VENTRALIGHT 5954680Recalls & reported problems

Summary

The FDA's MAUDE database contains 143 adverse event reports that list this exact device (DI 00801741031656), received between Apr 24, 2017 and Aug 5, 2026 — classified as 1 death, 125 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Defective Device” (102 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 143 reports, in the reporter's own words as published by the FDA.

• InjuryAug 5, 2026Patient-Device Incompatibility

  Per information provided:On (b)(6) 2015 - Patient was diagnosed with large ventral hernia thereby underwent laparoscopic repair with the implant of Ventralight ST Mesh using Echo PS (Device 1). Per op notes, "The hernia was reduced from the sac. A Ventralight ST Mesh using Echo PS (Device 1) was placed into peritoneal cavity and overlapped the defect and secured to fascia using SorbaFix tacks."On (b)(6)2016 - Patient was diagnosed with incisional hernia thereby underwent laparoscopic repair. Per op notes, "The mesh (Device 1) was tethered and stuck to the left lobe of the liver was left attached. Lysis of adhesions was done along the central abdomen down to the level of the recurrent ventral hernia. The stomach was found to be adhesed to the hernia contents and the anterior abdominal wall in the lower midline and sleeve was resected."On (b)(6) 2019 - Patient was diagnosed with incisional hernia thereby underwent open repair with the implant of Ventralight ST Mesh (Device 2). Per op notes, "The hernia was noted just to the right of midline. A Ventralight ST Mesh (Device 2) was placed in retrorectus space and sutured the mesh edges to the anterior abdominal wall fascia using sutures.

  Patient problems: Necrosis; Post Operative Wound Infection

  MAUDE report 50140030 ↗
• InjuryMay 27, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH VENTRAL AND UMBILICAL HERNIAS THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRIO ST (DEVICE 1). PER OP NOTES, "MIDLINE INCISION WAS MADE. FASCIA WAS OPENED. UNDERNEATH THE RECTUS MUSCLE ON BOTH HERNIAS A SPACE WAS CREATED. A VENTRIO ST (DEVICE 1) WAS PLACED AND SUTURED." ON (B)(6) 2016 - PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF BARD FLAT MESH (DEVICE 2). PER OP NOTES, "PREVIOUS MIDLINE INCISION WAS REMOVED. THE FASCIA WAS FREED. A BARD FLAT MESH WAS PLACED IN THE DEFECT AND SECURED USING SUTURES." (NOTE: THERE IS NO VISUALIZATION OF VENTRIO ST (DEVICE 1) IN THIS PROCEDURE). ON (B)(6) 2017 - PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH EXCISION OF VENTRIO ST (DEVICE 1), BARD FLAT MESH (DEVICE 2) AND IMPLANT OF VENTRALIGHT ST (DEVICE 3). PER OP NOTES, "THE OLD MESH (DEVICE 1 AND 2) WAS NOTED AND DISSECTED OUT. THE OLD MESHES (DEVICE 1 AND 2) WERE EXCISED AND REMOVED ENTIRELY. THE HERNIA DEFECT WAS NOTED AND REDUCED. A VENTRALIGHT ST (DEVICE 3) WAS PLACED AND SUTURED. THE MESH WAS TACKED LATERAL BORDERS." ON (

  Patient problems: Adhesion(s); Hernia

  MAUDE report 25299238 ↗
• InjuryApr 7, 2026Migration

  PER INFORMATION PROVIDED: (B)(6) 2016 - PATIENT WAS DIAGNOSED WITH TWO SEPARATE INCISIONAL HERNIAS THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF VENTRALIGHT ST MESH (DEVICE 1 AND 2). PER OP NOTES, ¿A LEFT SUBCOASTAL STAB INCISION WAS MADE. HERNIA DEFECTS WERE IDENTIFIED WHICH WERE SLIGHTLY OBSCURED BY THE OMENTUM AND IT WAS TAKEN DOWN. TWO SEPARATE HERNIAS WERE NOTED. MIDLINE HERNIA JUST ABOVE THE UMBILICUS AND LEFT LOWER QUADRANT HERNIA. THE FASCIAL DEFECTS WERE CLOSED WITH ABSORBABLE SUTURE AND TRANS-FASCIAL SUTURES. A VENTRALIGHT ST MESH (DEVICE 1) WAS PLACED INTRA-ABDOMINALLY AND ANCHORED TO THE ANTERIOR ABDOMINAL WALL WITH SUTURE AND ABSORBABLE TACKS WHICH COVERED THE MIDLINE FASCIAL DEFECT. A VENTRALIGHT ST MESH (DEVICE 2) WAS PLACED TO COVER THE LEFT LOWER QUADRANT FASCIAL DEFECT AND SECURED TO THE ABDOMINAL WALL WITH SUTURE AND ABSORBABLE TACKS.¿ (B)(6) 2018 - PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT ROBOTIC ASSISTED LAPAROSCOPIC REPAIR WITH EXCISION OF VENTRALIGHT ST MESH (DEVICE 1 AND 2) AND IMPLANT OF SYNTHETIC MESH. PER OP NOTES, ¿A LEFT SUBCOASTAL STAB INCISION WAS MADE. ADHESIONS IN THE LEFT UPPER AND LOWER QUADRANT AND MID ABDO

  Patient problems: Adhesion(s); Hernia

  MAUDE report 24797625 ↗
• InjuryFeb 26, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2012 - PATIENT WAS DIAGNOSED WITH INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF COMPOSIX KUGEL MESH (DEVICE 1). PER OP NOTES, "A COMPOSIX KUGEL MESH (DEVICE 1) WAS PLACED TO THE FASCIA USING PROLENE SUTURES." (B)(6) 2013 - PATIENT HAD BOWEL OBSTRUCTION. (B)(6) 2016 - PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL INCISIONAL HERNIA THEREBY UNDERWENT REPAIR WITH THE IMPLANT OF VENTRALIGHT ST MESH (DEVICE 2). PER OP NOTES, "THERE WAS OLD MESH THAT APPEARED TO BE FOLDED UPON ITSELF, WITH A LARGE HERNIA SAC. DENSE ADHESIONS WERE TAKEN DOWN. A VENTRALIGHT ST MESH (DEVICE 2) WAS PLACED USING PROLENE SUTURES." (B)(6) 2017 - PATIENT UNDERWENT SURGERY FOR BOWEL OBSTRUCTION.

  Patient problems: Obstruction/Occlusion

  MAUDE report 24457022 ↗
• InjuryDec 26, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2005 - PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF COMPOSIX E/X MESH (DEVICE 1). PER OPERATIVE NOTES, ¿AN ELLIPTICAL INCISION WAS MADE INTO THE PREVIOUS SCAR IN THE INFRAUMBILICAL AREA. THE INCISION WAS MADE AND CARRIED DOWN TO THE MIDLINE FASCIA. THE HERNIA SAC WAS DISSECTED OUT. A COMPOSIX E/X MESH (DEVICE 1) WAS PLACED AND SECURE IT WITH SUTURES.¿ (B)(6) 2005 - PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL HERNIA, THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRALEX MESH (DEVICE 2). PER OPERATIVE NOTES, ¿A STANDARD MIDLINE INCISION WAS MADE OVER THE PALPABLE MASS. THE HERNIA SAC WAS DISSECTED OUT. A VENTRALEX MESH (DEVICE 2) WAS PLACED IN A SUBFASCIAL POSITION AND SECURE IT WITH SUTURES.¿ (B)(6) 2005 - PATIENT WAS DIAGNOSED WITH NONHEALING ABDOMINAL WOUND THEREBY UNDERWENT OPEN REPAIR WITH DRAINAGE OF WOUND FLUID. (B)(6) 2014 - PATIENT WAS DIAGNOSED WITH SMALL BOWEL OBSTRUCTION, RECURRENT INCISIONAL HERNIA, ADHESION, THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRALIGHT ST MESH (DEVICE 3) AND EXPLANT OF COMPOSIX E/X MESH (DEVICE 1) AND VENTRALEX MESH (DEVICE 2). PER OPERATIVE NOTES, ¿AN

  Patient problems: Hernia

  MAUDE report 23897316 ↗
• InjuryNov 12, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2013 - PATIENT WAS DIAGNOSED WITH MULTIPLE RECURRENT INCISIONAL VENTRAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT OF VENTRALIGHT ST MESH (DEVICE 1 AND DEVICE 2). PER OPERATIVE NOTES, ¿AN INCISION WAS MADE IN THE LEFT LOWER QUADRANT. ALL ADHESIONS WERE TAKEN DOWN. HERNIA SACS WERE DISSECTED OUT. A VENTRALIGHT ST MESH (DEVICE 1) WAS PLACED INTO THE RIGHT LATERAL SIDEWALL OF THE ABDOMEN AND SECURE IT WITH SORBAFIX SUTURE TACKER. A VENTRALIGHT ST MESH (DEVICE 2) WAS PLACED INTO THE INFERIOR HERNIA DEFECT AND SECURE IT WITH SORBAFIX SUTURES.¿ ON (B)(6) 2014 - PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL VENTRAL HERNIA, ADHESION, THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH LYSIS OF ADHESION AND IMPLANT OF VENTRALIGHT ST MESH (DEVICE 3). PER OPERATIVE NOTES, ¿AN INCISION WAS MADE IN THE LEFT UPPER QUADRANT. THERE WAS NO MESH VISUALIZED. HERNIA SAC WAS DISSECTED FROM AN OLD PIECE OF MESH. LYSIS OF ADHESIONS WAS PERFORMED. A VENTRALIGHT ST MESH (DEVICE 3) WAS PLACED INTO THE ABDOMINAL CAVITY AND SECURE IT WITH TACKERS.¿

  Patient problems: Adhesion(s); Hernia

  MAUDE report 23531143 ↗
• InjuryAug 21, 2025Material Deformation; Material Deformation

  PER INFORMATION PROVIDED: (B)(6) 2019 - PATIENT WAS DIAGNOSED WITH VENTRAL HERNIA THEREBY UNDERWENT REPAIR WITH THE IMPLANT OF VENTRALIGHT ST MESH (DEVICE 1). (NOTE: NO IMPLANT DETAILS/PROCEDURE PROVIDED IN MEDICAL RECORDS). (B)(6) 2019 - PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL VENTRAL HERNIA, SCAR TISSUE, ADHESION THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRALIGHT ST MESH (DEVICE 2). PER OPERATIVE NOTES, ¿HERNIA SAC WAS DISSECTED. LYSIS OF ADHESION WAS PERFORMED. SCAR TISSUE WAS TAKEN DOWN. A VENTRALIGHT ST MESH (DEVICE 2) WAS PLACED AND SUTURED.¿ (B)(6) 2021 - PATIENT WAS DIAGNOSED WITH PAIN, MESH INFECTION, MESH FOLDED, ADHESION, SCAR TISSUE THEREBY UNDERWENT OPEN REPAIR WITH EXPLANT OF VENTRALIGHT ST MESH (DEVICE 1) AND VENTRALIGHT ST MESH (DEVICE 2) AND IMPLANT OF A SYNTHETIC MESH. PER OPERATIVE NOTES, ¿HERNIA SAC WAS DISSECTED. THE SCAR TISSUE WAS DISSECTED FREE. ADHESIONS WERE TAKEN DOWN. INFECTED VENTRALIGHT ST MESH (DEVICE 1) AND VENTRALIGHT ST MESH (DEVICE 2) WERE REMOVED. A SYNTHETIC MESH WAS PLACED AND SUTURED.¿

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

  MAUDE report 22859938 ↗
• InjuryJul 14, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2007- PATIENT WAS DIAGNOSED WITH INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF BARD FLAT MESH (DEVICE #1). PER OPERATIVE NOTES, ¿A BARD FLAT MESH (DEVICE #1) WAS PLACED AND SUTURED.¿ (B)(6) 2012 - PATIENT WAS DIAGNOSED WITH INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH EXPLANT OF BARD FLAT MESH (DEVICE #1) AND IMPLANT OF VENTRALIGHT ST MESH (DEVICE #2) AND BARD SOFT MESH (DEVICE #3). PER OPERATIVE NOTES, ¿OLD BARD FLAT MESH (DEVICE #1) WAS EXCISED. ONE VENTRALIGHT ST MESH (DEVICE #2) AND ONE BARD SOFT MESH (DEVICE #3) WAS PLACED AND SUTURED.¿ (B)(6) 2013 - PATIENT WAS DIAGNOSED WITH INTESTINAL PERFORATION, ADHESION, ABSCESS, MESH INFECTION, INFLAMMATION THEREBY UNDERWENT OPEN REPAIR WITH EXPLANT OF VENTRALIGHT ST MESH (DEVICE #2) AND BARD SOFT MESH (DEVICE #3), LYSIS OF ADHESION, ABSCESS, AND IMPLANT ONE SYNTHETIC MESH. PER OPERATIVE NOTES, ¿ABSCESS WERE DRAINED FROM INTRA-ABDOMINAL AREA. INFECTED VENTRALIGHT ST MESH (DEVICE #2) AND BARD SOFT MESH (DEVICE #3) WAS EXCISED COMPLETELY.¿ (B)(6) 2014 - PATIENT WAS DIAGNOSED WITH VENTRAL INCISIONAL HERNIA, ADHESION THEREBY UNDERWENT OPEN REPAIR WITH EXPLANT OLD BIOLOGICAL MESH

  Patient problems: Abscess; Bowel Perforation; Unspecified Infection

  MAUDE report 22492807 ↗
• InjuryMar 28, 2025Defective Device; Patient-Device Incompatibility; Defective Device; Patient-Device Incompatibility

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL VENTRALIGHT ST MESH ON (B)(6) 2014 AND (B)(6) 2016. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST BOTH THE DEVICES. 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: Adhesion(s); Hernia; Inflammation; Insufficient Information; Pain

  MAUDE report 21718137 ↗
• InjuryMar 27, 2025Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  PER INFORMATION PROVIDED BY PATIENT¿S ATTORNEY AND REVIEW OF PATIENT MEDICAL RECORDS: (B)(6)2009 - PATIENT WAS DIAGNOSED WITH VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF SEPRAMESH IP (DEVICE #1). PER OPERATIVE NOTES, ¿THERE WAS A MIDLINE HERNIA AND THEN AT THE INFERIOR ASPECT OF THE WOUND WAS ANOTHER LARGE HERNIA. ADHESIONS WERE TAKEN DOWN. A SEPRAMESH IP (DEVICE #1) WAS THEN PLACED POSTERIOR TO THE ABDOMINAL WALL USING SUTURES.¿ (B)(6)2011 - PATIENT WAS DIAGNOSED WITH LARGE RECURRENT VENTRAL HERNIA THEREBY UNDERWENT REPAIR WITH PARTIAL REMOVAL OF MESH (DEVICE #1) & IMPLANT OF VENTRALIGHT ST MESH (DEVICE #2). PER OPERATIVE NOTES, ¿IDENTIFIED THE HERNIA SAC AND WAS EXCISED. THERE WAS ONE LOOP OF BOWEL WHICH WAS MORE DENSELY ADHERENT TO THE MESH. THIS WAS TAKEN DOWN. EXCISING A SMALL PORTION OF THE OLD MESH (DEVICE #1), WHICH HAD BEEN SHRUNKEN AND CRUMPLED UP IN THE INFERIOR ASPECT OF THE INCISION, WHERE IT HAD PULLED AWAY FROM THE FASCIA FROM HER PREVIOUS REPAIR. THE DEFECT WAS REPAIRED WITH A VENTRALIGHT ST MESH (DEVICE #2) USING PROLENE SUTURES.¿ (B)(6)2015 - PATIENT WAS DIAGNOSED WITH LEFT FLANK INCISIONAL HERNIA THEREBY UNDERWENT REPAIR WITH THE IMPLANT OF V

  Patient problems: Abdominal Pain; Fibrosis; Hernia; Scar Tissue; Unspecified Infection

  MAUDE report 21705944 ↗
• InjuryDec 2, 2024Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  PER INFORMATION PROVIDED: (B)(6) 2012 - PATIENT WAS DIAGNOSED WITH MULTIPLE VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF BARD FLAT MESH (DEVICE #1). PER OPERATIVE NOTES, ¿MULTIPLE HERNIA SACS WERE CONNECTED INTO ONE LARGE HERNIA. PARTIAL OMENTECTOMY WAS PERFORMED. THE HERNIA SACS WERE RESECTED AND THE EDGES FRESHENED BACK AND ANCHORED WITH SUTURES. ADHESIOLYSIS HAD BEEN PERFORMED. A BARD FLAT MESH (DEVICE #1) WAS SEWN TO ANTERIOR ABDOMINAL WALL AS A BUTTRESS USING INTERRUPTED SUTURES.¿ (B)(6) 2012 - PATIENT WAS DIAGNOSED WITH INFECTED SEROMA THEREBY UNDERWENT INCISION AND DRAINAGE OF ABDOMINAL WALL AND VAC PLACEMENT. (B)(6) 2016 - PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF VENTRALIGHT ST MESH (DEVICE #2). PER OPERATIVE NOTES, ¿FIBROTIC TISSUE HAD INVAGINATED INTO FLAT MESH(DEVICE #1). THERE WAS BOWEL WITHIN TWO HERNIA SACS PRESENT ALONG THE MIDLINE. THE HERNIA SACS WERE EXCISED. THE SECOND HERNIA SAC IN THE EPIGASTRIUM WAS EXCISED, VENTRALIGHT ST MESH(DEVICE #2) WAS PLACED, EXTENDED ABOVE AND BELOW BOTH HERNIAS AND SUTURED.¿ (B)(6) 2016 - PATIENT WAS DIAGNOSED WITH INFECTED SEROMA THEREBY UNDERWENT IN

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

  MAUDE report 20817980 ↗
• InjuryNov 11, 2024Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  ADDENDUM PER INFORMATION PROVIDED: ON (B)(6) 2016: PATIENT WAS DIAGNOSED WITH EPIGASTRIC HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRALEX ST (DEVICE #1). PER OPERATIVE NOTES, "HERNIATED PREPERITONEAL FAT WAS IMMEDIATELY ENCOUNTERED AND REDUCED. A 6.4 CM VENTRALEX ST MESH (DEVICE #1) WAS PLACED." ON (B)(6) 2017: PATIENT WAS DIAGNOSED WITH RECURRENT INTRA-ABDOMINAL WALL HERNIA AND ABDOMINAL PAIN THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF VENTRALIGHT ST MESH (DEVICE #2). PER OPERATIVE NOTES, "THERE WERE OMENTAL ADHESIONS ATTACHED TO THE PREVIOUSLY PLACED MESH WHICH WERE DISSECTED AWAY. IT APPEARED THE PREVIOUSLY PLACED MESH HAD PARTIALLY MIGRATED FROM ITS ORIGINAL POSITION. THE MESH WAS LEFT IN PLACE. A PIECE OF VENTRALIGHT ST MESH (DEVICE #2) WAS PLACED OVERLAP OF THE REPAIR." ON (B)(6) 2018: PATIENT UNDERWENT REVISION SURGERY WITH REPAIR OF RECURRENT VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH REMOVAL OF MESH. PER OPERATIVE NOTES, "MIDLINE INCISION WAS MADE AND CARRIED DOWN TO DEFECT AND PREVIOUSLY PLACED MESH. MESH WAS DENSELY ADHERENT TO UNDERLYING OMENTUM. THE OMENTUM ADHERENT TO THE MESH WAS THEN RESECTED. THE SYNTHETIC MESH WAS SECURED TO POSTERIO

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

  MAUDE report 20649937 ↗
• InjuryOct 30, 2024Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  PER ADDITIONAL INFORMATION PROVIDED: (B)(6) 2008 - PATIENT WAS DIAGNOSED WITH INCISIONAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT OF VENTRALEX MESH (DEVICE #1). PER OPERATIVE NOTES, ¿A LARGE HERNIA SAC AT THE COLOSTOMY SITE ON THE LEFT AND SEVERAL SMALL MIDLINE DEFECTS ABOVE WERE NOTED, A SYNTHETIC MESH WAS PLACED, THE SUPERIOR RIGHT SIDE OF MESH PULLED AWAY SLIGHTLY FROM THE AREA AND A ROUND MESH VENTRALEX MESH (DEVICE #1) WAS PLACED AND SUTURED.¿ (B)(6) 2009 - PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT OPEN HERNIA REPAIR WITH THE IMPLANT OF SEPRAMESH IP (DEVICE #2) AND REMOVAL OF VENTRALEX MESH (DEVICE #1). PER OPERATIVE NOTES, ¿A HERNIA WAS IDENTIFIED AND CIRCUMFERENTIALLY DISSECTED DOWN TO THE FASCIA AND THE SAC WAS REMOVED. A LARGE WATER OF OMENTUM WAS INCARCERATED IN THE HERNIA WAS REDUCED. THE LEFT UPPER PORTION OF PRIOR MESH WAS SEPARATED AND THE RECURRENCE NOTED. ANOTHER HERNIA DEFECT WAS NOTED ABOVE THE PREVIOUS MESH (DEVICE #1) IN MIDLINE. THE MOST PORTION OF THE PREVIOUS MESH (DEVICE #1) WAS REMOVED. SOME PORTIONS OF THE MESH WERE DENSELY ADHERENT TO HEALTHY MUSCLE WERE LEFT INTACT. ADHESIONS WERE TAKEN DOWN. A SEPRAMES

  Patient problems: Hernia

  MAUDE report 20564686 ↗
• MalfunctionSep 6, 2024Expiration Date Error; Expiration Date Error

  AS REPORTED, DURING IPOM (LAPAROSCOPIC INTRAPERITONEAL PLACEMENT OF MESH) HERNIA REPAIR PROCEDURE, A VENTRALIGHT ST MESH WHICH HAD LABELED EXPIRATION DATE OF (B)(6) 2024 WAS IMPLANTED IN THE PATIENT ON (B)(6) 2024. IT WAS ALSO REPORTED THAT SURGEON DID NOT CONSIDER ANY FURTHER ACTION REGARDING ADDITIONAL MEDICAL TREATMENT OR ADDITIONAL SURGERY/DEVICE EXPLANT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20154242 ↗
• InjuryFeb 20, 2024Defective Device; Patient-Device Incompatibility; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT VENTRAL INCISIONAL HERNIA REPAIR WITH IMPLANT OF AN UNSPECIFIED BARD/DAVOL VENTRALEX HERNIA PATCH ON (B)(6) 2021. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE VENTRALEX HERNIA PATCH. 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: Hernia; Insufficient Information

  MAUDE report 18736595 ↗
• InjuryJan 13, 2024Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  PER INFORMATION PROVIDED BY PATIENT'S ATTORNEY: (B)(6) 2011 - PATIENT WAS DIAGNOSED WITH INCISIONAL VENTRAL HERNIA (X2) THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF VENTRALEX MESH (DEVICE #1) AND VENTRIO MESH (DEVICE #2). PER OPERATIVE NOTES, ¿THE COMPOUND HERNIA SAC WAS FOUND AND FREED FROM ATTACHMENTS. FOUND ADDITIONAL DEFECT INFERIORLY AND ANTERIORLY. PREVIOUS MESH THAT HAD BEEN STAPLED HAD PULLED APART. EXPOSED THE FASCIAL DEFECT AND PUT A LARGE PIECE OF VENTRALEX OVAL MESH (DEVICE #1) CIRCUMFERENTIALLY. THE INFERIOR VENTRAL DEFECT WITH INCARCERATED BOWEL AND OMENTUM WERE DISSECTED. THE FASCIAL DEFECT IN THE SUBXIPHOID WAS MUCH SMALLER, IT WAS ABLE TO FULLY BE OCCLUDED WITH A LARGE VENTRALEX KUGEL PATCH (VENTRIO - DEVICE #2) AND SEWED.¿ (NOTE, NO PRODUCT IDENTIFIERS PROVIDED FOR PREVIOUS MESH). (B)(6) 2014 - DURING HOSPITAL VISIT PATIENT WAS DIAGNOSED WITH HERNIA RECURRENCE. (B)(6) 2014 - PATIENT WAS DIAGNOSED WITH INCARCERATED RECURRENT VENTRAL HERNIA (X2) AND ABDOMINAL PANNUS THEREBY UNDERWENT REPAIR WITH EXPLANT OF THE DISLODGED MESH (DEVICE #2), LYSIS OF ADHESIONS AND PANNICULECTOMY. PER OPERATIVE NOTES. ¿FAIR AMOUNT OF SMALL AND LARGE BOWEL INCARCERATED VENTRAL HERNIA

  Patient problems: Adhesion(s); Hernia

  MAUDE report 18509413 ↗
• InjuryDec 15, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED, THE PATIENT WAS DIAGNOSED WITH A PARASTOMAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC INCISIONAL HERNIA MESH REPAIR WITH THE IMPLANT OF VENTRALIGHT ST MESH. POST IMPLANT THE PATIENT DEVELOPED A HERNIA RECURRENCE DUE TO MUSCLE RELAXATION AND UNDERWENT A SECOND OPERATION.

  Patient problems: Hernia

  MAUDE report 18334748 ↗
• InjuryNov 15, 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) 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 ventral hernia thereby underwent open repair with implant of Ventralight ST Mesh. Per op notes, "The old incision was opened in the medial aspect. A synthetic mesh was identified and removed. A Ventralight ST Mesh was placed in the defect and was secured against the abdominal wall using prolene sutures."(b)(6) 2016 - Patient underwent repair with removal of mesh. Per op notes, "The abdominal wound had a granulation tissue base. Two portions of Ventralight ST Mesh were excised."

  Patient problems: Granuloma; Insufficient Information; Pain

  MAUDE report 18138923 ↗
• InjuryNov 7, 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 INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF VENTRALIGHT ST (DEVICE #1). PER OPERATIVE NOTES, "THE HERNIA SAC WAS DISSECTED DOWN IN THE ABDOMINAL CAVITY AND THE SAC WAS OPENED. THE OMENTAL AND BOWEL ADHESIONS WERE TAKEN DOWN AND THE HERNIA SAC WAS RESECTED COMPLETELY. A PIECE OF VENTRALIGHT ST (DEVICE #1) WAS PLACED AND SUTURED.¿ (B)(6) 2014 - PATIENT VISITED HOSPITAL FOR ABDOMINAL PAIN. (B)(6) 2014 - PATIENT HAD SMALL RECURRENCE AT THE APEX MORE SUPERIOR ASPECT OF PRIOR HERNIA REPAIR. (B)(6) 2014 - PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA AND RIGHT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF VENTRALEX ST (DEVICE #2) AND SYNTHETIC MESH. PER OPERATIVE NOTES, "THE HERNIA DEFECT WAS IDENTIFIED AND THE SAC WAS OPENED. A VENTRALEX ST MESH (DEVICE #2) WAS PLACED TO THE UNDERSURFACE OF THE FASCIA AND SUTURED. THERE WAS SOME WEAKENING OF INGUINAL FLOOR. WE THEN PLACED A PIECE OF SYNTHETIC MESH AND SUTURED." (NOTE: THERE WAS NO MENTION/VISUALIZATION OF DEVICE #1). (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH SLIGHT RECURRENCE AT THE MIDPORTION O

  Patient problems: Abdominal Pain; Hernia; Obstruction/Occlusion

  MAUDE report 18083120 ↗
• InjuryOct 26, 2023Defective 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) 2023. 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) 2023. 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; Insufficient Information; Pain; Unspecified Infection

  MAUDE report 18012479 ↗
• MalfunctionSep 29, 2023Material Separation; Material Separation

  AS REPORTED, DURING A LAPAROSCOPIC VENTRAL HERNIA REPAIR PROCEDURE, THE VENTRALIGHT ST MESH WAS HYDRATED FOR 30 SECONDS AND WAS ROLLED IMMEDIATELY WITH ST COATING INSIDE. IT WAS REPORTED THAT THE HYDROGEL BARRIER WAS PEELING OFF AND BREAKING WHILE FIXATING THE MESH. IT WAS REPORTED THAT THE MESH WAS REMOVED, AND ANOTHER MESH WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17845592 ↗
• InjuryJun 8, 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 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: Abdominal Pain; Adhesion(s); Hernia; Insufficient Information

  MAUDE report 17085802 ↗
• InjuryJun 6, 2023Defective Device; Patient Device Interaction Problem; Migration; Defective Device; Patient Device Interaction Problem; Migration

  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

  Patient problems: Hernia

  MAUDE report 17073416 ↗
• InjuryMay 12, 2023Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  PER INFORMATION PROVIDED BY PATIENT'S ATTORNEY: (B)(6) 2008 - PATIENT WAS DIAGNOSED WITH INCARCERATED EPIGASTRIC HERNIA AND UNDERWENT OPEN REPAIR WITH COMPOSIX KUGEL MESH (DEVICE #1). PER THE OPERATIVE NOTES, "THE HERNIA CONTENTS WERE IDENTIFIED AND CIRCUMFERENTIALLY DISSECTED. THE PREPERITONEAL SPACE WAS THEN FURTHER BLUNTLY DISSECTED TO ACCOMMODATE PLACEMENT OF A COMPOSIX KUGEL MESH (DEVICE #1)." (B)(6) 2008 - PATIENT HAD POST-OPERATIVE SEROMA. (B)(6) 2013 - PATIENT WAS DIAGNOSED WITH RECURRENT EPIGASTRIC HERNIA, UNDERWENT LAPAROSCOPIC REPAIR AND COMPOSIX KUGEL MESH REMOVAL (DEVICE #1). PER THE OPERATIVE NOTES, "I ELECTED TO REMOVE THE PIECE OF INTRAPERITONEAL MESH (DEVICE #1) USING ELECTROCAUTERY. ONCE THIS HAD BEEN FREED, THE PREVIOUS OPEN INCISION OF THE PRIOR HERNIA REPAIR WAS OPENED AND THE OLD MESH WAS PULLED THROUGH THIS OPENING. A VENTRALEX PATCH (DEVICE #2) WAS THEN PLACED AND SEWN IN 4 QUADRANTS." (NOTE: THERE WERE NO PRODUCT IDENTIFIERS PROVIDED FOR DEVICE #2) (B)(6) 2013 - PATIENT VISITED HOSPITAL FOR ABDOMINAL PAIN AND WAS DIAGNOSED WITH VENTRAL HERNIA. (B)(6) 2013 - PATIENT UNDERWENT LAPAROSCOPIC CONVERTED TO OPEN HERNIA REPAIR WITH VENTRIO MESH (DEVICE #3) AND REMO

  Patient problems: Adhesion(s); Pain

  MAUDE report 16919553 ↗
• 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. ADDENDUM PER LEGAL CLAIM: ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR THE IMPLANT OF UNSPECIFIED BARD/DAVOL PERFIX PLUG ON (B)(6) 2013 AND VENTRALIGHT ST ON (B)(6) 2014 AND (B)(6) 2014. AS REPORTED, THE PLAINTIFF IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST ALL 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¿. THE ATTORNEY ALLEGED THAT THE PATIENT PASSED AWAY ON (B)(6) 2022 AND HAD "INJURIES, LOSSES SUFFERED PR

  Patient problems: Cellulitis; Hernia; Insufficient Information; Pain; Wound Dehiscence

  MAUDE report 16813434 ↗