VENTRALIGHT 5954600Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 00801741031632), received between Jul 13, 2017 and May 8, 2026 — classified as 16 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Defective Device” (11 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 25 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 8, 2026Material Separation

  AS REPORTED, DURING A LAPAROSCOPIC VENTRAL HERNIA REPAIR PROCEDURE, THE HYDROGEL (ST) BARRIER COATING CAME OFF ENTIRELY FROM THE VENTRALIGHT ST MESH. REPORTEDLY, THE MESH WAS HYDRATED IN SALINE (QUICK DIP 1-3 SECONDS) AND WAS ROLLED IMMEDIATELY WITH ST COATING INSIDE. THE HYDROGEL (ST) BARRIER WAS PEELING OFF AFTER INSERTING THROUGH THE 8MM ROBOT TROCAR. THE MESH WAS REMOVED, AND ANOTHER MESH WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25124103 ↗
• InjuryJun 16, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT UMBILICAL HERNIA REPAIR WITH IMPLANT OF VENTRALEX ST ON (B)(6) 2022. IT WAS ALLEGED THAT THE PATIENT HAD CLINICAL SIGNS OF INFECTION INCLUDING A NON-HEALING UMBILICAL WOUND, PERSISTENT YELLOW/GREEN DRAINAGE, MALODOROUS DRAINAGE, IMAGING WITH PHLEGMON/ ABSCESS, EXPOSED MESH FROM UMBILICAL INCISION SITE AND REMOVAL OF MESH ON (B)(6) 2022. DURING THIS PROCEDURE THE PATIENT WAS IMPLANTED WITH A VENTRALIGHT ST MESH. DUE TO THE MESH BEING IMPROPERLY PLACED IN A CONTAMINATED FIELD, THIS REVISION SURGERY WAS FURTHER COMPLICATED BY NONHEALING, DRAINING WOUND, POST OPERATIVE ABSCESS WITH MYOSITIS NECESSITATING DRAIN PLACEMENT, CULTURES WITH STAPH, DIPHTHEROID NECESSITATING ANTIBIOTIC THERAPY AND REMOVAL OF MESH ON (B)(6) 2023. DUE TO UNINCORPORATED MESH AND MESH INFECTION WITH MYCOBACTERIUM FORTUITUM MAKING FURTHER ANTIBIOTIC THERAPY NECESSARY. AS ALLEGED, THE PATIENT EXPERIENCED ADDITIONAL SURGICAL INTERVENTION, ADHESION, DISABILITY, RECURRENCE AND CHRONIC PAIN. 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

  Patient problems: Abscess; Bacterial Infection; Impaired Healing

  MAUDE report 22209729 ↗
• InjuryAug 28, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED BY PATIENT'S ATTORNEY: ON (B)(6) 2018 - PATIENT WAS DIAGNOSED WITH INCISIONAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF VENTRALIGHT ST MESH (DEVICE #1). PER OPERATIVE NOTES, ¿PORTS WERE INSERTED IN EPIGASTRIC AREA AND RIGHT ILIAC FOSSA. OMENTUM WAS REMOVED FROM HERNIA SAC. A VENTRALIGHT ST MESH (DEVICE #1) WAS POSITIONED OVER THE HERNIA DEFECT USING SUTURES. THE MESH WAS FIXED IN PLACE USING A DOUBLE CROWN OF CAPSURE (DEVICE #2 & #3) FASTENERS.¿ ON (B)(6) 2018 TO (B)(6) 2022 - DURING VISITS PATIENT HAD PAIN, DISCOMFORT, SLIGHT BULGE AND BRUISING AT THE SITE OF LAPAROSCOPIC HERNIA REPAIR THEREBY UNDERWENT PAIN MANAGEMENT. SURGEON FELT THAT THE PATIENT¿S DISCOMFORT AT THE SITE OF HERNIA REPAIR WAS EITHER DUE TO CHRONIC PAIN OR RELATED TO THE PATIENT¿S FIBROMYALGIA CONDITION. THIS FILE REPRESENTS VENTRALIGHT ST MESH (DEVICE #1).

  Patient problems: Abdominal Pain; Bruise/Contusion

  MAUDE report 20083991 ↗
• InjuryMay 2, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  ATTORNEY ALLEGES MULTIPLE PATIENTS HE REPRESENTS HAVE EXPERIENCE UNSPECIFIED INJURY AND ALLEGE THEY MAY HAVE REQUIRED ADDITIONAL MEDICAL/SURGICAL TREATMENT. ATTORNEY ALLEGES THIS PATIENT WAS TREATED WITH A VENTRALEX ST (DEVICE #1) AND VENTRALIGHT ST (DEVICE #2). CASE-SPECIFIC DETAILS NOT PROVIDED. ADDENDUM PER INFORMATION PROVIDED BY PATIENT'S ATTORNEY: (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH EPIGASTRIC HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF VENTRALEX ST (DEVICE #1) ON (B)(6) 2015. PER OPERATIVE NOTES, ¿DEFECT WAS IDENTIFIED AND EXTRAPERITONEAL FAT WAS REDUCED. A PRE-PERITONEAL SPACE WAS CREATED AND A LARGE VENTRALEX ST MESH WAS USED TO REPAIR THE DEFECT USING SUTURES.¿ (B)(6)2015 - PATIENT PRESENTS WITH CELLULITIS AND SEROMA OF UMBILICAL WOUND THEREBY UNDERWENT REPAIR. (B)(6)2016 -PATIENT HAD HERNIA RECURRENCE AND SCAR TISSUE. (B)(6)2016 -PATIENT WAS DIAGNOSED WITH RECURRENT SUPRAUMBILICAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT OF VENTRALIGHT ST (DEVICE #2) AND EXPLANT OF VENTRALEX ST (DEVICE #1). PER OPERATIVE NOTES, ¿ADHERENT OMENTUM TO LOWER MIDLINE WAS TAKEN DOWN. SOME FAT WAS PROTRUDING AND VENTRALEX ST MESH (DEVICE #1) WAS SCRUNCHED

  Patient problems: Abdominal Pain; Insufficient Information

  MAUDE report 19227712 ↗
• InjurySep 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 UNSPECIFIED BARD/DAVOL VENTRALEX HERNIA PATCH AND VENTRALIGHT ST ON (B)(6) 2015 AND/OR (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: Abdominal Pain; Adhesion(s); Hernia; Insufficient Information

  MAUDE report 15507316 ↗
• InjurySep 23, 2021Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED, A PATIENT UNDERWENT IMPLANT OF A BARD/DAVOL VENTRALIGHT ST MESH (DEVICE #1) ON (B)(6) 2021, WHICH WAS FIXATED USING A BARD/DAVOL CAPSURE FIXATION DEVICE (DEVICE #2). AS REPORTED, THE PATIENT DEVELOPED BOWEL OBSTRUCTION A WEEK LATER WHICH WAS MANAGED BY CONSERVATIVE METHODS (NIL ORAL). ABOUT 3-4 DAYS LATER, THE PATIENT DEVELOPED BOWEL OBSTRUCTION AGAIN; A CT-SCAN SHOWED BOWEL ADHESION AT THE UMBILICAL REGION. THE PATIENT UNDERWENT AN EXPLORATORY LAPAROSCOPY ON (B)(6) 2021, DURING WHICH THE BOWEL WAS NOTED TO BE DENSELY ADHERED TO THE MESH. BOTH THE MESH AND THE CAPSURE FASTENERS WERE REMOVED.

  Patient problems: Adhesion(s); Obstruction/Occlusion

  MAUDE report 12519276 ↗
• InjurySep 7, 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 ST AND VENTRALIGHT ST ON (B)(6) 2017 AND/OR (B)(6) 2018. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE 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: Insufficient Information; Pain

  MAUDE report 12434542 ↗
• MalfunctionAug 31, 2021Material Separation; Material Separation

  AS REPORTED, DURING A LAPAROSCOPIC VENTRAL HERNIA REPAIR PROCEDURE ON (B)(6) 2021, THE BARD/DAVOL VENTRALIGHT ST MESH WAS HYDRATED APPROXIMATELY 1-3 SECONDS, ROLLED WITH THE ST COATING INSIDE AND INSERTED THROUGH AN 8 MM TROCAR. AS REPORTED, WHEN THE SURGEON UNROLLED THE MESH, THE ST COATING WAS NOTED TO BE SEPARATING. AS REPORTED, THE MESH WAS REMOVED AND A NON-BARD/DAVOL MESH WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12396526 ↗
• InjuryJul 15, 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) 2019. 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); Hernia; Insufficient Information; Pain

  MAUDE report 12173176 ↗
• MalfunctionNov 4, 2020Expiration Date Error; Expiration Date Error

  AS REPORTED, DURING A LAPAROSCOPIC IPOM (INTRAPERITONEAL ONLAY MESH) PLUS PROCEDURE, THE PATIENT UNDERWENT IMPLANT OF A VENTRALIGHT ST 6" (15CM) MESH USING A 3 MM TROCAR AND TACKED IT WITH A NON-BARD (PROTACK) DEVICE. ONCE THE SURGEON DID THE PROCEDURE, THE NURSE NOTICED THAT THE MESH HAD EXPIRED 2 WEEKS AGO AND THEN THE MESH WAS REMOVED AND ANOTHER MESH WAS PLACED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10784982 ↗
• MalfunctionNov 4, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT, DURING A HERNIA REPAIR PROCEDURE, THE VENTRALIGHT ST, "DID NOT LOOK RIGHT" AND THE PRODUCT WAS DEEMED UNUSABLE. AS REPORTED, THE OR STAFF USED ANOTHER VENTRALIGHT ST MESH FOR THE CASE WITHOUT ANY ISSUE. THERE WAS NO REPORTED PATIENT HARM/INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10784340 ↗
• InjurySep 4, 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 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. IT IS ALLEGED 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. ADDENDUM PER MEDICAL RECORD AND PLAINTIFF PROFILE FORM: (B)(6) 2017 - PATIENT WAS DIAGNOSED WITH UMBILICAL HERNIA INCARCERATED THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT OF VENTRALIGHT ST MESH (DEVICE #1). PER OPERATIVE NOTES, ¿A VENTRALIGHT ST MESH (DEVICE #1) WAS PLACED AND SUTURED.¿ (B)(6) 2022 - PATIENT WAS DIAGNOSED WITH REDUCIBLE RECURRENT VENTRAL INCISIONAL HERNIA, ADHESION THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF PHASIX MESH (DEVICE #2). PER OPERATIVE NOTES, ¿A PHASIX MESH WAS PLACED AND SUTURED.¿

  Patient problems: Adhesion(s); Hernia; Injury

  MAUDE report 10495951 ↗
• InjuryAug 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 UNSPECIFIED BARD/DAVOL KUGEL HERNIA PATCH, VENTRALIGHT ST AND VENTRIO ST ON (B)(6) 2016 AND/OR (B)(6) 2019. 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: Hernia; Injury

  MAUDE report 10383931 ↗
• MalfunctionJul 13, 2020Expiration Date Error; Expiration Date Error

  AS REPORTED, THE PATIENT WAS IMPLANTED WITH A VENTRALIGHT ST MESH WHICH WAS 2 MONTHS BEYOND THE LABELED EXPIRATION DATE. THE SURGEON NOTED THAT THE PACKAGING WAS INTACT AND PRODUCT APPEARED TO FUNCTION AS INTENDED. THE SURGEON CHOSE TO LEAVE THE MESH IMPLANTED IN THE PATIENT AND HAS NO CLINICAL CONCERNS AT THIS TIME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10267904 ↗
• MalfunctionJun 1, 2020Material Separation; Material Separation

  AS REPORTED, DURING A ROBOTIC UMBILICAL HERNIA REPAIR PROCEDURE USING A VENTRALIGHT ST MESH, THE SURGEON ROLLED THE MESH, INSERTED IT THROUGH THE TROCAR AND UNROLLED IT TO PLACE IT ON THE DEFECT. WITHIN MOMENTS OF GETTING IT POSITIONED, THE YELLOW ¿ADHESION BARRIER RING (ST COATING)' SEPARATED FROM THE MESH. THE SURGEON DID NOT ATTEMPT TO REMOVE IT, BUT MANAGED TO PLACE THE MESH OVER THE DEFECT. AS REPORTED, THERE WAS NO PATIENT INJURY AND NO POST-OP COMPLICATIONS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10104814 ↗
• InjuryApr 25, 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 MESHES ON (B)(6) 2016 AND (B)(6) 2016. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST BOTH DEVICES. IT IS ALLEGED THAT THE PATIENT UNDERWENT 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: Disability; Hernia; Injury; Pain

  MAUDE report 9999074 ↗
• InjuryJan 23, 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 MESHES ON (B)(6) 2016. 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: Hernia; Injury

  MAUDE report 9621304 ↗
• InjuryAug 21, 2019Patient Device Interaction Problem; Patient Device Interaction Problem

  DOCTOR REPORTED THAT, UMBILICAL HERNIA RECURRED AT SAME SITE PREVIOUSLY TREATED WITH VENTRALIGHT ST. ADDENDUM: ON (B)(6) 2019 - THE PATIENT UNDERWENT THE REPAIR OF AN UMBILICAL HERNIA AND WAS IMPLANTED WITH A BARD VENTRALIGHT ST MESH. ON (B)(6) 2019 - THE PATIENT EXPERIENCED A HERNIA RECURRENCE. THE PATIENT DID NOT RECEIVE ANY ADDITIONAL SURGICAL INTERVENTION AT THIS TIME AND THE MESH REMAINS IMPLANTED.

  Patient problems: Hernia

  MAUDE report 8914598 ↗
• InjuryAug 9, 2019Defective Device; Material Deformation; Insufficient Device Problem Information; Migration; Defective Device; Material Deformation; Insufficient Device Problem Information; Migration

  ATTORNEY ALLEGES THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL VENTRALIGHT ST ON (B)(6) 2016. IT IS ALLEGED THAT THE PATIENT HAD SUBSEQUENT SURGICAL INTERVENTION DUE TO THE HERNIA MESH DEVICE(S). AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE BARD/DAVOL VENTRALIGHT ST. AS REPORTED, THE ATTORNEY ALLEGES PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Adhesion(s); Hernia; Injury

  MAUDE report 8879691 ↗
• InjuryMay 9, 2019Defective Device; Insufficient Device Problem Information; Patient Device Interaction Problem; Defective Device; Insufficient Device Problem Information; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT ON (B)(6) 2017, THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL VENTRALIGHT ST. IT IS ALLEGED THAT THE PATIENT HAD SUBSEQUENT SURGICAL INTERVENTION DUE TO THE HERNIA MESH DEVICE. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE VENTRALIGHT ST. AS REPORTED, THE ATTORNEY ALLEGES PRODUCT IS DEFECTIVE AND THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS.

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

  MAUDE report 8597241 ↗
• MalfunctionMay 9, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT ON (B)(6) 2019 A BARD VENTRALIGHT ST MESH WAS BEING PREPARED FOR A LAPAROSCOPIC VENTRAL HERNIA REPAIR PROCEDURE. AS REPORTED THE MESH WAS HYDRATED IN SALINE FOR 4-5 SECONDS AND THEN IS WAS NOTED THAT THE "SEPRAFILM BARRIER SCRAPED OFF BEFORE INSERTING IT INTO THE TROCAR." THE MESH WAS NOT USED, ANOTHER MESH WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8596601 ↗
• MalfunctionDec 18, 2018Incorrect, Inadequate or Imprecise Result or Readings; Insufficient Device Problem Information; Physical Resistance/Sticking; Incorrect, Inadequate or Imprecise Result or Readings; Insufficient Device Problem Information; Physical Resistance/Sticking

  IT WAS REPORTED THAT A PREVIOUSLY PLACE BARD VENTRALIGHT ST MESH WAS FOUND TO BE " STICKING TO THE INTESTINES WHICH MAY HAVE CAUSED COMPLICATIONS, THUS WAS REMOVED AND DISCARDED."

  Patient problems: Adhesion(s); No Consequences Or Impact To Patient

  MAUDE report 8177427 ↗
• InjurySep 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) 2015: THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL VENTRALIGHT ST. THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE BARD/DAVOL VENTRALIGHT ST. 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; Erosion; Hernia; Injury; Pain; Strangulation; Unspecified Infection

  MAUDE report 7891092 ↗
• InjuryApr 24, 2018Defective Device; No Apparent Adverse Event; Insufficient Device Problem Information; Defective Device; No Apparent Adverse Event; Insufficient Device Problem Information

  THE FOLLOWING WAS ALLEGED BY THE PATIENT'S ATTORNEY: THE (B)(6) 2014: THE PATIENT UNDERWENT HERNIA REPAIR. A BARD/DAVOL VENTRALEX ST, REFERENCE NUMBER (B)(4), LOT NUMBER HUXK1098 (DEVICE #1) WAS IMPLANTED IN THE PATIENT DURING THIS REPAIR. THE (B)(6) 2017: THE PATIENT UNDERWENT REMOVAL OF THE FAILED BARD/DAVOL VENTRALEX ST AND INSERTED A LARGER BARD/DAVOL VENTRALIGHT ST (DEVICE #2), REFERENCE NUMBER (B)(4).. PATIENT CONTINUES TO EXPERIENCE COMPLICATIONS RELATED TO THE ST BARD MESH. THE PATIENT HAS BEEN INJURED, SUSTAINED SEVERE AND PERMANENT PAIN, SUFFERING, ANXIETY, DEPRESSION, DISABILITY AND IMPAIRMENT. THE PATIENT'S ATTORNEY ALLEGES THAT THERE WAS AN ADVERSE OUTCOME RELATED TO THE "ST BARD MESH".

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

  MAUDE report 7454388 ↗
• MalfunctionJul 13, 2017Material Separation; Material Separation

  IT WAS REPORTED THAT ON (B)(6) 2017 A BARD VENTRALIGHT ST HERNIA PATCH WAS BEING PREPARED FOR A LAPAROSCOPIC VENTRAL HERNIA REPAIR PROCEDURE. AS REPORTED THE USER GAVE THE PATCH A "QUICK DIP IN STERILE WATER" AND THEN ROLLED THE PATCH HYDROGEL SIDE IN. THE SURGEON NOTED THAT THE HYDROGEL "DID NOT LOOK RIGHT" AND USED ANOTHER BARD VENTRALIGHT ST HERNIA PATCH WITHOUT ISSUE TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY. PHOTOS OF THE SAMPLE WERE PROVIDED. THE SAMPLE APPEARS TO HAVE BEEN HYDRATED AND ROLLED IN PREPARATION FOR INSERTION. THERE ARE VISIBLE VOIDS IN THE HYDROGEL BARRIER. THE SAMPLE WAS RETURNED FOR EVALUATION. THE SAMPLE EVALUATION CONFIRMS FOR SEPARATION OF THE HYDROGEL BARRIER. IF IMPLANTED THE SEPARATION OF THE HYDROGEL BARRIER COULD IMPACT THE ABILITY OF THE DEVICE TO PERFORM AS INTENDED AND COULD INCREASE THE RISK OF POST OPERATIVE COMPLICATIONS FOR THE PATIENT . THEREFORE AN MDR IS SUBMITTED TO DOCUMENT THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6711469 ↗