VENTRALIGHT 5955810Recalls & reported problems

Summary

The FDA's MAUDE database contains 60 adverse event reports that list this exact device (DI 00801741031786), received between Sep 6, 2017 and Jul 1, 2026 — classified as 1 death, 49 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Defective Device” (45 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 60 reports, in the reporter's own words as published by the FDA.

• InjuryJul 1, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2011 - PATIENT WAS DIAGNOSED WITH VENTRAL HERNIA THEREBY UNDERWENT REPAIR WITH IMPLANT OF VENTRALEX MESH (DEVICE 1). (NOTE: NO OPERATIVE NOTE IS AVAILABLE IN THE MRR FOR THIS PROCEDURE.) (B)(6) 2012 - PATIENT WAS DIAGNOSED WITH RECURRENT UMBILICAL HERNIA, PAIN, ADHESION THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH EXPLANT OF VENTRALEX MESH (DEVICE 1) AND IMPLANT OF SEPRAMESH IP (DEVICE 2). PER OPERATIVE NOTES, "AN INCISION WAS MADE INTO THE UMBILICAL REGION. THE HERNIA SAC WAS DISSECTED OUT. THERE WERE SOME ADHESIONS THAT WERE TO THE PREVIOUSLY PLACED MESH. ALL ADHESIONS WERE TAKEN DOWN SHARPLY. THE PREVIOUSLY PLACED (DEVICE 1) MESH WAS BUCKLED AT ONE POINT. OLD (DEVICE 1) WAS REMOVED FROM THE ABDOMINAL WALL. A SEPRAMESH IP (DEVICE 2) WAS PLACED INTO THE ABDOMEN AND SECURED IT WITH SUTURES." (B)(6) 2016 - PATIENT WAS DIAGNOSED WITH RECURRENT UMBILICAL HERNIA, PAIN, ADHESION THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH EXPLANT SEPRAMESH IP (DEVICE 2) AND IMPLANT OF VENTRALIGHT ST W/ ECHO MESH (DEVICE 3). PER OPERATIVE NOTES, "A MIDLINE INCISION WAS MADE OVERLYING THE HERNIA THROUGH THE SUBCUTANEOUS TISSUE. THE HERNIA SAC WAS DISSECTED OUT. THERE WERE DEN

  Patient problems: Hernia

  MAUDE report 25678169 ↗
• MalfunctionApr 3, 2026Detachment of Device or Device Component

  AS REPORTED, DURING A LAPAROSCOPIC VENTRAL HERNIA REPAIR PROCEDURE, A VENTRALIGHT ST MESH WITH ECHO POSITIONING SYSTEM WAS USED. DURING REMOVAL OF THE ECHO POSITIONING SYSTEM, THE INFLATION TUBE WAS NOT CUT BELOW THE ANCHOR FOLLOWING BALLOON DEFLATION. AS A RESULT, THE YELLOW ANCHOR REMAINED ATTACHED TO THE INFLATION TUBE AND WAS PULLED THROUGH THE PATIENT¿S ABDOMEN DURING REMOVAL. THIS CAUSED THE YELLOW ANCHOR TO BECOME LODGED WITHIN THE PATIENT¿S ANATOMY AND SUBSEQUENTLY DETACH. THE SURGEON WAS UNABLE TO LOCATE THE ANCHOR AND BELIEVES IT IS LODGED BETWEEN THE MESH AND THE PERITONEUM. THE PATIENT WILL BE MONITORED. THERE WAS NO PATIENT INJURY.

  Patient problems: Foreign Body In Patient

  MAUDE report 24778742 ↗
• InjuryAug 5, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  AS REPORTED, THE PATIENT UNDERWENT A LAPAROSCOPIC VENTRAL HERNIA REPAIR ON (B)(6) 2023, DURING WHICH A VENTRALIGHT ST WITH ECHO PS WAS USED FOR THE REPAIR. ON (B)(6) -2025, DURING A SUBSEQUENT ROBOTIC INCISIONAL HERNIA REPAIR PROCEDURE, IT WAS DISCOVERED THAT THE PREVIOUSLY IMPLANTED ECHO PS REMAINED INSIDE THE PATIENT'S BODY. THE ECHO PS WAS REMOVED DURING THE PROCEDURE AND IT WAS REPORTED THAT THE MESH WAS INTACT WITH NO FAULTS OR DEFECTS. THERE WAS NO PATIENT INJURY.

  Patient problems: Foreign Body In Patient

  MAUDE report 22716206 ↗
• MalfunctionMar 25, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, DURING AN INCISIONAL HERNIA REPAIR PROCEDURE USING A VENTRALIGHT ST W/ ECHO PS THE SURGEON CLOSED THE DEFECT WITH SUTURE PRIOR TO PULLING THE INFLATION TUBE UP AGAINST THE ABDOMINAL WALL. AS REPORTED THE INFLATION TUBE BROKE AND THE YELLOW ANCHOR DETACHED WHEN PULLED UP AGAINST THE ABDOMINAL WALL. REPORTEDLY, THE YELLOW ANCHOR WAS UNABLE TO BE RETRIEVED, AND WAS LEFT IN VIVO. THE PROCEDURE WAS ABLE TO BE COMPLETED USING THE SAME MESH. THERE WAS NO PATIENT INJURY.

  Patient problems: Foreign Body In Patient

  MAUDE report 21687095 ↗
• InjuryJul 17, 2024Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN BARD/DAVOL VENTRALIGHT ST WITH ECHO (CAT # 5955810 AND LOT # HUZD1926) ON (B)(6) 2015. 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 19759315 ↗
• MalfunctionApr 4, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, DURING A LAPAROSCOPIC VENTRAL HERNIA REPAIR PROCEDURE, THE SURGEON ATTEMPTED TO IMPLANT A VENTRALIGHT ST MESH USING ECHO PS WHICH WAS DEPLOYED THROUGH A 12MM TROCAR. THE MESH WOULD NOT LAY FLAT, AND THE SURGEON REMOVED THE DEVICE, DURING THE REMOVAL IT WAS NOTICED THAT ONE OF THE BLUE CONNECTORS THAT CONNECTS THE MESH TO THE ECHO BALLOON TOGETHER WAS MISSING. NOTE, THE OR STAFF DID NOT CHECK WHETHER THE CONNECTOR WAS PRESENT ON THE MESH WHEN INTRODUCED INTO THE PATIENT. THE PATIENT WAS NOT TAKEN BACK FOR ADDITIONAL SURGERY TO LOCATE THE CONNECTOR. A NEW VENTRALIGHT ST W/ ECHO MESH WAS USED TO COMPLETE THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19042666 ↗
• InjuryOct 20, 2023Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  PER INFORMATION PROVIDED BY THE ATTORNEY: (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH INCARCERATED INCISIONAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT OF VENTRALEX ST MESH (DEVICE #1). PER OPERATIVE NOTES, "THERE WAS A HERNIA TO THE RIGHT OF MIDLINE IN THE LOWER ABDOMEN. THE HERNIA WAS MEASURED AND IT WAS AT THE EDGE OF THE PRIOR BIOLOGICAL MESH, WHICH WAS WELL INCORPORATED. A LARGE VENTRALEX ST MESH (DEVICE #1) WAS PLACED INTO THE ABDOMINAL CAVITY AND TACKED.¿ (B)(6) 2016 TO (B)(6) 2016 - PATIENT FREQUENTLY VISITED HOSPITAL FOR RIGHT QUADRANT LOWER ABDOMINAL PAIN. (B)(6) 2016 - PATIENT WAS DIAGNOSED WITH PAIN AND ADHESIONS THEREBY UNDERWENT REPAIR WITH MESH REMOVAL. PER OPERATIVE NOTES, "MESH PROSTHESIS WAS THEN INCISED, THERE WERE SEVERE INTESTINAL AND OMENTAL ADHESIONS WHICH WERE DISSECTED FROM THE MESH PROSTHESIS AND MESH (DEVICE #1) WAS THEN EXPLANTED WITH SHARP DISSECTION. UPON REMOVAL OF ONE STAPLE, THERE WAS SOME CLEAR FLUID LEAK. THIS WAS POSSIBLY FROM A SEROMA ALTHOUGH IT WAS CONCERN OF POSSIBILITY OF A STAPLE BEING IN THE WALL OF THE BLADDER." (B)(6) 2016 - PATIENT VISITED HOSPITAL FOR ABDOMINAL PAIN. (B)(6) 2017 - PATIENT WAS DIAGNOSED WITH RECURRENT I

  Patient problems: Adhesion(s); Hemorrhage/Blood Loss/Bleeding; Hernia; Inflammation; Scar Tissue; Seroma

  MAUDE report 17975054 ↗
• InjuryNov 17, 2022Defective Device; Patient-Device Incompatibility; Defective Device; Patient-Device Incompatibility

  ATTORNEY ALLEGES: ON (B)(6) 2020, THE PLAINTIFF WAS IMPLANTED WITH BARD/DAVOL VENTRIO ST IN THE COURSE OF AN INCISIONAL HERNIA REPAIR SURGERY. ATTORNEY ALLEGES THAT; FURTHER TO THE IMPLANTATION WITH THE PRODUCT, PLAINTIFF SUFFERED THE DEVELOPMENT OF HERNIA RECURRENCE, GASTROINTESTINAL COMPLICATIONS AND CHRONIC PAIN. ATTORNEY ALLEGES THAT; ON (B)(6) 2020, THE PLAINTIFF UNDERWENT CORRECTIVE REVISION SURGERY AND WAS IMPLANTED WITH BARD/DAVOL VENTRALIGHT ST MESH WITH ECHO PS POSITIONING SYSTEM. IT IS ALSO ALLEGED THAT THE PLAINTIFF SUSTAINED INJURIES INCLUDING; HERNIA RECURRENCE, GASTROINTESTINAL COMPLICATIONS CHRONIC PAIN, PSYCHOLOGICAL AND EMOTIONAL INJURIES. IT IS ALLEGED THAT THE PLAINTIFF "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 THE PLAINTIFF SUFFERED PERMANENT INJURIES INCLUDING SCARRING, DISFIGUREMENT, PAIN AND PHYSICAL DISABILITY ." IT IS ALLEGED THAT THE PLAINTIFF CONTINUES TO UNDERGO MEDICAL CARE AND TREATMENT. IT IS ALSO ALLEGED THAT THE PATIENT SUSTAINED PERSONAL INJURY, EMOTIONAL DISTRESS AND THE DEVICE WAS D

  Patient problems: Deformity/ Disfigurement; Hernia; Pain; Scar Tissue; Unspecified Gastrointestinal Problem

  MAUDE report 15813929 ↗
• MalfunctionOct 20, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, A VENTRALIGHT ST W/ECHO PS WAS USED DURING A LAPAROSCOPIC VENTRAL HERNIA REPAIR PROCEDURE ON 30-SEP-2022. IT WAS REPORTED THAT DEVICE WAS HYDRATED AND ROLLED INSIDE PRIOR TO INSERTION. A 12MM TROCAR WAS USED AND THE MESH WAS SUCCESSFULLY FIXATED IN THE CORRECT POSITION. AS REPORTED, AFTER REMOVING THE ECHO PS FROM THE PATIENT¿S ABDOMEN ONE OF THE FOUR CONNECTORS WAS NOTED TO BE MISSING FROM THE ECHO PS. THE PATIENT¿S ABDOMINAL CAVITY INCLUDING THE MESH WERE SEARCHED/INSPECTED, HOWEVER THE MISSING CONNECTOR COULD NOT BE LOCATED. THE SURGEON COMPLETED THE PROCEDURE ASSUMING THE CONNECTOR WAS IN BETWEEN THE ABDOMEN AND THE MESH. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: Foreign Body In Patient

  MAUDE report 15640529 ↗
• InjuryMay 21, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  REPORTED PER CLINICAL TRIAL (B)(4): (B)(6) 2016 - SUBJECT PATIENT UNDERWENT PRIMARY ROBOTIC ASSISTED RIGHT LUMBAR HERNIA REPAIR PROCEDURE. A BARD/DAVOL VENTRALIGHT ST W/ECHO PS, WAS PLACED USING UNSPECIFIED SUTURES. FULL SKIN CLOSURE WAS ACHIEVED USING SUTURES AND ADHESIVE SKIN CLOSURE. THE SUBJECT PATIENT WAS DISCHARGED TO HOME ON (B)(6) 2016. (B)(6) 2016 - SUBJECT PATIENT WAS DIAGNOSED WITH SEROMA. ULTRASOUND SHOWED FLUID COLLECTION CONTAINING BLOOD OR DEBRIS. NO TREATMENT GIVEN. BY THE NEXT APPOINTMENT ON (B)(6) 2016, THE SEROMA WAS RESOLVED. 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 RECOVERED/RESOLVED.

  Patient problems: Seroma

  MAUDE report 14465636 ↗
• InjuryNov 15, 2021Defective 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 MESH ON (B)(6) 2016. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST VENTRALIGHT ST 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 DEVICE WAS DEFECTIVE.

  Patient problems: Adhesion(s); Granuloma; Hernia; Insufficient Information; Obstruction/Occlusion; Pain

  MAUDE report 12817865 ↗
• InjuryAug 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 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.

  Patient problems: Adhesion(s); Insufficient Information

  MAUDE report 12337897 ↗
• InjuryJul 13, 2021Defective Device; Material Deformation; Patient Device Interaction Problem; Defective Device; Material Deformation; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR THE 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 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: Abdominal Pain; Adhesion(s); Hernia; Insufficient Information; Necrosis; Pain; Unspecified Infection

  MAUDE report 12157082 ↗
• InjuryJun 30, 2021Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED, DURING AN UNKNOWN PROCEDURE ON (B)(6) 2021, THE PATIENT UNDERWENT IMPLANT OF A BARD/DAVOL VENTRALIGHT ST W/ ECHO POSITIONING SYSTEM. IT WAS REPORTED THAT THE PATIENT DEVELOPED A POSSIBLE BOWEL OBSTRUCTION POST IMPLANT OF THE MESH. ON (B)(6) 2021, THE PATIENT UNDERWENT SUBSEQUENT SURGICAL INTERVENTION TO REMOVE THE IMPLANTED MESH; IT WAS FOUND THAT THERE WERE SMALL BOWEL ADHESIONS TO THE BARD/DAVOL VENTRALIGHT ST MESH. IT WAS REPORTED THAT THE PATIENT WENT HOME TWO DAYS AFTER THE MESH WAS EXPLANTED AND IS DOING WELL.

  Patient problems: Adhesion(s); Obstruction/Occlusion

  MAUDE report 12091477 ↗
• InjuryApr 28, 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 HERNIA PATCH AND VENTRALIGHT ST ON (B)(6) 2019 AND/OR (B)(6) 2020. 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 11739316 ↗
• InjuryMar 16, 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 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); Insufficient Information; Pain

  MAUDE report 11496570 ↗
• InjuryFeb 2, 2021Defective 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 VENTRALIGHT ST (X2) ON (B)(6) 2017 AND XENMATRIX AB SURGICAL GRAFT ON (B)(6) 2018. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST VENTRALIGHT ST (X2). ATTORNEY ALLEGES THAT THE PATIENT SUSTAINED INJURIES 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: Adhesion(s); Disability; Fistula; Hernia; Injury; Pain; Unspecified Infection

  MAUDE report 11265506 ↗
• InjuryDec 10, 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) 2013. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE VENTRALIGHT ST. IT IS ALLEGED 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

  MAUDE report 10983532 ↗
• InjuryDec 3, 2020Defective Device; Insufficient Device Problem Information; Migration; Defective Device; Insufficient Device Problem Information; Migration

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR THE 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 DEVICE WAS DEFECTIVE.

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

  MAUDE report 10939491 ↗
• MalfunctionOct 14, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC ABDOMINAL VENTRAL HERNIA REPAIR PROCEDURE ON (B)(6) 2020, VENTRALIGHT ST MESH W/ ECHO POSITIONING SYSTEM (8X10, ELLIPSE) WAS USED. DURING PLACEMENT OF THE MESH THROUGH A 12MM TROCAR, THE ECHO PS BALLOON DETACHED FROM THE MESH AFTER INFLATION. AS REPORTED, THE SURGEON WORKED AROUND THE ISSUE AND WAS ABLE TO FIXATE THE MESH AND THE MESH WAS SUCCESSFULLY IMPLANTED. HOWEVER, AS REPORTED ¿IT CAUSED THE PROCESS TO BECOME MORE DIFFICULT WITH PLACEMENT.¿ THERE WAS NO REPORTED PATIENT INJURY AND THE SURGEON IS AN EXPERIENCED USER OF THE DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10678295 ↗
• InjuryAug 26, 2020Defective Device; Material Deformation; Insufficient Device Problem Information; Defective Device; Material Deformation; Insufficient Device Problem Information

  ATTORNEY ALLEGES THAT ON OR ABOUT (B)(6) 2014, THE PATIENT WAS IMPLANTED WITH A NON-BARD DAVOL MESH TO REPAIR AN UMBILICAL HERNIA. ON OR ABOUT (B)(6) 2015, THE PATIENT UNDERWENT AN ADDITIONAL SURGERY; A BARD/DAVOL VENTRALIGHT ST W/ECHO POSITIONING SYSTEM WAS IMPLANTED IN AN ATTEMPT TO REPAIR THE RECURRENT VENTRAL HERNIA DEFECT. UPON ENTERING THE ABDOMEN, THE SURGEON NOTED THERE WAS A RECURRENT HERNIA DEFECT WITH INCARCERATED OMENTUM. ADHESIONS WERE TAKEN DOWN. ON OR ABOUT (B)(6) 2019, THE PATIENT UNDERWENT SURGERY TO REMOVE THE INFECTED MESH AND A BARD/DAVOL PHASIX WAS IMPLANTED IN AN ATTEMPT TO REPAIR THE RECURRENT VENTRAL HERNIAS. UPON ENTERING THE ABDOMEN, THE SURGEON NOTED THE PRESENCE OF A COMPLEX PARTIAL BOWEL OBSTRUCTION. THE MESH HAD BECOME MATTED TO THE SMALL BOWEL AND OMENTUM. EXTENSIVE ADHESIONS WERE LYSED AND THE COMPLEX PARTIAL SMALL BOWEL OBSTRUCTION WAS RELEASED. THE INFECTED MESH WAS REMOVED. IT IS ALLEGED THAT THE MESH PRODUCTS CAUSED SERIOUS INJURY AND HAD TO BE REMOVED VIA INVASIVE SURGERY. ATTORNEY ALLEGES THAT THE PATIENT EXPERIENCED AND/OR CONTINUES TO EXPERIENCE PAIN, INFLAMMATION, NAUSEA, VOMITING, DIARRHEA, CHILLS, LOSS OF APPETITE, SEVERE PAIN AND SUFFERIN

  Patient problems: Disability; Obstruction/Occlusion; Unspecified Infection

  MAUDE report 10456820 ↗
• InjuryAug 14, 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 MARLEX MESH (BARD FLAT MESH) AND VENTRALIGHT ST ON (B)(6) 2012. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST BOTH DEVICES. IT IS ALLEGED THAT THE PATIENT SUSTAINED INJURIES ON (B)(6) 2012. 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. NOTE: THE DATE OF IMPLANT FOR VENTRALIGHT ST WILL BE CONSIDERED AS (B)(6) 2012, SINCE THE INITIAL LEGAL CLAIM IDENTIFIED THE IMPLANT DATE FOR THE MARLEX MESH (BARD FLAT MESH) AS (B)(6)2012. ADDENDUM PER ADDITIONAL INFORMATION PROVIDED: (B)(6) 2012 - PATIENT WAS DIAGNOSED WITH VENTRAL INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF BARD FLAT MESH (DEVICE #1). PER OPERATIVE NOTES, ¿ALL OF THE LAYERS OF THE ABDOMINAL WALL WERE VERY ATTENUATED INCLUDING FASCIA AND IT WAS THOUGHT THAT THIS WEAKNESS WAS LED TO HERNIA. A BARD FLAT MESH (DEVICE #1) WAS

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

  MAUDE report 10407886 ↗
• InjuryJun 16, 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 AND VENTRALIGHT ST ON (B)(6) 2011 AND/OR (B)(6) 2017. 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 SUSTAINED PERSONAL INJURY, EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Injury; Pain

  MAUDE report 10156537 ↗
• InjuryMay 20, 2020Defective Device; Insufficient Device Problem Information; Defective Device; Insufficient Device Problem Information

  ATTORNEY ALLEGES THAT ON OR ABOUT (B)(6) 2017, THE PATIENT UNDERWENT ROBOTIC-ASSISTED RETRORECTUS VENTRAL HERNIA REPAIR WITH BARD SOFT MESH. THE PATIENT¿S ATTORNEY ALLEGES THAT, ¿SUBSEQUENT TO IMPLANTATION OF THE BARD SOFT MESH, PATIENT BEGAN SUFFERING PAIN, RECURRENCE OF THE HERNIA, AND DECREASED MOBILITY, WHICH WORSENED OVER TIME. WHILE PATIENT'S PHYSICIANS SEARCHED FOR THE CAUSE OF PATIENT'S PAIN, PATIENT CONTINUED TO ENDURE PERSISTENT, DEBILITATING PAIN. THE PATIENT BEGAN SUFFERING EMOTIONAL DISTRESS AS A RESULT OF THE DEFECTIVE PRODUCT. THE PATIENT WAS REQUIRED TO UNDERGO REVISION SURGERY TO REMOVE AND REPLACE THE DEFECTIVE HERNIA MESH PATCH.¿ THE PATIENT UNDERWENT REMOVAL OF THE FAILED BARD SOFT MESH TO BE REPLACED BY VENTRALIGHT ST ON OR ABOUT (B)(6) 2019. BUT THE NEW VENTRALIGHT ST PRODUCT FARED NO BETTER. THE PATIENT¿S ATTORNEY ALSO ALLEGES THAT, ¿SUBSEQUENT TO IMPLANTATION OF THE VENTRALIGHT ST HERNIA MESH PATCH, PATIENT BEGAN SUFFERING PAIN, RECURRENCE OF THE HERNIA, AND DECREASED MOBILITY, WHICH WORSENED OVER TIME. WHILE PATIENT'S PHYSICIANS SEARCHED FOR THE CAUSE OF PATIENT'S PAIN, PATIENT CONTINUED TO ENDURE PERSISTENT, DEBILITATING PAIN. THE PATIENT BEGAN SUFFERING E

  Patient problems: Adhesion(s); Disability; Hernia

  MAUDE report 10075820 ↗
• InjuryMay 20, 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 VENTRALIGHT ST ON (B)(6) 2012 AND (B)(6) 2015. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST BOTH DEVICES. IT IS ALLEGED 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

  MAUDE report 10073683 ↗