VENTRALIGHT 5955790Recalls & reported problems

Summary

The FDA's MAUDE database contains 57 adverse event reports that list this exact device (DI 00801741031762), received between Mar 24, 2017 and Aug 27, 2026 — classified as 51 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Defective Device” (40 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 57 reports, in the reporter's own words as published by the FDA.

• InjuryAug 27, 2026Migration

  Per information provided:ON (b)(6) 2007 - Patient was diagnosed with umbilical and ventral hernia thereby underwent open repair with the implant of Ventralex Mesh (Device 1). Per op notes, "The umbilicus was mobilized off the fascia. The hernia sac was opened and reduced back into the abdomen. A Ventralex Mesh (Device 1) were placed through the defect against the abdominal wall using prolene sutures."ON (b)(6) 2019 - Patient was diagnosed with recurrent incisional hernia thereby underwent laparoscopic repair with the implant of Ventralight ST Mesh using Echo PS (Device 2). Per op notes, "The small bowel which was densely adherent to the prior mesh (Device 1) and suture material. A portion of the mesh and suture were left intact on the surface of the bowel and the bowel was mobilized; adhesions were taken down. A Ventralight ST Mesh using Echo PS (Device 2) was placed in the abdominal cavity using tacks." ON (b)(6)-2019 - Patient was diagnosed with perforated small bowel and abscess thereby underwent repair with removal of mesh (Device 1 and 2). Per op notes, "The patient had moderate abdominal pain. There was adjacent perforation to the mesh (Device 1 and 2) where it had migrated i

  Patient problems: Abdominal Pain; Abscess; Bowel Perforation

  MAUDE report 50482728 ↗
• MalfunctionApr 10, 2026Material Split, Cut or Torn

  AS REPORTED, DURING A LAPAROSCOPIC VENTRAL HERNIA REPAIR PROCEDURE, A PORTION OF THE GREEN ECHO BALLOON OF THE VENTRALIGHT ST W/ECHO PS SEPARATED DURING REMOVAL THROUGH A 12 MM TROCAR. THE PORTION WAS REMOVED FROM THE PATIENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24839578 ↗
• InjuryApr 1, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2012 - PATIENT WAS DIAGNOSED WITH VENTRAL HERNIA IN THE LOWER LEFT ABDOMINAL WALL THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRALEX MESH (DEVICE 1) AND BARD FLAT MESH (DEVICE 2). PER OP NOTES, ¿AN INCISION WAS MADE IN THE LEFT LOWER QUADRANT OVER A PREVIOUS TROCAR SITE INCISION. THE HERNIA SAC WAS IDENTIFIED AND DIVIDED OFF OF THE FASCIA. A VENTRALEX MESH (DEVICE 1) WAS PLACED DEEP TO THE FASCIA AND SECURED WITH MULTIPLE SUTURES. A BARD FLAT MESH (DEVICE 2) WAS PLACED TO OVERLAP SEVERAL CENTIMETERS IN ALL DIRECTIONS AND STAPLED TO THE FASCIA WITH SUTURES.¿ (B)(6) 2017 - PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL INCISIONAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH EXCISION OF VENTRALEX MESH (DEVICE 1) AND BARD FLAT MESH (DEVICE 2) AND IMPLANT OF VENTRALIGHT ST WITH ECHO PS (DEVICE 3). PER OP NOTES, ¿THE HERNIA DEFECT IN THE MIDLINE WAS IDENTIFIED. ADHESIOLYSIS OF FATTY ADHESIONS WERE MADE. PREVIOUSLY PLACED MESH (DEVICE 1 AND 2) WAS NOTED TO BE WITHIN THE HERNIA. IT WAS EXCISED COMPLETELY AND REMOVED FROM THE ABDOMINAL CAVITY. A VENTRALIGHT ST WITH ECHO PS (DEVICE 3) WAS PLACED AND SECURED TO THE SUPERIOR ASPECT OF THE PUBIC WITH TAC

  Patient problems: Hernia; Seroma

  MAUDE report 24757180 ↗
• InjuryFeb 18, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH VENTRAL AND PARASTOMAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF VENTRALIGHT ST USING ECHO PS (DEVICE 1 AND 2). PER OP NOTES, ¿EXTENSIVE ADHESIONS AT LLQ WERE LYSED. ADHESIONS OF EPIGASTRIC MIDLINE AND RLQ WERE TAKEN DOWN. BOTHE HERNIA SACS WERE IDENTIFIED AND A 10X15 CM VENTRALIGHT ST USING ECHO PS (DEVICE 1) WAS PLACED IN THE VENTRAL DEFECT AND TACKED. A 20X17 CM VENTRALIGHT ST USING ECHO PS WAS PLACED IN THE PARASTOMAL HERNIA AND TACKED.¿ ON (B)(6) 2019 - PATIENT WAS DIAGNOSED WITH INCISIONAL HERNIA THEREBY UNDERWENT REPAIR WITH REVISION SURGERY. PER OP NOTES, ¿A LARGE PORTION OF ABDOMINAL WALL COVERED WITH MESH (DEVICE 1 AND 2) WITH NUMEROUS ADHESIONS WERE TAKEN DOWN. THE DEFECT WAS IDENTIFIED AND SUPERIOR PORTION OF ONE MESH PIECES AS WELL AS THROUGH THE UMBILICUS AND PORTION OF MESH AT THIS LOCATION AT LLQ DEFECT. ALL THE ADHESIONS IN ABDOMINAL WALL WERE LYSED.¿

  Patient problems: Adhesion(s); Hernia

  MAUDE report 24378837 ↗
• InjuryFeb 11, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2010 - PATIENT WAS DIAGNOSED WITH VENTRAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF SEPRAMESH IP. PER OPERATIVE NOTES, ¿A SMALL INCISION WAS MADE IN THE RIGHT UPPER QUADRANT. ADHESIONS AND OMENTUM WERE REMOVED FROM ABDOMEN. A SEPRAMESH IP (DEVICE 1) WAS PLACED INTO THE PERITONEAL CAVITY AND CLOSED WITH SORBAFIX ABSORBABLE TACKERS.¿ (B)(6) 2014 - PATIENT WAS DIAGNOSED WITH INFECTED ABDOMINAL WALL MESH, ABSCESS, FISTULA, PURULENT DISCHARGE THEREBY UNDERWENT OPEN REPAIR WITH EXPLANT OF SEPRAMESH IP (DEVICE 1) AND DRAINAGE OF ABSCESS. PER OPERATIVE NOTES, ¿AN INCISION WAS MADE JUST ABOVE THE UMBILICUS. THERE WAS FISTULA WHICH WAS REMOVED. THERE WAS DENSE AMOUNT OF ABSCESS FLUID WHICH WAS DRAINED FROM ABDOMEN. ALL PURULENT FLUID WHICH WAS PRESENT INTO THE ABSCESS CAVITY, WERE DRAINED. PREVIOUSLY PLACED MESH SEPRAMESH IP (DEVICE 1) WAS EXCISED ENTIRELY. THE DEFECT WAS CLOSED WITH SUTURES.¿ (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL INCISIONAL HERNIA, ADHESION THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF VENTRALIGHT ST W/ ECHO MESH (DEVICE 2). PER OPERATIVE NOTES, ¿A SMALL LEFT SUBCOSTAL INCISION WAS MADE. THERE

  Patient problems: Abscess; Adhesion(s); Purulent Discharge; Unspecified Infection

  MAUDE report 24313181 ↗
• InjuryMar 6, 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 VENTRALIGHT ST WITH ECHO ON (B)(6) 2019. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE VENTRALIGHT ST WITH ECHO. 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 16485373 ↗
• InjuryJul 29, 2022Defective 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 VENTRALIGHT ST ON (B)(6) 2017. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST 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; Insufficient Information; Scar Tissue

  MAUDE report 15131110 ↗
• InjuryJul 18, 2022Defective Device; Material Deformation; 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 W/ ECHO ON (B)(6) 2012. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE VENTRALIGHT ST W/ ECHO. 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; Adhesion(s); Bacterial Infection; Hernia; Insufficient Information; Pain

  MAUDE report 15045028 ↗
• InjuryJul 5, 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 UNSPECIFIED BARD/DAVOL VENTRALIGHT ST (X2) ON (B)(6) 2020 AND (B)(6) 2021. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE 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: Adhesion(s); Hernia; Insufficient Information

  MAUDE report 14917308 ↗
• InjuryMay 24, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  REPORTED PER CLINICAL TRIAL DVL-HE-020: ON (B)(6) 2016 - SUBJECT PATIENT UNDERWENT A ROBOTIC ASSISTED MULTIPLE RECURRENT MIDLINE HERNIA (8CM X 30CM) REPAIR PROCEDURE DURING WHICH TWO BARD/DAVOL VENTRALIGHT ST USING ECHO PS WERE IMPLANTED USING SUTURES. FULL SKIN CLOSURE WAS ACHIEVED USING SUTURES AND ADHESIVE SKIN CLOSURE. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2017. ON 13-SEP-2018- SUBJECT PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL MIDLINE INFRAUMBILICAL INCISIONAL HERNIA. ON 19-NOV-2018- SUBJECT PATIENT UNDERWENT SURGERY TO REPAIR THE HERNIA (4.5CM X 10CM) RECURRENCE AND WAS IMPLANTED WITH BARD/DAVOL VENTRALIGHT ST USING ECHO PS. THE FASCIA WAS COMPLETELY CLOSED USING SUTURES AND FULL SKIN CLOSURE WAS ACHIEVED. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON 20-NOV-2018. PER THE STUDY CLINICIAN, THE REPORTED ADVERSE EVENT HAS BEEN ASSESSED AS SEVERE, 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: Hernia

  MAUDE report 14488796 ↗
• InjuryMay 19, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  REPORTED PER CLINICAL TRIAL (B)(4): (B)(6) 2017 - SUBJECT PATIENT UNDERWENT ROBOTIC ASSISTED PROCEDURE FOR MULTIPLE RECURRENT INCISIONAL HERNIA REPAIR. THE SIZE OF THE HERNIA DEFECT WAS 9CM X 10CM. A BARD/DAVOL VENTRALIGHT ST MESH W/ECHO PS WAS IMPLANTED WITH SUTURE. FULL SKIN CLOSURE WAS ACHIEVED USING ADHESIVE SKIN CLOSURE. THE PATIENT WAS DISCHARGED TO HOME ON (B)(6)2017. (B)(6) 2018 - SUBJECT PATIENT DEVELOPED NON-STUDY MIDLINE INCISIONAL HERNIA. A CT SCAN WAS PERFORMED AND FAT WITHIN THE HERNIA WAS IDENTIFIED. 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. THERE HAS BEEN NO ACTION TAKEN AT THIS TIME AND THE OUTCOME FOR THIS AE IS REPORTED AS NOT RECOVERED/ NOT RESOLVED.

  Patient problems: Hernia

  MAUDE report 14434610 ↗
• InjuryFeb 2, 2022Defective Device; Patient Device Interaction Problem; Migration; Defective Device; Patient Device Interaction Problem; Migration

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF UNSPECIFIED BARD/DAVOL VENTRALEX ON (B)(6) 2014 AND VENTRALIGHT ST ON (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: Adhesion(s); Hernia; Insufficient Information; Pain

  MAUDE report 13422270 ↗
• InjuryNov 24, 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) 2016. 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. ADDENDUM PER ADDITIONAL INFORMATION PROVIDED: (B)(6) 2016 - PATIENT WAS DIAGNOSED WITH INCARCERATED INCISIONAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF VENTRALIGHT ST USING ECHO PS. PER OP NOTES, ¿THE HERNIA SAC WAS IDENTIFIED WITH INCARCERATED BOWEL AND OMENTUM WERE REDUCED. THE HERNIA SAC WAS DISSECTED FREE. A VENTRALIGHT ST USING ECHO PS MESH WAS PLACED AND TACKED.¿ (B)(6) 2016 - PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL INCISIONAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH PARTIAL EXCISION OF VENTRALIGHT ST USING ECHO PS AND IMPLANT OF SYNTHETIC MESH. PER OP NOTES, ¿A LARGE HERNIA DEFECT WAS IDENTIFIED NEAR THE OLD MESH. ADHESIONS WERE TAKEN DOWN. THE OLD MESH WAS PARTIALLY REMOVED. THE HERNIA DEFECT WAS REDUCED. A SYNTHETIC MESH W

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

  MAUDE report 12867140 ↗
• MalfunctionNov 10, 2021Material Separation; Failure to Unfold or Unwrap; Material Separation; Failure to Unfold or Unwrap

  AS REPORTED, DURING A ROBOTIC-ASSISTED LAPAROSCOPIC VENTRAL HERNIA REPAIR PROCEDURE ON (B)(6) 2021, WHEN THE BARD/DAVOL VENTRALIGHT ST MESH W/ECHO PS WAS INSERTED THROUGH THE TROCAR, THE MESH EDGE WAS STUCK TO ITSELF AND WOULD NOT FULLY OPEN. AS REPORTED, THE MESH WAS REMOVED AND ANOTHER MESH WAS USED TO COMPLETE THE CASE. AS REPORTED, THE SURGEON IS AN EXPERIENCED USER AND THERE WAS NO PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12786217 ↗
• 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 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 THAT THE PATIENT SUSTAINED UNSPECIFIED INJURY 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 12674313 ↗
• InjuryOct 19, 2021Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT ON OR ABOUT (B)(6) 2009, THE PATIENT WAS IMPLANTED WITH A NON-BARD/DAVOL PRODUCT TO REPAIR AN UMBILICAL HERNIA. IT IS REPORTED THAT ON OR ABOUT (B)(6)2011, THE PATIENT UNDERWENT REVISION OF THE NON-BARD/DAVOL PRODUCT AND WAS IMPLANTED WITH A BARD/DAVOL VENTRALIGHT ST MESH TO REPAIR AN UMBILICAL HERNIA. IT IS ALLEGED THAT ON OR ABOUT (B)(6) 2012, THE PATIENT UNDERWENT AN UMBILICAL HERNIA REPAIR AND A BARD/DAVOL VENTRALIGHT ST MESH W/ECHO PS WAS IMPLANTED. IT IS ALLEGED THAT THE PATIENT UNDERWENT PARTIAL REMOVAL OF THE MESH PRODUCTS ON OR ABOUT (B)(6) 2012, (B)(6) 2015, (B)(6) 2015 AND (B)(6)2016. IT IS ALLEGED THAT THE PATIENT EXPERIENCED AND/OR CONTINUES TO EXPERIENCE SEVERE AND CHRONIC PAIN/DISCOMFORT, INFLAMMATION, DENSE ADHESIONS, ADHESIONS TO THE BOWEL AND MESH, RECURRENCE, INFECTION, OPEN DRAINING WOUND, ABSCESS, BOWEL ISSUES/COMPLICATIONS, AND MULTIPLE REVISION/REMOVAL SURGERIES. ATTORNEY ALLEGES THAT THE ST BARD MESH IMPLANTED IN THE PATIENT FAILED TO REASONABLY PERFORM AS INTENDED, CAUSED SERIOUS INJURY AND HAD TO BE SURGICALLY REMOVED VIA INVASIVE SURGERY, AND NECESSITATED ADDITIONAL INVASIVE SURGERY TO REPAIR THE HERNIA THAT THE ST BARD MESH WAS INIT

  Patient problems: Abscess; Adhesion(s); Hernia; Unspecified Infection

  MAUDE report 12661674 ↗
• InjuryAug 18, 2021Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR THE 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 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 MEDICAL RECORDS AND PLAINTIFF PROFILE FORM: (B)(6) 2018 - PATIENT WAS DIAGNOSED WITH VENTRAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT OF VENTRALIGHT ST USING ECHO PS (DEVICE #1). PER OP NOTES, "A VENTRALIGHT ST USING ECHO PS (DEVICE #1) WAS PLACED AND TACKED." (B)(6) 2019 - PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE REMOVAL OF VENTRALIGHT ST USING ECHO PS (DEVICE #1) AND IMPLANT OF VENTRALIGHT ST USING ECHO PS (DEVICE #2). PER OP NOTES, "THE MESH (DEVICE #1) APPEARED TO BE MIGRATED. LYSIS OF ADHESIONS WAS PERFORMED, AND THE MESH (DEVICE #1) WAS REM

  Patient problems: Insufficient Information; Pain

  MAUDE report 12335113 ↗
• InjuryJun 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 AN UNSPECIFIED BARD/DAVOL VENTRALIGHT ST ON (B)(6) 2014. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST 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); Insufficient Information; Obstruction/Occlusion; Pain

  MAUDE report 12036828 ↗
• InjuryMay 12, 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) 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. ADDENDUM PER MEDICAL RECORDS AND PLAINTIFF PROFILE FORM: (B)(6) 2015 ¿ PATIENT WAS DIAGNOSED WITH INCISIONAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT OF VENTRALIGHT ST USING ECHO PS. PER OP NOTES, ¿THE VENTRALIGHT ST MESH USING ECHO PS WAS PLACED INTO DEFECT AND SECURED USING SUTURES.¿ (B)(6) 2016 ¿ PATIENT WAS DIAGNOSED WITH SMALL BOWEL OBSTRUCTION SECONDARY TO ADHESIVE BAND THEREBY UNDERWENT OPEN REPAIR. PER OP NOTES, ¿MULTIPLE ADHESIONS WERE PERFORMED FROM THE OMENTUM TO THE MESH. THE SMALL BOWEL OBSTRUCTION WAS RELEASED AFTER BAND WAS RESECTED.¿ (B)(6) 2018 ¿ PATIENT WAS DIAGNOSED WITH INCARCERATED RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE. PER OP NOTES, ¿THE PATIENT HAD A COMPLEX HERNIA SCATTERED THROUGHOUT WITH MU

  Patient problems: Adhesion(s); Hernia; Insufficient Information; Obstruction/Occlusion; Scar Tissue

  MAUDE report 11815435 ↗
• InjuryMar 8, 2021Defective Device; Expulsion; Material Deformation; Patient Device Interaction Problem; Defective Device; Expulsion; Material Deformation; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR THE IMPLANT OF UNSPECIFIED BARD/DAVOL VENTRALIGHT ST (X2) ON (B)(6) 2018 AND (B)(6) 2019. 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: Adhesion(s); Hernia; Insufficient Information

  MAUDE report 11432452 ↗
• InjuryMar 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 THE IMPLANT OF UNSPECIFIED BARD/DAVOL VENTRALIGHT ST (X2) ON (B)(6) 2018 AND (B)(6) 2019. 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 11432451 ↗
• InjuryFeb 25, 2021Defective 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 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; Pain; Unspecified Infection

  MAUDE report 11377073 ↗
• InjuryFeb 5, 2021Defective Device; Material Deformation; Insufficient Device Problem Information; Migration; Defective Device; Material Deformation; Insufficient Device Problem Information; Migration

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF TWO UNSPECIFIED BARD/DAVOL VENTRALIGHT ST ON (B)(6) 2014 AND (B)(6) 2015. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST BOTH DEVICES. ATTORNEY ALLEGES THAT THE PATIENT SUSTAINED INJURIES ON (B)(6) 2014 AND (B)(6) 2015. 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; Seroma

  MAUDE report 11286617 ↗
• InjuryDec 14, 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) 2005. 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 SUSTAINED PERSONAL INJURY, EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Adhesion(s); Fibrosis; Hernia; Injury

  MAUDE report 11002181 ↗
• InjuryOct 27, 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 ON (B)(6) 2017 AND VENTRALIGHT ST ON (B)(6) 2017. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST BOTH DEVICES. IT IS ALLEGED THAT THE PATIENT UNDERWENT SURGERY FOR THE REMOVAL OF HERNIA MESH 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: Abscess; Adhesion(s); Disability; Injury; Necrosis; Pain

  MAUDE report 10743913 ↗