VENTRALIGHT 5990011Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 00801741130977), received between Jul 10, 2018 and Aug 5, 2025 — classified as 12 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (9 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 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 5, 2025Break; Break

  AS REPORTED, DURING ROBOTIC INCISIONAL HERNIA REPAIR A VENTRALIGHT ST ECHO 2 MESH WAS INSERTED INTO THE ABDOMEN AND IT WAS OBSERVED THAT 2 COILS (CONNECTORS) BROKE OFF AND LANDED ON THE SURGICAL DRAPES. THERE WAS NO PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22717731 ↗
• InjuryMay 2, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED, THE PATIENT UNDERWENT LAPAROSCOPIC VENTRAL HERNIA REPAIR IN (B)(6) 2024 WITH THE VENTRALIGHT ST W/ ECHO 2. THE PATIENT HAS HAD DISCOMFORT IN THE AREA OF THE MESH, AND "SEEMS TO BE HAVING AN ALLERGIC REACTION." THE SURGEON AND ALLERGIST WOULD LIKE TO PERFORM A REACTIVITY TEST; A SAMPLE MESH HAS BEEN PROVIDED FOR REACTIVITY TESTING. ADDENDUM: REACTIVITY TEST RESULTS CAME BACK NEGATIVE ON THE PATIENT; THERE WAS NO REACTION TO THE MESH.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 21952122 ↗
• InjuryApr 22, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED, THE PATIENT UNDERWENT A LAPAROSCOPIC VENTRAL HERNIA REPAIR PROCEDURE WITH THE IMPLANT OF VENTRALIGHT ST MESH W/ ECHO PS 2 ON (B)(6) 2025. IT WAS REPORTED THAT THE PATIENT HAS HAD ABDOMINAL PAIN SINCE THE PROCEDURE AND NOW HAS "FOUL-SMELLING URINE." CONTACT REPORTS THE PAIN "SHOOTS UP THE SIDE OF HER ABDOMEN WHILE EATING FOOD." THE PATIENT RECENTLY HAD A FALL AND HAS ISSUE WITH WALKING FROM ANOTHER CHRONIC CONDITION. REPORTEDLY, THE SURGEON TOLD THE PATIENT THAT SHE HAD A LOT OF SCAR TISSUE IN THE AREA OF WHERE THE MESH WAS IMPLANTED WHICH HAD TO BE REMOVED PRIOR TO IMPLANT. PATIENT HAD A FOLLOW UP WITH HER SURGEON ON (B)(6) 2025. AS REPORTED THE PATIENT "DOES NOT WANT TO ACCUSE ANYTHING UNTIL HER FOLLOW WITH THE SURGEON THAT DID THE MESH REPAIR." (NOTE, THE RESULTS OF THE FOLLOW-UP APPOINTMENT HAVE NOT BEEN REPORTED TO BD).

  Patient problems: Abdominal Pain

  MAUDE report 21881848 ↗
• MalfunctionMay 3, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, A VENTRALIGHT ST W/ ECHO 2 WAS USED DURING A LAPAROSCOPIC VENTRAL HERNIA REPAIR. AT THE COMPLETION OF THE PROCEDURE, IT WAS NOTED THAT ONE OF THE CONNECTORS FOR ECHO 2 WAS MISSING. IT WAS REPORTED, THE ISSUE WAS DISCOVERED AT THE COMPLETION OF THE CASE WHEN THE BLUE CONNECTORS WERE COUNTED. IT WAS REPORTED THAT THE SURGEON FELT THE BLUE CONNECTOR GOT STUCK BETWEEN THE MESH AND THE PATIENT'S FASCIA. THERE WAS NO FURTHER INTERVENTION REPORTED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: Foreign Body In Patient

  MAUDE report 19238696 ↗
• InjuryOct 4, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  AS PER MEDWATCH FORM, "PATIENT TO THE OR FOR RA (OPERATING ROOM FOR REGIONAL ANESTHESIA) LAPAROSCOPIC INCISIONAL UMBILICAL HERNIA REPAIR WITH BARD 11.4CM VENTRALIGHT MESH. WHILE PATIENT WAS IN PACU (POST-ANESTHESIA CARE UNIT,), IT WAS REALIZED THAT THE SCAFFOLD WAS NOT REMOVED FROM THE MESH DURING THE INITIAL PROCEDURE. PATIENT WAS TAKEN BACK TO THE OPERATING ROOM FOR A DIAGNOSTIC LAPAROSCOPY. THE ECHO 2 SCAFFOLDING WAS IDENTIFIED AND REMOVED WITH LUQ (LEFT UPPER QUADRANT) TROCHAR. THE PHYSICIAN CAREFULLY EXAMINED THE SCAFFOLDING AND IT WAS DETERMINED TO BE INTACT."

  Patient problems: Foreign Body In Patient

  MAUDE report 17867824 ↗
• MalfunctionAug 17, 2023Detachment of Device or Device Component; Material Split, Cut or Torn; Detachment of Device or Device Component; Material Split, Cut or Torn

  AS REPORTED, DURING LAPAROSCOPIC VENTRAL HERNIA REPAIR PROCEDURE, THE VENTRALIGHT ST W/ ECHO 2 MESH WAS USED. IT WAS REPORTED THAT THE SURGEON HYDRATED THE MESH FOR 1-3 SECONDS AND ROLLED WITH THE PS ON THE OUTSIDE OF THE MESH INSTEAD OF KEEPING IT ON THE INSIDE. IT WAS REPORTED THAT THE SURGEON PUSHED THE MESH THROUGH THE TROCAR INTO THE ABDOMEN AND FOUND THAT THE PS CAME OFF FROM THE MESH. IT WAS REPORTED THAT ALL THE PS AND THE MESH WERE REMOVED FROM THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH A NEW MESH. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17564812 ↗
• InjuryJul 13, 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 VENTRALEX ST ON (B)(6) 2013, VENTRALEX ON (B)(6) 2014 AND VENTRALIGHT ST ON (B)(6) 2022. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST ALL THE DEVICES. ATTORNEY ALLEGES GENERAL ALLEGATIONS FOR "PAST, PRESENT, AND FUTURE DAMAGES, INCLUDING BUT NOT LIMITED TO, MENTAL AND PHYSICAL PAIN AND SUFFERING FOR SEVERE AND PERMANENT PERSONAL INJURIES SUSTAINED BY THE PATIENT." IT IS ALSO ALLEGED THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Insufficient Information; Pain

  MAUDE report 17314610 ↗
• MalfunctionMay 17, 2023Break; Break

  AS REPORTED, DURING A PROCEDURE THE SURGEON INSERTED THE VENTRALIGHT ST W/ECHO 2 THROUGH A 10MM TROCAR. WHEN THE SURGEON ATTEMPTED TO PULL THE HOISTING SUTURE UP THROUGH THE DEFECT, THE HOISTING SUTURE BROKE. PER CONTACT THE INSTRUMENT USED TO PULL THE HOISTING SUTURE IS UNKNOWN. IT WAS REPORTED THAT ANOTHER MESH WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16944580 ↗
• InjuryApr 25, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED, THE PATIENT UNDERWENT A VENTRAL HERNIA REPAIR USING A VENTRALIGHT ST MESH ECHO 2 PS ON (B)(6) 2021. ABOUT 3 WEEKS POST IMPLANT, THE PATIENT EXPERIENCED HIGH BLOOD PRESSURE, SEVERE HEADACHES, AND PAIN ALL OVER. AS ALLEGED, THE PATIENT HAS A HISTORY OF ARTHRITIS BUT THE SEVERITY OF HER PAIN IN JOINTS INCREASED SINCE THE IMPLANT OF THE VENTRALIGHT ST MESH. AS REPORTED, THE PATIENT COMPLAINS OF SEVERE SHOOTING PAIN IN HER TAILBONE THAT SHOOTS UP HER SPINE AND INTO HER HEAD. NOTE, THE PATIENT HAD RECENT NECK SURGERY ON (B)(6) 2023 AND DEVELOPED A MRSA INFECTION WHICH WAS TREATED AGGRESSIVELY WITH IV ANTIBIOTICS. AS REPORTED, THE PATIENT HAS ¿MANY ALLERGIES AND IS VERY SENSITIVE TO MULTIPLE MATERIALS.¿ THE PATIENT DID NOT HAVE ANY VISIBLE REACTIONS ON THE SKIN POST IMPLANT, THE SYMPTOMS HAVE BEEN ALL SYSTEMIC AND THE PATIENT IS TAKING LORTAB FOR CHRONIC PAIN. THE PATIENT UNDERWENT REACTIVITY TESTING WITH MESH ON (B)(6) 2023 FOR 48 HOURS. IT WAS REPORTED THE PATIENT FELT UNWELL AND EXPERIENCED ITCHING AROUND THE AREA WHERE THE MESH WAS PLACED BUT NO OBVIOUS RASH. UPON REMOVAL OF THE MESH THE ITCHING STOPPED. AS REPORTED THE PATIENT¿S DOCTOR DOES NOT FEEL THE PATIENT HAD A ¿TR

  Patient problems: High Blood Pressure/ Hypertension; Neuralgia; Pain

  MAUDE report 16809588 ↗
• InjuryApr 8, 2023Defective Device; Patient Device Interaction Problem; Migration; Defective Device; Patient Device Interaction Problem; Migration

  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: Adhesion(s); Hernia; Insufficient Information

  MAUDE report 16705027 ↗
• MalfunctionOct 20, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  AS REPORTED, DURING LAPAROSCOPIC UMBILICAL HERNIA REPAIR PROCEDURE ON (B)(6) 2022, THE SURGEON USED THE VENTRALIGHT ST W/ECHO 2 DEVICE. IT WAS REPORTED THAT DURING THE PROCEDURE ONE 12MM PORT (FOR MESH INSERTION) AND TWO 5MM PORTS (FOR SCOPE AND FIXATION DEVICE) WERE USED. AS REPORTED, AFTER INSERTING THE MESH, THE 12MM PORT WAS REMOVED. ONCE THE MESH WAS TACKED INTO PLACE, THE SURGEON GRABBED THE THINNEST END OF THE ECHO 2 POSITIONING SYSTEM WITH A GRASPER, LINING UP THE WIRE WITH THE GRASPER AND REMOVED IT THROUGH THE 5MM PORT. AS REPORTED WHILE REMOVING THE ECHO 2 POSITIONING SYSTEM THROUGH THE 5MM PORT THE WHITE COVER (FRAME) AROUND THE WIRE TORE INTO TWO PIECES AND THE ENTIRE WIRE COME OUT OF THE FRAME. THE SURGEON VERIFIED THAT ALL PIECES WERE ACCOUNTED FOR. THERE WAS NO PATIENT INJURY AS A RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15641844 ↗
• MalfunctionOct 20, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  AS REPORTED, DURING LAPAROSCOPIC UMBILICAL HERNIA REPAIR PROCEDURE ON (B)(6) 2022, THE SURGEON USED THE VENTRALIGHT ST W/ECHO 2 DEVICE. IT WAS REPORTED THAT DURING THE PROCEDURE ONE 12MM PORT (FOR MESH INSERTION) AND TWO 5MM PORTS (FOR SCOPE AND FIXATION DEVICE) WERE USED. AS REPORTED, AFTER INSERTING THE MESH, THE 12MM PORT WAS REMOVED. ONCE THE MESH WAS TACKED INTO PLACE, THE SURGEON GRABBED THE THINNEST END OF THE ECHO 2 POSITIONING SYSTEM WITH A GRASPER, LINING UP THE WIRE WITH THE GRASPER AND REMOVED IT THROUGH THE 5MM PORT. AS REPORTED WHILE REMOVING THE ECHO 2 POSITIONING SYSTEM THROUGH THE 5MM PORT THE WHITE COVER (FRAME) AROUND THE WIRE TORE INTO TWO PIECES AND THE ENTIRE WIRE COME OUT OF THE FRAME. THE SURGEON VERIFIED THAT ALL PIECES WERE ACCOUNTED FOR. THERE WAS NO PATIENT INJURY AS A RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15641830 ↗
• MalfunctionOct 20, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  AS REPORTED, DURING LAPAROSCOPIC UMBILICAL HERNIA REPAIR PROCEDURE ON (B)(6) 2022, THE SURGEON USED THE VENTRALIGHT ST W/ ECHO 2 DEVICE. IT WAS REPORTED THAT DURING THE PROCEDURE ONE 12 MM PORT (FOR MESH INSERTION) AND TWO 5 MM PORTS (FOR SCOPE AND FIXATION DEVICE) WERE USED. AS REPORTED, AFTER INSERTING THE MESH, THE 12 MM PORT WAS REMOVED. ONCE THE MESH WAS TACKED INTO PLACE, THE SURGEON GRABBED THE THINNEST END OF THE ECHO 2 POSITIONING SYSTEM WITH A GRASPER, LINING UP THE WIRE WITH THE GRASPER AND REMOVED IT THROUGH THE 5 MM PORT. AS REPORTED WHILE REMOVING THE ECHO 2 POSITIONING SYSTEM THROUGH THE 5 MM PORT THE WHITE COVER (FRAME) AROUND THE WIRE TORE INTO TWO PIECES AND THE ENTIRE WIRE COME OUT OF THE FRAME. THE SURGEON VERIFIED THAT ALL PIECES WERE ACCOUNTED FOR. THERE WAS NO PATIENT INJURY AS A RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15641829 ↗
• InjuryMay 3, 2022Defective Device; Patient-Device Incompatibility; Patient Device Interaction Problem; Defective Device; Patient-Device Incompatibility; Patient Device Interaction Problem

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

  MAUDE report 14268603 ↗
• InjuryApr 5, 2022Defective Device; Patient-Device Incompatibility; Patient Device Interaction Problem; Defective Device; Patient-Device Incompatibility; Patient Device Interaction Problem

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

  Patient problems: Hernia; Insufficient Information

  MAUDE report 14013560 ↗
• InjuryNov 23, 2021Defective Device; Patient-Device Incompatibility; Patient Device Interaction Problem; Defective Device; Patient-Device Incompatibility; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL VENTRALIGHT ST ON (B)(6) 2020. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE VENTRALIGHT ST. IT IS ALLEGED THAT THE PATIENT HAD SUBSEQUENT SURGICAL INTERVENTION DUE TO THE HERNIA MESH DEVICE. ATTORNEY ALLEGES THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Hernia; Insufficient Information

  MAUDE report 12860033 ↗
• InjurySep 7, 2021Defective Device; Patient-Device Incompatibility; Patient Device Interaction Problem; Defective Device; Patient-Device Incompatibility; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL VENTRALIGHT ST ON (B)(6) 2020. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE VENTRALIGHT ST. ATTORNEY ALLEGES THAT THE PATIENT HAD SUBSEQUENT SURGICAL INTERVENTION DUE TO THE HERNIA MESH DEVICE. IT IS ALSO ALLEGED THAT THE PATIENT SUSTAINED PERSONAL INJURY, EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Hernia; Insufficient Information; Pain

  MAUDE report 12433163 ↗
• InjuryAug 30, 2021Defective Device; Patient-Device Incompatibility; Patient Device Interaction Problem; Defective Device; Patient-Device Incompatibility; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL VENTRALIGHT ST ON (B)(6) 2019. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE VENTRALIGHT ST. IT IS ALLEGED THAT THE PATIENT HAD SUBSEQUENT SURGICAL INTERVENTION DUE TO THE HERNIA MESH DEVICE. ATTORNEY ALLEGES THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Hernia; Insufficient Information

  MAUDE report 12382503 ↗
• MalfunctionAug 13, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED PER ECHO 2 CLINICAL TRIAL, (B)(4): THE SUBJECT PATIENT UNDERWENT A PRIMARY LAPAROSCOPIC REPAIR OF A VENTRAL UMBILICAL HERNIA USING A BARD/DAVOL VENTRALIGHT ST MESH W/ECHO 2 POSITIONING SYSTEM ALONG WITH EXCISION OF UMBILICAL STALK LESION ON (B)(6) 2019. DURING INSERTION, THE ECHO 2 PS SEPARATED FROM THE MESH UPON INSERTION INTO THE TROCAR. BOTH PIECES (MESH AND POSITIONING SYSTEM) WERE REMOVED FROM THE PATIENT. THE SURGEON UTILIZED ANOTHER VENTRALIGHT ST MESH W/ECHO 2 POSITIONING SYSTEM TO COMPLETE THE PROCEDURE. THE PATIENT WAS DISCHARGED THE SAME DAY. THE ADVERSE EVENT WAS ASSESSED BY THE CLINICIAN TO BE DEFINITIVELY RELATED TO THE PROCEDURE AND THE STUDY DEVICE, WITH A CLASSIFIED SEVERITY OF MILD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12321233 ↗
• MalfunctionJul 22, 2021Expiration Date Error; Expiration Date Error

  AS REPORTED, A BARD/DAVOL VENTRALIGHT ST W/ ECHO 2 POSITIONING SYSTEM WAS USED DURING A VENTRAL HERNIA REPAIR PROCEDURE ON (B)(6) 2021. AFTER THE MESH HAD BEEN FIXATED IT WAS NOTED THAT THE DEVICE HAD EXPIRED ON 28-JUN-2021. AS REPORTED, THE STAFF INDICATED THE MESH WAS GOING TO EXPIRE AT THE "END OF THE MONTH" AND IT WAS NOT REALIZED AT THE TIME THAT THE NEW MONTH ((B)(6)) HAD JUST STARTED, UNTIL LATER IN THE PROCEDURE WHEN THE MESH WAS ALREADY FIXED IN PLACE. AT THIS TIME THE SURGEON DID NOT WANT TO REMOVE THE MESH AS IT WOULD HAVE REQUIRED CONVERTING TO AN OPEN PROCEDURE. IT WAS ALSO REPORTED BY THE SURGEON THAT THE DEFECT WAS CLOSED PRIMARILY, AND PRIOR TO PLACING THE MESH REPORTED THAT THE MESH PACKAGING WAS IN GOOD CONDITION WITH PROPER STERILE TECHNIQUE USED THROUGHOUT THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY AND THE PATIENT WAS DISCHARGED HOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12211902 ↗
• InjuryJul 13, 2021Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL VENTRALIGHT ST ON (B)(6) 2019. 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) 2019 - PATIENT WAS DIAGNOSED WITH VENTRAL HERNIA THEREBY UNDERWENT ROBOTIC ASSISTED REPAIR WITH THE IMPLANT OF VENTRALIGHT ST USING ECHO PS 2. PER OP NOTES "A VENTRALIGHT ST USING ECHO PS 2 WAS PLACED AND SUTURED." (B)(6) 2019 - PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL HERNIA, PAIN THEREBY UNDERWENT OPEN REPAIR WITH EXPLANT OF MESH. PER OP NOTES "THE MESH WAS EXCISED IN ITS ENTIRETY, ADHESIOLYSIS PERFORMED AND SUTURE REPAIR WAS DONE."

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

  MAUDE report 12162825 ↗
• MalfunctionDec 13, 2019Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT ON (B)(6) 2019, DURING A LAPAROSCOPIC UMBILICAL HERNIA REPAIR, A BARD VENTRALIGHT ST W/ ECHO 2, WAS "DEFECTIVE AND THE PIECE DETACHED PRIOR TO USE WITH THE PATIENT." AS REPORTED, THERE WAS NO INJURY OR IMPACT TO THE PATIENT AND THE CASE WAS COMPLETED WITH THE USE "OF A DIFFERENT ITEM."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9465954 ↗
• MalfunctionNov 5, 2019Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2019 THE BARD VENTRALIGHT ST W/ ECHO 2 DEVICE WAS PLACED INTO THE ABDOMEN LAPAROSCOPICALLY AND THE MESH DETACHED FROM THE STRUCTURAL POSITIONER (FRAME). BOTH PARTS (FRAME AND MESH) WERE REMOVED FROM THE PATIENT AND A NEW MESH PRODUCT WAS INSERTED TO COMPLETE THE PROCEDURE. THERE WAS NO IMPACT OR INJURY TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9278897 ↗
• MalfunctionNov 5, 2019Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, THE POSITIONING SYSTEM OF A VENTRALIGHT ST MESH ECHO 2, DETACHED FROM THE MESH WHEN TRYING TO PLACE THE MESH IN THE PATIENT'S ABDOMEN. AS REPORTED, THE SURGEON COMPLETED THE CASE BY USING "ANOTHER PRODUCT". THERE WAS NO INJURY OR IMPACT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9278891 ↗
• MalfunctionSep 12, 2019Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  AS REPORTED PER CUSTOMER CONTACT: WHEN THE SURGEON WENT TO IMPLANT A BARD VENTRALIGHT ST W/ ECHO 2 PS THE DEVICE SEPARATED AND WAS UNABLE TO BE USED. AS REPORTED, TO COMPLETE THE CASE A REPLACEMENT ITEM WAS USED AND THERE WAS NO IMPACT OR INJURY TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9005598 ↗