Symbotex SYM2515ERecalls & reported problems

Summary

The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 10884521190474), received between Dec 12, 2017 and Nov 3, 2025 — classified as 1 death, 36 injuries.

The most frequently reported specific device problem is “Mechanics Altered” (19 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 37 reports, in the reporter's own words as published by the FDA.

• InjuryNov 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF AN UMBILICAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED ADHESIONS, RECURRENCE, PAIN, SUFFERING, SEROMA, INFLAMMATION AND EMOTIONAL DISTRESS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, HERNIA REPAIR AND MESH REMOVAL.

  Patient problems: Adhesion(s); Distress; Hernia; Inflammation; Pain; Seroma; Unspecified Tissue Injury

  MAUDE report 23456707 ↗
• InjuryNov 15, 2024Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Mechanics Altered; Adverse Event Without Identified Device or Use Problem

  THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF A VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DEFECTIVE MESH, FAILURE OF MESH, RECURRENCE, ADHESIONS, INFLAMMATION, INFECTION, SCARRING, NERVE DAMAGE, SCARRING, PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, MENTAL PAIN, DISABILITY. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, LYSIS OF ADHESIONS.

  Patient problems: Adhesion(s); Emotional Changes; Hernia; Inflammation; Muscle Weakness/Atrophy; Nerve Damage; Pain; Scar Tissue; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 20695656 ↗
• InjuryAug 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT'S ATTORNEY, ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR LAPAROSCOPIC THERAPEUTIC TREATMENT OF A VENTRAL HERNIA. IT WAS REPORTED, THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, ADHESIONS AND OBSTRUCTION.

  Patient problems: Adhesion(s); Hernia; Obstruction/Occlusion; Unspecified Tissue Injury

  MAUDE report 19945657 ↗
• InjuryMay 24, 2024Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Mechanics Altered; Adverse Event Without Identified Device or Use Problem

  THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF UMBILICAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, ABDOMINAL PAIN, INFLAMMATION, SCARRING, ADHESIONS, EMOTIONAL CHANGES, PAIN, DISABILITY, MESH FAILURE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY AND HERNIA REPAIR WITH NEW MESH.

  Patient problems: Abdominal Pain; Adhesion(s); Emotional Changes; Hernia; Inflammation; Pain; Scar Tissue; Unspecified Tissue Injury

  MAUDE report 19397531 ↗
• InjuryFeb 13, 2024Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Mechanics Altered; Adverse Event Without Identified Device or Use Problem

  THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF AN INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DEFECTIVE MESH, ABDOMINAL PAIN, RECURRENCE, ADHESIONS, OBSTRUCTION, INFLAMMATION, SCARRING, PAIN, MENTAL PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, REMOVAL OF MESH, FREED UP THE COLON, REMOVED SOME OF THE OMENTUM, SMALL BOWEL RESECTION.

  Patient problems: Abdominal Pain; Adhesion(s); Discomfort; Emotional Changes; Hernia; Inflammation; Obstruction/Occlusion; Pain; Scar Tissue; Unspecified Tissue Injury

  MAUDE report 18698916 ↗
• InjuryNov 10, 2023Migration or Expulsion of Device; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Migration or Expulsion of Device; Mechanics Altered; Adverse Event Without Identified Device or Use Problem

  THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF AN INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED INFECTION, HEMATOMA, DISRUPTION OF MESH AND SUTURE LINE, DEFECTIVE MESH, ABDOMINAL PAIN, RECURRENCE, ABSCESS, SCARRING, PAIN, MENTAL PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICATION, REMOVAL OF MESH, EXPLORATORY LAPAROTOMY, DRAINAGE OF ABSCESS, DEBRIDEMENT OF ABDOMINAL WALL, REMOVAL OF SUTURES.

  Patient problems: Abdominal Pain; Abscess; Emotional Changes; Hematoma; Hernia; Pain; Scar Tissue; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 18111815 ↗
• InjuryMay 25, 2023Migration or Expulsion of Device; Material Integrity Problem; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Migration or Expulsion of Device; Material Integrity Problem; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF AN INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED FAILURE OF MESH, MESH MIGRATION, MESH CONTRACTION, DEFECTIVE MESH, RECURRENCE, ADHESIONS, BOWEL PERFORATION, CORD LIMPOMA, INFLAMMATION, NERVE DAMAGE, PAIN, MENTAL PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, SCARRING, DISABILITY. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, REMOVAL OF MESH.

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Bowel Perforation; Burning Sensation; Discomfort; Dyspareunia; Emotional Changes; Hemorrhage/Blood Loss/Bleeding; Hernia; Inflammation; Nerve Damage; Nodule; Numbness; Obstruction/Occlusion; Pain; Scar Tissue; Sleep Dysfunction; Unspecified Tissue Injury

  MAUDE report 17003818 ↗
• InjuryMay 10, 2023Migration or Expulsion of Device; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Migration or Expulsion of Device; Mechanics Altered; Adverse Event Without Identified Device or Use Problem

  THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF AN INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED MESH PULLED AWAY, DEFECTIVE MESH, ABDOMINAL PAIN, RECURRENCE, PAIN, INFLAMMATION, SCARRING, MENTAL PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, HERNIA REPAIR WITH NEW MESH.

  Patient problems: Abdominal Pain; Adhesion(s); Discomfort; Emotional Changes; Hernia; Inflammation; Pain; Scar Tissue; Unspecified Tissue Injury

  MAUDE report 16906241 ↗
• InjuryJan 31, 2023Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Mechanics Altered; Adverse Event Without Identified Device or Use Problem

  THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF A VENTRAL HERNIA. IT WAS REPORTED THAT AFTER UNDERLAY IMPLANT, THE PATIENT EXPERIENCED ADHESIVE MASS, ABDOMINAL PAIN, NAUSEA, VOMITING, FAILURE OF MESH, DEFECTIVE MESH, PAIN, EMOTIONAL DISTRESS, MENTAL PAIN, ADHESIONS, OBSTRUCTION, INFLAMMATION, INFECTION, DISABILITY, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE. POST-OPERATIVE PATIENT TREATMENT INCLUDED DIAGNOSTIC LAP, LAP ENTEROLYSIS, INTERNAL HERNIA REDUCTION, OMENTECTOMY, PROCEDURE FOR SMALL BOWEL OBSTRUCTION, CT SCAN, AND LYSIS OF ADHESIONS.

  Patient problems: Abdominal Pain; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Distress; Emotional Changes; Inflammation; Nausea; Nodule; Obstruction/Occlusion; Pain; Unspecified Infection; Unspecified Tissue Injury; Vomiting

  MAUDE report 16275054 ↗
• InjuryOct 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT¿S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF A VENTRAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED INFECTION, HERNIA RECURRENCE, ADHESIONS, <(>&<)> ABSCESS. POST-OPERATIVE PATIENT TREATMENT INCLUDED USE OF BLAKE DRAIN.

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

  MAUDE report 15537817 ↗
• InjuryMay 10, 2022Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Mechanics Altered; Adverse Event Without Identified Device or Use Problem

  THE PATIENT¿S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF A INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DEFECTIVE DEVICE, SEVERE PAIN, ABSCESS, SCARRING, NERVE DAMAGE, INFECTION, SWELLING, BLEEDING RECURRENCE, INFLAMMATION, MENTAL PAIN, DISABILITY, IMPAIRMENT, MESH FAILURE, AND LOSS OF ENJOYMENT OF LIFE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY AND MESH REMOVAL.

  Patient problems: Abscess; Adhesion(s); Emotional Changes; Hemorrhage/Blood Loss/Bleeding; Hernia; Inflammation; Nerve Damage; Pain; Scar Tissue; Swelling/ Edema; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 14349860 ↗
• InjuryJan 2, 2022Migration or Expulsion of Device; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Migration or Expulsion of Device; Mechanics Altered; Adverse Event Without Identified Device or Use Problem

  THE PATIENT¿S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF A VENTRAL INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED MENTAL PAIN/ANGUISH, PAIN, DISABILITY, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, DEFECTIVE MESH, AND EMOTIONAL DISTRESS. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICAL TREATMENT.

  Patient problems: Abdominal Distention; Abdominal Pain; Adhesion(s); Anxiety; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Ascites; Distress; Emotional Changes; Fever; Fluid Discharge; Hematoma; Hernia; Inflammation; Nausea; Nerve Damage; Numbness; Obstruction/Occlusion; Pain; Pneumonia; Respiratory Failure; Seroma; Unspecified Tissue Injury; Vomiting

  MAUDE report 13139274 ↗
• InjuryMay 19, 2021Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem; Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem

  THE PATIENT¿S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF A HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED ADHESIONS, RECURRENCE, PAIN, BOWEL INVOLVEMENT, AND DETACHED MESH. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY AND REMOVAL.

  Patient problems: Adhesion(s); Hernia; Pain; Unspecified Tissue Injury

  MAUDE report 11852161 ↗
• InjuryMay 11, 2021Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Mechanics Altered; Adverse Event Without Identified Device or Use Problem

  THE PATIENT¿S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF A ABDOMINAL HERNIA . IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED MESH DESIGN DEFECT. POST-OPERATIVE PATIENT TREATMENT INCLUDED HERNIA REPAIR SURGERY WITH MESH, AND REVISION SURGERY.

  Patient problems: Distress; Hernia; Unspecified Tissue Injury

  MAUDE report 11807803 ↗
• InjuryMar 26, 2021Migration or Expulsion of Device; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Patient Device Interaction Problem; Migration or Expulsion of Device; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Patient Device Interaction Problem

  THE PATIENT¿S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF A HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, FAILURE OF MESH, MESH MIGRATION, SEROMA, ADHESIONS, INFLAMMATION, FOREIGN BODY GIANT CELL REACTION, AND FIBROSIS. POST-OPERATIVE PATIENT TREATMENT INCLUDED MESH REMOVAL SURGERY AND HERNIA REPAIR WITH MESH.

  Patient problems: Adhesion(s); Failure of Implant; Fibrosis; Foreign Body Reaction; Hernia; Inflammation; Pain; Seroma; Unspecified Tissue Injury

  MAUDE report 11575687 ↗
• InjuryMar 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT¿S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR LAPAROSCOPIC THERAPEUTIC TREATMENT OF A RIGHT INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE AND PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Hernia; Pain; Unspecified Tissue Injury

  MAUDE report 11461892 ↗
• InjuryDec 28, 2020Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  THE PATIENT¿S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF AN ABDOMINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED ADHESIONS, RECURRENCE, CHRONIC PAIN, AND DISCOMFORT. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, MESH REMOVAL, AND HERNIA REPAIR WITH NEW MESH.

  Patient problems: Abdominal Pain; Adhesion(s); Discomfort; Emotional Changes; Hernia; Inflammation; Pain; Scar Tissue; Unspecified Tissue Injury

  MAUDE report 11080159 ↗
• InjuryNov 16, 2020Migration or Expulsion of Device; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Migration or Expulsion of Device; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  THE PATIENT¿S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT A VENTRAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, HEMATOMA, OBSTRUCTION, BLEEDING, FISTULA, SEROMA, NAUSEA, VOMITING, LOSS OF APPETITE, DULL STABBING ABDOMINAL PAIN, ACID REFLUX, IRREGULAR BOWEL MOVEMENTS, NECROTIZING SOFT TISSUE INFECTION, PERFORATION, PERFORATED ULCER, DIVERTICULUM, PAIN, DISCOMFORT, MESH INFECTION, ADHESIONS, MENTAL PAIN, SCARRING, PERMANENT IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, DEFECTIVE MESH, INFLAMMATION, MESH MIGRATION, FAILURE OF MESH, AND ABDOMINAL PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICATION, SUTURE OF SMALL INTESTINE FOR PERFORATED ULCER, REVISION SURGERY, MESH INTERVENTION SURGERY, AND REMOVAL OF MESH.

  Patient problems: Abdominal Pain; Abscess; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Ascites; Decreased Appetite; Dehydration; Diarrhea; Discomfort; Distress; Emotional Changes; Fistula; Hematoma; Hemorrhage/Blood Loss/Bleeding; Hernia; Inflammation; Lethargy; Nausea; Necrosis; Obstruction/Occlusion; Pain; Perforation; Scar Tissue; Seroma; Ulcer; Unspecified Infection; Unspecified Tissue Injury; Vomiting

  MAUDE report 10848264 ↗
• InjuryJul 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT¿S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR LAPAROSCOPIC THERAPEUTIC TREATMENT OF AN INCISIONAL VENTRAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, SEROSAL TEARS, AND ADHESIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, SEROSAL TEARS REPAIRED, HERNIA SAC/EXCESS MESH REMOVED, AND HERNIA REPAIR WITH NEW MESH.

  Patient problems: Adhesion(s); Distress; Hernia; Injury; Unspecified Tissue Injury

  MAUDE report 10292131 ↗
• InjuryJul 9, 2020Migration or Expulsion of Device; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Migration or Expulsion of Device; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  THE PATIENT¿S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF AN ABDOMINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED MESH DETACHMENT, ADHESIONS TO SMALL INTESTINE, CHRONIC ABDOMINAL PAIN, RECURRENCE, AND MESH EROSION THROUGH BOWEL WALL. POST-OPERATIVE PATIENT TREATMENT INCLUDED A BOWEL RESECTION AND REVISION SURGERY.

  Patient problems: Abdominal Distention; Abdominal Pain; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Cardiovascular Dysfunction/Insufficiency; Discomfort; Emotional Changes; Erosion; Fibrosis; Fistula; Hemorrhage/Blood Loss/Bleeding; Hernia; Hyperplasia; Hypersensitivity/Allergic reaction; Inflammation; Injury; Neovascularization; Obstruction/Occlusion; Pain; Scar Tissue; Stenosis; Swelling/ Edema; Unspecified Tissue Injury

  MAUDE report 10251943 ↗
• InjuryJun 5, 2020Migration or Expulsion of Device; Material Deformation; Material Integrity Problem; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Material Split, Cut or Torn; Migration or Expulsion of Device; Material Deformation; Material Integrity Problem; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Material Split, Cut or Torn

  THE PATIENT¿S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF A HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED EVENTRATION OF MESH, ADHESIONS, FAILURE OF MESH, MESH MIGRATION, CONTRACTION OF MESH, PAIN, AND SCARRING. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY AND REMOVAL OF MESH.

  Patient problems: Abdominal Distention; Adhesion(s); Ascites; Discomfort; Emotional Changes; Failure of Implant; Hernia; Inflammation; Injury; Pain; Scar Tissue; Scarring; Unspecified Tissue Injury

  MAUDE report 10123732 ↗
• InjuryMar 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT¿S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF A VENTRAL INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED ADHESIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, PORT PLACED THROUGH PREVIOUS MESH, AND LYSIS OF ADHESIONS.

  Patient problems: Adhesion(s); Injury

  MAUDE report 9886080 ↗
• InjuryMar 13, 2020Migration or Expulsion of Device; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Migration or Expulsion of Device; Mechanics Altered; Adverse Event Without Identified Device or Use Problem

  THE PATIENT¿S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF AN ABDOMINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENT HERNIA, ADHESIONS AND SMALL BOWEL OBSTRUCTION. POST-OPERATIVE PATIENT TREATMENT INCLUDED RECURRENT HERNIA REPAIR, EXCISION OF OLD MESH AND LYSIS OF ADHESIONS.

  Patient problems: Abdominal Distention; Adhesion(s); Burning Sensation; Discomfort; Emotional Changes; Fibrosis; Foreign Body Reaction; Hernia; Inflammation; Injury; Obstruction/Occlusion; Pain; Scar Tissue; Unspecified Tissue Injury

  MAUDE report 9828486 ↗
• InjuryJan 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT¿S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF A HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, MENTAL PAIN, PERMANENT IMPAIRMENT, AND LOSS OF ENJOYMENT OF LIFE. POST-OPERATIVE PATIENT TREATMENT INCLUDED BOWEL RESECTION AND MESH REMOVAL.

  Patient problems: Abscess; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Emotional Changes; Inflammation; Injury; Obstruction/Occlusion; Pain; Tachycardia; Unspecified Tissue Injury

  MAUDE report 9639063 ↗
• DeathDec 11, 2019Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  THE PATIENT¿S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF AN INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED FISTULA, INFECTION AND DENSE ADHESIONS OF SMALL BOWEL TO THE MESH. POST-OPERATIVE PATIENT TREATMENT INCLUDED SMALL BOWEL RESECTION AND MESH REMOVAL SURGERY. INFORMATION RECEIVED INDICATES THE PATIENT IS DECEASED. NO INFORMATION WAS PROVIDED REGARDING THE CIRCUMSTANCES OF EXPIRATION OR ANY ASSOCIATION WITH THIS DEVICE.

  Patient problems: Abscess; Adhesion(s); Distress; Fistula; Fluid Discharge; Injury; Necrosis; Nodule; Pain; Perforation; Seroma; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 9450784 ↗