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Symbotex SYM2015Recalls & reported problems

Sofradim Production · Composite Mesh,Monofilament Polyester with Absorbable Collagen Film and Marking · Class 2 · Implant

All models of Symbotex (31)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Quick summary

This Sofradim Symbotex mesh is a surgical polyester mesh used to repair hernias. Its 241 reports describe hernias returning, pain, scar tissue sticking to organs and mesh moving out of place, and some led to repeat surgery. The reports include 232 injuries and 2 deaths, and reports fell from 13 in the prior 12 months to 6 in the last 12 months. No recalls name this device.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports
242
Deaths reported
2
Injuries reported
233
Recalls naming it
0

Summary

The FDA's MAUDE database contains 242 adverse event reports that list this exact device (DI 10884521190450), received between Sep 21, 2017 and Jul 30, 2026 — classified as 2 deaths, 233 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Mechanics Altered” (124 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.

Reports received per month

Nov 2023: 1 reportsDec 2023: 3 reportsJan 2024: 1 reportsFeb 2024: 3 reportsMar 2024: 1 reportsApr 2024: 1 reportsMay 2024: 3 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 2 reportsNov 2024: 0 reportsDec 2024: 3 reportsJan 2025: 0 reportsFeb 2025: 1 reportsMar 2025: 2 reportsApr 2025: 0 reportsMay 2025: 4 reportsJun 2025: 1 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 2 reportsOct 2025: 0 reportsNov 2025: 1 reportsDec 2025: 1 reportsJan 2026: 0 reportsFeb 2026: 1 reportsMar 2026: 0 reportsApr 2026: 1 reportsMay 2026: 1 reportsJun 2026: 0 reportsJul 2026: 2 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520264
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem232
  • Mechanics Altered124
  • Migration or Expulsion of Device64
  • Patient Device Interaction Problem47
  • Insufficient Device Problem Information25
  • Material Split, Cut or Torn20
  • Material Deformation12
  • Material Integrity Problem11

Patient problems

  • Hernia197
  • Adhesion(s)194
  • Unspecified Tissue Injury191
  • Pain188
  • Emotional Changes120
  • Injury101
  • Inflammation100
  • Scar Tissue94

Recent adverse event reports

The 25 most recent of 242 reports, in the reporter's own words as published by the FDA.

  • InjuryJul 30, 2026Adverse 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 a ventral hernia. It was reported that after the implant, the patient experienced pain, infection, hernia recurrence, inflammation, adhesions, perforation, <(>&<)> erosion. Post-operative patient treatment included lysis of adhesions, mesh removal, small bowel resection, anastomosis, hernia repair with mesh, <(>&<)> use of JP drain.

    Patient problems: Adhesion(s); Erosion; Hernia; Inflammation; Pain; Perforation; Unspecified Infection; Unspecified Tissue Injury

    MAUDE report 50082666 ↗
  • InjuryJul 28, 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 an incisional hernia. It was reported that after implant, the patient experienced pain, recurrence, adhesions, obstruction, scar tissue and difficulty having bowel movements. Post-operative patient treatment included medication, hernia repair with new mesh, lysis of adhesions and hernia repair.

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

    MAUDE report 50059929 ↗
  • InjuryMay 26, 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 AN INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, PAIN AND SUFFERING.

    Patient problems: Hernia; Pain; Unspecified Tissue Injury

    MAUDE report 25281114 ↗
  • InjuryApr 6, 2026Migration or Expulsion of Device; 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 UMBILICAL AND VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED ADHESIONS, PERFORATION, MESH MIGRATION, PAIN, SUFFERING, FAILURE OF MESH TO MAINTAIN REPAIR, UNINCORPORATED MESH, EMOTIONAL DISTRESS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, BLUNT AND SHARP DISSECTION, DIAGNOSTIC LAPAROSCOPY, LYSIS OF ADHESIONS, PARTIAL MESH EXPLANT AND REPAIR OF PARTIAL THICKNESS SMALL BOWEL INJURY.

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

    MAUDE report 24792268 ↗
  • InjuryFeb 10, 2026Adverse Event Without Identified Device or Use Problem

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

    Patient problems: Hernia; Pain; Unspecified Tissue Injury

    MAUDE report 24306215 ↗
  • InjuryDec 1, 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 PARASTOMAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, INFECTION, RECURRENCE, BLEEDING, ABDOMINAL DISTENTION, NON-HEALING ABDOMINAL WOUND, ABSCESS, INCARCERATED HERNIA, SUFFERING, UNABLE TO USE ABDOMINAL MUSCLES, DISFIGUREMENT, STOMA BLEEDING, AND SEPSIS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, REMOVAL OF MESH, MEDICATION, AND COLOSTOMY BAG USE.

    Patient problems: Abdominal Distention; Abscess; Deformity/ Disfigurement; Hemorrhage/Blood Loss/Bleeding; Hernia; Impaired Healing; Pain; Sepsis; Unspecified Infection; Unspecified Tissue Injury

    MAUDE report 23686807 ↗
  • InjuryNov 12, 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED MESH FAILURE, PAIN, EMOTIONAL CHANGES, DISCOMFORT, RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, REMOVAL OF MESH, MEDICATION, AND HERNIA REPAIR WITH NEW MESH.

    Patient problems: Discomfort; Emotional Changes; Hernia; Pain; Unspecified Tissue Injury

    MAUDE report 23536692 ↗
  • InjurySep 19, 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 A HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED EMOTIONAL DISTRESS, RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY AND HERNIA REPAIR WITH NEW MESH.

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

    MAUDE report 23099857 ↗
  • InjurySep 18, 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED MESH FAILURE, PAIN, RECURRENCE, ADHESIONS, EMOTIONAL CHANGES, DISCOMFORT. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, HERNIA REPAIR WITH NEW MESH, MEDICATION.

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

    MAUDE report 23088599 ↗
  • InjuryJun 16, 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 PARASTOMAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, RECURRENCE, ADHESIONS, AND OBSTRUCTIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, SMALL BOWEL RESECTION, DEBRIDEMENT, LYSIS OF ADHESIONS, REMOVAL OF MESH, AND HERNIA REPAIR WITH NEW MESH.

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

    MAUDE report 22215192 ↗
  • InjuryMay 27, 2025Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Material Split, Cut or Torn; 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 VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED MESH FRACTURE, DEFECTIVE MESH, ABDOMINAL PAIN, RECURRENCE, ADHESIONS, ABSCESS, SCARRING, PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, MENTAL PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REMOVAL OF MESH, LYSIS OF ADHESIONS, HERNIA REPAIR.

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

    MAUDE report 22090866 ↗
  • InjuryMay 27, 2025Material Deformation; Adverse Event Without Identified Device or Use Problem; Material Deformation; 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 BALLOONED INWARD, PAIN, RECURRENCE, HEMATOMA, INFLAMMATION, AND NAUSEA. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICATION.

    Patient problems: Hematoma; Hernia; Inflammation; Nausea; Pain; Unspecified Tissue Injury

    MAUDE report 22090021 ↗
  • InjuryMay 6, 2025Mechanics 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, SCARRING, PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, MENTAL PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, LYSIS OF ADHESIONS, SMALL BOWEL RESECTION.

    Patient problems: Abdominal Pain; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Decreased Appetite; Discomfort; Emotional Changes; Hernia; Obstruction/Occlusion; Pain; Scar Tissue; Unspecified Gastrointestinal Problem; Unspecified Tissue Injury

    MAUDE report 21968917 ↗
  • InjuryMay 1, 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, INFECTION, RECURRENCE, HEMATOMA, INFLAMMATION, ADHESIONS, BOWEL OBSTRUCTION, BLEEDING, SEROMA. POST-OPERATIVE PATIENT TREATMENT INCLUDED REMOVAL OF MESH, INTENSIVE CARE (ICU), 11 BLOOD TRANSFUSION, LIFE SUPPORT FOR SEVERAL DAYS.

    Patient problems: Adhesion(s); Hematoma; Hemorrhage/Blood Loss/Bleeding; Hernia; Inflammation; Obstruction/Occlusion; Pain; Seroma; Unspecified Infection; Unspecified Tissue Injury

    MAUDE report 21947348 ↗
  • InjuryMar 28, 2025Mechanics 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 LAPAROSCOPIC THERAPEUTIC TREATMENT OF A VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DEFECTIVE MESH, ADHESIONS, PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, MENTAL PAIN, DISABILITY, EROSION, BOWEL CONSTRICTIONS, DISTENTION, OBSTRUCTION, ACUTE ENTERITIS, ISCHEMIC CHANGES, ULCERATION, ABSCESS FORMATION, PERITONITIS, ABDOMINAL RASH, ALLERGY, CONSTIPATION, BLOATING, FECAL RETENTION, ABDOMINAL PAIN, & NAUSEA. POST-OPERATIVE PATIENT TREATMENT INCLUDED REMOVAL OF MESH, LYSIS OF ADHESIONS, BOWEL RESECTION, MEDICATION, CT SCAN, & EXPLORATORY LAPAROTOMY.

    Patient problems: Abdominal Distention; Abdominal Pain; Abscess; Adhesion(s); Constipation; Emotional Changes; Erosion; Hypersensitivity/Allergic reaction; Inflammation; Ischemia; Nausea; Obstruction/Occlusion; Pain; Peritonitis; Rash; Ulcer; Unspecified Tissue Injury

    MAUDE report 21722782 ↗
  • InjuryMar 18, 2025Migration 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 BUNCHED UP, FAILURE OF MESH, PAIN, RECURRENCE, ADHESIONS, FOREIGN BODY REACTION, ABDOMINAL PAIN, DISCOMFORT.

    Patient problems: Abdominal Pain; Adhesion(s); Discomfort; Foreign Body Reaction; Hernia; Pain; Unspecified Tissue Injury

    MAUDE report 21636764 ↗
  • InjuryFeb 5, 2025Adverse 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 A VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, RECURRENCE, INFLAMMATION, ADHESIONS, FOREIGN BODY REACTION, INFECTION, ALLERGIC REACTION, OBSTRUCTION, PERFORATION, ABDOMINAL PAIN, AND NUMBNESS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, PARTIAL REMOVAL OF MESH, REMOVAL OF MESH, AND MEDICATION.

    Patient problems: Abdominal Pain; Adhesion(s); Foreign Body Reaction; Hernia; Hypersensitivity/Allergic reaction; Inflammation; Numbness; Obstruction/Occlusion; Pain; Perforation; Unspecified Infection; Unspecified Tissue Injury

    MAUDE report 21316676 ↗
  • MalfunctionDec 13, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC ÉVENTRATION PROCEDURE, THE MESH WAS IMPLANTED, VENTRAL HERNIA FOLLOWING THE IMPLANTATION. THE PROSTHESIS WAS NOTED TO HAVE A HOLE IN THE MIDDLE. THE MESH WAS NOT IMPLANTED IN A CONTAMINATED FIELD. THE DEVICE WAS EXPLANTED.

    Patient problems: Insufficient Information

    MAUDE report 20925101 ↗
  • MalfunctionDec 13, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

    IT WAS REPORTED THAT DURING A PROCEDURE, THERE WAS A HOLE ON THE MESH.

    Patient problems: Insufficient Information

    MAUDE report 20925098 ↗
  • MalfunctionDec 13, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

    IT WAS REPORTED THAT DURING A PROCEDURE, THERE WAS A HOLE ON THE MESH.

    Patient problems: Insufficient Information

    MAUDE report 20925039 ↗
  • InjuryOct 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    ACCORDING TO THE REPORTER, POST-OPERATIVE A EXTENDED TOTALLY EXTRAPERITONEAL (ETEP) HERNIA REPAIR, THE SURGEON WAS NOT ABLE TO CLOSE THE POSTERIOR FACIAL SHEET AND SO A MESH WAS APPLIED INTRAPERITONEAL TO COVER THE POSTERIOR FACIAL SHEET. THE PATIENT HAD A DYSMOTILITY OF THE SMALL INTESTINE AS A RESULT OF REACTION TO COATING NET. THE SURGEON SAW MUCUS-LIKE DROPS FROM THE NET AND REACTION ON THE SEROSA SIDE OF THE SMALL INTESTINE. THE PATIENT HAD A BLOOD LOSS OF LESS THAN 50 ML DUE TO THE ISSUE. A SMALL BOWEL RESECTION WAS PERFORMED. THE PATIENT DEVELOPED AN ILEUS DUE TO THE ISSUE WHICH HAD TO BE RE-OPERATED AND RE-ADMITTED TO THE HOSPITAL.

    Patient problems: Foreign Body Reaction; Hemorrhage/Blood Loss/Bleeding; Obstruction/Occlusion; Tissue Breakdown; Unspecified Gastrointestinal Problem

    MAUDE report 20493965 ↗
  • InjuryOct 10, 2024Adverse 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 A VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, RECURRENCE, INFLAMMATION, ADHESIONS, PERFORATION, SUTURE GRANULOMA, AND INCARCERATION OF HERNIA. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICATION, BOWEL RESECTION, AND USE OF DRAIN.

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

    MAUDE report 20422557 ↗
  • InjuryMay 28, 2024Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

    PLI 20 THE PATIENT¿S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, INFLAMMATION, ADHESIONS, INFECTION, RECURRENCE, OBSTRUCTIONS, FISTULAS, SCAR TISSUE, PERFORATION. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, REMOVAL OF MESH, LYSIS OF ADHESIONS, SMALL BOWEL FISTULA REPAIR, EXPLORATORY LAPAROTOMY, EXTENSIVE LYSIS OF ADHESIONS, SMALL BOWEL RESECTION WITH PRIMARY REANASTOMOSIS.

    Patient problems: Adhesion(s); Fistula; Hernia; Inflammation; Obstruction/Occlusion; Pain; Perforation; Scar Tissue; Unspecified Infection; Unspecified Tissue Injury

    MAUDE report 19404267 ↗
  • InjuryMay 28, 2024Adverse 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 A VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED ADHESIONS, PAIN, INFLAMMATION, OBSTRUCTIONS, BLEEDING, SEROMA, PERFORATION, ABDOMINAL PAIN, RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICATION.

    Patient problems: Abdominal Pain; Adhesion(s); Hemorrhage/Blood Loss/Bleeding; Hernia; Inflammation; Obstruction/Occlusion; Pain; Perforation; Seroma; Unspecified Tissue Injury

    MAUDE report 19403401 ↗
  • InjuryMay 10, 2024Migration or Expulsion of Device; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Migration or Expulsion of Device; 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 MESH MIGRATION, DEFECTIVE MESH, FAILURE OF MESH, ABDOMINAL PAIN, RECURRENCE, FOREIGN BODY REACTION, PAIN, MENTAL PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, DISABILITY. POST-OPERATIVE PATIENT TREATMENT INCLUDED REMOVAL OF MESH.

    Patient problems: Abdominal Pain; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Emotional Changes; Foreign Body Reaction; Hernia; Hypersensitivity/Allergic reaction; Pain; Unspecified Tissue Injury

    MAUDE report 19288430 ↗

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