VENTRALIGHT 5954810Recalls & reported problems

Summary

The FDA's MAUDE database contains 62 adverse event reports that list this exact device (DI 00801741031687), received between Jun 9, 2017 and Aug 14, 2026 — classified as 1 death, 55 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Defective Device” (43 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 62 reports, in the reporter's own words as published by the FDA.

• InjuryAug 14, 2026Patient-Device Incompatibility

  Per information provided:On (b)(6) 2019 - Patient was diagnosed with incarcerated umbilical hernia with small bowel obstruction thereby underwent open repair with implant of Ventralight ST Mesh (Device 1). Per operative notes, "An incision was made above the umbilicus down towards the umbilicus. Near the umbilicus area the hernia sac was identified and taken down sharply. A Ventralight ST Mesh (Device 1) was placed into the defect and closed the defect with sutures."On (b)(6) 2019 - Patient was diagnosed with small bowel obstruction, adhesions thereby underwent laparoscopic repair with implant of abdominal lysis of adhesions and release of small bowel obstruction. Per operative notes, "An incision was made into the umbilical region. There were some adhesions in the anterior abdominal wall which were taken down sharply. The small bowel obstructions were then released from abdomen. The defect was closed with sutures."On (b)(6 )2020 - Patient was diagnosed with recurrent incisional hernia, thereby underwent robotic assisted laparoscopic repair with implant of Ventralight ST Mesh (Device 2). Per operative notes, "A transverse incision was made in the left upper quadrant. The hernia sac

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

  MAUDE report 50260299 ↗
• InjuryMar 2, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2016 - PATIENT WAS DIAGNOSED WITH VENTRAL INCISIONAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF VENTRALIGHT ST (DEVICE 1). PER OP NOTES, ¿THE HERNIA SAC WAS IDENTIFIED IN THE RIGHT UPPER ABDOMEN AND DISSECTED FREE. THE BOWEL INCARCERATED IN HERNIA WAS REDUCED. ADHESIONS WERE LYSED. OMENTAL ADHESIONS WERE LYSED. A VENTRALIGHT ST (DEVICE 1) WAS PLACED AND TACKED USING SORBAFIX TACKER.¿ (B)(6) 2016 - PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH EXCISION OF VENTRALIGHT ST (DEVICE 1) AND IMPLANT OF VENTRALIGHT ST (DEVICE 2 AND 3). PER OP NOTES, ¿THE PREVIOUS SUTURES WERE REMOVED. THE PREVIOUS INCISION WAS OPENED. ADHESIONS WERE LYSED. THE PRIOR MESH (DEVICE 1) WAS IDENTIFIED AND EXCISED. INTRA-ABDOMINAL ADHESIONS WERE LYSED. A LARGE HERNIA DEFECT WAS NOTED AND EXCISED THE SAC. TWO VENTRALIGHT ST (DEVICE 2 AND 3) WERE PLACED AND SUTURED TOGETHER.¿ (B)(6) 2019 - PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH EXCISION OF VENTRALIGHT ST (DEVICE 2 AND 3). PER OP NOTES, ¿MIDLINE SCAR WAS OPENED. FILMY ADHESIONS OF SMALL BOWEL TO ABDOMINAL WALL WERE LY

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

  MAUDE report 24484112 ↗
• InjuryAug 28, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2006 - PATIENT WAS DIAGNOSED WITH INCARCERATED VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRALEX MESH (DEVICE 1). PER OP NOTES, "A VENTRALEX MESH (DEVICE 1) WAS PLACED INTO THE ABDOMINAL WALL USING PROLENE SUTURES." (B)(6) 2018 - PATIENT WAS DIAGNOSED WITH RECURRENT INCARCERATED VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH REMOVAL OF MESH (DEVICE 1) AND IMPLANT OF XENMATRIX (DEVICE 2). PER OP NOTES, "A MIDLINE INCISION WAS MADE. ADHESIOLYSIS WAS PERFORMED, THE OLD MESH (DEVICE 1) WAS EXCISED. A XENMATRIX (DEVICE 2) WAS PLACED INTO RECTRO RECTUS SPACE USING PROLENE SUTURES." (B)(6) 2018 - PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRALIGHT ST MESH (DEVICE 3). PER OP NOTES, "THE PREVIOUSLY PLACED BIOLOGIC MESH (DEVICE 2) HAD TORN IN HALF AND RETRACTED. DENSE ADHESIONS TO THE MESH WERE CLEARED. A VENTRALIGHT ST MESH (DEVICE 3) WAS PLACED ABOVE THE LEVEL OF THE BIOLOGIC MESH (DEVICE 2) AND BELOW HE PERITONEUM." (B)(6) 2019 - PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF VENTRALIGHT ST MESH USING EC

  Patient problems: Adhesion(s); Hernia

  MAUDE report 22910924 ↗
• MalfunctionAug 8, 2025Use of Device Problem; Use of Device Problem

  AS REPORTED, A VENTRALIGHT ST MESH WITH A LABELED EXPIRATION DATE OF (B)(6) 2025 WAS IMPLANTED IN THE PATIENT ON (B)(6) 2025, WHICH WAS BEYOND ITS LABELED EXPIRATION DATE. THERE WAS NO REPORTED PATIENT INJURY, CHANGE IN COURSE OF TREATMENT, OR ANY MEDICAL/SURGICAL INTERVENTION DUE TO THE ISSUE. AS REPORTED, IT WAS DECIDED TO LEAVE THE MESH IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22749091 ↗
• InjuryAug 1, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2019 - PATIENT WAS DIAGNOSED WITH INCARCERATED VENTRAL HERNIA THEREBY UNDERWENT REPAIR WITH THE IMPLANT OF THE BARD VENTRALIGHT ST MESH (DEVICE #1). PER OPERATIVE NOTES, ¿HERNIA SAC WAS DISSECTED. A VENTRALIGHT ST MESH (DEVICE #1) WAS PLACED AND SECURE IT WITH SUTURE.¿ (B)(6) 2019 - PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL HERNIA, ADHESION THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH EXPLANT OF THE BARD VENTRALIGHT ST MESH (DEVICE #1) AND IMPLANT OF BARD VENTRALIGHT ST (DEVICE #2). PER OPERATIVE NOTES, ¿HERNIA SAC WAS DISSECTED. ALL ADHESIONS WERE TAKEN DOWN. PREVIOUSLY PLACED MESH BARD VENTRALIGHT ST MESH (DEVICE #1) WAS TOTALLY REMOVED. ONE BARD VENTRALIGHT ST (DEVICE #2) WAS PLACED AND SUTURED.¿ (B)(6) 2019 - PATIENT WAS DIAGNOSED WITH WOUND INFECTION THEREBY UNDERWENT OPEN REPAIR WITH WOUND WASHOUT AND PLACEMENT OF VAC DRESSING. (B)(6) 2019 - PATIENT WAS DIAGNOSED WITH WOUND, ADHESION, INFECTION THEREBY UNDERWENT OPEN REPAIR WITH WOUND WASHOUT, VAC PLACEMENT, EXPLANT OF BARD VENTRALIGHT ST MESH (DEVICE #2) AND IMPLANT ONE BIOLOGICAL MESH. PER OPERATIVE NOTES, ¿WOUND WAS IRRIGATED. PREVIOUSLY PLACED BARD VENTRALIGHT ST MESH (DEVICE #2) WAS TOTA

  Patient problems: Adhesion(s); Unspecified Infection

  MAUDE report 22684688 ↗
• InjuryMay 2, 2025Defective Device; Patient-Device Incompatibility; Patient Device Interaction Problem; Defective Device; Patient-Device Incompatibility; Patient Device Interaction Problem

  PER INFORMATION PROVIDED: (B)(6) 2013- PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE REMOVAL OF SYNTHETIC MESH AND IMPLANT OF VENTRALIGHT ST MESH (DEVICE #1). PER OPERATIVE NOTES, ¿IN THE RIGHT UPPER QUADRANT THERE WAS A PREVIOUSLY PLACED SYNTHETIC MESH WHICH WAS ADHERED TO THE ABDOMINAL WALL AS WELL AS TO THE OMENTUM AND TO THE SMALL BOWEL. THE SYNTHETIC MESH WAS DISSECTED OFF THE ANTERIOR WALL AND PORTION OF THIS MESH WAS LEFT BEHIND. THEN A VENTRALIGHT ST MESH (DEVICE #1) WAS PLACED USING SUTURES AROUND THE RIGHT LOWER PERIPHERY WHICH WERE THEN PULLED TRANSFASCIALLY.¿ (B)(6) 2014 - PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL INCISIONAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH REMOVAL OF VENTRALIGHT ST MESH (DEVICE #1) AND IMPLANT OF VENTRALIGHT ST MESH (DEVICE #2). PER OPERATIVE NOTES, ¿THERE WAS A MODERATE AMOUNT OF ADHESION. THE AREA OF HERNIA HAD BEEN ESSENTIALLY FLOATED OFF ITS ATTACHMENTS TO THE UNDERLYING FASCIA BY WHAT APPEARED TO BE SOME FAT NECROSIS AND PERHAPS AN OLD BURNED-OUT ABSCESS. THE DETACHED PORTION OF THE VENTRALIGHT ST MESH (DEVICE #1) WAS EXCISED SHARPLY. THEN A VENTRALIGHT ST MESH (DEVICE #2)

  Patient problems: Adhesion(s); Hernia

  MAUDE report 21949492 ↗
• InjuryApr 3, 2025Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  PER INFORMATION PROVIDED: (B)(6) 2010 - PATIENT WAS DIAGNOSED WITH INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF VENTRIO MESH (DEVICE #2). PER OPERATIVE NOTES, ¿THE SCAR WAS EXCISED. THE FASCIA AND HERNIA DEFECT WERE DISSECTED FREE. ADHESIONS WERE TAKEN DOWN FROM THE ANTERIOR ABDOMINAL WALL. A VENTRIO MESH (DEVICE #1) WAS PLACED DEEP TO FASCIA, BUT IT COULD NOT LAID FLAT AND CONTINUING TO BUCKLE OVER, WAS REMOVED. THUS, A VENTRIO MESH (DEVICE #2) WAS PLACED AND SECURED TO THE ABDOMINAL WALL USING TACKS.¿ (B)(6) 2011 - PATIENT HAD ABDOMINAL PAIN AND WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT COMPOSIX L/P USING ECHO PS (DEVICE #3). PER OPERATIVE NOTES, ¿A MIDLINE ABDOMINAL WALL DEFECT JUST ABOVE THE LEVEL OF THE UMBILICUS WAS NOTED. THERE WAS SOME COLON ADHERENT TO THE RIGHT LATERAL EDGE OF THE HERNIA. ADHESIONS OF OMENTUM AND COLON WERE TAKEN DOWN. THE ATTACHMENTS TO THE HERNIA SAC AND POSTERIOR ASPECT OF THE ANTERIOR ABDOMINAL WALL WERE TAKEN DOWN UP TO THE LEVEL OF THE SUPERIOR EDGE OF THE PREVIOUSLY PLACED MESH (DEVICE #2). THE COMPOSIX L/P USING ECHO PS (DEVICE #3) WAS POSITIONED AGAINST POSTERIOR A

  Patient problems: Adhesion(s); Hernia

  MAUDE report 21759629 ↗
• InjuryMar 25, 2025Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  PER INFORMATION PROVIDED: (B)(6)2014 - PATIENT WAS DIAGNOSED WITH INCARCERATED INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF VENTRALEX ST (DEVICE #1). PER OPERATIVE NOTES, ¿TWO HERNIAS ONE IN THE RIGHT UMBILICUS AND ABOVE MIDLINE WERE IDENTIFIED, BOTH HERNIA SACS WERE EXCISED. A VENTRALEX ST (DEVICE #1) WAS PLACED AND SUTURED." (B)(6)2017 - PATIENT WAS DIAGNOSED WITH RECURRENT INCARCERATED INCISIONAL HERNIA, SMALL BOWEL OBSTRUCTION INVOLVING OLD MESH THEREBY UNDERWENT OPEN REPAIR WITH REMOVAL OF VENTRALEX ST (DEVICE #1) AND IMPLANT OF VENTRALIGHT ST MESH (DEVICE #2). PER OPERATIVE NOTES, ¿THE SMALL BOWEL WAS DENSELY ADHERED TO THE OLD MESH (DEVICE #1), REMOVING THE BOWEL FROM THE MESH KEEPING THE MESH OFF IT AND REMOVING IN ITS ENTIRETY. ADHESIONS WERE TAKEN DOWN AND A VENTRALIGHT ST MESH (DEVICE #2) WAS PLACED INTO THE DEFECT AND SUTURED." (B)(6)2018 - PATIENT WAS DIAGNOSED WITH ENTEROCUTANEOUS FISTULA THEREBY UNDERWENT EXPLANT OF VENTRALIGHT ST MESH (DEVICE #2). PER OPERATIVE NOTES, ¿THE MIDLINE SCAR WAS REMOVED. THE ENTERIC FISTULA WAS RIGHT IN THE MIDDLE OF THE MESH (DEVICE #2). ADHESIONS WERE TAKEN DOWN AND VENTRALIGHT ST MESH (DEVICE #2) WAS REMOVED. THE

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

  MAUDE report 21686005 ↗
• 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) 2014 - PATIENT WAS DIAGNOSED WITH INCISIONAL HERNIA AND PARASTOMAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF COLLAMEND FM MESH (DEVICE #1). PER OPERATIVE NOTES, ¿ADHESIONS WERE TAKEN DOWN. COLLAMEND FM MESH IS INSERTED DIRECTLY AND SUTURED. ¿ (B)(6) 2014 TO (B)(6) 2018 - DURING MULTIPLE VISITS PATIENT HAD ABDOMINAL PAIN, HEMATOMA, ABSCESS, RECURRENT INCISIONAL HERNIA AND BECAME UNWELL WITH FEATURES OF SEPSIS DUE TO PREVIOUS STERCORAL PERFORATION WITH PRESENCE OF ERYTHEMA. (B)(6) 2018 - PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT OPEN ABDOMINAL WALL RECONSTRUCTION WITH THE IMPLANT OF VENTRALIGHT ST (DEVICE #2) AND PARTIAL EXPLANT OF COLLAMEND FM (DEVICE #1). PER OPERATIVE NOTES, ¿HERNIA SAC WAS IDENTIFIED. THE OLD MESH (DEVICE #1) WAS RELEASED WHEREAS NOT ABLE TO REMOVE ALL THE MESH. A VENTRALIGHT ST MESH (DEVICE #2) WAS PL

  Patient problems: Abscess; Erosion; Insufficient Information; Purulent Discharge; Sepsis; Wound Dehiscence

  MAUDE report 19214764 ↗
• InjuryOct 30, 2023Defective 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 TWO UNSPECIFIED BARD/DAVOL VENTRALIGHT ST ON (B)(6) 2019 AND (B)(6) 2021. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST BOTH THE 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 18028473 ↗
• InjuryJun 6, 2023Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  PER INFORMATION PROVIDED BY THE PATIENT'S ATTORNEY: (B)(6)2014 - PATIENT WAS DIAGNOSED WITH VENTRAL INCISIONAL HERNIA AT THE ROBOTIC PROSTATE SURGERY SITE AND UNDERWENT OPEN REPAIR WITH VENTRALEX ST MESH (DEVICE #1). PER OPERATIVE NOTES, " HERNIA SAC IDENTIFIED. THEREFORE VENTRALEX MESH (DEVICE #1) WAS PLACED AND SUTURED¿. (B)(6)2014 - PATIENT UNDERWENT OPEN RECURRENT VENTRAL INCISIONAL HERNIA REPAIR. PER OPERATIVE NOTES, "THE MESH WAS NOTED TO BE CRUMPLED MEDIALLY FROM THE RIGHT, BUT WAS INTACT ON THE LEFT. THE MESH WAS THEN SEPARATED FROM THE SURROUNDING TISSUES WAS STRETCHED BACK OUT INTO ITS NORMAL POSITION, REIMPLANTED AND STITCHES WERE PLACED ". (B)(6)2015 - PATIENT UNDERWENT OPEN RECURRENT VENTRAL INCISIONAL HERNIA REPAIR WITH REMOVAL OF THE MESH AND IMPLANTED WITH VENTRALIGHT ST MESH (DEVICE #2). PER OPERATIVE NOTES, "THE MESH HAD PULLED OUT FROM ONE SIDE COMPLETELY. THE MESH (DEVICE #1) WAS REMOVED COMPLETELY. WE THEREFORE SELECTED VENTRALIGHT ST MESH (DEVICE #2) AND PLACED INTO THE ABDOMINAL DEFECT¿. (B)(6)2015 - PATIENT UNDERWENT OPEN REPAIR OF VENTRAL INCISIONAL HERNIA WITH EXPLANT OF VENTRALIGHT ST (DEVICE #2) AND IMPLANTED WITH ANOTHER VENTRALIGHT ST MESH (DEVICE #3).

  Patient problems: Hernia

  MAUDE report 17074815 ↗
• DeathApr 26, 2023Defective 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 PERFIX PLUG AND VENTRALIGHT ST ON (B)(6)2013 AND/OR (B)(6)2014 AND/OR (B)(6)2014. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST ALL 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.

  Patient problems: Hernia; Insufficient Information; Pain

  MAUDE report 16813472 ↗
• InjuryApr 19, 2023Defective Device; Patient-Device Incompatibility; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL VENTRALIGHT ST ON (B)(6) 2013. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE VENTRALIGHT ST. ATTORNEY ALLEGES THAT THE PATIENT HAD SUBSEQUENT SURGICAL INTERVENTION DUE TO THE HERNIA MESH DEVICE. IT IS ALSO ALLEGED THAT THE PATIENT SUSTAINED PERSONAL INJURY, EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

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

  MAUDE report 16768435 ↗
• MalfunctionJan 13, 2023Expiration Date Error; Expiration Date Error

  AS REPORTED, DURING A LAPAROSCOPIC VENTRAL HERNIA REPAIR ON (B)(6) 2022, THE PATIENT WAS IMPLANTED WITH THE BARD/DAVOL VENTRALIGHT ST MESH WHICH WAS EXPIRED ON 28-JUN-2022. IT WAS REPORTED THAT THE MESH HAS BEEN LEFT IMPLANTED AND THE PATIENT HAS NOT RECEIVED ANY ADDITIONAL MEDICAL/SURGICAL TREATMENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16157499 ↗
• InjuryJul 6, 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. IT IS ALLEGED THAT THE PATIENT SUSTAINED UNSPECIFIED INJURY AND EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

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

  MAUDE report 14926580 ↗
• MalfunctionMay 20, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  REPORTED PER CLINICAL TRIAL: ON (B)(6) 2017: SUBJECT PATIENT UNDERWENT PRIMARY LAPAROSCOPIC MIDLINE INFRAUMBILICAL HERNIA REPAIR PROCEDURE. A BARD/DAVOL VENTRALIGHT ST MESH WAS PLACED IN UNDERLAY FASHION INTRA-PERITONEALLY USING A MECHANICAL FIXATION DEVICE AND SUTURE. FULL SKIN CLOSURE WAS ACHIEVED WITH SUTURES AND ADHESIVE SKIN CLOSURE. THE PATIENT WAS DISCHARGED TO HOME ON (B)(6) 2017. ON (B)(6) 2017: SUBJECT PATIENT WAS DIAGNOSED WITH SEROMA WHICH RESOLVED ON (B)(6) 2018. NO ACTION TAKEN. THIS AE IS CLINICALLY ASSESSED TO BE POSSIBLY RELATED TO THE STUDY DEVICE AND DEFINITELY RELATED TO THE PROCEDURE. THIS HAS BEEN ASSESSED AS A NON-SERIOUS ADVERSE EVENT OF MILD SEVERITY AND HAS RESOLVED. THE REPORTED ADVERSE EVENT DOES NOT MEET THE DEFINITION OF A SAE (SERIOUS ADVERSE EVENT).

  Patient problems: Seroma

  MAUDE report 14457345 ↗
• InjuryMay 20, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  REPORTED PER CLINICAL TRIAL (B)(4): (B)(6) 2014 - SUBJECT PATIENT UNDERWENT LAPAROSCOPIC MULTIPLE RECURRENT MIDLINE HERNIA REPAIR. THE SIZE OF THE HERNIA DEFECT WAS 15CM X 9CM. A BARD/DAVOL VENTRALIGHT ST MESH WAS PLACED AND FIXATED USING SORBAFIX FIXATION DEVICE AND SUTURES. FASCIA AND SKIN CLOSURE WAS ACHIEVED WITH SUTURES. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2014. (B)(6) 2014 - PATIENT WAS DIAGNOSED WITH SEROMA. (B)(6) 2015 - DOCTOR NOTES STATE POSSIBLE RECURRENCE; CT ORDERED DURING THIS VISIT CONFIRMED SEROMA. (B)(6) 2015 - SURGEON ORDERED ULTRASOUND-GUIDED ASPIRATION OF SEROMA . (B)(6) 2015 - ULTRASOUND-GUIDED ASPIRATION OF SEROMA PERFORMED. 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.

  Patient problems: Seroma

  MAUDE report 14454633 ↗
• InjuryFeb 1, 2022Material Deformation; Material Deformation

  AS REPORTED, THE PATIENT UNDERWENT IMPLANT OF A BARD/DAVOL VENTRALIGHT ST MESH IN 2019. AS REPORTED, ON (B)(6) 2022, A CT SCAN REVEALED THE POSSIBILITY OF RECURRENT HERNIA AT THE SAME LOCATION AND IT WAS REPORTED THAT THE MESH APPEARED TO BE "FLIPPED".

  Patient problems: Hernia

  MAUDE report 13419071 ↗
• MalfunctionSep 15, 2021Contamination; Material Separation; Contamination; Material Separation

  IT WAS REPORTED THAT IMMEDIATELY AFTER OPENING THE BARD/DAVOL VENTRALIGHT ST WHEN ATTACHING THE NEEDLE THREAD TO THE MESH, IT WAS NOTICED THAT A GEL-LIKE FOREIGN MATERIAL WAS ATTACHED. IT WAS REPORTED THAT ANOTHER DEVICE WAS USED TO COMPLETE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY. SUBSEQUENT INFORMATION RECEIVED, INDICATES THAT THE REPORTED "FOREIGN MATERIAL" IS POSSIBLY REFERRING TO THE ST GEL COATING OF THE MESH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12475771 ↗
• InjuryAug 6, 2021Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL VENTRALIGHT ST ON (B)(6) 2018. 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. ATTORNEY ALLEGES THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Insufficient Information; Necrosis; Purulent Discharge; Seroma

  MAUDE report 12291211 ↗
• InjuryMay 20, 2021Defective Device; 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) 2013. 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.Addendum per additional information provided:On (b)(6) 2013 - Patient was diagnosed with ventral hernia thereby underwent open repair with the implant of Ventralight ST Mesh (Device 1). Per op notes, "A midline incision was made, the Ventralight ST Mesh (Device 1) was placed into the fascia using prolene sutures." On (b)(6) 2015 - Patient underwent abdominal wall suture granuloma excision.On (b)(6) 2016 - Patient underwent abdominal wall suture granuloma excision. Per op notes, "Incision was made of the suture granuloma site, the excision site. Noted the mesh (Device 1) base of the debrided."On (b)(6) 2020 - Patient had abdominal wall abscess thereby underwe

  Patient problems: Abscess; Adhesion(s); Granuloma; Hernia; Insufficient Information; Necrosis; Pain; Unspecified Infection

  MAUDE report 11853674 ↗
• InjuryMay 19, 2021Defective Device; Patient-Device Incompatibility; Patient Device Interaction Problem; Defective Device; Patient-Device Incompatibility; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR THE IMPLANT OF UNSPECIFIED BARD/DAVOL VENTRALEX ST, VENTRIO AND VENTRALIGHT ST MESH ON (B)(6) 2015 AND/OR (B)(6) 2016 AND/OR (B)(6) 2020. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST ALL DEVICES. IT IS ALLEGED THAT THE PATIENT SUSTAINED UNSPECIFIED INJURIES ON (B)(6) 2016 AND (B)(6) 2020. 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; Insufficient Information; Pain

  MAUDE report 11847929 ↗
• InjuryMay 12, 2021Defective Device; Patient-Device Incompatibility; Patient Device Interaction Problem; Defective Device; Patient-Device Incompatibility; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL VENTRALIGHT ST ON (B)(6) 2011. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE VENTRALIGHT ST. ATTORNEY ALLEGES THAT THE PATIENT HAD SUBSEQUENT SURGICAL INTERVENTION DUE TO THE HERNIA MESH DEVICE. IT IS ALSO ALLEGED THAT THE PATIENT SUSTAINED PERSONAL INJURY, EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Adhesion(s); Insufficient Information

  MAUDE report 11815509 ↗
• InjuryNov 18, 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) 2017. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE VENTRALIGHT ST. ATTORNEY ALLEGES THAT THE PATIENT HAD SUBSEQUENT SURGICAL INTERVENTION DUE TO THE HERNIA MESH DEVICE. IT IS ALSO ALLEGED THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

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

  MAUDE report 10860428 ↗
• InjuryNov 16, 2020Detachment of Device or Device Component; Material Split, Cut or Torn; Detachment of Device or Device Component; Material Split, Cut or Torn

  THE FOLLOWING WAS REPORTED VIA MAUDE EVENT REPORT (MW5097358) ALLEGING ADVERSE OUTCOMES AGAINST VENTRALIGHT ST: "IMPLANTED VENTRALIGHT ST MESH TORE FROM ORIGINAL SURGICAL SITE."

  Patient problems: No Information

  MAUDE report 10842638 ↗