Symbotex SYM1510OSRecalls & reported problems

Summary

The FDA's MAUDE database contains 48 adverse event reports that list this exact device (DI 10884521190399), received between Oct 10, 2017 and Jun 3, 2025 — classified as 1 death, 44 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Mechanics Altered” (23 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 48 reports, in the reporter's own words as published by the FDA.

• InjuryJun 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 INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, ADHESIONS, PAIN, FOREIGN BODY REACTION, AND DISCOMFORT.

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

  MAUDE report 22137490 ↗
• InjurySep 17, 2024Migration 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 IMPLANT, THE PATIENT EXPERIENCED MESH SEPARATION, PAIN, RECURRENCE, ADHESIONS, MESH DISRUPTION, AND MESH FAILURE. POST OPERATIVE TREATMENT INCLUDED MEDICATION.

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

  MAUDE report 20238512 ↗
• InjuryJul 11, 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 THERAPEUTIC TREATMENT OF A VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, RECURRENCE, ADHESIONS, OBSTRUCTION, ABDOMINAL MASS, ABDOMINAL PAIN, AND PAIN WHEN BENDING OR WALKING.

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

  MAUDE report 19724080 ↗
• InjuryFeb 14, 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 A VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DEFECTIVE MESH, ABDOMINAL PAIN, RECURRENCE, FISTULA, INFECTION, ADHESIONS, SCARRING, PAIN, MENTAL PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, DISCOMFORT, BLADDER ISSUES. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICATION, REMOVAL OF MESH, LYSIS OF ADHESIONS, SMALL BOWEL RESECTION.

  Patient problems: Abdominal Pain; Adhesion(s); Emotional Changes; Fistula; Hernia; Pain; Scar Tissue; Unspecified Infection; Unspecified Kidney or Urinary Problem; Unspecified Tissue Injury

  MAUDE report 18707184 ↗
• InjuryDec 7, 2023Mechanics 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, ABDOMINAL PAIN, RECURRENCE, ADHESIONS, 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; Pain; Scar Tissue; Unspecified Tissue Injury

  MAUDE report 18283780 ↗
• InjuryNov 10, 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 ABDOMINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DEFECTIVE MESH, ABDOMINAL PAIN, RECURRENCE, SCARRING, PAIN, MENTAL PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REMOVAL OF MESH, ABDOMINAL WALL EXPLORATION.

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

  MAUDE report 18113767 ↗
• InjuryAug 28, 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 VENTRAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED CHRONIC PAIN, FOREIGN BODY CELL REACTION, FISTULIZED DERMAL ABSCESS, FIBROSIS, LYMPHOPLASMACYTIC INFLAMMATION, LABS ABNORMAL FOR WBC; PLATELETS, RECURRENCE, LEFT GROIN ABSCESS, ADHESIONS, FISTULOUS TRACT, INFECTED SKIN, SEROSANGUINOUS DRAINAGE FROM UPPER ABDOMEN WOUND, WOUND DEHISCENCE, <(>&<)> SEROMA. POST-OPERATIVE PATIENT TREATMENT INCLUDED HERNIA REPAIR WITH MESH, EXCISIONAL DEBRIDEMENT OF LEFT GROIN ABSCESS, EXPLORATORY LAP, LYSIS OF ADHESIONS, MESH REMOVAL, COMPONENT SEPARATION, DEBRIDEMENT OF INFECTED SKIN, JP DRAINS, WOUND VAC, HOSPITALIZATION, IV FLUIDS, PAIN MEDICATION, <(>&<)> ANTIBIOTICS.

  Patient problems: Abscess; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Fibrosis; Fistula; Fluid Discharge; Foreign Body Reaction; Hernia; Inflammation; Pain; Seroma; Unspecified Infection; Unspecified Tissue Injury; Wound Dehiscence

  MAUDE report 17638966 ↗
• InjuryAug 4, 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, SCARRING, PAIN, MENTAL PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, REMOVAL OF MESH, HERNIA REPAIR WITH NEW MESH, LYSIS OF ADHESIONS, COMPONENT SEPARATION.

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

  MAUDE report 17461033 ↗
• InjuryJun 30, 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 INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DEFECTIVE MESH, ABDOMINAL PAIN, BOWEL OBSTRUCTION, RECURRENCE, ADHESIONS, SCARRING, PAIN, MENTAL PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE. POST-OPERATIVE PATIENT TREATMENT INCLUDED HERNIA REPAIR WITH NEW MESH, TAKE DOWN OF ADHESIONS.

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

  MAUDE report 17237524 ↗
• InjuryJun 8, 2023Migration 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 A VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED ABDOMINAL PAIN, BLOATING, BOWEL OBSTRUCTION, FATIGUE, FISTULA, ADHESIONS, SCAR TISSUE, PAIN, MENTAL PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, DISABILITY, ENTEROTOMY. POST-OPERATIVE PATIENT TREATMENT INCLUDED REMOVAL OF MESH, HERNIA REPAIR WITH NEW MESH, MEDICATION, CT SCAN, RECEIVED IV FLUIDS, SMALL INTESTINE RESECTION, COMPONENT SEPARATION, LYSIS OF ADHESIONS.

  Patient problems: Abdominal Distention; Abdominal Pain; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Ascites; Diarrhea; Discomfort; Emotional Changes; Erosion; Fatigue; Fistula; Hematoma; Hernia; Inflammation; Muscle Weakness/Atrophy; Nausea; Obstruction/Occlusion; Pain; Scar Tissue; Seroma; Unspecified Tissue Injury; Vomiting

  MAUDE report 17087707 ↗
• InjuryMay 18, 2023Mechanics 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 VENTRAL INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DEFECTIVE MESH, MESH ERODED INTO THE SMALL BOWEL, ADHESIONS, PAIN, INFLAMMATION, BOWEL INJURY, RECURRENCE, SCARRING, MENTAL PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, SMALL BOWEL RESECTION.

  Patient problems: Abdominal Pain; Adhesion(s); Deformity/ Disfigurement; Discomfort; Emotional Changes; Erosion; Hemorrhage/Blood Loss/Bleeding; Hernia; Hiccups; Inflammation; Nodule; Obstruction/Occlusion; Pain; Perforation; Scar Tissue; Sexual Dysfunction; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 16955111 ↗
• InjuryJan 27, 2023Mechanics 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 A VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED SUFFERING, RECURRENCE, BOWEL/INTESTINAL OBSTRUCTION, ABSCESS, FAILURE OF MESH, DEFECTIVE MESH, PAIN, EMOTIONAL DISTRESS, INFECTION, EROSION, ADHESIONS, INFLAMMATION, MENTAL PAIN, DISABILITY, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE. POST-OPERATIVE PATIENT TREATMENT INCLUDED RESECTION OF MESH-CAUSED ERODED BOWEL, EXTENSIVE LYSIS OF ADHESIONS, REMOVAL OF MESH, VENTRAL HERNIA REPAIR.

  Patient problems: Abscess; Adhesion(s); Anemia; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Ascites; Bacterial Infection; Burning Sensation; Cellulitis; Distress; Electrolyte Imbalance; Emotional Changes; Erosion; Erythema; Fungal Infection; Hemorrhage/Blood Loss/Bleeding; Hernia; Impaired Healing; Inflammation; Low Blood Pressure/ Hypotension; Obstruction/Occlusion; Pain; Purulent Discharge; Scar Tissue; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 16259605 ↗
• MalfunctionJan 5, 2023Degraded; Degraded

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC VENTRAL HERNIA REPAIR, WHEN THE MESH HAD BEEN INSERTED INTO THE DEVICE, THE SURGEON NOTICED THAT THE MESH MATERIAL APPEARED COMPROMISED AS THE MESH WAS UNFOLDED. THE COLLAGEN BARRIER APPEARED TO BE FLAKING OFF. A NEW MESH WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16102655 ↗
• InjuryNov 22, 2022Mechanics 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 AN INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, EMOTIONAL DISTRESS, DEFECTIVE DEVICE, MENTAL ANGUISH, MENTAL PAIN, DISABILITY, IMPAIRMENT, AND LOSS OF ENJOYMENT OF LIFE. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICAL TREATMENT.

  Patient problems: Abdominal Distention; Abdominal Pain; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Ascites; Cough; Distress; Emotional Changes; Fibrosis; Foreign Body Reaction; Hernia; Inflammation; Nodule; Pain; Scar Tissue; Unspecified Tissue Injury

  MAUDE report 15841386 ↗
• InjuryOct 21, 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 IMPLANT, THE PATIENT EXPERIENCED BULGING HARDENING OF STOMACH, IMPAIRMENT, PAIN, RECURRENCE, AND ADHESIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, AND MEDICATION.

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

  MAUDE report 15653437 ↗
• InjuryApr 11, 2022Material Deformation; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Material Deformation; 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 MENTAL PAIN, SCARRING, PERMANENT IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, DEFECTIVE MESH, PAIN, DISCOMFORT, INFLAMMATION, RECURRENCE, MESH PROLAPSED THROUGH HERNIA DEFECT, AND ADHESIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED PARTIAL OMENTECTOMY AND REMOVAL OF MESH.

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Emotional Changes; Hernia; Inflammation; Muscle Weakness/Atrophy; Pain; Scar Tissue; Unspecified Tissue Injury

  MAUDE report 14073751 ↗
• InjuryFeb 15, 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 AN INGUINAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED FAILURE OF MESH, PAIN, MENTAL PAIN, SCARRING, PERMANENT IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, DEFECTIVE MESH, INFLAMMATION, ADHESIONS, AND MESH MIGRATION. POST-OPERATIVE PATIENT TREATMENT INCLUDED MESH INTERVENTION SURGERY.

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

  MAUDE report 13534720 ↗
• InjuryDec 27, 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 VENTRAL INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED PAIN, INFLAMMATION, DISCOMFORT, MENTAL PAIN/SUFFERING, DEVICE DEFECTIVE, SCARRING, LOSS OF ENJOYMENT OF LIFE.

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

  MAUDE report 13091153 ↗
• InjuryAug 16, 2021Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Migration or Expulsion of Device; 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 MESH TORN AWAY ON RIGHT SIDE, ADHESIONS, RECURRENCE, AND MESH EROSION INTO VISCERA. POST-OPERATIVE PATIENT TREATMENT INCLUDED HERNIA REPAIRED WITH MESH, EXPLANT OF MOST OF MESH, PARTIAL RESECTION OF OMENTUM, RIGHT/ LEFT MYOFASCIAL ADVANCEMENT FLAPS, RESECTION OF SKIN/SUBCUTANEOUS TISSUE, AND SMALL BOWEL RESECTION.

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

  MAUDE report 12329321 ↗
• InjuryJul 2, 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 LAPAROSCOPIC THERAPEUTIC TREATMENT OF A VENTRAL INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED OPEN DRAINING WOUND, ADHESIONS, NECROSIS, ABSCESS, INFECTION, SEROMA-LIKE FLUID, AND PAIN/DISCOMFORT. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY AND REMOVAL OF MESH.

  Patient problems: Abscess; Adhesion(s); Bacterial Infection; Cramp(s) /Muscle Spasm(s); Discomfort; Emotional Changes; Erythema; Fever; Fluid Discharge; Hyperresponsive to stimuli; Impaired Healing; Inflammation; Necrosis; Pain; Peritonitis; Purulent Discharge; Scar Tissue; Seroma; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 12109095 ↗
• InjuryJun 25, 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 THERAPEUTIC TREATMENT OF A INCARCERATED VENTRAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED ADHESIONS, RECURRENCE, ABDOMINAL PAIN, NAUSEA, VOMITING, BRUISED BOWEL, AND OBSTRUCTION. POST-OPERATIVE PATIENT TREATMENT INCLUDED MESH REMOVAL, HERNIA REPAIR WITH MESH, LYSIS OF ADHESIONS, DISSECTION OF IMBEDDED MESH FROM BOWEL, ADMISSION TO HOSPITAL, ICU, DIAGNOSTIC LAPAROSCOPY, TEMPORARY ABDOMINAL CLOSURE, HERNIA SAC REMOVED, AND REVISION SURGERY.

  Patient problems: Abdominal Pain; Adhesion(s); Bruise/Contusion; Hernia; Nausea; Obstruction/Occlusion; Unspecified Tissue Injury; Vomiting

  MAUDE report 12070721 ↗
• InjuryJun 11, 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 INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER THE UNDERLAY IMPLANT, THE PATIENT EXPERIENCED HERNIA RECURRENCE, ENTEROTOMY, SCARRING, LOSS OF ABDOMINAL DOMAIN, SCAR TISSUE, MESH ROLLED INWARD CAUSING SMALL BOWEL OBSTRUCTION AND ADHESIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED EXPLORATORY LAPAROTOMY, REPAIR OF ENTEROTOMY, MESH REMOVAL SURGERY, HERNIA REPAIR SURGERY WITH MESH, ADMISSION TO HOSPITAL, REPAIR OF UNAVOIDABLE ENTEROTOMY, PRIMARY CLOSURE, SEGMENTAL SMALL BOWEL RESECTION, BILATERAL RECTUS ADVANCEMENT FLAPS, AND EXTENSIVE LYSIS OF ADHESIONS.

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

  MAUDE report 11985153 ↗
• InjuryJun 4, 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 AN INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED HERNIA RECURRENCE, ADHESIONS, ABDOMINAL PAIN, DISCOMFORT, MESH FAILED, DEFECTIVE MESH, MENTAL ANGUISH, SCARRING, DISFIGUREMENT, PAIN, DISABILITY, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, EMOTIONAL DISTRESS, AND TENDERNESS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY AND HERNIA REPAIR WITH NEW MESH.

  Patient problems: Abdominal Distention; Abdominal Pain; Adhesion(s); Constipation; Deformity/ Disfigurement; Discomfort; Distress; Emotional Changes; Hernia; Pain; Scar Tissue; Unspecified Tissue Injury

  MAUDE report 11940674 ↗
• DeathJun 1, 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 THERAPEUTIC TREATMENT OF A RIGHT FLANK INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED CHRONIC PAIN, ADHESIONS, INFECTIONS, CHRONIC WOUND, AND FISTULA. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY AND WOUND VAC. INFORMATION RECEIVED INDICATES THE PATIENT IS DECEASED. NO INFORMATION WAS PROVIDED REGARDING THE CIRCUMSTANCES OF EXPIRATION OR ANY ASSOCIATION WITH THIS DEVICE.

  Patient problems: Adhesion(s); Fistula; Impaired Healing; Insufficient Information; Pain; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 11917137 ↗
• 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 AN ABDOMINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DESIGN DEFECT. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Distress; Unspecified Tissue Injury

  MAUDE report 11807173 ↗