2) WAS PLACED OVER THE RECURRENT DEFECT IN INTRAPERITONEAL SPACE AND SECURED INPLACED WITH SUTURES CIRCUMFERENTIALLY.¿ NI- NI - 2022 ¿ PATIENT HAD SMALL BOWEL BLOCKAGE THEREBY UNDERWENT REPAIR.

    Patient problems: Obstruction/Occlusion

    MAUDE report 24616073 ↗
  • InjuryJun 12, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

    PER INFORMATION PROVIDED: ON (B)(6) 2006 - PATIENT WAS DIAGNOSED WITH ABDOMINAL WALL DEFECT 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 TACKED." ON (B)(6) 2007 - PATIENT WAS DIAGNOSED WITH VULVAR ABSCESS THEREBY UNDERWENT DRAINAGE OF ABSCESS ON LEFT. ON (B)(6) 2007 - PATIENT WAS DIAGNOSED WITH POST NEOVAGINA CREATION AND STRESS URINARY INCONTINENCE THEREBY UNDERWENT BURCH URETHROPEXY. ON (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH FISTULA AND VENTRAL INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF XENMATRIX MESH (DEVICE # 2) AND RESECTION OF FISTULA AND COLON WITH LONG HARTMANN. PER OPERATIVE NOTES, "LYSIS OF ADHESIONS PERFORMED. THE XENMATRIX MESH (DEVICE # 2) WAS PLACED IN AN INTERPOSITION FASHION AND SUTURED." ON (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH OPEN WOUND THEREBY UNDERWENT OPEN REPAIR WITH THE REMOVAL OF MESH (DEVICE # 2) AND IMPLANT OF VENTRALIGHT ST (DEVICE # 3). PER OPERATIVE NOTES, "THE MESH (DEVICE # 2) HAD SEPARATED AND FAILED. THE MESH WAS REMOVED. SUTURE ABSCESS WAS FOUND ON LEFT UPPER QUADRANT. ADHESIONS BETWEEN FASCIA AND BOWEL WAS REMOV

    Patient problems: Abscess; Adhesion(s); Granuloma

    MAUDE report 22196588 ↗
  • InjuryMay 23, 2024Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

    ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF UNSPECIFIED BARD/DAVOL VENTRALIGHT ST WITH ECHO 2 (X2), AND BARD MESH (BARD FLAT MESH) ON (B)(6) 2022 AND/OR (B)(6) 2023. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST ALL 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. ADDENDUM PER LEGAL CLAIM: ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF UNSPECIFIED BARD/DAVOL VENTRALIGHT ST, OVAL VENTRALIGHT ST AND BARD MESH (BARD FLAT MESH) ON (B)(6) 2022 AND/OR (B)(6) 2023. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST ALL 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

    Patient problems: Insufficient Information; Pain

    MAUDE report 19379111 ↗
  • InjuryJul 24, 2023Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

    PER INFORMATION PROVIDED BY PATIENT'S ATTORNEY: (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH INCISIONAL HERNIA AND UNDERWENT OPEN REPAIR WITH THE IMPLANT OF VENTRALEX ST MESH. PER OPERATIVE NOTES, "SMALL BOWEL ADHESIONS TO THE HERNIA SAC WERE DISSECTED OFF AND THE BOWEL WAS RETURNED BACK INTO THE PERITONEAL CAVITY. A VENTRALEX ST (DEVICE #1) WAS INTRODUCED INTO THE PERITONEAL CAVITY AND SUTURED THE PATCH TO OVERLYING ANTERIOR ABDOMINAL WALL FASCIA THROUGH THE RETENTION STRAPS OF THE PATCH". (B)(6) 2015 AND (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH ABDOMINAL PAIN, DISTENTION, INTESTINAL PERFORATION, RECURRENT INCARCERATED INCISIONAL HERNIA WITH SMALL BOWEL OBSTRUCTION AND ABDOMINAL WALL MASS. (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH SWISS CHEESE RECURRENT INCISIONAL HERNIA AND UNDERWENT ENTEROLYSIS, LAPAROSCOPIC REPAIR WITH THE EXPLANT OF VENTRALEX ST MESH AND IMPLANTED WITH VENTRALIGHT ST MESH. PER OPERATIVE NOTES, "THERE WAS A VENTRALEX ST MESH (DEVICE #1) THAT WAS SCRUNCHED UP IN A TACO-LIKE FASHION IN THE LEFT LOWER QUADRANT. THIS CONTAINED ADHESIONS TO BOWEL AND OMENTUM, WHICH TOOK DOWN CAREFULLY. ONCE THE ENTIRE INCARCERATED BOWEL WAS FREED, INTRODUCED A VENTRALIGHT ST (DEVICE #2)

    Patient problems: Abscess; Bowel Perforation; Drug Resistant Bacterial Infection; Hernia; Obstruction/Occlusion; Sepsis

    MAUDE report 17378264 ↗
  • InjuryMar 30, 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 VENTRALIGHT ST ON (B)(6) 2018. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE VENTRALIGHT ST. 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; Pain; Seroma

    MAUDE report 13956628 ↗
  • InjuryJan 3, 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 COMPOSIX L/P ON (B)(6) 2010 AND VENTRALIGHT ST ON (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 AND THE DEVICE WAS DEFECTIVE.

    Patient problems: Insufficient Information; Pain

    MAUDE report 13140548 ↗
  • InjuryAug 3, 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 VENTRALEX HERNIA PATCH, VENTRALEX ST PATCH & VENTRALIGHT ST ON (B)(6) 2015 AND/OR (B)(6) 2016. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST ALL DEVICES. 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. ADDENDUM PER ADDITIONAL INFORMATION PROVIDED: (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH VENTRAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF VENTRALEX MESH (DEVICE #1). (NOTE: NO IMPLANT OP-NOTES WERE PROVIDED FOR THIS PROCEDURE.) (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH SEPSIS, SMALL BOWEL PERFORATION THEREBY UNDERWENT OPEN REPAIR WITH REMOVAL OF VENTRALEX MESH (DEVICE #1). PER OP NOES, "A SMALL BOWEL PERFORATION WAS IDENTIFIED. THE VENTRALEX MESH (DEVICE #1) WAS COMPLETELY EXPLANTED." (B)(6) 2016 - PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC CONVERTED TO OPEN REPAIR WITH IMPLANT OF VENTRALEX ST MESH (DEVICE #2) AND VENTRALIGHT ST

    Patient problems: Fistula; Insufficient Information

    MAUDE report 12272100 ↗
  • InjuryJul 18, 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 ON (B)(6) 2011, MARLEX MESH (BARD FLAT MESH) ON (B)(6) 2014 AND A SEPRAMESH COMPOSITE IP. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST SEPRAMESH COMPOSITE IP AND VENTRALEX. 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: Hernia; Insufficient Information; Pain

    MAUDE report 12186534 ↗
  • InjuryOct 29, 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 VENTRALIGHT ST ON (B)(6) 2015. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE VENTRALIGHT 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; Injury; Scar Tissue; Seroma

    MAUDE report 10754608 ↗
  • InjurySep 18, 2020Biocompatibility; Biocompatibility

    IT WAS REPORTED THAT FOLLOWING IMPLANT OF A VENTRALIGHT ST, THE PATIENT HAD ADVERSE EFFECTS LIKE ALLERGY TYPE EDEMA OF LIPS, NECK AND WAS TREATED WITH SOLUMEDROL (CORTICOSTEROID) BY THE SURGEON. IT HAD EVOLVED AND TURNED INTO HIVES ON UPPER AND LOWER LIMBS. THERE WAS NO INCREASE IN TEMPERATURE AND BLOOD CULTURE WAS NEGATIVE.

    Patient problems: Edema; Reaction; Urticaria

    MAUDE report 10553445 ↗
  • InjuryApr 2, 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 VENTRALIGHT ST ON (B)(6) 2014. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE VENTRALIGHT ST. 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: Disability; Injury; Pain; Seroma; Unspecified Infection

    MAUDE report 9917679 ↗
  • InjuryNov 21, 2019Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information; Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information

    ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL VENTRALIGHT ST (DEVICE #1) OR AN UNSPECIFIED BARD/DAVOL VENTRIO ST (DEVICE #2) ON (B)(6) 2014 OR (B)(6) 2017. 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 VENTRALIGHT ST (DEVICE #1) AND THE VENTRIO ST (DEVICE #2). AS REPORTED, THE ATTORNEY ALLEGES PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

    Patient problems: Adhesion(s); Hernia; Injury

    MAUDE report 9357740 ↗
  • InjurySep 18, 2019Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information; Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information

    ATTORNEY ALLEGES THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL VENTRALIGHT ST ON (B)(6) 2015. 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 VENTRALIGHT ST. AS REPORTED, THE ATTORNEY ALLEGES PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

    Patient problems: Abscess; Adhesion(s); Fistula; Injury; Unspecified Infection

    MAUDE report 9082464 ↗
  • InjuryAug 21, 2019Defective Device; Insufficient Device Problem Information; Patient Device Interaction Problem; Migration; Defective Device; Insufficient Device Problem Information; Patient Device Interaction Problem; Migration

    ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL VENTRALIGHT ST ON (B)(6) 2013. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE VENTRALIGHT 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; Fluid Discharge; Hernia; Injury; Pain; Unspecified Infection

    MAUDE report 8914869 ↗
  • InjuryJun 25, 2019Defective Device; Insufficient Device Problem Information; Migration; Defective Device; Insufficient Device Problem Information; Migration

    ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL VENTRALIGHT ST (DEVICE #1) ON (B)(6) 2015 AND AN UNSPECIFIED VENTRALIGHT ST (DEVICE #2) ON (B)(6) 2017. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE TWO (2) VENTRALIGHT ST (DEVICE #1) AND (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; Fibrosis; Hernia; Injury; Pain; Seroma

    MAUDE report 8732719 ↗
  • InjuryJun 6, 2019Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information; Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information

    ATTORNEY ALLEGES THAT ON (B)(6) 2014, THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL VENTRALIGHT ST AND AN UNSPECIFIED BARD/DAVOL PHASIX. IT IS ALLEGED THAT THE PATIENT HAD SUBSEQUENT SURGICAL INTERVENTION DUE TO THE HERNIA MESH DEVICE. AS REPORTED, THE PATIENT IS ONLY MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE VENTRALIGHT ST. AS REPORTED, THE ATTORNEY ALLEGES PRODUCT IS DEFECTIVE AND THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS.

    Patient problems: Adhesion(s); Hernia; Injury

    MAUDE report 8676247 ↗
  • InjuryMay 31, 2019Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information; Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information

    ATTORNEY ALLEGES THAT ON (B)(6) 2012 OR (B)(6) 2013, THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL VENTRIO (DEVICE #1) OR AN UNSPECIFIED BARD/DAVOL VENTRALIGHT ST (DEVICE #2). THE ATTORNEY ALLEGES THE PATIENT HAD ADHESIONS, HERNIA RECURRENCE, AND PAIN. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE VENTRIO (DEVICE #1) AND VENTRALIGHT 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: Abdominal Pain; Adhesion(s); Disability; Hernia

    MAUDE report 8659903 ↗
  • InjuryApr 1, 2019Defective Device; No Apparent Adverse Event; Insufficient Device Problem Information; Defective Device; No Apparent Adverse Event; Insufficient Device Problem Information

    ATTORNEY ALLEGES PER SHORT FORM (SEE ATTACHED) THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL VENTRALEX ST (DEVICE#1) AND AN UNSPECIFIED BARD/DAVOL VENTRALIGHT ST (DEVICE#2) ON (B)(6) 2014 AND (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 VENTRALEX ST (DEVICE #1) AND THE VENTRALIGHT ST (DEVICE #2). AS REPORTED, THE ATTORNEY ALLEGES PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE

    Patient problems: Injury; No Clinical Signs, Symptoms or Conditions

    MAUDE report 8469832 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.