VENTRALIGHT 5955680Recalls & reported problems

Summary

The FDA's MAUDE database contains 116 adverse event reports that list this exact device (DI 00801741031755), received between Sep 11, 2017 and Aug 27, 2026 — classified as 101 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Defective Device” (84 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 116 reports, in the reporter's own words as published by the FDA.

• InjuryAug 27, 2026Patient-Device Incompatibility

  Per information provided:On (b)(6) 2014 - Patient was diagnosed with small bowel obstruction, internal hernia, adhesion, incisional hernia thereby underwent open repair with the implant of Bard Flat Mesh (Device 1). Per op notes, "A midline incision was undertaken from the infraumbilical to suprapubic region in the midline. Bands of adhesion causing an internal hernia and twisting of the small bowel adjacent to the hernia consistent with small bowel obstruction as noted. A lightweight Bard Flat Mesh (Device 1) was placed as an only over the fascia and secured using sutures."On (b)(6) 2017 - Patient was diagnosed with multiple ventral hernias thereby underwent robot assisted repair with the implant of Ventralight ST Mesh using Echo (Device 2). Per op notes, "A ventral hernia in the midline near the umbilical region was identified. Nine abdominal wall hernias was noted. A Ventralight ST Mesh using Echo (Device 2) was placed into the defect and secured using tacks."On (b)(6) 2017 - Patient had hiatal hernia, intraabdominal adhesion, bowel stuck to mesh, perforation thereby underwent repair. (Note: There is no op notes provided for this procedure in medical records)

  Patient problems: Adhesion(s); Bowel Perforation

  MAUDE report 50479623 ↗
• InjuryAug 3, 2026Patient-Device Incompatibility

  Per information provided:On (b)(6) 2014 - Patient was diagnosed with periumbilical ventral hernia thereby underwent laparoscopic repair with the implant of Ventrio ST mesh (Device 1). Per op notes, "A Ventrio ST mesh (Device 1) was placed into the abdominal cavity, secured over the hernia defect and umbilicus with the tacks. "On (b)(6) 2015 - Patient was diagnosed with recurrent ventral hernia thereby underwent laparoscopic repair with the removal of mesh (Device 1) and implant of Ventralight ST Mesh using Echo PS (Device 2). Per op notes, "A lot of omental adhesions to previous mesh that was removed. There was herniation around the peripheral edge of mesh; the previous mesh (Device 1) was removed. A Ventralight ST Mesh using Echo PS (Device 2) was placed to the abdominal cavity using sutures."On (b)(6) 2016 - Patient had abdominal wall defect thereby underwent abdominal wall reconstruction with bilateral myofascial flaps. Per op notes, "The anterior abdominal wall fascia was encountered. The mesh removal would carry the excessive morbidity for the patient. Therefore, the previously placed mesh (Device 2) was left in place. A biologic mesh was then placed."

  Patient problems: Hernia

  MAUDE report 50114027 ↗
• InjuryApr 2, 2026Migration

  PER MEDICAL RECORDS AND PLAINTIFF PROFILE FORM: (B)(6) 2005: PATIENT WAS DIAGNOSED WITH INCARCERATED INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF KUGEL PATCH (DEVICE 1). PER OP NOTES, ¿PREVIOUS UPPER MIDLINE INCISION WAS EXCISED. THE HERNIA SAC WAS IDENTIFIED AND BOWEL CONTENTS WERE REDUCED. A KUGEL PATCH (DEVICE 1) WAS PLACED INTO THE PERITONEAL CAVITY WITH PTFE PORTION TO THE ABDOMINAL ORGANS AND THE POLYPROPYLENE PORTION ADJACENT TO THE ANTERIOR ABDOMINAL WALL, THEN SECURED IN PLACE AROUND THE FASCIAL DEFECT WITH SUTURE.¿ (B)(6) 2007: PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF SYNTHETIC MESH AND EXCISION OF KUGEL PATCH (DEVICE 1). PER OP NOTES, ¿THE MIDLINE INCISION WAS MADE THROUGH THE PREVIOUS SCAR AND CARRIED DOWN TO THE HERNIA SAC. PREVIOUS MESH (DEVICE 1) WAS NOTED TO BE FOLDED BACK ON ITSELF. THE MESH WAS COMPLETELY REMOVED. THE RIGHT LATERAL ASPECT APPEARED TO HAVE HETEROTROPHIC CALCIFICATION AND THIS WAS REMOVED. ADHESIONS WERE LYSED. THE INTRAABDOMINAL PLACEMENT OF SYNTHETIC MESH WAS PERFORMED AND SECURED WITH SUTURE.¿ (B)(6) 2009: PATIENT WAS DIAGNOSED WITH INCARCERATED SMALL BOWEL WITH RECURR

  Patient problems: Adhesion(s); Hernia

  MAUDE report 24766470 ↗
• InjuryMar 9, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2012 ¿ PATIENT WAS DIAGNOSED WITH VENTRAL INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRALIGHT ST MESH (DEVICE 1). PER OPERATIVE NOTES, ¿A VENTRAL INCISIONAL HERNIA AT THE SITE OF OLD TROCAR SITE WAS DISSECTED DOWN AND EXCESS SAC WAS RELEASED. THE ADHESIONS OF OMENTUM WERE RELEASED, AND PERITONEUM WAS CLOSED WITH SUTURES. A VENTRALIGHT ST MESH (DEVICE 1) WAS PLACED OVER THE DEFECT AND SECURED IT TO THE FASCIAL EDGES WITH SUTURES.¿ (B)(6) 2014 ¿ PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL INCISIONAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF VENTRALIGHT ST USING ECHO PS MESH (DEVICE 2) AND VENTRALIGHT ST (DEVICE 3). PER OPERATIVE NOTES, ¿A HERNIA DEFECT IN THE MIDLINE LEANING TOWARDS THE LEFT AT THE LEVEL ABOVE THE UMBILICUS WAS NOTED. SCAR TISSUES WERE EXCISED AND VENTRALIGHT ST USING ECHO PS MESH (DEVICE 2) WAS PLACED INTO THE POSITION COVERING THE ENTIRE DEFECT AND TACKED IN PLACE. IN THE RIGHT SIDE OF THE MIDLINE, THAT WAS NOT COVERED BY THE MESH (DEVICE 2), THEREFORE ANOTHER VENTRALIGHT ST MESH (DEVICE 3) WAS PULLED INTO THE POSITION COVERING AND OVERLAPPING THE PRIOR MESH (DEVICE 2) AND ENTIRE FASCIAL D

  Patient problems: Adhesion(s); Hernia; Seroma

  MAUDE report 24546091 ↗
• InjuryMar 4, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2012 - PATIENT WAS DIAGNOSED WITH RECURRENT UMBILICAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF VENTRALEX ST MESH (DEVICE 1). PER OPERATIVE NOTES, ¿IN THE MIDLINE, THE UMBILICAL HERNIA CONTAINING HERNIA SAC WAS RESECTED AND FASCIAL DEFECT WAS CLOSED, VENTRALEX ST MESH (DEVICE 1) WAS PLACED OVER THE FASCIA INCORPORATING THE MESH, ADHESIONS WERE REMOVED AND FASCIA WAS SUTURED AND TACKED WITH SORBAFIX TACKERS.¿ (B)(6) 2013 ¿ PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF VENTRALIGHT ST USING ECHO PS MESH (DEVICE 2). PER OPERATIVE NOTES, ¿THE PRIOR UMBILICAL MESH (DEVICE 1) WAS NOTED SLIGHTLY PROTRUDE INTO THE HERNIA CAUSING RECURRENCE. THE HERNIA SAC WAS REDUCED AND TO THE HERNIA DEFECT, A VENTRALIGHT ST USING ECHO PS MESH (DEVICE 2) WAS PLACED TO COVER THE RECURRENT HERNIA. THE FASCIA WAS CLOSED, SUTURED AND TACKED CIRCUMFERENTIALLY.¿ (B)(6) 2017 - PATIENT WAS DIAGNOSED WITH WOUND DEHISCENCE AND DIAPHRAGMATIC DEFECT THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF BIOLOGICAL MESH. PER OPERATIVE NOTES, ¿ADHESIONS BETWEEN OMENTUM AND PRIOR HERNIA MESH (DEVICE 1 AND 2)

  Patient problems: Adhesion(s); Wound Dehiscence

  MAUDE report 24504904 ↗
• InjuryFeb 18, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2013: PATIENT WAS DIAGNOSED WITH RIGHT SPIGELIAN HERNIA THEREBY UNDERWENT LAPAROSCOPIC CONVERTED TO OPEN REPAIR WITH THE IMPLANT OF BARD FLAT MESH (DEVICE 1). PER OP NOTES, ¿THE HERNIA SAC WAS DISSECTED AWAY FROM THE SURROUNDING TISSUE AND EXCISED FROM EDGES OF FASCIA. A BARD FLAT MESH (DEVICE 2) WAS CUT TO SIZE AND PLACED OVER THE CLOSED DEFECT IN ONLAY FASHION AND SECURED IN PLACE USING SUTURES.¿ (B)(6) 2014: PATIENT WAS DIAGNOSED WITH RECURRENT SPIGELIAN HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF VENTRALIGHT ST MESH (DEVICE 2). PER OP NOTES, ¿A WIDE MOUTHED DEFECT IN SOFT TISSUE WAS APPRECIATED. A SHEET OF VENTRALIGHT ST MESH (DEVICE 2) WAS PLACED INTO DEFECT AND TACKED ALONG THE CENTRAL PORTION OF DEFECT.¿ (B)(6) 2015: PATIENT WAS DIAGNOSED WITH INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF VENTRALEX ST MESH (DEVICE 3). PER OP NOTES, ¿PATIENT HAD INCISIONAL HERNIA FROM PRIOR TROCAR SITE. THE HERNIA SAC WAS SEPARATED FROM ATTACHMENTS. A LARGE VENTRALEX ST MESH (DEVICE 3) WAS POSITIONED INTO ABDOMINAL CAVITY AND TAILS ANCHORED TO THE OVERLYING FASCIA USING SUTURES.¿ (B)(6): 2017 ¿ PATIENT WAS DIAGNOSED WITH VENT

  Patient problems: Abscess; Adhesion(s); Hernia; Seroma

  MAUDE report 24378111 ↗
• InjuryDec 26, 2025Migration; Migration

  PER INFORMATION PROVIDED: ON (B)(6) 2005 ¿ PATIENT WAS DIAGNOSED WITH VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF SEPRAMESH IP (DEVICE 1). PER OP NOTES, ¿MULTIPLE HERNIA DEFECT IN MIDLINE WERE ENCOUNTERED. THE SEPRAMESH IP (DEVICE 1) WAS LAID ON THE TOP OF FASCIA AND SUTURED.¿ ON (B)(6) 2013 ¿ PATIENT HAD PAIN AND WAS DIAGNOSED WITH INCARCERATED VENTRAL AND INCISIONAL HERNIA; UMBILICAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF VENTRALEX PATCH (DEVICE 2). PER OP NOTES, ¿PREVIOUS UPPER MIDLINE ABDOMINAL INCISION EXTENDED TO THE SUPERIOR ASPECT OF THE UMBILICUS. THE SCAR TISSUE WAS TAKEN OFF. THE HERNIA SAC WAS NOTED WITH SOME NECROTIC OMENTUM. THERE WERE SOME ADHESIONS TO THE ABDOMINAL WALL WITH THE SMALL BOWEL. A SMALL UMBILICAL HERNIA WAS NOTED. A VENTRALEX MESH (DEVICE 2) WAS PLACED UNDERLAY AND AFFIXED TO THE ABDOMINAL WALL USING SUTURE.¿ (NOTE: THERE WAS NO MENTION/VISUALIZATION OF DEVICE 1 IN THIS PROCEDURE) ON (B)(6) 2015 ¿ PATIENT WAS DIAGNOSED WITH VENTRAL INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF SYNTHETIC MESH. PER OP NOTES, ¿THE HERNIA SAC WAS MORE TO THE LEFT OF THE MIDLINE INCISION. THE PREVIOUS MESH REPAIR I

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

  MAUDE report 23897324 ↗
• InjuryDec 5, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2014 ¿ PATIENT WAS DIAGNOSED WITH UMBILICAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF BARD FLAT MESH (DEVICE 1). PER OPERATIVE NOTES, ¿THE HERNIA SAC WAS IDENTIFIED AND EXCISED. A BARD FLAT MESH (DEVICE 1) WAS PLACED AND TACKED THE MESH TO THE ANTERIOR FASCIA.¿ ON (B)(6) 2015 ¿ PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH REMOVAL OF BARD FLAT MESH (DEVICE 1) AND AN IMPLANT OF VENTRALIGHT ST USING ECHO PS (DEVICE 2). PER OPERATIVE NOTES, ¿THE PREVIOUS BARD FLAT MESH (DEVICE 1) WAS FOUND TO BE BALLED UP, AND IT WAS EXCISED COMPLETELY. THE DEFECT WAS CLOSED USING SUTURES. UMBILICUS WAS TACKED DOWN TO THE FASCIA. A VENTRALIGHT ST USING ECHO PS (DEVICE 2) WAS PLACED AND TACKED CIRCUMFERENTIALLY.¿ ON (B)(6) 2018 ¿ PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT ROBOTIC ASSISTED LAPAROSCOPIC REPAIR. PER OPERATIVE NOTES, ¿ADHESIONS WERE TAKEN DOWN. THE PREVIOUS OLD MESH (DEVICE 2) WHICH WAS LEFT IN PLACE IN THE PREPERITONEAL SPACE. A SYNTHETIC MESH WAS PLACED INTO THE ABDOMINAL CAVITY AND SUTURED.¿

  Patient problems: Adhesion(s); Hernia

  MAUDE report 23726156 ↗
• MalfunctionNov 24, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  AS REPORTED, OPENED STERILE FOIL PACKAGING AND THE FOIL WERE COMPROMISED OF A VENTRALIGHT ST W/ECHO MESH. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23632135 ↗
• InjuryJul 31, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2014: PATIENT WAS DIAGNOSED WITH VENTRAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF VENTRALIGHT ST USING ECHO PS (DEVICE #1). PER OP NOTES, ¿A LARGE VENTRAL HERNIA SAC WAS IDENTIFIED WITH OMENTUM. A SMALL AMOUNT OF ATTACHED COLON WAS REDUCED. THE OMENTUM WAS REMOVED COMPLETELY. A VENTRALIGHT ST USING ECHO PS (DEVICE #1) WAS PLACED AND TACKED.¿ (B)(6) 2014: PATIENT WAS DIAGNOSED WITH SMALL BOWEL OBSTRUCTION WITH ABDOMINAL PAIN AND ADHESIONS THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF VENTRALIGHT ST USING ECHO PS (DEVICE #2) AND LYSIS OF ADHESIONS. (NOTE: THERE IS NO OPERATIVE NOTES PROVIDED FOR THIS PROCEDURE). (B)(6) 2015: PATIENT WAS DIAGNOSED WITH PERFORATION, INFECTED MESH AND HIATAL HERNIA WITH ABDOMINAL PAIN THEREBY UNDERWENT OPEN REPAIR WITH EXCISION VENTRALIGHT ST USING ECHO PS (DEVICE #1 AND #2) AND IMPLANT OF BIOLOGICAL MESH. PER OPERATION NOTES, ¿THE FREE FLOATING FECAL AND PURULENT CONTAMINATION IN ABDOMINAL CAVITY WERE REMOVED AND IRRIGATED. A LARGE PIECE OF TACKED INFECTED OLD MESH (DEVICE #1 & #2) WAS IDENTIFIED AND REMOVED ENTIRELY. A LARGE HIATAL HERNIA DEFECT WAS IDENTIFIED, EXCISED AND REPAIRED USING SUT

  Patient problems: Bowel Perforation; Purulent Discharge; Unspecified Infection

  MAUDE report 22673997 ↗
• InjuryMay 5, 2025Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  PER INFORMATION PROVIDED: ON (B)(6) 2017 - PATIENT WAS DIAGNOSED WITH MULTIPLE INCISIONAL HERNIAS THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT OF TWO VENTRALIGHT ST USING ECHO PS (DEVICE #1 & #2). PER OPERATIVE NOTES, ¿TWO HERNIAS WERE NOTED AT THE UMBILICUS AND INFRA UMBILICUS LOCATION. INCARCERATED OMENTUM AND SMALL BOWEL WERE TAKEN OUT OF THE MULTIPLE HERNIAS. THE VENTRALIGHT ST USING ECHO PS (DEVICE #1 & #2) WAS PLACED IN THE ABDOMINAL CAVITY AND TACKED BY SUTURES.¿ ON (B)(6) 2017 - PATIENT WAS DIAGNOSED WITH SMALL BOWEL PERFORATION THEREBY UNDERWENT EXPLORATORY LAPAROSCOPIC REPAIR WITH EXPLANT OF VENTRALIGHT ST USING ECHO PS (DEVICE #1 & #2) AND IMPLANT OF BIOLOGICAL MESH. PER OPERATIVE NOTES, ¿THE HERNIA SAC WAS NOTED. THE VENTRALIGHT ST USING ECHO PS (DEVICE #1 & #2) WAS REMOVED ENTIRELY. DEFECT IN SMALL BOWEL WAS NOTED. A BIOLOGICAL MESH WAS PLACED IN AN UNDERLAY MANNER POSTERIOR TO FASCIA, THEN SECURED BY SUTURES.¿ ATTORNEY ALLEGES THAT THE PATIENT HAD BOWEL OBSTRUCTION, BOWEL PERFORATION, INFECTION, PAIN AND SUFFERING.

  Patient problems: Abdominal Pain; Bowel Perforation

  MAUDE report 21959708 ↗
• InjuryMay 5, 2025Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  PER INFORMATION PROVIDED: (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH MULTIPLE VENTRAL HERNIAS THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT OF VENTRALIGHT ST USING ECHO PS (DEVICE #1, #2). PER OPERATIVE NOTES, ¿TWO HERNIAS WERE SEEN AND ONE WAS REDUCED INFERIORLY AND ONE WITH ADHERENT TISSUE SUPERIORLY. THE VENTRALIGHT ST USING ECHO PS (DEVICE #1) WAS PLACED AND TACKED. THE INFERIOR HERNIA DEFECT WAS REPAIRED USING VENTRALIGHT ST USING ECHO PS (DEVICE #2) AND CLOSED USING SUTURE.¿ (B)(6) 2016 - PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT ROBOTIC ASSISTED REPAIR WITH THE REMOVAL OF MESH. PER OPERATIVE NOTES, ¿MULTIPLE ADHESIONS WERE TAKEN DOWN. A LARGE HERNIA EXTENDING FROM THE SUPRAPUBIC TO SUBXIPHOID WAS NOTED. INCARCERATED SMALL BOWEL, OMENTUM, COLON WERE REDUCED. THE SYNTHETIC MESH WAS PLACED AND SECURED TO THE FASCIAL LAYER USING SUTURE.¿

  Patient problems: Adhesion(s); Hernia

  MAUDE report 21958225 ↗
• InjuryFeb 21, 2025Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  PER INFORMATION PROVIDED: (B)(6) 2008 - PATIENT WAS DIAGNOSED WITH BILATERAL REDUCIBLE LARGE DIRECT INGUINAL HERNIA AND PAIN THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF TWO PERFIX PLUG (DEVICE #1 & #2). PER OPERATIVE NOTES, ¿THERE WAS DIRECT DEFECT, THIS WAS REPAIRED BY LARGER SIZE PERFIX PLUG (DEVICE #1) AND FLOOR OF THE INGUINAL CANAL WAS REINFORCED WITH ONLAY MESH. SIMILAR PROCEDURE WAS PERFORMED ON RIGHT SIDE USING LARGER SIZE PERFIX PLUG (DEVICE #2) AND ONLAY MESH.¿ (B)(6) 2013 - PATIENT UNDERWENT COLONOSCOPY WITH REMOVAL OF POLYP IN SIGMOID AND RECTUM. (B)(6) 2016 - PATIENT WAS DIAGNOSED WITH RIGHT INCARCERATED RECURRENT INGUINAL HERNIA AND UMBILICAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF 3DMAX LIGHT (DEVICE #3) AND VENTRALEX ST (DEVICE #4). PER OPERATIVE NOTES, ¿AN INCARCERATED DIRECT HERNIA WAS REDUCED AND IDENTIFIED THE PRIOR MESH (DEVICE #2) WADDED UP NEXT TO THE DEFECT. THE ADHESIONS WERE TAKEN DOWN TO CLEAR THE PREPERITONEAL SPACE, THEN PLACED A LARGE 3DMAX LIGHT MESH COVERING ALL MYOPECTINEAL ORIFICES AND TACKED IN PLACE. THE UMBILICAL HERNIA SAC WAS TRANSECTED, A MEDIUM VENTRALEX ST MESH WAS USED AS AN UNDERLAY AND SUTURED IN PLACE.¿ (B)(6) 201

  Patient problems: Drug Resistant Bacterial Infection; Inflammation

  MAUDE report 21432640 ↗
• InjuryFeb 21, 2025Defective Device; Patient-Device Incompatibility; Migration; Defective Device; Patient-Device Incompatibility; Migration

  PER INFORMATION PROVIDED: ON (B)(6) 2008 - PATIENT WAS DIAGNOSED WITH BILATERAL REDUCIBLE LARGE DIRECT INGUINAL HERNIA AND PAIN THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF TWO PERFIX PLUG (DEVICE #1 & #2). PER OPERATIVE NOTES, ¿THERE WAS DIRECT DEFECT, THIS WAS REPAIRED BY LARGER SIZE PERFIX PLUG (DEVICE #1) AND FLOOR OF THE INGUINAL CANAL WAS REINFORCED WITH ONLAY MESH. SIMILAR PROCEDURE WAS PERFORMED ON RIGHT SIDE USING LARGER SIZE PERFIX PLUG (DEVICE #2) AND ONLAY MESH.¿ ON (B)(6) 2013 - PATIENT UNDERWENT COLONOSCOPY WITH REMOVAL OF POLYP IN SIGMOID AND RECTUM. ON (B)(6) 2016 - PATIENT WAS DIAGNOSED WITH RIGHT INCARCERATED RECURRENT INGUINAL HERNIA AND UMBILICAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF 3DMAX LIGHT (DEVICE #3) AND VENTRALEX ST (DEVICE #4). PER OPERATIVE NOTES, ¿AN INCARCERATED DIRECT HERNIA WAS REDUCED AND IDENTIFIED THE PRIOR MESH (DEVICE #2) WADDED UP NEXT TO THE DEFECT. THE ADHESIONS WERE TAKEN DOWN TO CLEAR THE PREPERITONEAL SPACE, THEN PLACED A LARGE 3DMAX LIGHT MESH COVERING ALL MYOPECTINEAL ORIFICES AND TACKED IN PLACE. THE UMBILICAL HERNIA SAC WAS TRANSECTED, A MEDIUM VENTRALEX ST MESH WAS USED AS AN UNDERLAY AND SUTURED IN PLACE.¿ O

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

  MAUDE report 21432634 ↗
• InjuryJan 8, 2025Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  PER INFORMATION PROVIDED BY PATIENT'S ATTORNEY: ON (B)(6) 2002 - PATIENT WAS DIAGNOSED WITH SYMPTOMATIC UMBILICAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF COMPOSIX MESH (DEVICE #1). PER OPERATIVE NOTES, ¿THE INCARCERATED HERNIA WAS OPENED AND EXCISED. JOINED TWO HERNIAS CLOSE TO EACH OTHER AND A COMPOSIX MESH (DEVICE #1) WAS AFFIXED TO THE FASCIA PERIPHERALLY USING SUTURES.¿ ON (B)(6) 2010 - PATIENT WAS DIAGNOSED WITH INCARCERATED UMBILICAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH REMOVAL OF MESH (DEVICE #1).PER OPERATIVE NOTES, ¿THE HERNIA SAC WAS INCISED AND ADHESIONS WERE LYSED. A BILAYER TYPE OF MESH (DEVICE #1) WITH POLYP PROPERLY INSIDE WHICH WAS ADHERENT TO THE ANTERIOR ABDOMINAL WALL WAS FOLDED OVER WHERE THE SMALL BOWEL WAS ADHERENT. THE REMAINDER OF THE MESH (DEVICE #1) WAS EXCISED COMPLETELY AND A PIECE OF BIOLOGICAL MESH WAS PLACED.¿ ON (B)(6) 2011 - PATIENT WAS DIAGNOSED WITH MULTIPLE RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF A BIOLOGICAL MESH. ON (B)(6) 2011 - PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF VENTRALIGHT ST MESH USING ECHO PS (DEVICE #2). PE

  Patient problems: Hernia; Necrosis; Obstruction/Occlusion

  MAUDE report 21102311 ↗
• InjuryOct 21, 2024Defective Device; Material Deformation; Patient Device Interaction Problem; Defective Device; Material Deformation; Patient Device Interaction Problem

  PER INFORMATION PROVIDED: (B)(6) 2013 - PATIENT WAS DIAGNOSED WITH VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF VENTRIO MESH (DEVICE #1). PER OPERATIVE NOTES, ¿THE HERNIA WAS IDENTIFIED JUST TO THE RIGHT OF THE MIDLINE. A VENTRIO HERNIA PATCH (DEVICE#1) WAS THEN PLACED INTRAABDOMINALLY USING SUTURES. ¿(B)(6) 2015 - PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT OF VENTRALIGHT ST USING ECHO PS (DEVICE #2) AND REMOVAL OF VENTRIO MESH (DEVICE #1). PER OPERATIVE NOTES, ¿THE ADHESIONS WERE TAKEN DOWN FROM THE ANTERIOR ABDOMINAL WALL. THE VENTRIO MESH (DEVICE #1) WAS LOOSE AND CURLED UP AND THIS VENTRIO MESH (DEVICE #1) WAS REMOVED. THEN A VENTRALIGHT ST USING ECHO PS (DEVICE #2) WAS PLACED INTO THE ABDOMEN USING TACKERS.¿ (B)(6) 2017 - PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT OF VENTRALIGHT ST USING ECHO PS (DEVICE #3). PER OPERATIVE NOTES, ¿THE LOWER EDGE OF THE OLD MESH (DEVICE #2) HAD TENTED UP INTO THE HERNIA. THE ADHESIONS WERE LYSED, THEN AN ANOTHER VENTRALIGHT ST USING ECHO PS MESH (DEVICE #3) WAS USED FOR REPAIR AND SECURED BY TACKERS.

  Patient problems: Adhesion(s); Hernia

  MAUDE report 20492478 ↗
• InjuryJun 6, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  PER VOLUNTARY MEDWATCH REPORT # ((B)(4)): PATIENT HAD PLANNED PROCEDURE DURING WHICH MESH VENTRALIGHT WAS PLACED. PATIENT LEFT OR (OPERATING ROOM) AND WAS SENT TO PACU (POST ANESTHESIA CARE UNIT). DURING NEXT CASE, SURGEONS REALIZED THEY HAD LEFT A PORTION OF THE MESH DEPLOYMENT DEVICE IN SURGICAL SITE AREA. PATIENT CAME BACK TO THE OR TO RETRIEVE THE RETAINED FOREIGN BODY. PER ADDITIONAL INFORMATION PROVIDED IN FOLLOW UP: THE PROCEDURE WAS A LAPAROSCOPIC UMBILICAL HERNIA REPAIR USING A VENTRALIGHT ST W/ ECHO PS. AS REPORTED, THE BALLOON WAS REMOVED FROM THE MESH, BUT WAS NOT INITIALLY RETRIEVED FROM THE PERITONEAL CAVITY.

  Patient problems: Foreign Body In Patient

  MAUDE report 19477826 ↗
• InjuryNov 22, 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 15 X 20 CM WITH ECHO ON (B)(6) 2022. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE VENTRALIGHT 15 X 20 CM WITH ECHO. 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: Insufficient Information; Pain

  MAUDE report 18190075 ↗
• MalfunctionSep 7, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, DURING HERNIA REPAIR SURGERY, VENTRALIGHT ST W/ ECHO PS WAS INSERTED THROUGH THE 12 MM TROCAR, AND IT WAS NOTED THAT ONE OF THE BLUE CONNECTORS WAS MISSING. IT WAS STATED BY THE CUSTOMER THAT IT APPEARED TO HAVE DETACHED DURING INSERTION INTO THE TROCAR. THE MESH CONNECTOR WAS FOUND ON THE FIELD, OUTSIDE OF THE PATIENT. IT WAS REPORTED THAT NOTHING WAS LEFT INSIDE THE PATIENT'S BODY AND THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17702249 ↗
• MalfunctionMar 14, 2023Material Separation; Material Separation

  AS REPORTED, DURING A LAPAROSCOPIC PROCEDURE THE VENTRALIGHT ST W/ECHO PS MESH WAS INSERTED THROUGH THE 8MM ROBOTIC TROCAR, THE MESH GOT STUCK AND RESULTED IN A PIECE OF THE MESH/POSITIONING SYSTEM BREAKING WHEN REMOVED. IT WAS REPORTED THAT THE MESH DID NOT ENTER THE ABDOMEN AND ALL PIECES WERE REMOVED. AS REPORTED, ANOTHER OF THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE USING UPSIZED TROCAR. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16538667 ↗
• InjuryMar 1, 2023Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF UNSPECIFIED BARD/DAVOL PHASIX ST AND VENTRALIGHT ST ON (B)(6) 2019. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE BOTH 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: Insufficient Information; Pain

  MAUDE report 16460107 ↗
• InjuryFeb 20, 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 unspecified Bard/Davol Ventralight ST on (b)(6) 2016 and Phasix ST on (b)(6) 2021. As reported, the patient is making a claim for an adverse patient outcome against both devices. Attorney alleges that the patient had subsequent surgical intervention due to the Hernia Mesh device. It is also alleged that the patient experienced emotional distress and the device was defective.Addendum Per additional information provided:(b)(6) 2016 - Patient was diagnosed with recurrent incisional hernia thereby underwent laparoscopic repair with the implant of Ventralight ST Mesh using Echo PS (Device 1). Per op notes, "The Ventralight ST Mesh using Echo PS (Device 1) was placed to the ventral area using tacks." (b)(6) 2022 - Patient was diagnosed with recurrent ventral hernia thereby underwent robotic assisted laparoscopic repair with the removal of old mesh (Device 1) and implant of Phasix ST mesh (Device 2). Per op notes, "The old mesh (Device 1) was removed. A Phasix ST mesh (Device 2) was placed to the anterior abdominal wall using sutures."

  Patient problems: Hernia; Insufficient Information

  MAUDE report 16403713 ↗
• InjuryFeb 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) 2019. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE VENTRALIGHT ST. ATTORNEY ALLEGES THAT THE PATIENT HAD SUBSEQUENT SURGICAL INTERVENTION DUE TO THE HERNIA MESH DEVICE. IT IS ALSO ALLEGED THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Hernia; Insufficient Information; Pain

  MAUDE report 16325458 ↗
• InjuryJan 28, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  PER JOURNAL ARTICLE: "COMPARISON OF TWO DIFFERENT CONCEPTS OF MESH AND FIXATION TECHNIQUE IN LAPAROSCOPIC VENTRAL HERNIA REPAIR: A RANDOMIZED CONTROLLED TRIAL": PURPOSE: THE AIM OF THIS STUDY WAS TO COMPARE TWO DIFFERENT MESH/FIXATION SYSTEM CONCEPTS (NON-BARD/DAVOL PHYSIOMESH/SECURE-STRAP (PH GROUP) AND VENTRALIGHT ST/SORBAFIX (VS GROUP) FOR LAPAROSCOPIC VENTRAL HERNIA REPAIR IN 50 PATIENTS WITH RESPECT TO POSTOPERATIVE COMPLICATIONS. CONCLUSION: THE PH SYSTEM WAS ASSOCIATED WITH SIGNIFICANTLY GREATER HERNIA RECURRENCES AND POSTOPERATIVE PAIN COMPARED WITH THE VS SYSTEM. THIS CONFIRMS THE SUPERIORITY OF THE ELASTIC (VENTRALIGHT ST) MESH CONCEPT, WHICH MAY BE A SAFER AND MORE EFFICACIOUS OPTION FOR LAPAROSCOPIC VENTRAL HERNIA REPAIRS. THIS WAS SINGLE-CENTER, PROSPECTIVE, RANDOMIZED STUDY DESIGNED TO INCLUDE 50 PATIENTS RECRUITED FOR EACH GROUP (PH & VS) FROM 01-NOV-2012 TO 31-AUG-2013, WITH A PLANNED INTERIM ANALYSIS FOR SAFETY AFTER 25 PATIENTS. AFTER THE ENROLLMENT OF 25 PATIENTS IN BOTH GROUPS, THE TRIAL WAS TERMINATED DUE TO COMPLICATIONS OBSERVED IN THE PH GROUP. FIVE RECURRENCES WERE OBSERVED IN THE PH GROUP IN THE FIRST 6 MONTHS AND NONE IN THE VS GROUP. PAIN WAS NOTED IN 22

  Patient problems: Pain; Seroma

  MAUDE report 16261210 ↗
• MalfunctionSep 20, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, DURING A LAPAROSCOPIC VENTRAL HERNIA REPAIR PROCEDURE ON (B)(6) 2022, THE SURGEON INSERTED BARD/DAVOL VENTRALIGHT ST W/ECHO PS THROUGH A 12 MM TROCAR. AFTER GRASPING THE BLUE RETRIEVAL LOOP ON THE INFLATION TUBE, THE SURGEON ATTEMPTED TO PULL IT THROUGH THE SKIN INCISION AND THE YELLOW ANCHOR BROKE OFF. AS REPORTED, THE SURGEON SEARCHED THE PATIENT REPEATEDLY TO OBTAIN THE YELLOW ANCHOR BUT COULD NOT RETRIEVE IT. AS REPORTED, THE PATIENT IS OBESE AND THE SURGEON FELT IT WAS IN THE PATIENT'S BEST INTEREST TO COMPLETE THE CASE AND NOT ATTEMPT TO CONTINUE SEARCHING FOR THE YELLOW ANCHOR AS IT WOULD BE MORE OF A RISK TO THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15457084 ↗