VENTRALIGHT 5955113Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 00801741031694), received between Jul 7, 2017 and Dec 28, 2023 — classified as 22 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Defective Device” (17 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 26 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 28, 2023Expiration Date Error; Expiration Date Error

  AS REPORTED, DURING A LAPAROSCOPIC VENTRAL HERNIA REPAIR, ON (B)(6) 2023 THE PATIENT WAS INADVERTENTLY IMPLANTED WITH AN EXPIRED VENTRALIGHT ST W/ECHO PS MESH. THE LABELED EXPIRATION DATE OF MESH IS 28-NOV-2023. THERE WAS NO REPORTED PATIENT INJURY, CHANGE IN COURSE OF TREATMENT, OR ANY MEDICAL/SURGICAL INTERVENTION DUE TO THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18408473 ↗
• InjurySep 5, 2023Defective 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) 2014. AS REPORTED THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST VENTRALIGHT ST. ATTORNEY ALLEGES THAT THE PATIENT HAD REVISION SURGERY ON (B)(6) 2016. 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; Abscess; Adhesion(s); Bacterial Infection; Insufficient Information; Pain

  MAUDE report 17681244 ↗
• InjuryJun 22, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  A PATIENT UNDERWENT A LAPAROSCOPIC REPAIR OF MIDLINE MULTI-RECURRENT COMPLEX VENTRAL (INCISIONAL) HERNIA 15CM X 23CM WITH MULTIPLE DEFECTS ON(B)(6) 2020. A VENTRALIGHT ST W/ECHO PS WAS USED FOR THE REPAIR. SURGEON REPORTS ON (B)(6) 2023 THE PATIENT HAD A HERNIA RECURRENCE. SURGEON NOTED THE MESH HAS SPLIT IN MIDLINE. THE CAUDAL EDGE WAS FLOATING FREE FROM THE ABDOMINAL WALL. THE CRANIAL EDGE WAS SECURE. THE LEFT AND RIGHT SIDES WERE ATTACHED. THE LOWER MIDLINE SUTURE LINE WAS ALSO DISRUPTED. PER SURGEON, ¿I AM NOT ENTIRELY SURE WHY THE MIDLINE MESH AND SUTURE REPAIR HAS FAILED. I DON¿T THINK ANY MESH WAS SALVAGED¿ (FOR EVALUATION/ RETURN).

  Patient problems: Hernia

  MAUDE report 17181382 ↗
• InjuryDec 1, 2022Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  PER JOURNAL ARTICLE IN HERNIA (2022) TITLED, ¿SEVEN YEARS OF PREOPERATIVE BTA ABDOMINAL WALL PREPARATION AND THE MACQUARIE SYSTEM FOR SURGICAL MANAGEMENT OF COMPLEX VENTRAL HERNIA.¿ . FEATURED WAS A SINGLE-CENTER PROSPECTIVE COHORT STUDY BETWEEN NOVEMBER 2012 AND DECEMBER 2019, 88 CONSECUTIVE PATIENTS UNDERWENT COMPLEX VENTRAL HERNIA (CVH) REPAIR USING PRE-OPERATIVE BOTULINUM TOXIN A (BTA) INJECTION AND THE MACQUARIE SYSTEM OF MANAGEMENT WITH BARD/DAVOL SEPRAMESH, VENTRIO ST, VENTRALIGHT ST AND VENTRALIGHT ST W/ECHO PS. CLINICAL EXAMINATION AND FUNCTIONAL NON-CONTRAST ABDOMINAL CT SCANS, ULTRASOUNDS WERE USED TO ASSESS COMPLICATIONS AND RECURRENCES ENCOUNTERED. SURGICAL COMPLICATIONS OCCURRED IN 22 (25.0%) PATIENTS. RECURRENCE 2 (2.3%), HEMATOMA (REQUIRED INTERVENTION) 2 (2.3%), SEROMA 7 (8.0% REQUIRED ASPIRATIONS), INFERIOR EPIGASTRIC ARTERY BLEED 1 (1.1% REQUIRED EMBOLIZATION), ONE (1.1%) PATIENT HAD A SUPERFICIAL SURGICAL SITE INFECTION MANAGED WITH ANTIBIOTICS AND PERCUTANEOUS DRAINAGE, SUTURE IRRITATION 1(1.1%). IT WAS ALSO REPORTED THAT A PATIENT DEVELOPED CENTRAL ABDOMINAL PAIN 9 MONTHS AFTER THE OPERATION. INFORMATION IS PRESENTED WITHOUT PATIENT/CASE SPECIFIC DETAILS. THIS

  Patient problems: Abdominal Pain; Hematoma; Hernia; Seroma; Unspecified Infection

  MAUDE report 15892578 ↗
• InjuryJul 1, 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 VENTRALIGHT ST ON (B)(6) 2020. 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: Abdominal Pain; Adhesion(s); Hernia; Inflammation; Insufficient Information

  MAUDE report 14886223 ↗
• InjuryMay 23, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  REPORTED PER CLINICAL TRIAL DVL-HE-020: ON 03-JUN-2014- SUBJECT PATIENT UNDERWENT ROBOTIC ASSISTED INCISIONAL HERNIA REPAIR PROCEDURE. A BARD/DAVOL VENTRALIGHT ST WAS IMPLANTED USING ECHO PS AND FIXATED WITH BARD/DAVOL SORBAFIX FIXATION DEVICE AND SUTURES. THE SIZE OF THE HERNIA DEFECT WAS 30CM. FULL SKIN CLOSURE WAS ACHIEVED USING ADHESIVE SKIN CLOSURE. ON 08-JUL-2017- SUBJECT PATIENT PRESENTED TO EMERGENCY DEPARTMENT WITH ABDOMINAL PAIN AND THE PATIENT'S CT SCAN REVEALED VENTRAL INCISIONAL RECURRENT HERNIA. AS REPORTED, THE SURGEON ADVISED THE PATIENT THAT A SURGERY COULD NOT BE PERFORMED UNTIL THE BMI REDUCES TO <50. AS REPORTED, THE PATIENT HAD NOT RETURNED YET. PER THE STUDY CLINICIAN, THE REPORTED ADVERSE EVENT HAS BEEN ASSESSED AS SEVERE IN SEVERITY, POSSIBLY RELATED TO THE STUDY DEVICE AND POSSIBLY RELATED TO THE INDEX PROCEDURE. THE OUTCOME FOR THIS AE IS REPORTED HAS NOT RECOVERED/NOT RESOLVED.

  Patient problems: Abdominal Pain; Hernia

  MAUDE report 14468981 ↗
• MalfunctionMay 23, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  REPORTED PER CLINICAL TRIAL (B)(4): (B)(6) 2014 - SUBJECT PATIENT UNDERWENT ROBOTIC ASSISTED INCISIONAL HERNIA REPAIR PROCEDURE. A BARD/DAVOL VENTRALIGHT ST WAS IMPLANTED USING ECHO PS AND FIXATED WITH BARD/DAVOL SORBAFIX FIXATION DEVICE AND SUTURES. THE SIZE OF THE HERNIA DEFECT WAS 30CM. FULL SKIN CLOSURE WAS ACHIEVED USING ADHESIVE SKIN CLOSURE. (B)(6) 2014 - SUBJECT PATIENT WAS DIAGNOSED WITH SEROMA WHICH WAS NOTED AT PREVIOUS HERNIA SITE. NO TREATMENT WAS GIVEN AND THE SEROMA WAS NOT SEEN/MENTIONED AT THE NEXT FOLLOW UP VISIT ON (B)(6) 2014. 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 RECOVERED/RESOLVED.

  Patient problems: Seroma

  MAUDE report 14468979 ↗
• InjuryJun 9, 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 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; Insufficient Information; Scar Tissue

  MAUDE report 11969990 ↗
• InjuryFeb 5, 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 TWO 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 11286619 ↗
• InjuryFeb 1, 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 11257006 ↗
• InjuryJan 28, 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 AN UNSPECIFIED BARD/DAVOL VENTRALIGHT ST ON (B)(6) 2011. 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: Adhesion(s); Disability; Injury; Pain

  MAUDE report 11248622 ↗
• InjuryJan 27, 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 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. 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: Hernia; Injury; Seroma; Unspecified Infection

  MAUDE report 11241557 ↗
• 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) 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 ALLEGED THAT THE PATIENT SUSTAINED PERSONAL INJURY. IT IS ALSO ALLEGED THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

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

  MAUDE report 11002716 ↗
• InjuryJun 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 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 ADDITIONAL INFORMATION PROVIDED: (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH UMBILICAL HERNIA THEREBY UNDERWENT ROBOTIC-ASSISTED LAPAROSCOPIC REPAIR WITH IMPLANT OF VENTRALIGHT ST USING ECHO PS. PER OP NOTES, "A VENTRALIGHT ST USING ECHO PS WAS PLACED AND SUTURED." (B)(6) 2019 - PATIENT WAS DIAGNOSED WITH MULTIPLE INCARCERATED RECURRENT VENTRAL HERNIAS THEREBY UNDERWENT OPEN REPAIR WITH EXPLANT OF VENTRALIGHT ST USING ECHO PS. PER OP NOTES, "ADHESIONS WERE TAKEN DOWN AND A VENTRALIGHT ST USING ECHO PS WAS REMOVED COMPLETELY."

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

  MAUDE report 10205651 ↗
• InjuryMay 28, 2020Defective 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) 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: Adhesion(s); Disability; Hernia; Injury; Pain

  MAUDE report 10096370 ↗
• InjuryMar 13, 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 VENTRALIGHT ST W/ECHO PS ON (B)(6) 2017 AND BARD SOFT MESH ON (B)(6) 2019. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST VENTRALIGHT ST W/ECHO PS. 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: Abdominal Pain; Adhesion(s); Injury; Scar Tissue; Unspecified Infection

  MAUDE report 9829147 ↗
• InjuryMar 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 UNSPECIFIED BARD/DAVOL VENTRALEX HERNIA PATCH AND VENTRALIGHT ST ON (B)(6) 2015 AND/OR (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 HAD SUBSEQUENT SURGICAL INTERVENTION DUE TO THE HERNIA MESH DEVICE. ATTORNEY ALSO ALLEGES THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

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

  MAUDE report 9797746 ↗
• InjuryJan 3, 2020Defective Device; Insufficient Device Problem Information; Defective Device; Insufficient Device Problem Information

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR REPAIR OF AN UMBILICAL HERNIA ON OR ABOUT (B)(6) 2009 AND A NON-BARD/DAVOL PRODUCT WAS IMPLANTED TO REPAIR THE HERNIA DEFECT. IT IS ALLEGED BY THE ATTORNEY THAT THE PATIENT UNDERWENT SURGICAL REPAIR FOR RECURRENCE OF THE HERNIA DEFECT ON OR ABOUT (B)(6) 2010 AND A BARD/DAVOL VENTRALEX MESH WAS IMPLANTED TO REPAIR THE HERNIA DEFECT. IT IS ALSO ALLEGED BY THE ATTORNEY THAT THE PATIENT UNDERWENT A REPAIR OF A RECURRENCE OF THE HERNIA DEFECT ON OR ABOUT (B)(6) 2012 AND A BARD/DAVOL VENTRALIGHT ST MESH WITH ECHO PS POSITIONING SYSTEM WAS IMPLANTED. AS REPORTED, THE PATIENT UNDERWENT REVISION SURGERY FOR THE VENTRALIGHT ST MESH ON OR ABOUT (B)(6) 2018. DURING THE PROCEDURE, ¿VERY THICK SCAR TISSUE¿ OVER THE MESH WAS NOTED. THE INFECTED MESH WAS METICULOUSLY DISSECTED FREE FROM ITS ¿UNDURATED ATTACHMENTS WITH SURROUNDING INFLAMMATION.¿ PURULENCE FROM THE RIGHT SIDE OF THE WOUND AND ¿TREMENDOUS ADHESIONS FROM THE CHRONIC INFLAMMATION" WAS NOTED. DUE TO THE DEGREE OF INFECTION, ANOTHER PROSTHETIC WAS NOT PLACED. AS REPORTED, THE PATIENT UNDERWENT REVISION SURGERY FOR THE NON-BARD/DAVOL PRODUCT ON OR ABOUT (B)(6) 2018. DURING THE PROCED

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

  MAUDE report 9546990 ↗
• InjuryDec 24, 2019Defective Device; Insufficient Device Problem Information; Defective Device; Insufficient Device Problem Information

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR REPAIR OF VENTRAL INCISIONAL HERNIA WITH A NON BARD/ DAVOL PROCEED MESH ON OR ABOUT (B)(6) 2009. ON OR ABOUT (B)(6) 2010, THE PATIENT UNDERWENT A SURGICAL MESH REMOVAL AND REPAIR OF A RECURRENCE OF THE HERNIA DEFECT. IT IS ALSO ALLEGED BY THE PATIENT'S ATTORNEY THAT ON OR ABOUT (B)(6) 2012, THE PATIENT UNDERWENT A REPAIR OF A RECURRENCE OF THE HERNIA DEFECT AND A BARD VENTRALIGHT ST MESH WITH ECHO PS POSITIONING SYSTEM, REFERENCE NUMBER 5955113, LOT NUMBER HUWC0648 WAS IMPLANTED ON THE SAME DAY. AS ALLEGED, THE PATIENT HAS SUFFERED AND WILL CONTINUE TO SUFFER PHYSICAL PAIN AND SUFFERING, AS WELL AS MENTAL ANGUISH, EMOTIONAL DISTRESS, INJURY, ANXIETY, DEPRESSION, DISABILITY AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Disability; Injury; Pain

  MAUDE report 9516525 ↗
• InjuryOct 17, 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) 2017. 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; Hernia; Injury; Pain

  MAUDE report 9203313 ↗
• InjuryAug 15, 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 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: Abscess; Adhesion(s); Disability; Hernia; Injury; Obstruction/Occlusion; Pain; Unspecified Infection

  MAUDE report 8898797 ↗
• InjuryAug 21, 2018Defective Device; Insufficient Device Problem Information; Defective Device; Insufficient Device Problem Information

  THE FOLLOWING WAS ALLEGED BY THE PATIENT'S ATTORNEY: ON (B)(6) 2015: THE PATIENT UNDERWENT LAPAROSCOPIC REPAIR OF AN INCARCERATED VENTRAL HERNIA. A VENTRALIGHT ST W/ECHO (DEVICE #1) AND/OR A VENTRALIGHT ST W/ECHO (DEVICE #2) WAS IMPLANTED IN THE PATIENT DURING THIS REPAIR. ON (B)(6) 2016: THE PATIENT UNDERWENT AN EXPLORATORY LAPAROTOMY PROCEDURE. UPON ENTERING THE PATIENT'S ABDOMEN. THE PHYSICIAN NOTED THAT HE PERFORMED AN EXTENSIVE LYSIS OF ADHESIONS AND FREED THE SMALL BOWEL OFF OF THE MESH. THE ATTORNEY ALLEGES PRIOR TO AND AFTER THIS PROCEDURE, PATIENT SUFFERED SEVERE AND DEBILITATING PAIN. PATIENT ALSO REQUIRES FURTHER MEDICAL TREATMENT, INCLUDING LIKELY NEED FOR FUTURE SURGERIES. THE VENTRALIGHT ST W/ ECHO (DEVICE #1 AND/OR DEVICE #2) IMPLANTED IN THE PATIENT FAILED TO REASONABLY PERFORM AS INTENDED. THE PATIENT'S ATTORNEY ALLEGES GENERAL ALLEGATIONS FOR PAST, PRESENT, AND FUTURE DAMAGES, INCLUDING BUT NOT LIMITED TO, PAIN AND SUFFERING FOR SEVERE AND PERMANENT PERSONAL INJURIES SUSTAINED BY PATIENT, PERMANENT IMPAIRMENT, MENTAL PAIN AND SUFFERING.

  Patient problems: Adhesion(s); Disability; Injury

  MAUDE report 7803235 ↗
• InjuryOct 5, 2017Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A PROCEDURE IN WHICH A BARD VENTRALIGHT ST W/ ECHO PS WAS USED. AS REPORTED THE SURGEON FIXATED THE MESH USING BARD SORBAFIX TACKERS AND THEN REMOVED THE BALLOON (ECHO PS). IT IS REPORTED THAT ONCE THE BALLOON (ECHO PS) WAS REMOVED IT WAS NOTED THAT SOME OF THE TACKERS WERE DETACHED. THE MESH WAS REINFORCED USING A NON BARD FIXATION DEVICE. AS REPORTED EIGHT DAYS POST IMPLANT THE HERNIA RECURRED WITH STRANGULATION OF ENTRAILS AS THE TACKERS DID NOT FIX THE MESH, THE MESH WAS FOLDED AND INTRODUCED INTO THE HERNIA DEFECT CAUSING THE PATIENT PAIN. THE PATIENT UNDERWENT AN ADDITIONAL PROCEDURE TO REMOVE THE MESH, IT WAS NOTED THAT THE BARD SORBAFIX TACKERS DID NOT FIX THE MESH CORRECTLY.

  Patient problems: Hernia; Pain

  MAUDE report 6918970 ↗
• InjuryOct 3, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  THE FOLLOWING WAS REPORTED VIA MAUDE EVENT REPORT (MW5071859): "HAD HERNIA REPAIR. THEY USED VENTRALIGHT ST MESH WITH ECHO PS POSITIONING SYSTEM. THE MESH WAS FAULTY, AS I NOW HAVE ANOTHER HERNIA IN SAME PLACE, WITH CONSTANT DISCOMFORT. WHEN IT RIPS I GET TERRIBLE PAIN. I HAVE BEEN TOLD BY DR'S THAT THEY WILL NOT OPERATE ON IT AGAIN UNTIL IT BECOMES LIFE THREATENING. THIS MESH HAS CAUSED SO MUCH PAIN AND DISCOMFORT."

  Patient problems: Hernia; Pain

  MAUDE report 6912042 ↗
• MalfunctionAug 1, 2017Material Separation; Material Separation

  IT WAS REPORTED THAT A BARD VENTRALIGHT ST W/ ECHO WAS BEING USED FOR LAPAROSCOPIC IPOM PROCEDURE. AS REPORTED THE MESH WAS HYDRATED FOR 1-3 SECONDS IN SALINE, ROLLED WITH THE COATED SIDE INWARDS AND INSERTED THROUGH A 15MM TROCAR. IT IS REPORTED THAT AFTER THE MESH WAS INSERTED IT WAS NOTED THAT THE HYDROGEL COATING HAD PEELED AWAY FROM THE POLYPROPYLENE (MESH) AND CRIMPED. THE DEVICE WAS REMOVED AND NOT USED IN THE CASE. THERE WAS NO PATIENT INJURY AND IT IS REPORTED THAT THE PATIENT IS WELL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6757116 ↗