VENTRALIGHT 5954450Recalls & reported problems

Summary

The FDA's MAUDE database contains 131 adverse event reports that list this exact device (DI 00801741031618), received between Oct 30, 2017 and Sep 28, 2026 — classified as 110 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Defective Device” (91 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 131 reports, in the reporter's own words as published by the FDA.

• InjurySep 28, 2026Patient-Device Incompatibility

  Patient problems: Fatigue; Muscle Weakness/Atrophy; Pain; Unspecified Gastrointestinal Problem

  MAUDE report 50918119 ↗
• InjuryJul 28, 2026Material Deformation

  Per information provided:(b)(6) 2014 - Patient was diagnosed with multiple incisional hernias from the periumbilical region thereby underwent laparoscopic repair with implant of three Ventralight ST Mesh (Device 1, 2 and 3). Per op notes, "An incision was made in a transverse fashion in the epigastric region just to the left of midline. A small periumbilical hernia was identified. The hernia was present in the superficial layers of the abdominal wall. The adhesions were taken down. Another fascial defect was noted and the source of each of these hernias were cleared back. Defects were noted in the periumbilical area, right hemi-abdomen and midline lower abdomen. The Ventralight ST Mesh (Device 1) was placed to the right hemi-abdomen defect and secured with tack. The midline lower abdominal defect was closed in a similar fashion with an Ventralight ST Mesh (Device 2). The periumbilical area was covered with a second circular Ventralight ST Mesh (Device 3) and secured in with an outer crown and inner crown of tacks."(b)(6) 2018 - Patient was diagnosed with recurrent umbilical hernia thereby underwent laparoscopic repair with excision of Ventralight ST Mesh (Device 3) and implant of u

  Patient problems: Pain

  MAUDE report 50053188 ↗
• InjuryJun 8, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2014 - PATIENT WAS DIAGNOSED WITH INCARCERATED INCISIONAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT OF VENTRALIGHT ST MESH (DEVICE 1). PER OP NOTES, "INCISIONAL HERNIA AT UMBILICUS WAS NOTED. THE DEFECT WAS LARGE. A VENTRALIGHT ST MESH (DEVICE 1) WAS PLACED INTO ABDOMINAL CAVITY AND SECURED TO ABDOMINAL WALL USING SORBAFIX TACKS." (B)(6) 2018 - PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL HERNIA, INTRAABDOMINAL ADHESIONS THEREBY UNDERWENT ROBOTIC REPAIR WITH THE REMOVAL OF MESH (DEVICE 1) AND IMPLANT OF VENTRALIGHT ST MESH (DEVICE 2). PER OP NOTES, "ABDOMINAL WALL ADHESION WERE LYSED. A RECURRENT VENTRAL HERNIA WAS IDENTIFIED WITH MESH PARTLY COVERING THE HERNIA DEFECT. THE PREVIOUSLY PLACED MESH (DEVICE 1) WAS REMOVED EXTRACORPOREALLY. LEFT INGUINAL MESH WAS NOTED. A VENTRALIGHT ST MESH (DEVICE 2) WAS PLACED AND SECURED TO ANTERIOR ABDOMINAL WALL USING SUTURES." (B)(6) 2019 - PATIENT WAS DIAGNOSED WITH VENTRAL HERNIA, INTRAABDOMINAL ADHESIONS THEREBY UNDERWENT OPEN REPAIR. PER OP NOTES, ¿ADHESIONS WERE NOTED BETWEEN THE OMENTUM AND SMALL BOWEL TO THE ANTERIOR ABDOMINAL WALL AND LOWER ABDOMINAL WALL WAS LYSED. A PRIOR VENTRAL

  Patient problems: Adhesion(s); Hernia

  MAUDE report 25426096 ↗
• InjuryMar 26, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2018 - PATIENT WAS DIAGNOSED WITH SYMPTOMATIC INCARCERATED VENTRAL INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF VENTRALIGHT ST MESH USING ECHO PS (DEVICE 1). PER OP NOTES, "A VENTRALIGHT ST MESH USING ECHO PS (DEVICE 1) WAS PLACED IN THE ABDOMEN THROUGH THE MIDLINE DEFECT USING SUTURES." ON (B)(6) 2019 - PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE REMOVAL OF MESH (DEVICE 1) AND IMPLANT OF VENTRALIGHT ST MESH (DEVICE 2). PER OP NOTES, "THE PREVIOUS MESH WAS NOTED FOLDING INTO THE INFERIOR ASPECT OF THE HERNIA DEFECT. THE OMENTAL ADHESIONS TO THE ANTERIOR ABDOMINAL WALL INCLUDING THE PREVIOUS MESH WERE THEN TAKEN. THE RECURRENT HERNIA WAS IDENTIFIED. A SMALL MIDLINE INCISION WAS THEN MADE, VENTRALIGHT ST MESH (DEVICE 2) WAS THEN PLACED USING TACKS." ON (B)(6) 2019 - PATIENT WAS DIAGNOSED WITH INFECTED HEMATOMA ABDOMINAL WALL THEREBY UNDERWENT INCISION AND DRAINAGE. PER OP NOTES, "THE PATIENT HAD HEMATOMA TO THE LEFT OF MIDLINE. THE FASCIA APPEARED INTACT AND THERE WAS NO EVIDENCE OF MESH INVOLVEMENT."

  Patient problems: Hematoma; Unspecified Infection

  MAUDE report 24698229 ↗
• InjuryMar 9, 2026Material Deformation

  PER INFORMATION PROVIDED: ON (B)(6) 2009 ¿ PATIENT WAS DIAGNOSED WITH INCARCERATED INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF COMPOSIX KUGEL MESH (DEVICE 1). PER OPERATIVE NOTES, ¿ IN THE LOWER MIDLINE, ABOVE THE UMBILICUS DOWN TO THE SYMPHYSIS PUBIS, THE HERNIA SAC WAS REMOVED. THE ADHESIONS OF SMALL BOWEL WITHIN THE SAC WAS TAKEN DOWN. THE DEFECT WAS CLOSED AND COMPOSIX KUGEL MESH (DEVICE 1) WAS PLACED OVER THE DEFECT AND SECURED WITH SUTURES CIRCUMFERENTIALLY.¿ ON (B)(6) 2013 ¿ PATIENT WAS DIAGNOSED WITH RECURRENT ABDOMINAL WALL VENTRAL HERNIAS (X2) THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRALIGHT ST MESH (DEVICE 2). PER OPERATIVE NOTES, ¿ THE RECURRENT HERNIA ABOVE AND BELOW THE PREVIOUSLY PLACED MESH (DEVICE 1) IN MIDLINE WAS NOTED. THE SUPERIOR DEFECT IN SUPRAPUBIC AREA AND INFERIOR DEFECT IN SUPRAUMBILICAL AREA WAS NOTED. IN THE SUPERIOR PORTION OF THE UMBILICUS, HERNIA SAC WAS ENCOUNTERED AND DISSECTED FREE DOWN TO THE LEVEL OF FASCIA. THE SUPERIOR EDGE OF THE PRIOR MESH (DEVICE 1) HAD PULLED AWAY FROM THE MUSCLE. OMENTAL ADHESIONS TO THE FASCIA WAS TAKEN DOWN. INFERIORLY SMALL BOWEL AND COLON WERE ADHERED TO PRIOR MESH (DEVICE 1). ADHESIONS WE

  Patient problems: Adhesion(s); Hernia

  MAUDE report 24543946 ↗
• InjuryMar 5, 2026Adverse Event Without Identified Device or Use Problem

  AS REPORTED, THE PATIENT UNDERWENT AN UMBILICAL HERNIA REPAIR PROCEDURE WITH PLACEMENT OF A VENTRALIGHT ST MESH AND A RIGHT INGUINAL HERNIA REPAIR WITH A 3DMAX MESH ON (B)(6) 2020. ON (B)(6) 2024 THE PATIENT UNDERWENT A COLECTOMY DUE TO CHRONIC DIVERTICULOSIS. DURING THE COLECTOMY, THE PREVIOUSLY PLACED VENTRALIGHT ST MESH WAS CUT THROUGH BY THE SURGEON, AND ALTHOUGH THE COLECTOMY WAS COMPLETED, THE PARTIALLY CUT MESH WAS ELECTED TO BE LEFT IN PLACE. FOLLOWING THIS SURGERY, A SMALL OPEN AREA ON THE PATIENT¿S ABDOMEN DEVELOPED, WHICH PROGRESSIVELY ENLARGED INTO A SIGNIFICANT WOUND REQUIRING WOUND CARE FOR APPROXIMATELY SEVEN MONTHS, AND THE MESH WAS NOTED TO BE PROTRUDING THROUGH THE SKIN. THE VENTRALIGHT ST MESH WAS SUBSEQUENTLY REMOVED ON (B)(6) 2024, AND A NON-BD MESH WAS IMPLANTED TO REPAIR A NEWLY DEVELOPED HERNIA. THE COMPLAINANT STATES THAT NO INHERENT ISSUE WAS BELIEVED TO EXIST WITH THE ORIGINAL VENTRALIGHT ST MESH, AND THAT THE COMPLICATIONS WERE FELT TO HAVE BEEN CAUSED BY THE MESH BEING CUT DURING THE COLECTOMY PROCEDURE AND LEFT IN PLACE. NOTE, THE 3DMAX MESH PLACED FOR REPAIR OF THE RIGHT INGUINAL HERNIA REMAINS IMPLANTED.

  Patient problems: Wound Dehiscence

  MAUDE report 24517863 ↗
• InjuryFeb 4, 2026Migration

  PER INFORMATION PROVIDED: ON (B)(6) 2011 ¿ PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT OF VENTRALIGHT ST MESH (DEVICE 1). PER OP NOTES, ¿A RECURRENT UMBILICAL HERNIA ENCOUNTERED WITH INCARCERATED OMENTUM. AN OLD PATCH WAS EXCISED. A PIECE OF VENTRALIGHT ST MESH (DEVICE 1) WAS PLACED INTO COVER THE FASCIAL DEFECT USING SORBAFIX TACKS.¿ (NOTE: THE OLD MESH EXPLANTED IN THIS PROCEDURE WAS UNKNOWN) ON (B)(6) 2015 ¿ PATIENT WAS DIAGNOSED WITH SUPRAUMBILICAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF VENTRALEX ST MESH (DEVICE 2). PER OP NOTES, ¿EXTENSIVE ADHESION CONFINED TO ANTERIOR ABDOMINAL WALL ALONG WITH A SMALL HERNIA WHICH WAS LOCATED ABOVE THE UMBILICUS. A CIRCULAR VENTRALEX ST MESH (DEVICE 2) WAS PLACED THROUGH THE HERNIAL SAC AND SECURED USING TACKS.¿ (NOTE: THERE IS MENTION/VISUALIZATION OF DEVICE 1 IN THIS PROCEDURE) ON (B)(6) 2016 ¿ PATIENT HAD PAIN AND WAS DIAGNOSED WITH RECURRENT VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF VENTRALEX ST MESH (DEVICE 3). PER OP NOTES, ¿THE HERNIA WAS LOCATED SLIGHTLY ON THE MEDIAL SIDE WAS DISSECTED AWAY FROM THE SURROUNDING TISSUE. A CIRCULAR V

  Patient problems: Adhesion(s); Hernia

  MAUDE report 24256331 ↗
• InjuryNov 27, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2013 ¿ PATIENT WAS DIAGNOSED WITH UMBILICAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRALEX ST MESH (DEVICE 1). PER OPERATIVE NOTES, ¿A SYMPTOMATIC UMBILICAL HERNIA DEFECT WAS REDUCED. THE VENTRALEX ST MESH (DEVICE 1) WAS PLACED OVER THE HERNIA DEFECT AND SECURED WITH SUTURES AND TACKS.¿ (B)(6) 2015 ¿ PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL HERNIA AND CHRONIC PAIN THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH REMOVAL OF VENTRALEX ST MESH (DEVICE 1) AND IMPLANT OF VENTRALIGHT ST MESH (DEVICE 2). PER OPERATIVE NOTES, ¿THE MESH (DEVICE 1) WAS CURLED AND DISSECTED FREE AND REMOVED FROM ITS CURLED POSITION. THE RECURRENT DEFECT IN THE MIDPORTION WAS CLOSED WITH SUTURES AND ROUND VENTRALIGHT ST MESH (DEVICE 2) WAS PLACED OVER THE DEFECT AND THEN TACKED AND SUTURED.¿ (B)(6) 2017 - PATIENT WAS DIAGNOSED WITH PAIN THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH REMOVAL OF MESH (DEVICE 2). PER OPERATIVE NOTES, ¿ADHESIONS OF OMENTUM ONTO MIDLINE ALONG AREA OF MESH (DEVICE 2) WERE REDUCED. THE MESH (DEVICE 2) IN THE MIDLINE WAS REMOVED, AND FLAPS WERE RAISED IN LEFT UPPER QUADRANT AND FASCIA WAS CLOSED WITH SUTURES.¿

  Patient problems: Adhesion(s); Pain

  MAUDE report 23665079 ↗
• InjuryNov 21, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2013 ¿ PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF VENTRALIGHT ST MESH (DEVICE 1) AND VENTRALEX ST MESH (DEVICE 2). PER OPERATIVE NOTES, ¿THIS WAS A RECURRENT HERNIA LATERAL TO THE OLD MESH THAT HAD BEEN PLACED. ADHESIONS WERE LYSED AND THE TWO DEFECTS IN THE LEFT LOWER QUADRANT WAS NOTED, AND A VENTRALIGHT ST MESH (DEVICE 1) WAS PLACED INTO THE PERITONEAL CAVITY AND TACKED. IN THE RIGHT UPPER QUADRANT WHERE THE SECOND HERNIA WAS NOTED AND A VENTRALEX ST MESH (DEVICE 2) WAS PLACED INTO THE PERITONEAL CAVITY AND TACKED.¿ (NOTE: THE PREVIOUSLY PLACED MESH WAS UNKNOWN) (B)(6) 2014 ¿ PATIENT WAS DIAGNOSED WITH ABDOMINAL WALL ABSCESS THEREBY UNDERWENT OPEN REPAIR WITH REMOVAL OF VENTRALIGHT ST MESH (DEVICE 1) AND VENTRALEX ST MESH (DEVICE 2). PER OPERATIVE NOTES, ¿A VISIBLE PIECE OF VENTRALIGHT ST MESH (DEVICE 1) WAS NOTED AND SUPERIOR TO THIS A VENTRALEX ST MESH (DEVICE 2) WAS ALSO NOTED. THERE WERE A FEW LOOPS OF SMALL BOWEL WERE DENSELY ADHERENT BELOW THE AREA OF THE INFECTED MESH. THE VENTRALIGHT ST MESH (DEVICE 1) AND VENTRALEX ST MESH (DEVICE 2) WERE REMOVED.¿

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

  MAUDE report 23615918 ↗
• MalfunctionNov 7, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  AS REPORTED: ¿AFTER OPENING THE BOX, A YELLOW PAPER-LIKE FOREIGN OBJECT WAS FOUND INSIDE¿ (LOT NUMBERS HUKQ0767 AND HUJP1924). ADDITIONAL FOLLOW-UP INFORMATION STATES: ¿REGARDING THE FOREIGN MATERIAL, IT IS CONFIRMED THAT WHAT APPEARS TO BE A RELIC (SCRATCH?) IS PRESENT ON THE BAG INSIDE THE STERILIZATION PACKAGING AND IN THE CENTER OF THE MESH OF HUKQ0767.¿ NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23496891 ↗
• MalfunctionNov 7, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  AS REPORTED: ¿AFTER OPENING THE BOX, A YELLOW PAPER-LIKE FOREIGN OBJECT WAS FOUND INSIDE¿ (LOT NUMBERS HUKQ0767 AND HUJP1924). ADDITIONAL FOLLOW-UP INFORMATION STATES: ¿REGARDING THE FOREIGN MATERIAL, IT IS CONFIRMED THAT WHAT APPEARS TO BE A RELIC (SCRATCH?) IS PRESENT ON THE BAG INSIDE THE STERILIZATION PACKAGING AND IN THE CENTER OF THE MESH OF HUKQ0767.¿ NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23496883 ↗
• InjuryJul 17, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER ADDITIONAL INFORMATION PROVIDED: (B)(6) 2012 ¿ PATIENT WAS DIAGNOSED WITH RIGHT INGUINAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF 3DMAX MESH (DEVICE #1). PER OPERATIVE NOTES, ¿INDIRECT INGUINAL HERNIA SAC WAS DISSECTED AND LARGE SIZE 3DMAX MESH (DEVICE #1) WAS PLACED AND TACKED AND SUTURED.¿ (B)(6) 2013 ¿ PATIENT WAS DIAGNOSED WITH RECURRENT RIGHT INGUINAL HERNIA AND LEFT INGUINAL HERNIA AND UMBILICAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC AND OPEN REPAIR WITH IMPLANT OF VENTRALIGHT ST MESH (DEVICE #2) AND TWO PERFIX PLUG (DEVICE #3 AND #4). PER OPERATIVE NOTES, ¿IN LEFT UPPER QUADRANT, A UMBILICAL HERNIA DEFECT WAS NOTED AND PLACED WITH 3DMAX MESH (DEVICE#2). IN THE LEFT LOWER QUADRANT, MEDIAL DEFECT IN THE CORD WAS NOTED AND PERFIX PLUG (DEVICE #3) WAS PLACED AND SUTURED. IN THE RIGHT-SIDE LOWER QUADRANT,¿ A LARGE AMOUNT OF SCARRING WITH DIRECT HERNIA WAS NOTED. A PERFIX PLUG (DEVICE #4) WAS PLACED AND SUTURED AND TACKED.¿ (B)(6) 2021 ¿ PATIENT HAD ADHESIONS, ABDOMINAL PAIN THEREBY UNDERWENT LAPAROSCOPIC REPAIR THEREBY UNDERWENT LYSIS OF ADHESIONS. PER OPERATIVE NOTES, ¿OMENTAL ADHESIONS WERE TAKEN DOWN, THE MESH (DEVICE #2) WAS SEEN DEPRESSED IN THE CENTRE

  Patient problems: Abdominal Pain; Adhesion(s)

  MAUDE report 22528809 ↗
• InjuryJul 7, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2014 - PATIENT WAS DIAGNOSED WITH INCISIONAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF COMPOSIX KUGEL (DEVICE #1). PER OPERATIVE NOTES, ¿THE HERNIA DEFECT WAS IDENTIFIED AND DISSECTED FREE. THE ADHESIONS WERE LYSED. A COMPOSIX KUGEL (DEVICE #1) WAS PLACED AND TACKED. (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH EXCISION OF COMPOSIX KUGEL (DEVICE #1) AND IMPLANT OF VENTRALIGHT ST (DEVICE #2). PER OPERATIVE NOTES, ¿THE PRIOR MESH WAS IDENTIFIED TO BE SEPARATED FROM FASCIA. THE OLD MESH (DEVICE #1) WAS REMOVED. THE HERNIA DEFECT WAS IDENTIFIED AND REPAIRED WITH VENTRALIGHT ST (DEVICE #2) AND SUTURED. (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH POST OPERATIVE SMALL BOWEL OBSTRUCTION THEREBY UNDERWENT OPEN REPAIR WITH EXCISION OF VENTRALIGHT ST (DEVICE #2). PER OPERATIVE NOTES, ¿THE OLD MESH WAS IDENTIFIED AND REMOVED. THE SMALL WAS IDENTIFIED TO BE OBSTRUCTED AND LOOPS OF SMALL BOWEL WAS RELEASED. ALL THE BOWEL ADHESIONS WERE TAKEN DOWN AND SUTURED.

  Patient problems: Adhesion(s); Obstruction/Occlusion

  MAUDE report 22410834 ↗
• MalfunctionMay 22, 2025Unsealed Device Packaging; Unsealed Device Packaging

  AS ALLEGED, WHEN THE INNER FOIL PACKAGE OF THE VENTRALIGHT ST MESH WAS OPENED, THE CUSTOMER REPORTS THAT THE CORNER OF THE MESH ENVELOPE WAS SEALED IN THE FOIL PACKAGING. THE OPERATING ROOM STAFF DID NOT TRUST IT TO BE STERILE AND WAS NOT USED. THE PROCEDURE WAS COMPLETED WITH ANOTHER MESH. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22071189 ↗
• 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: Hernia

  MAUDE report 21759630 ↗
• 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 AS

  Patient problems: Hernia

  MAUDE report 21759628 ↗
• 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 21718135 ↗
• MalfunctionMar 12, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  AS REPORTED, A SURGEON WAS CONCERNED THAT THE PACKAGING (FOIL STERILE POUCH) OF A VENTRALIGHT ST MESH HAD A HOLE IN IT. THE PRODUCT WAS NOT IMPLANTED. THERE WAS NO INJURY TO THE PATIENT. THE SALES REP STATED HE DID NOT SEE ANY BREACH OR HOLE IN THE FOIL POUCH OR THE OUTER PRODUCT CARTON. THERE IS NO DAMAGE NOTED TO THE PACKAGING; THE FOIL POUCH APPEARS TO HAVE A CREASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21582221 ↗
• InjuryMar 7, 2025Defective Device; Patient Device Interaction Problem; Migration; Defective Device; Patient Device Interaction Problem; Migration

  PER INFORMATION PROVIDED: (B)(6) 2010 - PATIENT WAS DIAGNOSED WITH INCISIONAL HERNIA (X4) THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF COMPOSIX KUGEL MESH (DEVICE #1). PER OPERATIVE NOTES, ¿THE HERNIAS WERE IDENTIFIED, THERE WAS OMENTAL FAT WITHIN THESE WHICH WERE REDUCED. A COMPOSIX KUGEL MESH (DEVICE #1) WAS ADVANCED INTO PERITONEAL CAVITY PLACED AT THE LEVEL OF UMBILICUS AND TACKED TO COVER ALL ANTERIOR ABDOMINAL HERNIAS.¿ (B)(6) 2016 - PATIENT WAS DIAGNOSED WITH ANTERIOR ABDOMINAL WALL INFECTION AND ENTEROCUTANEOUS FISTULA THEREBY UNDERWENT REPAIR WITH REMOVAL OF MESH (DEVICE #1). PER OPERATIVE NOTES, ¿THERE WAS A WOUND DRAINING SEROUS TO BILIOUS LOOKING FLUID JUST ABOVE THE UMBILICUS AND A LARGE PORTION OF MESH (DEVICE #1) SEEN INVOLVED IN INFECTION. THE SMALL INTESTINE WAS ADHESED TO MESH SPECIFICALLY 2 PORTIONS OF JEJUNUM HAD FISTULIZED TO MESH WITH OPEN INTESTINE AND SUCCUSS LEAKING OUT. AFTER MOST OF THE MESH AND TACKS WERE REMOVED SOME OF IT WAS LEFT AS THERE WAS SIGNIFICANT ADHESION OF COLON AND WERE NOT INFECTED. PIECE OF INTESTINE WAS REMOVED, AND ANASTOMOSIS WAS CREATED WITH SUTURE.¿ (B)(6) 2017 - PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL HERNIA THEREBY UN

  Patient problems: Drug Resistant Bacterial Infection; Impaired Healing; Purulent Discharge

  MAUDE report 21546146 ↗
• InjuryJan 9, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED, DURING A PROCEDURE THE PATIENT WAS IMPLANTED WITH VENTRALIGHT ST MESH ON (B)(6) 2024. IT WAS REPORTED THAT A WEEK LATER THE PATIENT DEVELOPED BACTERIAL INFECTION. IT WAS FURTHER REPORTED THAT THE PATIENT UNDERWENT MESH EXPLANT ON (B)(6) 2024 AND THE PATIENT IS DOING FINE NOW.

  Patient problems: Bacterial Infection

  MAUDE report 21112802 ↗
• InjuryFeb 5, 2024Defective 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) 2019. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE VENTRALIGHT ST. ATTORNEY ALLEGED THAT THE PATIENT HAD INJURIES ON (B)(6) 2019, AND ON (B)(6) 2020 AND UNDERWENT REVISION SURGERY. 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; Obstruction/Occlusion; Pain; Scar Tissue

  MAUDE report 18638861 ↗
• MalfunctionJan 24, 2024Material Separation; Material Separation

  AS REPORTED, DURING A ROBOTIC UMBILICAL HERNIA REPAIR, THE VENTRALIGHT ST MESH WAS HYDRATED (HYDRATION TIME UNKNOWN) PRIOR TO INSERTION THROUGH AN 8MM TROCAR. IT WAS REPORTED THAT THE VENTRALIGHT ST MESH WAS FOLDING OVER AND PEELING ITSELF APART DURING PLACEMENT. A NEW VENTRALIGHT ST MESH WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18569535 ↗
• InjuryJan 10, 2024Device Appears to Trigger Rejection; Defective Device; Patient Device Interaction Problem; Device Appears to Trigger Rejection; Defective Device; Patient Device Interaction Problem

  PER INFORMATION PROVIDED BY PATIENT'S ATTORNEY: (B)(6) 2014 - PATIENT WAS DIAGNOSED WITH SYMPTOMATIC UMBILICAL HERNIA AND POSSIBLE INGUINAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT OF VENTRALIGHT ST MESH (DEVICE #1), PERFIX PLUG (DEVICE #2) AND VENTRALEX ST (DEVICE #3). PER OPERATIVE NOTES, "UMBILICAL HERNIA SAC WAS REDUCED. A VENTRALIGHT ST MESH (DEVICE #1) WAS PLACED IN THE ABDOMINAL WALL INTO THE PERITONEAL CAVITY AND TACKED. THE DIRECT INGUINAL DEFECT ON THE LEFT WAS IDENTIFIED AND A PERFIX PLUG (DEVICE #2) WAS PLACED INTO THE DEFECT. SOME OF THE PERITONEUM WAS PLACED OVER THE MESH. ANOTHER VENTRALEX ST (DEVICE #3) SMALL CIRCLE PATCH WAS SECURED OVER THE DEFECT AND TACKED THE MESH TO THE ABDOMINAL WALL AND INGUINAL WALL." 10-DEC-2014 - PATIENT WITH ABDOMINAL PAIN, MILD HERNIATION IN UMBILICAL AREA AND RECURRENT LEFT INGUINAL HERNIA HAD LAPAROSCOPIC-OPEN REPAIR WITH THE IMPLANT OF VENTRALIGHT ST W/ ECHO PS (DEVICE #4) AND PERFIX PLUG (DEVICE #5) ALONG WITH THE REMOVAL OF DISLODGED PERFIX PLUG (DEVICE #2). PER OPERATIVE NOTES, "ADHESIONS INVOLVING A PORTION OF MESH WERE TAKEN DOWN AND NO RECURRENT DEFECT WAS FOUND. THERE WAS SOME PROTRUSION ESSENTIALLY WITHIN

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

  MAUDE report 18485943 ↗
• InjuryDec 7, 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) 2010. 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.Addendum per additional information provided:(b)(6) 2012. Patient was diagnosed with ventral hernia thereby underwent laparoscopic repair with the implant of Ventralight ST Mesh. Per op notes, ¿A ventral hernia was seen left and inferior to the umbilicus and lateral to the rectus muscle. A Ventralight ST Mesh was placed into peritoneal cavity and secured using sutures.¿(b)(6) 2020. Patient was diagnosed with ventral spigelian hernia thereby underwent robotic to open repair with the implant of synthetic mesh. Per op notes, ¿There were multiple loops of small bowel and omentum were completely reduced. A spigelian hernia sac was encountered on the superior edge of prior mesh. A synthetic mesh was placed covering the defect into the space usin

  Patient problems: Hernia; Insufficient Information

  MAUDE report 18281105 ↗
• InjuryNov 1, 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 VENTRALEX ST AND VENTRALIGHT ST. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST VENTRALIGHT ST WHICH WAS IMPLANTED ON (B)(6) 2022. ATTORNEY ALLEGES THAT THE PATIENT HAD REVISION SURGERY 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: Hernia; Insufficient Information; Pain

  MAUDE report 18046340 ↗