VENTRALIGHT 5954460Recalls & reported problems

Summary

The FDA's MAUDE database contains 157 adverse event reports that list this exact device (DI 00801741031625), received between Jun 20, 2014 and Sep 17, 2026 — classified as 142 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Defective Device” (112 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 157 reports, in the reporter's own words as published by the FDA.

• InjurySep 17, 2026Patient-Device Incompatibility

  Addendum per additional information provided:(b)(6) 2017 - Patient was diagnosed with bilateral recurrent inguinal hernias thereby underwent laparoscopic repair with the implant of two Ventralight ST Mesh (Device 1 - left and 2 - right). Per op notes, "Two Ventralight ST Mesh (Device 1 and 2) were placed on both left and right inguinal regions of the abdomen using sutures."(b)(6) 2019 - Patient was diagnosed with bilateral recurrent inguinal hernias thereby underwent robotic repair with the implant of two Ventralight ST Mesh using Echo PS (Device 3 - left and 4 - right). Per op notes, "In the left lower quadrant at the site of the recurrent hernia in the direct space. A Ventralight ST Mesh using Echo PS (Device 3 - left) was placed to the cooper's ligament using sutures, the previous mesh (Device 1) was closed partially. In the right lower quadrant, a Ventralight ST Mesh using Echo PS (Device 4 - right) was placed to over lap the previously placed mesh (Device 2). There were adhesions noted in the right side."

  Patient problems: Adhesion(s); Hernia

  MAUDE report 50797645 ↗
• InjurySep 3, 2026Patient-Device Incompatibility

  Per information provided:(b)(6) 2017 - Patient was diagnosed with parastomal hernia thereby underwent open repair with implant of Ventralight ST Mesh (Device 1). Per operative notes, "A long midline skin incision was made and brought down sharply through fascia. There was some previously placed mesh identified which was intact. There were several adhesions. The hernia sac was dissected out. A Ventralight ST Mesh (Device 1) was placed into the abdominal cavity and secured it with sutures."(b)(6) 2018 - Patient was diagnosed with recurrent parastomal hernia with partial obstruction, seroma, adhesion, thereby underwent open repair with implant of Ventralight ST Mesh (Device 2). Per operative notes, "A midline incision was made through old incision site. The hernia sac was dissected out. There was a small chronic seroma in the midportion of the wound. There was some moderate number of adhesions in the small bowel to the midline wound, all adhesions were taken down sharply. There was small bowel, which was obstructive, all obstructions were taken down. Previously placed Ventralight ST Mesh (Device 1) was identified. A Ventralight ST Mesh (Device 2) was placed into the abdominal wall and

  Patient problems: Abscess; Adhesion(s); Hernia; Obstruction/Occlusion; Scar Tissue; Seroma

  MAUDE report 50588121 ↗
• 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 unk

  Patient problems: Pain

  MAUDE report 50052059 ↗
• InjuryJul 3, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2012 - PATIENT WAS DIAGNOSED WITH BILATERAL VENTRAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF VENTRALIGHT ST MESH (DEVICE 1 AND 2). PER OP NOTES, "THE SUBCOASTAL INCISION WAS MADE. TWO LATERAL VENTRAL WALL HERNIAS WERE IDENTIFIED AND CONSISTENT WITH SPIGELIAN HERNIAS. NO EVIDENCE OF INGUINAL DEFECT WAS NOTED. THE HERNIA SACS WERE REMOVED. A VENTRALIGHT ST MESH (DEVICE 1) WAS PLACED ON RIGHT AND VENTRALIGHT ST MESH (DEVICE 2) WAS PLACED ON LEFT SIDE OF THE ABDOMEN AND TACKED." ON (B)(6) 2013 - PATIENT WAS DIAGNOSED WITH SPIGELIAN HERNIA THEREBY UNDERWENT OPEN REPAIR WITH EXCISION OF VENTRALIGHT ST MESH (DEVICE 1). PER OP NOTES, "A PFANNENSTIEL INCISION WAS MADE. THE FASCIA WAS CLEARED TO THE UMBILICUS. THE MIDLINE WAS OPENED AND ADHESIONS TO THE PRIOR MESHES WERE TAKEN DOWN. HERNIA WAS NOT IDENTIFIED BUT RATHER AN EVENTRATION OF THE MESH ON THE RIGHT SIDE (DEVICE 1) WAS NOTED. THE MESH ON THE LEFT (DEVICE 2) WAS LEFT IN PLACE. THE MESH ON THE RIGHT (DEVICE 1) WAS REMOVED, AND THE DEFECT WAS CLOSED WITH SUTURE." ON (B)(6) 2016 - PATIENT WAS DIAGNOSED WITH RECURRENT LEFT LOWER QUADRANT INCISIONAL HERNIA THEREBY UNDERWENT LAPAROSCO

  Patient problems: Adhesion(s); Fibrosis; Hernia; Necrosis; Pain

  MAUDE report 25704652 ↗
• InjuryApr 2, 2026Patient-Device Incompatibility

  PER INFORMATION RECEIVED, (B)(6) 2016 - PATIENT WAS DIAGNOSED WITH BILATERAL INGUINAL HERNIAS THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF VENTRALIGHT ST (DEVICE 1 AND 2). PER OP NOTES, ¿ON THE LEFT INGUINAL REGION, THE HERNIA DEFECT WAS NOTED AND REDUCED. A VENTRALIGHT ST (DEVICE 1) WAS PLACED AND SUTURED. ON THE RIGHT INGUINAL REGION, A SMALL HERNIA DEFECT WAS NOTED AND REDUCED. A VENTRALIGHT ST (DEVICE 2) WAS PLACED AND SUTURED.¿ (B)(6) 2016 - PATIENT WAS DIAGNOSED WITH RECURRENT BILATERAL INGUINAL HERNIAS THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF SYNTHETIC MESHES. PER OP NOTES, ¿OLD INCISION ON THE RIGHT GROIN WAS OPENED. A LARGE HERNIA DEFECT WAS NOTED AND DISSECTED FREE. ADHESIONS WERE DISSECTED OUT. A SYNTHETIC MESH WAS PLACED AND SUTURED. ON THE LEFT INGUINAL REGION, A DIRECT HERNIA DEFECT WAS NOTED AND REDUCED. ADHESIONS WERE TAKEN DOWN. A SYNTHETIC MESH WAS PLACED AND SUTURED.¿ (NOTE: THERE IS NO VISUALIZATION OF PRIOR MESHES (DEVICE 1 AND 2) IN THIS PROCEDURE)

  Patient problems: Adhesion(s); Hernia

  MAUDE report 24766769 ↗
• InjuryMar 25, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH EPIGASTRIC AND UMBILICAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF VENTRALIGHT ST WITH ECHO PS (DEVICE 1) AND VENTRALIGHT ST MESH (DEVICE 2). PER OP NOTES, ¿A RIGHT LOWER QUADRANT STAB INCISION WAS MADE. OMENTAL ADHESIONS IN THE MIDLINE AND THE HERNIA OMENTUM WAS REDUCED AND TAKEN DOWN. A LEFT UPPER QUADRANT STAB INCISION WAS MADE. A VENTRALIGHT ST WITH ECHO PS (DEVICE 1) WAS PLACED IN THE HERNIA DEFECTS WHERE 3 SMALL INCISIONS WERE MADE IN THE EPIGASTRIC REGION OVER THE EPIGASTRIC HERNIA AND SECURED WITH METAL TACKER. ANOTHER SMALL INCISION WAS MADE OVER THE UMBILICUS. INFERIORLY AT THE UMBILICUS THE OVERLAP WAS NOT 2 CM SO A VENTRALIGHT ST MESH (DEVICE 2) WAS PLACED AND ANCHORED TO THE ABDOMINAL WALL WITH SUTURES.¿ (B)(6) 2017 - PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH EXCISION OF VENTRALIGHT ST WITH ECHO PS (DEVICE 1) AND VENTRALIGHT ST MESH (DEVICE 2) AND IMPLANT OF VENTRIO ST MESH (DEVICE 3). PER OP NOTES, ¿MIDLINE INCISION WAS MADE AND THE HERNIA SAC WAS OPENED AND EXCISED. SMALL HERNIAS WERE IDENTIFIED SUPERIORLY AND INFERIORLY. OLD MESH (DEVICE

  Patient problems: Hernia

  MAUDE report 24686052 ↗
• InjuryFeb 25, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2014 - PATIENT WAS DIAGNOSED RECURRENT INCISIONAL HERNIA, ADHESION THEREBY UNDERWENT OPEN REPAIR WITH ALLOMAX SURGICAL GRAFT (DEVICE 1) AND VENTRALIGHT ST MESH (DEVICE 2). PER OPERATIVE NOTES, ¿AN INCISION WAS MADE THROUGH PREVIOUS SCAR. PREVIOUSLY PLACED SYNTHETIC MESH WAS EXCISED. A PIECE OF ALLOMAX SURGICAL GRAFT (DEVICE 1) WAS PLACED INTO THE ABDOMINAL CAVITY AND TACKED WITH SUTURES. A VENTRALIGHT ST MESH (DEVICE 2) WAS PLACED WITH ALLOMAX SURGICAL GRAFT (DEVICE 1) AND SECURE BOTH MESHES WITH SUTURES.¿ ON (B)(6) 2016 - PATIENT WAS DIAGNOSED WITH INCARCERATED INCISIONAL VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRIO ST MESH (DEVICE 3). PER OPERATIVE NOTES, ¿AN INCISION WAS MADE INTO THE LEFT LOWER QUADRANT. AN INCARCERATED INCISIONAL RECURRENT VENTRAL HERNIA SAC WAS PRESENT IN THE LEFT LOWER ABDOMINAL WALL, WHICH WAS EXCISED. A VENTRIO ST MESH (DEVICE 3) WAS DEPLOYED FOR THE ENTIRE AREA AND TACKED INTO THE ABDOMINAL WALL.¿ ON (B)(6) 2017 - PATIENT WAS DIAGNOSED WITH INCARCERATED RECURRENT INCISIONAL VENTRAL HERNIA, ADHESION THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRALEX ST MESH (DEVICE 4). PER OPERATIVE NOTES, ¿A

  Patient problems: Hernia

  MAUDE report 24444423 ↗
• InjuryJan 23, 2026Patient-Device Incompatibility

  AS REPORTED PER MEDWATCH REPORT (MW5180032): "I HAD TO HAVE A POLYPROPYLENE MESH IMPLANTED INTO MY CHEST WALL AFTER HAVING A TUMOR REMOVED. SINCE IMPLANTATION I AM SUFFERING FROM CONSTANT PAIN DUE TO THE MESH. PERMANENT SUTURES ARE ALSO PROTRUDING TO SKIN SURFACE AND CATCHING WITH ANY ARM MOVEMENT." ADDENDUM PER ADDITIONAL INFORMATION RECEIVED: AS REPORTED, A VENTRALIGHT ST MESH WAS IMPLANTED ON (B)(6) 2025 DURING A CHEST WALL RECONSTRUCTION PROCEDURE. IT WAS REPORTED THAT ON (B)(6) 2026, PERMANENT SUTURES THAT HAD BECOME VISIBLE THROUGH THE SKIN AND WERE CAUSING DAILY DISCOMFORT WERE REMOVED.

  Patient problems: Pain; Pocket Erosion

  MAUDE report 24158353 ↗
• InjuryDec 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PER JOURNAL ARTICLE: "MANAGEMENT OF MASSIVE FLANK HERNIA AFTER LATERAL LUMBAR FUSION: PREOPERATIVE BOTULINUM TOXIN INJECTIONS AND OPEN REPAIR ¿ A CASE REPORT". INCISIONAL FLANK HERNIAS REPRESENT A COMPLICATION AFTER LATERAL LUMBAR SPINE SURGERY. GIVEN THE INCREASING RATE OF LATERAL LUMBAR INTERBODY FUSIONS, THE RATE OF INCISIONAL FLANK HERNIAS WILL INCREASE. PREOPERATIVE MANAGEMENT INVOLVED CT-GUIDED BOTULINUM TOXIN INJECTIONS INTO THE LATERAL ABDOMINAL WALL MUSCLES TO RELAX AND LENGTHEN THEM, FACILITATING CLOSURE. DEFINITIVE TREATMENT WAS AN OPEN FLANK HERNIA REPAIR WITH MESH REINFORCEMENT, ENSURING OPTIMAL MYOFASCIAL RE-APPROXIMATION AND SKIN CLOSURE. CONCLUSION AT THE 2-WEEK FOLLOW-UP, PAIN WAS IMPROVING, BUT SWELLING AT THE LEFT FLANK SURGICAL SITE SUGGESTED A POSTOPERATIVE SEROMA. BY THE 4-WEEK FOLLOW-UP, THE SEROMA, PAIN, AND DISCOMFORT HAD COMPLETELY RESOLVED, THOUGH BULGING IN THE LEFT LATERAL ABDOMINAL WALL WAS NOTED. A CT SCAN AT 2 MONTHS SHOWED NO EVIDENCE OF THE PREVIOUS HERNIA DEFECT. THE PATIENT EXPERIENCED COMPLETE RESOLUTION OF PAIN AND ABDOMINAL WALL DEFECT, THE USE OF PRE-OPERATIVE BOTULINUM TOXIN INJECTIONS PRIOR TO MASSIVE LATERAL FLANK HERNIA REPAIR IS RECOMMEN

  Patient problems: Seroma

  MAUDE report 23816484 ↗
• InjuryDec 12, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2014 - PATIENT WAS DIAGNOSED WITH INCARCERATED INFRAUMBILICAL AND PERIUMBILICAL INCISIONAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF VENTRALIGHT ST (DEVICE 1). PER OP NOTES, ¿A LARGE INCARCERATED INCISIONAL HERNIA AT THE LEVEL OF UMBILICUS. THE HERNIA WAS REDUCED. THE INCARCERATED OMENTUM WAS REDUCED. A VENTRALIGHT ST (DEVICE 1) WAS PLACED AND TACKED.¿ ON (B)(6) 2017 - PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL VENTRAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC CONVERTED TO OPEN REPAIR WITH EXCISION OF VENTRALIGHT ST (DEVICE 1) AND IMPLANT OF VENTRALIGHT ST (DEVICE 2), VENTRIO ST (DEVICE 3). PER OP NOTES, ¿THE HERNIA SAC WAS IDENTIFIED AND ADHERENT TO ABDOMINAL WALL. THE CONTENTS OF HERNIA SAC WERE REDUCED. THE FAILED PRIOR MESH (DEVICE 1) WAS RESECTED. THE HERNIA SAC ALSO EXCISED. A VENTRALIGHT ST (DEVICE 2) WAS PLACED AND INTRA-ABDOMINAL CAVITY AND SECURED WITH SUTURES. THE VENTRIO ST (DEVICE 3) WAS PLACED AND TACKED.¿ ON (B)(6) 2017 - PATIENT WAS DIAGNOSED WITH FASCIAL DEHISCENCE WITH SMALL BOWEL EVISCERATION THEREBY UNDERWENT OPEN REPAIR WITH EXCISION OF VENTRALIGHT ST (DEVICE 2), VENTRIO ST (DEVICE 3) AND IMPLANT OF PHASIX

  Patient problems: Wound Dehiscence

  MAUDE report 23788639 ↗
• InjuryDec 5, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH VENTRAL HERNIA/UMBILICAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF VENTRALEX MESH (DEVICE 1). PER OPERATIVE NOTES, ¿AN INFRAUMBILICAL INCISION WAS MADE. HERNIA SAC WAS DISSECTED OUT. A VENTRALEX MESH (DEVICE 1) WAS PLACED INTO THE ABDOMEN AND SECURE IT WITH SUTURES.¿ (B)(6) 2018 - PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA, ADHESION UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRALIGHT ST MESH (DEVICE 2) AND EXPLANT OF VENTRALEX MESH (DEVICE 1). PER OPERATIVE NOTES, ¿AN INCISION WAS MADE OVER THE SITE OF THE HERNIA THROUGH THE SKIN AND SUBCUTANEOUS TISSUE. AFTER OPENING THE FASCIA PREVIOUSLY PLACED VENTRALEX MESH (DEVICE 1) WAS REMOVED. ALL ADHESIONS WERE TAKEN DOWN. A VENTRALIGHT ST MESH (DEVICE 2) WAS PLACED INTO THE DEFECT AND CLOSED WITH SUTURES.¿ (B)(6) 2018 ¿ PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA. REVISION SURGERY WAS PERFORMED. (NOTE: NO INFORMATION PROVIDED IN MRR ABOUT THIS PROCEDURE.).

  Patient problems: Hernia

  MAUDE report 23728011 ↗
• InjuryDec 5, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH BILATERAL INGUINAL HERNIAS, UMBILICAL HERNIA, THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF BARD FLAT MESH (DEVICE 1 AND 2). PER OP NOTES, ¿A DIRECT INGUINAL HERNIA WAS IDENTIFIED IN THE LEFT INGUINAL REGION AND WAS DISSECTED. A BARD FLAT MESH (DEVICE 1) WAS PLACED IN THE DEFECT REGION AND SUTURED. A SMALL INDIRECT HERNIA WAS IDENTIFIED IN THE RIGHT INGUINAL REGION AND WAS REDUCED. A BARD FLAT MESH (DEVICE 2) WAS PLACED AND SECURED IN POSTERIOR ABDOMINAL WALL. ANOTHER HERNIA WAS IDENTIFIED IN UMBILICAL REGION, DISSECTED AND SUTURED¿. ON (B)(6) 2017- PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL HERNIA, THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF VENTRIO ST MESH (DEVICE 3). PER OP NOTES, ¿INCISION WAS MADE THROUGH OLD SCAR WHICH WAS PARTIALLY EXCISED. THE HERNIA DEFECT WAS THEN IDENTIFIED THROUGH THE ABDOMINAL WALL TISSUES. A VENTRIO ST MESH (DEVICE 3) WAS PLACED AND SUTURED¿. ON (B)(6) 2017- PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA, THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRALIGHT ST MESH (DEVICE 4) AND EXPLANT OF VENTRIO ST MESH (DEVICE 3). PER OP NOTES, ¿THE SCAR TISSUE WAS

  Patient problems: Abdominal Pain

  MAUDE report 23725966 ↗
• InjurySep 12, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2008 - PATIENT WAS DIAGNOSED WITH LARGE NON-REDUCIBLE SUPRAUMBILICAL VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF VENTRALEX MESH (DEVICE 1). PER OPERATIVE NOTES, ¿HERNIA SAC WAS DISSECTED OUT. A VENTRALEX MESH (DEVICE 1) WAS PLACED INTO THE SUBFASCIAL PLANE SUPRAUMBILICAL REGION AND SECURE IT WITH SUTURES.¿ (B)(6) 2018 - PATIENT WAS DIAGNOSED WITH VENTRAL EPIGASTRIC INCISIONAL HERNIA, PRIOR INCISION WAS IN THE SAME AREA THEREBY UNDERWENT ROBOTIC REPAIR WITH IMPLANT OF VENTRALIGHT ST MESH (DEVICE 2). PER OPERATIVE NOTES, ¿HERNIA SAC WAS DISSECTED OUT. A VENTRALIGHT ST MESH (DEVICE 2) WAS PLACED INTO THE ANTERIOR OF ABDOMINAL WALL AND SECURE IT WITH SUTURES.¿ (B)(6) 2019 - PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL EPIGASTRIC HERNIA LEFT SIDE OF THE MIDLINE, ADHESION, THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF SYNTHETIC MESH AND EXPLANT OF VENTRALEX MESH (DEVICE 1) AND VENTRALIGHT ST MESH (DEVICE 2). PER OPERATIVE NOTES, ¿HERNIA SAC WAS DISSECTED OUT. DENSE OMENTAL ADHESIONS WERE INTO THE ANTERIOR WALL. ADHESIONS WERE TAKEN DOWN. PREVIOUSLY PLACED MESHES WERE REMOVED PARTIALLY. THE DEFECT APPEARED LATERALLY AND LEFT OF THE

  Patient problems: Adhesion(s); Hernia

  MAUDE report 23035785 ↗
• MalfunctionJul 28, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED, ON (B)(6) 2025 THE PATIENT WAS IMPLANTED WITH A VENTRALIGHT ST MESH. AS REPORTED IN FOLLOW UP TWO OR THREE DAYS POST IMPLANT THE PATIENT REPORTED BLOATING. IT WAS STATED THAT NO MEDICAL OR SURGICAL INTERVENTION WAS PERFORMED FOR THE SYMPTOM.

  Patient problems: Unspecified Gastrointestinal Problem

  MAUDE report 22626864 ↗
• MalfunctionJul 25, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED, ON (B)(6) 2025 THE PATIENT WAS IMPLANTED WITH A VENTRALIGHT ST MESH. AS REPORTED IN FOLLOW UP TWO OR THREE DAYS POST IMPLANT THE PATIENT REPORTED BLOATING. IT WAS STATED THAT NO MEDICAL OR SURGICAL INTERVENTION WAS PERFORMED FOR THE SYMPTOM.

  Patient problems: Unspecified Gastrointestinal Problem

  MAUDE report 22610368 ↗
• InjuryJul 18, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2011 - PATIENT WAS DIAGNOSED WITH INCISIONAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT OF THE SEPRAMESH IP (DEVICE #1). PER OPERATIVE NOTES, ¿A BARD SEPRAMESH IP (DEVICE #1) WAS PLACED AND SUTURED.¿ ON (B)(6) 2011 - PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF VENTRALIGHT ST MESH (DEVICE #2). PER OPERATIVE NOTES, ¿HERNIA SAC WAS DISSECTED. A VENTRALIGHT ST MESH (DEVICE #2) WAS PLACED AND SUTURED.¿ ON (B)(6) 2014 - PATIENT WAS DIAGNOSED WITH POST LAPAROSCOPIC GASTRIC BYPASS, SYMPTOMATIC GRED, SYMPTOMATIC HIATAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH REMOVAL OF SYMPTOMATIC HIATAL HERNIA. ON (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH SMALL BOWEL OBSTRUCTION THEREBY UNDERWENT REPAIR WITH LYSIS OF ADHESION, EXPLORATORY LAPAROTOMY. ON (B)(6) 2016 - PATIENT WAS DIAGNOSED WITH SYMPTOMATIC GERD, SYMPTOMATIC HIATAL HERNIA, RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT ROBOTIC ASSISTED REPAIR WITH IMPLANT OF THE VENTRALIGHT ST W/ ECHO MESH (DEVICE #3). PER OPERATIVE NOTES, ¿HERNIA SAC WAS DISSECTED FREE. A VENTRALIGHT ST W/ ECHO MESH (DEVICE #3) WAS PLACED AND SUTURED.¿

  Patient problems: Hernia

  MAUDE report 22540276 ↗
• MalfunctionMay 28, 2025Unsealed Device Packaging; Unsealed Device Packaging

  AS REPORTED, DURING A VENTRAL HERNIA REPAIR PROCEDURE WHEN THE STERILE FOIL POUCH CONTAINING THE ENVELOPE WITH THE VENTRALIGHT ST MESH WAS OPENED, THE ENVELOPE WAS NOTED TO BE STUCK WITHIN THE SEAL OF THE STERILE FOIL POUCH. THE CUSTOMER FELT THE MESH WAS UNSTERILE AND USED ANOTHER MESH TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22099733 ↗
• InjuryApr 25, 2025Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  PER INFORMATION PROVIDED: (B)(6) 2010 - PATIENT WAS DIAGNOSED WITH LARGE RIGHT LOWER QUADRANT ANTERIOR ABDOMINAL WALL INCARCERATED INCISIONAL HERNIA WITH SMALL BOWEL OBSTRUCTION THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF COMPOSIX E/X MESH (DEVICE #1). PER OPERATIVE NOTES, "THE HERNIA DEFECT IN THE RIGHT LOWER QUADRANT WAS NOTED TO BE QUITE LARGE WITH INCARCERATED BOWEL. ENTEROLYSIS WAS PERFORMED. SECOND HERNIA WAS SUPERIOR NEAR THE UMBILICUS, THIS WAS REPAIRED. A COMPOSIX E/X MESH (DEVICE #1) WAS PLACED ON UNDERSURFACE OF FASCIA AND SUTURED." (B)(6) 2013 - PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA AT RIGHT LOWER QUADRANT AND ADHESIONS THEREBY UNDERWENT LAPAROSCOPIC REPAIR. PER OPERATIVE NOTES, "DENSE ADHESIONS WERE ENCOUNTERED. TWO LOOPS OF BOWEL STUCK IN THE HERNIA SAC WAS REDUCED. THE SMALL BOWEL ADHERED TO THE EDGE OF MESH (DEVICE #1) AND HERNIA SAC ITSELF. A PORTION OF SEROMUSCULAR LAYER IN THE MESH WAS EXCISED. THE BOWEL WAS REPAIRED. THE FASCIAL DEFECT ALSO WAS REPAIRED WITH SUTURES, REAPPROXIMATING THE OLD MESH (DEVICE #1) SUPERIORLY AND LATERALLY. A PIECE OF BIOLOGIC MESH WAS PLACED." (B)(6) 2013 - PATIENT WAS DIAGNOSED WITH SEROMA AT RIGHT LOWER QUADRAN

  Patient problems: Seroma; Unspecified Infection

  MAUDE report 21906693 ↗
• InjuryMar 19, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  AS REPORTED, USING THE SCROLL TECHNIQUE THE VENTRALIGHT ST MESH WAS IMPLANTED ON THE WRONG/REVERSED SIDE (ST COATED SIDE ORIENTED AGAINST THE ABDOMINAL WALL INSTEAD OF FACING THE BOWEL.) POSTOPERATIVELY THE PATIENT WAS DIAGNOSED WITH ILEUS.

  Patient problems: Obstruction/Occlusion

  MAUDE report 21646622 ↗
• MalfunctionJan 3, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  AS REPORTED, DURING A PROCEDURE ON (B)(6) 2024, AFTER OPENING THE FOIL POUCH AND REMOVING THE VENTRALIGHT ST MESH (DEVICE #1), THE OR STAFF NOTICED SOME CREASING ON THE FOIL POUCH AND GOT NERVOUS ABOUT USING THE MESH THEREFORE A SECOND VENTRALIGHT ST MESH (DEVICE #2) WAS OPENED, AND THE SAME THING OCCURRED AS SUCH CHOSE NOT TO USE THE MESHES. IT WAS REPORTED THAT A THIRD MESH (DEVICE #3) WAS USED TO COMPLETE THE CASE WITHOUT ANY FURTHER ISSUES. REPORTEDLY SALES REP DID NOT SEE ANY HOLES IN THE FOIL POUCHES AND THE OUTER PACKAGING WAS INTACT WITH NO DAMAGE NOTED PRIOR TO USE. THIS FILE REPRESENTS DEVICE #1.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21068795 ↗
• MalfunctionJan 3, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  AS REPORTED, DURING A PROCEDURE ON (B)(6)2024, AFTER OPENING THE FOIL POUCH AND REMOVING THE VENTRALIGHT ST MESH (DEVICE #1), THE OR STAFF NOTICED SOME CREASING ON THE FOIL POUCH AND GOT NERVOUS ABOUT USING THE MESH THEREFORE A SECOND VENTRALIGHT ST MESH (DEVICE #2) WAS OPENED, AND THE SAME THING OCCURRED AS SUCH CHOSE NOT TO USE THE MESHES. IT WAS REPORTED THAT A THIRD MESH (DEVICE #3) WAS USED TO COMPLETE THE CASE WITHOUT ANY FURTHER ISSUES. REPORTEDLY SALES REP DID NOT SEE ANY HOLES IN THE FOIL POUCHES AND THE OUTER PACKAGING WAS INTACT WITH NO DAMAGE NOTED PRIOR TO USE. THIS FILE REPRESENTS DEVICE #2.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21068782 ↗
• MalfunctionDec 13, 2024Unsealed Device Packaging; Unsealed Device Packaging

  AS REPORTED, DURING A HERNIA SURGERY PROCEDURE, WHEN THE INNER PACKAGING WAS OPENED TO TAKE THE VENTRALIGHT ST MESH, IT WAS FOUND THAT THERE WAS AN AIR LEAKAGE IN THE INNER PACKAGING. IT WAS REPORTED THAT THE SURGEON WORRIED ABOUT THE RISK OF CONTAMINATION AND DID NOT USE THE PRODUCT. WHEN THE SURGEON TOOK OUT THE MESH, THE GLOVES WERE CONTAMINATED WITH THE PATIENT'S BLOOD AND THEN DISPOSED OF AS CONTAMINATED GARBAGE. IT WAS REPORTED THAT THERE WAS NO DAMAGE IN OUTER PACKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20924897 ↗
• InjuryDec 2, 2024Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  PER INFORMATION PROVIDED: (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH RECURRENT INCARCERATED VENTRAL INCISIONAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT OF COMPOSIX E/X MESH (DEVICE #1). PER OPERATIVE NOTES, ¿THE HERNIA SAC WAS DISSECTED AND REDUCED. A BARD COMPOSIX E/X MESH (DEVICE #1) WAS PLACED IN AN UNDERLAY FASHION, EXTRACORPOREALLY SUTURES PLACED CIRCUMFERENTIALLY AROUND THE MESH. IT WAS ROLLED UP AND PLACED IN THE PERITONEAL CAVITY AND THEN FIXED CIRCUMFERENTIALLY USING SECURSTRAP DEVICE.¿ (B)(6) 2016 - PATIENT WAS DIAGNOSED WITH ABDOMINAL PAIN, SWELLING, RECURRENT VENTRAL INCISIONAL HERNIA WITH COMPLICATIONS OF PREVIOUSLY PLACED MESH THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF VENTRALIGHT ST MESH (DEVICE #2) AND EXPLANT OF COMPOSIX E/X MESH (DEVICE #1). PER OPERATIVE NOTES, ¿THE COMPOSIX E/X MESH (DEVICE #1) WAS CAREFULLY DISSECTED OFF WITH SUTURES AND REMOVED. THERE WERE TWO PORTIONS OF MESH, ONE APPEARED TO BE DUAL LAYER OF GORE-TEX MESH AND OTHER WAS A DISC OF MESH THAT WAS SECONDARILY PLACED HAD A CLOUDY FLUID ASSOCIATED WITH IT, ALSO VERY THICKENED AND CONTRACTED. IT WAS ELECTED TO REPAIR THE ABDOMINAL MIDLINE USING A DUAL LAYER PROLENE MESH THE

  Patient problems: Adhesion(s); Hernia

  MAUDE report 20817900 ↗
• InjuryNov 6, 2024Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  PER ADDITIONAL INFORMATION PROVIDED: ON (B)(6) 2014 - PATIENT WAS DIAGNOSED WITH UMBILICAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT OF VENTRIO ST MESH (DEVICE #1) AND SORBAFIX ENHANCED (DEVICE #2). PER OPERATIVE NOTES, ¿THE HERNIA WAS MEASURED, A VENTRIO ST MESH (DEVICE #1) WAS THEN PLACED INTO THE ABDOMINAL WALL AND TACKED WITH SORBAFIX ENHANCED (DEVICE #2)." ON (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH ABDOMINAL PAIN, RECURRENT HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE REMOVAL OF MESH (DEVICE#1), SORBAFIX ENHANCED (DEVICE#2) AND IMPLANT OF VENTRALIGHT ST MESH (DEVICE#3). PER OPERATIVE NOTES, ¿IF COULD TAKE OUT THE MESH AND THE TACKS, MAY BE HIS PAIN WOULD GO AWAY, PARTICULARLY IF REMOVAL OF THE TACKS. THE MESH WAS DISSECTED OFF POSTERIORLY AND NOTED THAT INFERIOR OF THE MESH HAD ALREADY PULLED AWAY FROM THE FASCIA AND THE HERNIA WAS RECURRING. ALL THE MESH (DEVICE #1) AND TACKS (DEVICE #2) WERE REMOVED. A VENTRALIGHT ST MESH (DEVICE#3) WAS THEN PLACED INTO THE ABDOMEN." ON (B)(6) 2017 - PATIENT WAS DIAGNOSED WITH ABDOMINAL PAIN AND INTRA-ABDOMINAL ADHESIONS TO THE MESH AND BOWEL OBSTRUCTION THEREBY UNDERWENT OPEN REPAIR WITH THE REMOVAL OF MESH (DEVICE #3)

  Patient problems: Abdominal Pain; Adhesion(s); Obstruction/Occlusion

  MAUDE report 20618838 ↗
• MalfunctionOct 18, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED BY THE CUSTOMER, POWERPICC SOLO CATHETER, GUIDEWIRE DRAWING. NO OTHER INFORMATION WAS PROVIDED. (B)(6) 2024: DURING EVALUATION OF THE RETURNED STYLET, THE CORE WIRE WAS FOUND TO BE SEVERELY ELONGATED AND BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20481347 ↗