VENTRALIGHT 5954113Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 00801741031595), received between Mar 9, 2018 and Mar 25, 2026 — classified as 28 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (20 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 31 reports, in the reporter's own words as published by the FDA.

• InjuryMar 25, 2026Patient-Device Incompatibility

  PER INFORMATION RECEIVED, ON (B)(6) 2017, PATIENT WAS DIAGNOSED WITH INCARCERATED INCISIONAL HERNIA, THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRIO MESH (DEVICE 1). PER OP NOTES, ¿A LONGITUDINAL INCISION WAS MADE FROM THE PREVIOUS SCAR. THE HERNIA SAC WAS IDENTIFIED. MULTIPLE ADHESIONS BETWEEN THE HERNIA SAC IN THE SMALL INTESTINE WAS NOTED AND ADHESIOLYSIS WAS PERFORMED. A VENTRIO MESH (DEVICE 1) WAS PLACED INTO THE ABDOMEN AND SECURED IN TWO PLACES WITH SUTURES. A SMALL DEFECT IN THE UPPER CENTRAL PORTION OF THE MESH WAS NOTED AND DRAINS WERE PLACED.¿ ON (B)(6) 2017 PATIENT WAS DIAGNOSED WITH ABDOMINAL WALL ABSCESS, THEREBY UNDERWENT OPEN REPAIR OF INCISION AND DRAINAGE. PER OP NOTES, ¿THE WOUND WAS OPENED AND PURULENT FLUID WAS NOTED. GRANULATION TISSUE WAS NOTED AT THE PERIPHERY OF THE WOUND AND THERE WAS NO EXPOSED MESH PRESENT. WOUND VAC DRESSING APPLIED.¿ ON (B)(6) 2017, PATIENT WAS DIAGNOSED WITH ABDOMINAL WALL ABSCESS X 2, THEREBY UNDERWENT OPEN REPAIR OF INCISION AND DRAINAGE. PER OP NOTES, ¿ABSCESS CAVITY WAS NOTED IN THE SUBCUTANEOUS TISSUES. PURULENT FLUID WAS NOTED TO BE EMANATING FROM THE INFERIOR ASPECT OF THE WOUND WHERE THE PREVIOUS WOUND VAC IN PLACE. THE

  Patient problems: Abscess; Fistula

  MAUDE report 24686452 ↗
• InjuryApr 30, 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 VENTRALIGHT ST. CASE-SPECIFIC DETAILS NOT PROVIDED. ADDENDUM PER INFORMATION PROVIDED BY PATIENT'S ATTORNEY: (B)(6) 2020 - PATIENT WAS DIAGNOSED WITH SYMPTOMATIC PARASTOMAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC SUGARBAKER REPAIR WITH THE IMPLANT OF VENTRALIGHT ST MESH. PER OPERATIVE NOTES, ¿OMENTAL ADHESIONS TO PREVIOUS MIDLINE LAPAROTOMY WOUND AND RIGHT ILIAC FOSSA TAKEN DOWN AND PARASTOMAL HERNIA DEFECT CLOSED WITH SUTURES. A VENTRALIGHT ST MESH (DEVICE #1) WAS PLACED USING ENDOCATCH DEVICE. MESH TACKED TO ABDOMINAL WALL WITH 2 ROWS OF TACKERS (DEVICE #2, #3) AND CHECKED TO ENSURE COLON HELD LOOSELY. HOLDING SUTURES TIED TO FASCIA AND CUT." (B)(6) 2020 TO (B)(6) 2022 - PATIENT WAS DIAGNOSED WITH HERNIA RECURRENCE, ABDOMINAL PAIN THEREBY HAD PAINKILLER MEDICATIONS. SURGEON FELT THAT THE PAIN WAS CAUSED BY CLIPS (TACKERS - DEVICE #2, #3) THAT WERE USED TO SECURE THE MESH AND LIKELY THERE MAY BE AN IRRITATED PERFORATING NERVE IN ABDOMINAL WALL. (B)(6) 2022 - PATIENT HAD DIAGNOSTIC

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

  MAUDE report 19214762 ↗
• InjuryJun 6, 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)2021. 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: Abscess; Insufficient Information; Unspecified Infection

  MAUDE report 17069751 ↗
• InjuryJul 5, 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 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: Insufficient Information; Pain

  MAUDE report 14917288 ↗
• InjuryMay 25, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  REPORTED PER CLINICAL TRIAL DVL-HE-020: (B)(6) 2018 - SUBJECT PATIENT UNDERWENT MULTIPLE RECURRENT OPEN MIDLINE UMBILICAL HERNIA REPAIR, DURING WHICH A BARD/DAVOL VENTRALIGHT ST MESH WAS PLACED IN UNDERLAY FASHION IN AN INTRA-PERITONEAL REGION USING NON-BARD/DAVOL MECHANICAL FIXATION AND SUTURES. FASCIA AND FULL SKIN CLOSURE WAS ACHIEVED WITH SUTURES. THE PATIENT WAS DISCHARGED ON (B)(6)2018. (B)(6) 2018 - THE PATIENT PRESENTED WITH ACUTE ABDOMINAL PAIN RELATED TO HERNIA RECURRENCE. PER THE STUDY CLINICIAN, THE REPORTED ADVERSE EVENT (ABDOMINAL PAIN) HAS BEEN ASSESSED AS MILD IN SEVERITY, POSSIBLY RELATED TO THE STUDY DEVICE AND POSSIBLY RELATED TO THE INDEX PROCEDURE. THE OUTCOME FOR THIS AE IS REPORTED AS RECOVERED/RESOLVED. (B)(6) 2019 - SUBJECT PATIENT WAS DIAGNOSED WITH HERNIA RECURRENCE DURING A PHYSICAL EXAM. (B)(6) 2019 - SUBJECT PATIENT UNDERWENT SURGERY FOR MESH REMOVAL AND IMPLANTED WITH ANOTHER BARD/DAVOL VENTRALIGHT ST MESH. THE PATIENT WAS DISCHARGED ON (B)(6) 2018. PER THE STUDY CLINICIAN, THE REPORTED ADVERSE EVENT (HERNIA RECURRENCE) HAS BEEN ASSESSED AS SEVERE IN SEVERITY, NOT RELATED TO THE STUDY DEVICE AND DEFINITELY RELATED TO THE INDEX PROCEDURE. THE OUTCOME F

  Patient problems: Abdominal Pain; Hernia

  MAUDE report 14495195 ↗
• InjuryMay 24, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  REPORTED PER CLINICAL TRIAL(B)(4): (B)(6) 2013 - SUBJECT PATIENT UNDERWENT LAPAROSCOPIC MIDLINE HERNIA REPAIR (24CM X 14CM) PROCEDURE DURING WHICH A BARD/DAVOL VENTRALIGHT ST MESH WAS IMPLANTED WITH SUTURE. FULL SKIN CLOSURE WAS ACHIEVED USING ADHESIVE SKIN CLOSURE. THE PATIENT WAS DISCHARGED TO HOME ON (B)(6) 2013. IT WAS NOTED THAT THE SUBJECT EXPERIENCED ABDOMINAL PAIN AT EVERY FOLLOW-UP AFTER THE PROCEDURE. (B)(6) 2015 - SUBJECT PATIENT PRESENTED WITH ABDOMINAL PAIN AND DIAGNOSED WITH ADHESIONS AND UNDERWENT EXPLORATORY LAPAROSCOPIC SURGERY FOR LYSIS OF ADHESIONS. THE PATIENT DISCHARGED FROM THE HOSPITAL ON (B)(6) 2015. PER THE STUDY CLINICIAN, THE REPORTED ADVERSE EVENT HAS BEEN ASSESSED AS MODERATE IN SEVERITY, POSSIBLY RELATED TO THE STUDY DEVICE, DEFINITELY RELATED TO THE PROCEDURE. THE OUTCOME FOR THIS AE IS REPORTED HAS RECOVERED/RESOLVED.

  Patient problems: Abdominal Pain; Adhesion(s)

  MAUDE report 14490040 ↗
• InjuryMay 24, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  REPORTED PER CLINICAL TRIAL (B)(6): ON (B)(6) 2013 - SUBJECT PATIENT UNDERWENT OPEN RECURRENT MIDLINE HERNIA REPAIR PROCEDURE DURING WHICH A BARD/DAVOL VENTRALIGHT ST MESH WAS IMPLANTED WITH SUTURES. FULL SKIN CLOSURE WAS ACHIEVED USING ADHESIVE SKIN CLOSURE. THE PATIENT WAS DISCHARGED TO HOME ON (B)(6) 2013. ON (B)(6) 2013 - SUBJECT PATIENT WAS PRESENTED WITH PURULENT INCISIONAL DRAINAGE AND DIAGNOSED WITH SURGICAL WOUND INFECTION. SUBJECT PATIENT WAS ADMITTED TO HOSPITAL FOR INTRAVENOUS (IV) ANTIBIOTICS AND CULTURE TESTED POSITIVE FOR METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS (MRSA). PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) LINE WAS PLACED AND PATIENT WAS TREATED WITH INTRAVENOUS (IV) AND ORAL ANTIBIOTICS. THE SUBJECT PATIENT WAS DISCHARGED TO HOME ON (B)(6) 2013. PER THE STUDY CLINICIAN, THE REPORTED ADVERSE EVENT HAS BEEN ASSESSED AS MODERATE IN SEVERITY, POSSIBLY RELATED TO THE STUDY DEVICE AND DEFINITELY RELATED TO THE INDEX PROCEDURE. THE OUTCOME FOR THIS AE IS REPORTED AS RECOVERED/RESOLVED. ON (B)(6) 2013, THE PATIENT DEVELOPED MIDLINE INCISION WOUND OPENING AND THE PATIENT WAS ADMINISTERED WITH IV AND PO ANTIBIOTICS. THE REPORTED EVENT END DATE WAS (B)(6) 2013. PER

  Patient problems: Wound Dehiscence

  MAUDE report 14489190 ↗
• InjuryMay 24, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  REPORTED PER CLINICAL TRIAL (B)(4): (B)(6) 2013 - SUBJECT PATIENT UNDERWENT OPEN RECURRENT MIDLINE HERNIA REPAIR PROCEDURE DURING WHICH A BARD/DAVOL VENTRALIGHT ST MESH WAS IMPLANTED WITH SUTURES. FULL SKIN CLOSURE WAS ACHIEVED USING ADHESIVE SKIN CLOSURE. THE PATIENT WAS DISCHARGED TO HOME ON (B)(6) 2013. (B)(6) 2013 - SUBJECT PATIENT WAS PRESENTED WITH PURULENT INCISIONAL DRAINAGE AND DIAGNOSED WITH SURGICAL WOUND INFECTION. SUBJECT PATIENT WAS ADMITTED TO HOSPITAL FOR INTRAVENOUS (IV) ANTIBIOTICS AND CULTURE TESTED POSITIVE FOR METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS (MRSA). PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) LINE WAS PLACED AND PATIENT WAS TREATED WITH INTRAVENOUS (IV) AND ORAL ANTIBIOTICS. THE SUBJECT PATIENT WAS DISCHARGED TO HOME ON (B)(6) 2013. PER THE STUDY CLINICIAN, THE REPORTED ADVERSE EVENT HAS BEEN ASSESSED AS MODERATE IN SEVERITY, POSSIBLY RELATED TO THE STUDY DEVICE AND DEFINITELY RELATED TO THE INDEX PROCEDURE. THE OUTCOME FOR THIS AE IS REPORTED AS RECOVERED/RESOLVED. (B)(6) 2013 - SUBJECT PATIENT WAS DIAGNOSED WITH MIDLINE INCISION WOUND OPENING DURING THE PERIOD OF INCISIONAL INFECTION. AS REPORTED, THE PATIENT WAS TREATED WITH INTRAVENOUS (IV) AN

  Patient problems: Bacterial Infection

  MAUDE report 14489033 ↗
• InjuryMay 20, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  REPORTED PER CLINICAL TRIAL (B)(6): ON (B)(6) 2013 - SUBJECT PATIENT UNDERWENT A PRIMARY LAPAROSCOPIC HERNIA REPAIR AND WAS IMPLANTED WITH A BARD/DAVOL VENTRALIGHT ST MESH. THE HERNIA DEFECT WAS 23 X 13 CM EXTENDING FROM OLD OSTOMY SITE TO MIDLINE. THE MESH WAS FIXATED USING MECHANICAL FIXATION (SORBAFIX) AND SUTURES. FASCIA CLOSURE WAS ACHIEVED; FULL SKIN CLOSURE WAS ACHIEVED USING ADHESIVE SKIN CLOSURE. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2013. ON (B)(6) 2014 - SUBJECT PATIENT PRESENTED WITH ABDOMINAL PAIN AND RIGHT UPPER QUADRANT BULGE AFTER COUGHING FIT. THE SURGEON REQUESTED A CT TO RULE OUT RECURRENCE; PATIENT DID NOT UNDERGO CT OR RETURNED TO CLINIC. ON (B)(6) 2014 - PATIENT WAS DIAGNOSED WITH INCISIONAL HERNIA RECURRENCE DURING PHYSICAL EXAM. PER THE STUDY CLINICIAN, THE REPORTED ADVERSE EVENT HAS BEEN ASSESSED AS MODERATE IN SEVERITY, POSSIBLY RELATED TO THE STUDY DEVICE AND TO THE INDEX PROCEDURE. THE OUTCOME FOR THIS AE IS REPORTED AS NOT RECOVERED/ NOT RESOLVED.

  Patient problems: Abdominal Pain; Hernia

  MAUDE report 14454871 ↗
• InjuryMay 20, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  REPORTED PER CLINICAL TRIAL (B)(6): ON (B)(6) 2014 - SUBJECT PATIENT UNDERWENT AN OPEN FIRST TIME RECURRENT INCISIONAL HERNIA (10X20 CM, LLQ) REPAIR PROCEDURE. A BARD/DAVOL VENTRALIGHT ST MESH WAS PLACED USING MECHANICAL FIXATION AND SUTURES. FULL SKIN CLOSURE WAS ACHIEVED USING STAPLES. THE PATIENT WAS DISCHARGED TO HOME ON (B)(6) 2014. ON (B)(6) 2019 - SUBJECT PATIENT WAS DIAGNOSED WITH INTRA-ABDOMINAL BACTERIAL/MESH INFECTION. DRAINAGE NOTED DURING APPOINTMENT. CULTURE POSITIVE FOR FINEGOLDIA MAGNA, TREATED WITH IV ANTIBIOTICS. ON (B)(6) 2019 - SUBJECT PATIENT UNDERWENT COMPLETE MESH EXCISION WITH DRAIN PLACEMENT. THE PATIENT WAS DISCHARGED TO HOME ON (B)(6) 2019. PER THE STUDY CLINICIAN, THE REPORTED ADVERSE EVENT HAS BEEN ASSESSED AS SEVERE IN SEVERITY, DEFINITELY RELATED TO THE STUDY DEVICE AND POSSIBLY RELATED TO THE INDEX PROCEDURE. THE OUTCOME FOR THIS AE IS REPORTED AS RECOVERED/RESOLVED.

  Patient problems: Bacterial Infection

  MAUDE report 14454628 ↗
• MalfunctionMay 20, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  REPORTED PER CLINICAL TRIAL (B)(6): ON (B)(6) 2013: SUBJECT PATIENT UNDERWENT A PRIMARY LAPAROSCOPIC HERNIA REPAIR AND WAS IMPLANTED WITH A BARD/DAVOL VENTRALIGHT ST MESH. THE HERNIA DEFECT WAS 23 X 13 CM EXTENDING FROM OLD OSTOMY SITE TO MIDLINE. THE MESH WAS FIXATED USING MECHANICAL FIXATION (SORBAFIX) AND SUTURES. FASCIA CLOSURE WAS ACHIEVED; FULL SKIN CLOSURE WAS ACHIEVED USING ADHESIVE SKIN CLOSURE. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2013. ON (B)(6) 2013: SUBJECT PATIENT WAS DIAGNOSED WITH SEROMAS AT PREVIOUS HERNIA SITES DURING THE 1ST FOLLOW-UP VISIT. ON (B)(6) 2013: NO ISSUES NOTED DURING 2ND VISIT. NO TREATMENT GIVEN. PER THE STUDY CLINICIAN, THE REPORTED ADVERSE EVENT HAS BEEN ASSESSED AS MILD IN SEVERITY, POSSIBLY RELATED TO THE STUDY DEVICE AND POSSIBLY RELATED TO THE INDEX PROCEDURE. THE OUTCOME FOR THIS AE IS REPORTED AS RECOVERED/RESOLVED.

  Patient problems: Seroma

  MAUDE report 14454420 ↗
• InjuryMay 19, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  REPORTED PER CLINICAL TRIAL (B)(4): ON (B)(6) 2017 - SUBJECT PATIENT UNDERWENT A PRIMARY LAPAROSCOPIC MIDLINE UMBILICAL HERNIA REPAIR PROCEDURE. A BARD/DAVOL VENTRALIGHT ST MESH WAS PLACED IN UNDERLAY FASHION AND WAS FIXATED USING A NON-BARD/DAVOL FIXATION DEVICE ALONG WITH A NON-BARD/DAVOL TI-CRON MECHANICAL SUTURE WITH 4 FIXATION POINTS. THE PATIENT WAS DISCHARGED TO HOME ON (B)(6) 2017. ON (B)(6) 2018 - SUBJECT PATIENT WAS DIAGNOSED WITH MIDLINE UMBILICAL HERNIA RECURRENCE. ON (B)(6) 2019 - SUBJECT PATIENT UNDERWENT AN OPEN LAPAROTOMY PROCEDURE TO REPAIR THE HERNIA RECURRENCE AND A PERMANENT SYNTHETIC MESH WAS PLACED IN A SANDWICH FASHION AND THE PATIENT WAS DISCHARGED TO HOME ON (B)(6) 2019. PER THE STUDY CLINICIAN, THE REPORTED ADVERSE EVENT HAS BEEN ASSESSED MODERATE SEVERITY, POSSIBLY RELATED TO THE STUDY DEVICE AND POSSIBLY RELATED TO THE PROCEDURE. THE OUTCOME FOR THIS AE IS REPORTED AS RECOVERED/RESOLVED.

  Patient problems: Hernia

  MAUDE report 14434613 ↗
• MalfunctionMar 2, 2022Material Separation; Material Separation

  AS REPORTED, DURING A HERNIA REPAIR PROCEDURE ON (B)(6) 2022, THE BARD/DAVOL VENTRALIGHT ST MESH WAS HYDRATED TWICE IN A NORMAL SALINE AND GENTAMICIN SOLUTION FOR SIGNIFICANTLY LONGER THAN THE IFU RECOMMENDED 1-3 SECONDS. AS REPORTED, THE MESH "OOZED GREEN GEL-LIKE SUBSTANCE" DURING FIXATION. IT WAS REPORTED THAT THE SURGEON IMPLANTED THE SAME MESH WITHOUT ANY OTHER DISTURBANCE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13651609 ↗
• InjuryDec 29, 2021Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF TWO UNSPECIFIED BARD/DAVOL COMPOSIX KUGEL HERNIA PATCH ON (B)(6) 2007 AND VENTRALIGHT ST ON 05-OCT-2020. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST BOTH THE 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 ADDITIONAL INFORMATION PROVIDED: ON (B)(6) 2020, PATIENT UNDERWENT SURGERY FOR REPAIR OF RECURRENT HERNIA AND IMPLANTED WITH VENTRALIGHT ST MESH ON (B)(6) 2021, PATIENT UNDERWENT TAKEDOWN OF ENTEROCUTANEOUS FISTULA, EXTENSIVE LYSIS OF ADHESIONS, MESH EXCISION (VENTRALIGHT ST MESH), SMALL BOWEL RESECTION, COLON RESECTION, DEBRIDEMENT OF ABDOMINAL WALL AND REPAIR OF RECURRENT DEFECT. ATTORNEY ALLEGES THAT THE PATIENT EXPERIENCED ABSCESS, ADHESIONS, BOWEL PERFORATION, BOWEL REMOVAL, FISTULAE, INFECTION, MESH SHRINKAGE, PAIN, RECURRENCE, ONGOING AND PERMANENT AFIB, WOUND VAC, ACUTE INFLAMMATION AND

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

  MAUDE report 13115821 ↗
• InjuryJul 5, 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); Hernia; Insufficient Information; Pain

  MAUDE report 12116198 ↗
• InjuryJun 22, 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. 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; Insufficient Information

  MAUDE report 12042120 ↗
• MalfunctionFeb 8, 2021Expiration Date Error; Expiration Date Error

  AS REPORTED, DURING A PROCEDURE ON (B)(6) 2021, A BARD/DAVOL VENTRALIGHT ST MESH EXPIRED ON 28-DEC-2020 WAS IMPLANTED IN A PATIENT. THE REPORTED EVENT WAS IDENTIFIED AFTER THE PROCEDURE. THE IMPLANT WAS ON CONSIGNMENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11292247 ↗
• InjuryDec 18, 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) 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. ADDENDUM PER ADDITIONAL INFORMATION PROVIDED: (B)(6) 2019 - PATIENT WAS DIAGNOSED WITH LATERAL RECTUS ABDOMINUS MUSCLE THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF VENTRALIGHT ST. PER OPERATIVE NOTES, ¿THE FLAP WAS ELEVATED FROM THE ABDOMINAL WALL TO THE LEVEL OF THE LATERAL RECTUS ABDOMINUS MUSCLE. THEN A VENTRALIGHT ST WAS USED FOR REPAIR AND SECURED BY SUTURES.¿ (B)(6) 2020 - PATIENT WAS DIAGNOSED WITH RECURRENT LEFT VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH REMOVAL OF VENTRALIGHT ST MESH. PER OPERATIVE NOTES, ¿MESH APPEARED TO BE TORN FROM THE LEFT ABDOMINAL WALL WAS REMOVED. THEN A PIECE OF BIOLOGIC MESH WAS USED FOR REPAIR AND SECURED BY SUTURES.¿

  Patient problems: Hernia; Injury

  MAUDE report 11036279 ↗
• InjuryDec 4, 2020Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information; Migration; Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information; Migration

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL VENTRALIGHT ST ON (B)(6) 2012. 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) 2012 ¿ PATIENT WAS DIAGNOSED WITH MULTIPLE ABDOMINAL ADHESIONS; LARGE RECURRENT VENTRAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT OF VENTRALIGHT ST MESH. PER OP NOTES, ¿A VENTRALIGHT ST MESH WAS PLACED ON THE DEFECTS AND SECURED USING TACKS.¿ (B)(6) 2013 ¿ PATIENT WAS DIAGNOSED WITH INCARCERATED RECURRENT VENTRAL HERNIA WITH PARTIAL SMALL BOWEL OBSTRUCTION THEREBY UNDERWENT OPEN REPAIR WITH REMOVAL OF MESH. PER OP NOTES, ¿A VERY LARGE HERNIA SAC WAS NOTED. THE ENTIRE PREVIOUS MESH HAD BEEN RETRACTED FROM SIDEWALL AND LEAVING A GAP WAS EXCISED. LYSIS OF ADHESION WAS PERFORMED. THE B

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

  MAUDE report 10943249 ↗
• InjurySep 15, 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 THE IMPLANT OF UNSPECIFIED BARD/DAVOL VENTRALEX ST 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 VENTRALEX ST PATCH. 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 10533556 ↗
• InjuryJun 16, 2020Defective Device; Material Deformation; Insufficient Device Problem Information; Defective Device; Material Deformation; Insufficient Device Problem Information

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF UNSPECIFIED BARD MESH (BARD FLAT MESH) ON (B)(6) 2011 AND 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 REVISION SURGERY ON (B)(6) 2019. 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; Fistula; Injury; Pain; Scar Tissue; Unspecified Infection

  MAUDE report 10156550 ↗
• InjuryJun 9, 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) 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: Injury; Pain

  MAUDE report 10132514 ↗
• InjuryApr 22, 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) 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: Injury; Pain; Unspecified Infection

  MAUDE report 9984909 ↗
• InjuryApr 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 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 THE DEVICES. IT IS ALSO ALLEGED THAT THE PATIENT SUSTAINED INJURIES ON (B)(6) 2019. 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 INJURIES SUSTAINED BY THE PATIENT." IT IS ALSO ALLEGED THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Disability; Injury; Pain

  MAUDE report 9960973 ↗
• InjuryMay 21, 2019Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information; Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information

  ATTORNEY ALLEGES THAT ON (B)(6) 2016 OR (B)(6) 2017, THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL VENTRALIGHT ST (DEVICE #1) OR AN UNSPECIFIED BARD/DAVOL DULEX (DEVICE #2). 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 (DEVICE #1) AND DULEX (DEVICE #2). AS REPORTED, THE ATTORNEY ALLEGES PRODUCT IS DEFECTIVE AND THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS.

  Patient problems: Injury; Pain

  MAUDE report 8629156 ↗