Symbotex SYM2520Recalls & reported problems

Summary

The FDA's MAUDE database contains 130 adverse event reports that list this exact device (DI 10884521190481), received between Oct 4, 2017 and Mar 19, 2026 — classified as 128 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Mechanics Altered” (62 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 130 reports, in the reporter's own words as published by the FDA.

• InjuryMar 19, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING A SURGICAL PROCEDURE IN (B)(6) 2019 FOR AN UMBILICAL HERNIA AND DIASTASIS, A HIGH EVENTRATION OCCURRED, INDICATING RECURRENCE OR NEW HERNIATION AFTER THE INITIAL SURGERY, AND IT WAS ALLEGED THAT THE FIRST PROSTHESES FAILED. A SECOND OPERATION WAS PERFORMED IN (B)(6) 2020 WITH IMPLANTATION OF MESH. SINCE THESE PROCEDURES, THE INDIVIDUAL EXPERIENCED CHRONIC AND VERY FREQUENT STOMACH PAIN, DIGESTION PROBLEMS, ACCUMULATED FATIGUE, INABILITY TO RESUME SPORTS AND NORMAL LIFE, HEART PROBLEMS WITH TACHYCARDIA, SUSPICION OF MYOCARDITIS AND/OR PERICARDITIS, SYMPTOMS SIMILAR TO A HEART ATTACK, LUNG PROBLEMS, HOSPITALIZATION, AND ONGOING MONITORING OF THE LUNGS. NUMEROUS MEDICAL TESTS WERE CONDUCTED, WHICH REVEALED NO SPECIFIC FINDINGS, AND A DIAGNOSIS OF "LONG COVID" WAS MADE. THE INDIVIDUAL ALSO REPORTED PSYCHOLOGICAL IMPACT AND CONSEQUENCES ON MORALE.

  Patient problems: Abdominal Pain; Fatigue; Hernia; Tachycardia; Unspecified Gastrointestinal Problem; Unspecified Heart Problem; Unspecified Respiratory Problem

  MAUDE report 24637813 ↗
• InjuryMar 9, 2026Adverse 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 UNSPECIFIED ADVERSE OUTCOME.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 24546394 ↗
• InjuryNov 3, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; 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 INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED ADHESIONS, PAIN, SUFFERING, MESH FAILURE, EMOTIONAL DISTRESS, RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, MESH REMOVAL, CLOSURE OF ABDOMINAL WALL, WOUND VAC PLACEMENT AND HERNIA REPAIR WITH NEW MESH.

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

  MAUDE report 23457746 ↗
• InjurySep 17, 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 INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, RECURRENCE, ADHESIONS, OBSTRUCTION, WEIGHT LOSS. POST-OPERATIVE PATIENT TREATMENT INCLUDED INTERVENTION SURGERY AND REMOVAL OF MESH.

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

  MAUDE report 23079196 ↗
• InjuryMay 12, 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 A VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, RECURRENCE, INFLAMMATION, ADHESIONS, NAUSEA, AND LACK OF MOBILITY. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, REMOVAL OF MESH, HERNIA REPAIR WITH NEW MESH, AND MEDICATION.

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

  MAUDE report 22007163 ↗
• InjuryMay 12, 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 A VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, RECURRENCE, INFLAMMATION, ADHESIONS, NAUSEA, AND LACK OF MOBILITY. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICATION.

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

  MAUDE report 22007162 ↗
• MalfunctionApr 29, 2025Detachment of Device or Device Component; Material Split, Cut or Torn; Detachment of Device or Device Component; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, IT WAS OBSERVED THAT THE MESH COVERING CAME OFF. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21931153 ↗
• InjuryFeb 20, 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 A HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED EMOTIONAL DISTRESS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

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

  MAUDE report 21426019 ↗
• InjuryJan 17, 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 A HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED AN UNSPECIFIED ADVERSE EVENT. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Abscess; Ascites; Hernia; Pain; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 21180174 ↗
• InjuryDec 10, 2024Mechanics Altered; Adverse Event Without Identified Device or Use Problem; 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 INCISIONAL UMBILICAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DEFECTIVE MESH, DISCOMFORT, INFLAMMATION, ADHESIONS, SCARRING, PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, MENTAL PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED MESH REVISION.

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

  MAUDE report 20893936 ↗
• InjuryOct 28, 2024Mechanics Altered; Adverse Event Without Identified Device or Use Problem; 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 A VENTRAL INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DEFECTIVE MESH, RECURRENCE, ADHESIONS, SCARRING, PAIN, MENTAL PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE. POST-OPERATIVE PATIENT TREATMENT INCLUDED HERNIA REPAIR WITH NEW MESH, LEFT/RIGHT MYOFASCIAL CUTANEOUS RECTUS ABDOMINIS MUSCLE RELEASE, TRANSVERSUS ABDOMINIS RELEASE.

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

  MAUDE report 20547197 ↗
• InjurySep 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POSTOPERATIVELY, AN INCISIONAL HERNIA UNDERWENT CLOSURE WITH A DOUBLE-FACED MESH. THE PATIENT WAS REOPERATED DUE TO TRANSVERSE COLON PERFORATION AND PRONOUNCED ADHESIONS. THE REOPERATION INVOLVED COLOSTOMY AND REMOVAL OF THE MESH FROM THE INTESTINAL LOOP. THE PATIENT IS CURRENTLY STABLE. IT WAS ALSO REPORTED THAT THE PATIENT WAS HOSPITALIZED FOR TWO MONTHS. IT WAS ALSO CONFIRMED BY THE SURGEON THAT THE MESH CAUSED ALL THIS PROBLEM FOR THE PATIENT.

  Patient problems: Adhesion(s); Perforation; Tissue Breakdown

  MAUDE report 20247808 ↗
• InjuryAug 22, 2024Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Material Split, Cut or Torn; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Material Split, Cut or Torn

  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, FAILURE OF MESH, ABDOMINAL PAIN, RECURRENCE, SCARRING, PAIN, MENTAL PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE. POST-OPERATIVE PATIENT TREATMENT INCLUDED HERNIA REPAIR WITH NEW MESH, BILATERAL COMPONENT SEPARATION, JP DRAIN PLACED.

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

  MAUDE report 20043833 ↗
• InjuryJul 30, 2024Mechanics 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 INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DEFECTIVE MESH, RECURRENCE, ABDOMINAL PAIN, INFECTION, ADHESIONS, SCARRING, PAIN, MENTAL PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REMOVAL OF MESH, HERNIA REPAIR WITH NEW MESH.

  Patient problems: Abdominal Pain; Adhesion(s); Burning Sensation; Emotional Changes; Fluid Discharge; Hernia; Pain; Scar Tissue; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 19863663 ↗
• InjuryJul 2, 2024Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction 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 PAIN, INFECTION, RECURRENCE, ABSCESS, FREE-FLOATING MESH, DISCOMFORT, DEFECTIVE MESH. POST-OPERATIVE PATIENT TREATMENT INCLUDED DRAINAGE OF ABSCESS, ABDOMINAL WALL DEBRIDEMENT, DISSECTION OF MESH, REMOVAL OF MESH.

  Patient problems: Abscess; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Hematoma; Hernia; Hypersensitivity/Allergic reaction; Inflammation; Itching Sensation; Pain; Seroma; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 19662265 ↗
• InjuryJun 3, 2024Mechanics 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 A VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DEFECTIVE MESH, ABDOMINAL PAIN, RECURRENCE, PAIN, MENTAL PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, SCARRING. POST-OPERATIVE PATIENT TREATMENT INCLUDED REMOVAL OF MESH, HERNIA REPAIR WITH NEW MESH, BILATERAL SOFT TISSUE ADVANCEMENT.

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

  MAUDE report 19455626 ↗
• InjuryApr 18, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  ACCORDING TO THE REPORTER, AFTER A LAPAROSCOPIC PARAUMBILICAL HERNIA REPAIR PROCEDURE, DURING ABDOMINAL WALL REPAIR, THE SURGEON FOUND THAT THE MESH FIBERS WERE NOT PRESENT IN THE CENTER OF THE DEFECT DUE TO MESH MATERIAL EROSION, WHICH LED TO ANOTHER HERNIA PROTRUSION. ANOTHER LAPAROSCOPIC PARAUMBILICAL HERNIA REPAIR PROCEDURE WAS PERFORMED USING A NEW MESH TO COVER THE DEFECT.

  Patient problems: Hernia

  MAUDE report 19133440 ↗
• InjuryDec 15, 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 IMPLANT, THE PATIENT EXPERIENCED DEFECTIVE MESH, ABDOMINAL PAIN, RECURRENCE, ADHESIONS, INFLAMMATION, SCARRING, PAIN, MENTAL PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE. POST-OPERATIVE PATIENT TREATMENT INCLUDED HERNIA REPAIR WITH NEW MESH.

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

  MAUDE report 18339729 ↗
• InjuryDec 15, 2023Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Patient Device Interaction Problem; Mechanics Altered; 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 AN INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DEFECTIVE MESH, ABDOMINAL PAIN, DISCOMFORT, ADHESIONS, FOREIGN BODY REACTION, SEROMA, MASS, SCARRING, PAIN, MENTAL PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, DISFIGUREMENT, DISABILITY. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, REMOVAL OF MESH, HERNIA REPAIR WITH SUTURES.

  Patient problems: Abdominal Distention; Abdominal Pain; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Decreased Appetite; Deformity/ Disfigurement; Discomfort; Emotional Changes; Foreign Body Reaction; Hypersensitivity/Allergic reaction; Nodule; Pain; Perforation; Scar Tissue; Seroma; Unspecified Tissue Injury

  MAUDE report 18338210 ↗
• InjuryOct 20, 2023Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Material Split, Cut or Torn; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction 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 VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DEFECTIVE MESH, FAILURE OF MESH, MESH FRACTURED, INFECTION, RECURRENCE, SCAR TISSUE, SINUS TRACT, CELLULITIS, SEPSIS, INFLAMMATION, NERVE DAMAGE, SCARRING, PAIN, MENTAL PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, DISABILITY. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, REMOVAL OF MESH, EXCISION OF SCAR TISSUE.

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Cellulitis; Emotional Changes; Fistula; Fluid Discharge; Hemorrhage/Blood Loss/Bleeding; Hernia; Hypersensitivity/Allergic reaction; Inflammation; Nerve Damage; Pain; Scar Tissue; Sepsis; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 17977580 ↗
• InjuryOct 10, 2023Adverse 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 IMPLANT, THE PATIENT EXPERIENCED PAIN, RECURRENCE, ADHESIONS, SEROMA, OBSTRUCTION. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICATION, RECURRENT HERNIA REPAIR, SMALL BOWEL RESECTION AND LYSIS OF ADHESIONS.

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

  MAUDE report 17907173 ↗
• InjurySep 29, 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 AN INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DEFECTIVE MESH, ABDOMINAL PAIN, RECURRENCE, ADHESIONS, BOWEL OBSTRUCTION, SCARRING, PAIN, MENTAL PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REMOVAL OF MESH, DIAGNOSTIC LAPAROSCOPY, LYSIS OF ADHESIONS, HERNIA REPAIR, SMALL BOWEL RESECTION.

  Patient problems: Abdominal Pain; Adhesion(s); Emotional Changes; Hernia; Hypersensitivity/Allergic reaction; Impaired Healing; Inflammation; Obstruction/Occlusion; Pain; Scar Tissue; Unspecified Tissue Injury

  MAUDE report 17844800 ↗
• InjuryJun 12, 2023Detachment of Device or Device Component; Material Split, Cut or Torn; Detachment of Device or Device Component; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING AN OPEN VENTRAL HERNIA REPAIR, ON MESH IMPLANT, AFTER OPENING THE PACKAGE, THE MESH WAS DAMAGE. IT WAS STATED THAT THERE WAS LIKE HONEYCOMB SHAPED PIECES OF STUFF COMING OFF OF THE MESH. IT WAS ALSO MENTIONED THAT A COMPONENT FELL INTO THE CAVITY OF THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 17107246 ↗
• InjuryMay 25, 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 A VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED MESH FOLDED, DEFECTIVE MESH, ABDOMINAL PAIN, RECURRENCE, INFLAMMATION, ADHESIONS, PAIN, MENTAL PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, SCARRING. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, REMOVAL OF MESH, HERNIA REPAIR.

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

  MAUDE report 17004222 ↗
• InjuryMay 9, 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 AN INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DEFECTIVE MESH, ABDOMINAL PAIN, RECURRENCE, INFLAMMATION, ADHESIONS, PAIN, SCARRING, MENTAL PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, REMOVAL OF MESH, HERNIA REPAIR WITH NEW MESH.

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

  MAUDE report 16896358 ↗