VENTRALIGHT 5954790Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00801741031663), received between Sep 13, 2017 and Oct 31, 2025 — classified as 1 death, 20 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Defective Device” (18 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• InjuryOct 31, 2025Migration; Migration

  PER INFORMATION PROVIDED: (B)(6) 2015- PATIENT UNDERWENT HERNIA REPAIR WITH IMPLANT OF 3DMAX MESH (DEVICE 1) (NOTE: THERE IS NO INFORMATION PROVIDED REGARDING 3DMAX IN MEDICAL RECORDS AND PLAINTIFF PROFILE FORM). (B)(6) 2016- PATIENT WAS DIAGNOSED WITH INCISIONAL HERNIA THEREBY UNDERWENT REPAIR WITH IMPLANT OF VENTRALIGHT ST. (PPF/MRR) (NOTE: THERE IS NO OPERATIVE NOTES PROVIDED FOR THIS PROCEDURE IN MEDICAL RECORDS). (B)(6) 2016- PATIENT UNDERWENT PARTIAL REMOVAL OF INFECTED 3DMAX MESH (DEVICE 1) AND VENTRALIGHT ST MESH (DEVICE 2) (PPF) (NOTE: THERE IS NO OPERATIVE NOTES PROVIDED FOR THIS PROCEDURE IN MEDICAL RECORDS). (B)(6) 2017- ATTORNEY ALLEGES REMOVAL OF 3DMAX MESH (DEVICE 1) AND VENTRALIGHT ST MESH (DEVICE 2). (PPF) (NOTE: THERE IS NO OPERATIVE NOTES PROVIDED FOR THIS PROCEDURE IN MEDICAL RECORDS).

  Patient problems: Pain; Scar Tissue; Unspecified Infection

  MAUDE report 23434083 ↗
• InjuryJan 8, 2024Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  PER LEGAL COURT FILE: ATTORNEY ALLEGES THAT THE PATIENT WAS IMPLANTED WITH THE BARD/DAVOL VENTRALIGHT ST MESH COLLECTIVELY KNOWN AS "MESH PRODUCT". ON (B)(6) 2011, PATIENT WAS DIAGNOSED WITH RECURRENT INCARCERATED INCISIONAL HERNIA AND IMPLANTED WITH A 17.8CM X 22.9CM SIZED PIECE OF A VENTRALIGHT ST MESH (CAT #5954790, LOT #HUUJ0736). 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 18464082 ↗
• InjuryOct 3, 2023Defective Device; Patient Device Interaction Problem; Migration; 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) 2013. 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: Abdominal Pain; Hernia; Insufficient Information; Seroma; Unspecified Infection

  MAUDE report 17858648 ↗
• DeathJul 5, 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 VENTRALIGHT ST ON (B)(6) 2015. AS REPORTED, THE PLAINTIFF 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 AND WRONGFUL DEATH OF THE PATIENT. IT IS ALSO ALLEGED THAT THE PLAINTIFF EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Adhesion(s); Hernia; Insufficient Information; Nerve Damage; Seroma; Unspecified Infection

  MAUDE report 14917264 ↗
• MalfunctionMay 21, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  REPORTED PER CLINICAL TRIAL DVL-HE-020: (B)(6) 2013 SUBJECT PATIENT UNDERWENT A PRIMARY OPEN MIDLINE INFRA UMBILICAL HERNIA REPAIR PROCEDURE, DURING WHICH A BARD/DAVOL VENTRALIGHT ST MESH WAS IMPLANTED USING MECHANICAL FIXATION AND SUTURES. FULL SKIN CLOSURE WAS ACHIEVED USING STAPLES. THE SUBJECT PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2013. (B)(6) 2013 SUBJECT PATIENT WAS DIAGNOSED WITH SIGNIFICANT ECCHYMOSIS IN THE LOWER ABDOMEN. NO TREATMENT GIVEN. NOTED IMPROVEMENT ON THE 2ND FOLLOW UP VISIT; NO ECCHYMOSIS WAS NOTED ON THE 3RD FOLLOW-UP VISIT. PER THE STUDY CLINICIAN, THE REPORTED ADVERSE EVENT HAS BEEN ASSESSED AS MILD IN SEVERITY, POSSIBLY RELATED TO THE STUDY DEVICE AND DEFINITELY RELATED TO THE INDEX PROCEDURE. THE OUTCOME FOR THIS AE IS REPORTED AS RESOLVED.

  Patient problems: Ecchymosis

  MAUDE report 14464997 ↗
• InjuryMay 21, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  REPORTED PER CLINICAL TRIAL (B)(4): (B)(6) 2013 - SUBJECT PATIENT UNDERWENT A PRIMARY OPEN MIDLINE INFRA UMBILICAL HERNIA REPAIR PROCEDURE, DURING WHICH A BARD/DAVOL VENTRALIGHT ST MESH WAS IMPLANTED USING MECHANICAL FIXATION AND SUTURES. FULL SKIN CLOSURE WAS ACHIEVED USING STAPLES. THE SUBJECT PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2013. (B)(6) 2013 - SUBJECT PATIENT UNDERWENT PHYSICAL EXAM AND DIAGNOSED WITH SEROMA. NO TREATMENT WAS PROVIDED. PER THE STUDY CLINICIAN, THE REPORTED ADVERSE EVENT HAS BEEN ASSESSED AS MODERATE IN SEVERITY, POSSIBLY RELATED TO THE STUDY DEVICE AND DEFINITELY RELATED TO THE INDEX PROCEDURE. THE OUTCOME FOR THIS AE IS REPORTED AS UNKNOWN.

  Patient problems: Seroma

  MAUDE report 14464966 ↗
• InjuryMay 21, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  REPORTED PER CLINICAL TRIAL (B)(4): (B)(6) 2013 - SUBJECT PATIENT UNDERWENT A PRIMARY OPEN MIDLINE INFRA UMBILICAL HERNIA REPAIR PROCEDURE, DURING WHICH A BARD/DAVOL VENTRALIGHT ST MESH WAS IMPLANTED USING MECHANICAL FIXATION AND SUTURES. FULL SKIN CLOSURE WAS ACHIEVED USING STAPLES. THE SUBJECT PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2013. (B)(6) 2015 - SUBJECT PATIENT UNDERWENT A LAPAROSCOPIC SURGERY FOR PRESUMED HYDROSALPINX, BUT UPON INSPECTION, THERE WAS NO HYDROSALPINX OR CYST FOUND, SEVERE INTRAABDOMINAL ADHESIONS WERE FOUND, WHICH WERE TAKEN DOWN. THE PATIENT WAS DISCHARGED THE SAME DAY. 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 RECOVERED/RESOLVED.

  Patient problems: Adhesion(s)

  MAUDE report 14464954 ↗
• InjuryJan 8, 2022Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT ON (B)(6) 2015, THE PATIENT WAS IMPLANTED WITH TWO BARD/DAVOL VENTRALIGHT ST MESHES IN THE COURSE OF A 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 AND HERNIA RECURRENCE, NECESSITATING FURTHER REPARATIVE SURGERY WHICH OCCURRED ON (B)(6) 2018. IT IS ALLEGED 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 THAT 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 SURGER

  Patient problems: Hernia; Obstruction/Occlusion; Pain; Swelling/ Edema

  MAUDE report 13200870 ↗
• InjuryApr 8, 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 VENTRALIGHT ST ON (B)(6) 2017. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE VENTRALIGHT ST. IT IS ALLEGED THAT THE PATIENT SUSTAINED INJURIES ON (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: Bowel Perforation; Insufficient Information; Pain; Sepsis; Unspecified Infection

  MAUDE report 11634056 ↗
• InjuryMar 22, 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 THE IMPLANT OF UNSPECIFIED BARD/DAVOL VENTRALEX ON (B)(6) 2006 AND VENTRALIGHT ST ON (B)(6) 2011. 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: Abdominal Pain; Hernia; Insufficient Information; Pain; Seroma

  MAUDE report 11537233 ↗
• InjuryNov 11, 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 VENTRALEX HERNIA PATCH ON (B)(6) 2006 AND VENTRALIGHT ST ON (B)(6) 2012. 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: Injury; Pain

  MAUDE report 10821297 ↗
• InjuryNov 11, 2020Defective Device; Insufficient Device Problem Information; Migration; Defective Device; Insufficient Device Problem Information; Migration

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF UNSPECIFIED BARD/DAVOL VENTRIO AND VENTRALIGHT ST ON (B)(6) 2011 AND/OR (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; Hernia; Injury; Pain

  MAUDE report 10821279 ↗
• InjuryJul 23, 2020Defective Device; Insufficient Device Problem Information; Defective Device; Insufficient Device Problem Information

  ATTORNEY ALLEGES THAT ON OR ABOUT (B)(6) 2013, PLAINTIFF UNDERWENT SURGERY FOR REPAIR OF AN INCISIONAL VENTRAL HERNIA. A NON-BARD/DAVOL MESH WAS IMPLANTED IN AN ATTEMPT TO REPAIR THE HERNIA DEFECT. ON OR ABOUT (B)(6) 2017, PLAINTIFF UNDERWENT AN ADDITIONAL SURGERY FOR REPAIR OF A RECURRENT INCISIONAL HERNIA. THE SURGEON IMPLANTED A BARD/DAVOL VENTRALIGHT ST IN THE PLAINTIFF'S ABDOMEN IN AN ATTEMPT TO REPAIR THE RECURRENT HERNIA DEFECT. UPON ENTERING THE ABDOMEN, THE SURGEON NOTED EXTENSIVE BOWEL ADHESIONS DENSELY ADHERENT TO THE MESH. THE BOWEL WAS SO ADHERENT TO THE MESH THAT THE SURGEON HAD TO INCISE THE MESH AND LEAVE A PORTION OF THE MESH ON THE BOWEL TO PREVENT FURTHER SEROSAL INJURY. THE SURGEON SPENT APPROXIMATELY THREE AND ONE-HALF HOURS LYSING ADHESIONS. THE SURGEON REPAIRED A SEROSAL TEAR, WHICH WAS UNAVOIDABLE DUE TO THE SEVERITY OF THE BOWEL ADHESIONS TO THE MESH. THE RECURRENT HERNIA WAS REPAIRED PRIMARILY. IT IS ALLEGED THAT ON OR ABOUT (B)(6) 2018, PLAINTIFF UNDERWENT A GASTRECTOMY AND REVISION OF THE MESH BY THE SURGEON. UPON ENTERING THE ABDOMEN, THE SURGEON SPENT APPROXIMATELY TWO HOURS PERFORMING A DIFFICULT LYSIS OF ADHESIONS SEPARATING LOOPS OF INTESTINE FROM T

  Patient problems: Adhesion(s); Disability; Inflammation

  MAUDE report 10313974 ↗
• InjuryFeb 18, 2020Defective 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 UNSPECIFIED BARD/ DAVOL COMPOSIX AND VENTRALIGHT ST ON (B)(6) 2003 AND/OR (B)(6) 2011. 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: Injury; Pain

  MAUDE report 9719677 ↗
• InjuryDec 19, 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 TWO UNSPECIFIED BARD/ DAVOL VENTRALIGHT ST ON (B)(6) 2018 AND (B)(6) 2019. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST BOTH VENTRALIGHT ST MESHES. THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2019 FOR THE VENTRALIGHT ST MESH IMPLANTED ON (B)(6) 2018. 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 9498078 ↗
• InjuryAug 15, 2019Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information; Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information

  ATTORNEY ALLEGES THAT ON (B)(6) 2017, THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL VENTRALIGHT ST. 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); Hernia; Injury; Joint Dislocation; Pain

  MAUDE report 8899455 ↗
• InjuryJul 11, 2019Defective 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 AN UNSPECIFIED BARD/DAVOL VENTRALIGHT ST ON (B)(6) 2016. ATTORNEY ALLEGES UNSPECIFIED INJURIES RELATED TO A DEFECT IN THE VENTRALIGHT ST. AS REPORTED, PATIENT HAD REVISION SURGERY ON (B)(6) 2016. 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: Abdominal Pain; Abscess; Adhesion(s); Disability; Fibrosis; Injury; Necrosis; Pain; Scar Tissue; Unspecified Infection

  MAUDE report 8782324 ↗
• InjuryMar 29, 2019Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information; Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information

  PER LEGAL COMPLAINT: (B)(6) 2015 - PATIENT UNDERWENT SURGERY DURING WHICH THE PATIENT WAS IMPLANTED WITH AN UNSPECIFIED BARD/DAVOL VENTRALIGHT ST. 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."

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

  MAUDE report 8465963 ↗
• InjuryJan 16, 2019Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information; Defective Device; Insufficient Device Problem Information

  THE FOLLOWING WAS ALLEGED BY THE PATIENT'S ATTORNEY: (B)(6) 2016: THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL VENTRALIGHT ST(DEVICE #1). (B)(6) 2017: THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL VENTRALIGHT ST(DEVICE #2). (B)(6) 2017: THE PATIENT HAD UNSPECIFIED INJURIES RELATED TO A DEFECT IN THE VENTRALIGHT ST(DEVICE #1) AND UNDERWENT REVISION SURGERY. THE PATIENT IS ONLY MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE TWO (2) VENTRALIGHT ST(DEVICE #1 AND DEVICE#2). 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: Disability; Injury; Pain

  MAUDE report 8254929 ↗
• InjuryDec 4, 2018Defective Device; Insufficient Device Problem Information; Patient Device Interaction Problem; Defective Device; Insufficient Device Problem Information; Patient Device Interaction Problem

  THE PATIENT'S ATTORNEY HAS ALLEGED THE FOLLOWING: (B)(6) 2011- PATIENT UNDERWENT LAPAROSCOPIC REPAIR OF A VENTRAL HERNIA AND A BARD/DAVOL VENTRALIGHT ST BARD MESH WAS IMPLANTED. (B)(6) 2015- THE PATIENT WAS ADMITTED FOR NAUSEA, VOMITING, ABDOMINAL PAIN, AND IRREGULAR BOWELS. IT WAS ULTIMATELY DETERMINED THAT SURGICAL INTERVENTION WAS NECESSARY. ON THE SAME DAY, THE PATIENT UNDERWENT SURGERY TO REMOVE THE FAILED MESH AND REPAIR A RECURRENT HERNIA. DURING THE PROCEDURE, THE SURGEON NOTED DENSE ADHESIONS AND PIECES OF THE PREVIOUSLY PLACED MESH AT THE SITE OF RECURRENT HERNIA. AS ALLEGED, PRIOR TO AND AFTER THIS PROCEDURE, THE PATIENT SUFFERED SEVERE AND DEBILITATING PAIN. THE PATIENT ALSO REQUIRES FURTHER MEDICAL TREATMENT, INCLUDING LIKELY NEED FOR FUTURE SURGERIES. THE ATTORNEY ALLEGES THAT THE PATIENT SUFFERED PERMANENT INJURIES AND SIGNIFICANT PAIN AND SUFFERING. ADDENDUM PER ADDITIONAL INFORMATION PROVIDED: (B)(6) 2011 - PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL HERNIA WITH INTERMITTENT SMALL BOWEL OBSTRUCTION THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT OF VENTRALIGHT ST MESH. PER OPERATIVE NOTES, "THE ABDOMINAL WALL DEFECT WAS IDENTIFIED AND THE ADHESIONS WERE NOT

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

  MAUDE report 8129034 ↗
• MalfunctionMay 7, 2018Material Separation; Material Separation

  IT WAS REPORTED THAT WHILE PLACING A BDI SURGERY / DAVOL VENTRALIGHT ST MESH IN THE PATIENT DURING A LAPAROSCOPIC VENTRAL HERNIA REPAIR CASE THE "SEPRA BARRIER (HYDROGEL) CAME OFF IN CHUNKS." AS REPORTED THE SURGEON HYDRATED THE MESH FOR 5 - 7 SECONDS IN STERILE, ROOM TEMPERATURE SALINE AND INTRODUCED THE MESH THROUGH A SKIN INCISION. THE SURGEON REPORTS THAT THE MESH WAS NOT OVER HYDRATED. THE MESH WAS REMOVED AND DISCARDED. THE CASE WAS COMPLETED WITH ANOTHER VENTRALIGHT ST MESH. THE SURGEON HAS USED THIS PRODUCT FOR SEVERAL YEARS, AND IS FAMILIAR WITH THE TECHNOLOGY AND TECHNIQUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7491861 ↗
• InjuryApr 19, 2018Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information; Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information

  THE FOLLOWING WAS ALLEGED BY THE PATIENT'S ATTORNEY: ON (B)(6) 2016 - THE PATIENT WAS DIAGNOSED WITH A VENTRAL HERNIA. ON (B)(6) 2016 - THE PATIENT UNDERWENT VENTRAL HERNIA REPAIR WITH AN UNSPECIFIED BARD/DAVOL VENTRALIGHT ST HERNIA MESH PRODUCT. AS REPORTED, IN THE MONTHS FOLLOWING THE (B)(6) 2016 IMPLANT OF THE VENTRALIGHT ST MESH, THE PATIENT CONTINUED TO EXPERIENCE CHRONIC ABDOMINAL PAIN, AND FURTHER EXPERIENCED SEVERAL INFECTIONS, AS WELL AS FLUID DRAINING FROM THE UMBILICUS. THE MESH CONTINUES TO CAUSE CHRONIC ABDOMINAL PAIN, INFECTIONS, AND FISSURES. THE MESH REQUIRES SURGICAL REMOVAL, BUT CANNOT BE REMOVED. THE PATIENT'S ATTORNEY ALSO ALLEGES THAT THE VENTRALIGHT ST IS DEFECTIVE AND, "AS A RESULT OF HAVING THE PRODUCT IMPLANTED, THE PATIENT HAS EXPERIENCED SIGNIFICANT PHYSICAL PAIN AND SUFFERING", "HAS SUSTAINED PERMANENT INJURY, HAS UNDERGONE MEDICAL TREATMENT AND WILL LIKELY UNDERGO FURTHER MEDICAL TREATMENT AND PROCEDURES."

  Patient problems: Abdominal Pain; Disability; Pain; Unspecified Infection

  MAUDE report 7444362 ↗
• InjurySep 13, 2017Defective Device; Insufficient Device Problem Information; Patient Device Interaction Problem; Defective Device; Insufficient Device Problem Information; Patient Device Interaction Problem

  THE FOLLOWING WAS REPORTED TO DAVOL BY THE PATIENT'S ATTORNEY: BETWEEN 12/2012 AND 02/2016 THE PATIENT UNDERWENT VENTRAL HERNIA REPAIR WITH IMPLANT OF MULTIPLE BARD MESH DEVICES INCLUDING A COMPOSIX KUGEL HERNIA PATCH (DEVICE #1 (B)(6)2012), VENTRIO PATCH DEVICE (DEVICE #2 (B)(6) 2013), VENTRALIGHT ST (DEVICE #3 (B)(6) 2015) AND A SECOND VENTRIO PATCH (DEVICE #4 (B)(6) 2016). BETWEEN 2012 AND 2017 THE PATIENT UNDERWENT MULTIPLE REVISION PROCEDURES DUE TO RECURRENT VENTRAL HERNIA WITH CHRONIC INFECTED WOUND. THE PATIENT UNDERWENT PARTIAL EXCISION OF INFECTED MATERIAL (DEVICE #1) IN (B)(6) 2013. TWO MONTHS LATER, THE PATIENT UNDERWENT A REVISION PROCEDURE WERE THE SURGEON NOTED THE PREVIOUSLY IMPLANTED MESH (DEVICE #1), HAD "ROLLED" DOWN THE AB WALL AND HAD TO BE FREED UP AND SMOOTHED OUT TO BE AFFIXED BACK TO THE AB WALL. BETWEEN 02/2016 AND 04/2016, THE PATIENT UNDERWENT EXTENSIVE WOUND CARE OF HER ABD WOUND INFECTION. IN EARLY 2017 THE PATIENT WAS DIAGNOSED WITH FLUID COLLECTION AROUND HER MESH AND UNDERWENT AN ATTEMPTED ASPIRATION PROCEDURE WHICH FAILED. THE PATIENT UNDERWENT AN ULTRASOUND GUIDED DRAINAGE OF PROBABLE SEROMA. NO ADDITIONAL INFORMATION WAS PROVIDED BEYOND THIS PROC

  Patient problems: Hernia; Insufficient Information; Seroma; Unspecified Infection

  MAUDE report 6862366 ↗