Symbotex SYM2015OSRecalls & reported problems

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 10884521190467), received between Jun 27, 2017 and Aug 22, 2025 — classified as 1 death, 34 injuries, 1 malfunction.

The most frequently reported specific device problem is “Mechanics Altered” (15 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 36 reports, in the reporter's own words as published by the FDA.

• InjuryAug 22, 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: Abdominal Pain; Abscess; Adhesion(s); Distress; Fluid Discharge; Nerve Damage; Obstruction/Occlusion; Pain; Seroma; Sleepiness/Drowsiness/Somnolence; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 22878012 ↗
• InjuryAug 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: Abscess; Distress; Fistula; Hernia; Pain; Scar Tissue; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 22856744 ↗
• InjuryApr 25, 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 AN INCISIONAL 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, MESH REVISION, HERNIA REPAIR WITH NEW MESH, LYSIS OF ADHESIONS.

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

  MAUDE report 21913498 ↗
• InjuryAug 27, 2024Migration 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED MESH MIGRATION, PAIN, INFECTION, RECURRENCE, ADHESIONS, FISTULA, MESH EROSION. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, MESH REMOVAL, SMALL BOWEL RESECTION, APPENDECTOMY, EXPLORATORY LAPAROTOMY, HERNIA REPAIR WITH NEW MESH, MEDICATION.

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

  MAUDE report 20078455 ↗
• InjuryJul 5, 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, AND OBSTRUCTION.

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

  MAUDE report 19684921 ↗
• InjuryMay 10, 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 A VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DEFECTIVE MESH, RECURRENCE, CHRONIC WOUND DRAINAGE, INFECTION, EROSION,ADHESIONS, ABDOMINAL PAIN, DISCOMFORT, DISFIGUREMENT, SCARRING, PAIN, MENTAL PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, DISABILITY. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, REMOVAL OF MESH, HERNIA REPAIR WITH NEW MESH, LYSIS OF ADHESIONS, WOUND VAC.

  Patient problems: Abdominal Pain; Adhesion(s); Deformity/ Disfigurement; Discomfort; Emotional Changes; Erosion; Fluid Discharge; Hernia; Impaired Healing; Pain; Scar Tissue; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 19288995 ↗
• InjuryApr 15, 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, INFECTION, OPEN WOUND, SCARRING, PAIN, MENTAL PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REMOVAL OF MESH, HERNIA REPAIR WITH NEW MESH, EXPLORATORY LAPAROTOMY, LYSIS OF ADHESIONS, ABDOMINAL DEBRIDEMENT, WOUND VAC.

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

  MAUDE report 19111655 ↗
• InjuryJul 13, 2023Material Deformation; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Material Deformation; 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 EPIGASTRIC VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DEFECTIVE MESH, FAILURE OF MESH, RECURRENCE, SEROMA, ADHESIONS, SMALL BOWEL PERFORATION, ABDOMINAL PAIN, DISCOMFORT, ENTEROTOMY, SCARRING, PAIN, MENTAL PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, DISABILITY. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, PARTIAL REMOVAL OF MESH, HERNIA REPAIR WITH NEW MESH, BILATERAL COMPONENT SEPARATION, LYSIS OF ADHESIONS, ENTEROTOMY REPAIRED WITH SUTURES.

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

  MAUDE report 17317799 ↗
• InjuryDec 13, 2022Adverse 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 ACUTE CHRONIC PAIN, INFECTION, HERNIA RECURRENCE, ADHESIONS, OBSTRUCTIONS, FISTULAS, PERFORATION, AND SUFFERING. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICAL TREATMENT.

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

  MAUDE report 15973844 ↗
• InjuryNov 25, 2022Mechanics 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 MESH FAILURE, NONCORPORATION, PAIN, INFECTION, RECURRENCE, HEMATOMA, INFLAMMATION, ADHESIONS, AND ABSCESS. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICATION, USE OF DRAIN, DEBRIDEMENT.

  Patient problems: Abscess; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Ascites; Discomfort; Erythema; Fever; Fluid Discharge; Hematoma; Hemorrhage/Blood Loss/Bleeding; Hernia; Inflammation; Necrosis; Pain; Purulent Discharge; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 15865085 ↗
• InjuryJun 2, 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 VENTRAL INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PURULENT DISCHARGE, PAIN, INFECTION, ADHERED TO BOWEL, RECURRENCE, ADHESIONS, INFLAMMATION, MENTAL PAIN, PERMANENT PHYSICAL SCARRING, DEFECTIVE DEVICE, PERMANENT IMPAIRMENT, SUFFERING, LOSS OF ENJOYMENT OF LIFE . POST-OPERATIVE PATIENT TREATMENT INCLUDED BOWEL RESECTION AND MESH REMOVAL.

  Patient problems: Abdominal Distention; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Constipation; Discomfort; Emotional Changes; Fluid Discharge; Foreign Body Reaction; Hernia; Inflammation; Obstruction/Occlusion; Pain; Purulent Discharge; Scar Tissue; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 14578568 ↗
• InjuryOct 24, 2021Migration 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 INFLAMMATION, MESH MIGRATION, PAIN, MENTAL PAIN, SCARRING, PERMANENT IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, DEFECTIVE MESH, HERNIA RECURRENCE, ADHESIONS, AND ABDOMINAL PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Abdominal Pain; Abscess; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Decreased Appetite; Emotional Changes; Hernia; Hypersensitivity/Allergic reaction; Inflammation; Muscle Weakness/Atrophy; Obstruction/Occlusion; Pain; Perforation; Scar Tissue; Seroma; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 12686976 ↗
• InjuryOct 24, 2021Migration 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 INFLAMMATION, MESH MIGRATION, PAIN, MENTAL PAIN, SCARRING, PERMANENT IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, DEFECTIVE MESH, HERNIA RECURRENCE, ADHESIONS, AND ABDOMINAL PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Abdominal Pain; Abscess; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Decreased Appetite; Emotional Changes; Hernia; Hypersensitivity/Allergic reaction; Inflammation; Muscle Weakness/Atrophy; Obstruction/Occlusion; Pain; Perforation; Scar Tissue; Seroma; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 12686975 ↗
• InjuryJun 18, 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 VENTRAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED ADHESIONS, HERNIA RECURRENCE, PAIN, AND MESH FAILURE. POST-OPERATIVE PATIENT TREATMENT INCLUDED ADDITIONAL SURGERY, AND MESH REMOVAL.

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

  MAUDE report 12026725 ↗
• 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 THERAPEUTIC TREATMENT OF A VENTRAL INCISIONAL HERNIA HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, ABSCESS, ADHESIONS, BOWEL INCARCERATION, AND BOWEL OBSTRUCTION. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY AND MODIFICATION.

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

  MAUDE report 11461897 ↗
• InjuryDec 1, 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 A VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DISTENTION, SEROMA, DEFECTIVE MESH, PAIN, SUFFERING, INFLAMMATION, ADHESIONS, MESH MIGRATION, MENTAL PAIN, DISABILITY, IMPAIRMENT, MESH FAILURE, LOSS OF ENJOYMENT OF LIFE, BOWEL OBSTRUCTION, RECURRENCE, AND ABDOMINAL PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED X-RAYS, IV FLUIDS, NG TUBE, ADVANCING DIET, ANTINAUSEA/ANTIEMETIC MEDICATIONS, PAIN MEDICATION, MESH REVISION, REVISION SURGERY AND MESH REMOVAL.

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

  MAUDE report 10929889 ↗
• InjuryNov 6, 2020Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Material Integrity 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 RECURRENCE, MESH CONTRACTION, ADHESIONS, AND FOREIGN BODY REACTION. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, REMOVAL OF MESH, AND HERNIA REPAIR WITH MESH.

  Patient problems: Adhesion(s); Foreign Body Reaction; Hernia; Injury

  MAUDE report 10804556 ↗
• InjuryJul 8, 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 AN ABDOMINAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED RECURRENCE AND PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED HERNIA REPAIR WITH REVISION SURGERY.

  Patient problems: Distress; Hernia; Injury; Pain; Unspecified Tissue Injury

  MAUDE report 10247772 ↗
• InjuryJul 8, 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 THE IMPLANT, THE PATIENT EXPERIENCED CHRONIC PAIN AND INFECTION. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Injury; Pain; Unspecified Infection

  MAUDE report 10246778 ↗
• InjuryJun 19, 2020Mechanics 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 TREATMENT OF AN INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED INFECTED MESH. POST-OPERATIVE PATIENT TREATMENT INCLUDED REMOVAL SURGERY.

  Patient problems: Abdominal Pain; Abscess; Adhesion(s); Emotional Changes; Fistula; Hernia; Impaired Healing; Injury; Pain; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 10176452 ↗
• InjuryMay 19, 2020Degraded; Migration or Expulsion of Device; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Material Split, Cut or Torn; Degraded; Migration or Expulsion of Device; 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 THE IMPLANT, THE PATIENT EXPERIENCED HERNIA RECURRENCE, NAUSEA, VOMITING, MESH TORN, ABDOMINAL WALL DEFECT, PAIN, MENTAL PAIN, SCARRING, PERMANENT IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, DEFECTIVE MESH, ABDOMINAL PAIN, FAILURE OF MESH, INFLAMMATION, INFECTION, NERVE DAMAGE, DISABILITY, SMALL BOWEL INJURY, AND ADHESIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, LYSIS OF ADHESIONS, AND MESH REMOVAL.

  Patient problems: Abdominal Pain; Adhesion(s); Emotional Changes; Hernia; Inflammation; Injury; Nausea; Nerve Damage; Obstruction/Occlusion; Pain; Perforation; Scar Tissue; Unspecified Gastrointestinal Problem; Unspecified Infection; Unspecified Tissue Injury; Vomiting

  MAUDE report 10071608 ↗
• InjuryJan 30, 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 OPEN THERAPEUTIC TREATMENT OF AN INCISIONAL HERNIA AS WELL AS BILATERAL INGUINAL HERNIAS. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, INCARCERATED INGUINAL HERNIA, ADHESIVE DISEASE, MENTAL PAIN, DISABILITY, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, DEFECTIVE MESH, RECURRENCE, ADHESIONS, AND MESH MIGRATION. POST-OPERATIVE PATIENT TREATMENT INCLUDED MESH REMOVAL, SMALL BOWEL RESECTION, HERNIA REPAIR WITH NEW MESH, ANALYSIS OF ADHESIONS.

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

  MAUDE report 9649752 ↗
• InjuryDec 20, 2019Mechanics 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 ABDOMINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED HERNIA RECURRENCE, ADHESIONS, AND BOWEL INCARCERATION. POST-OPERATIVE PATIENT TREATMENT INCLUDED RESECTION, REMOVAL SURGERY, AND HERNIA REPAIR WITH NEW MESH.

  Patient problems: Abdominal Distention; Abdominal Pain; Abscess; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Ascites; Bacterial Infection; Bruise/Contusion; Constipation; Cramp(s) /Muscle Spasm(s); Deformity/ Disfigurement; Diarrhea; Discomfort; Distress; Electrolyte Imbalance; Emotional Changes; Erythema; Fever; Hernia; Impaired Healing; Injury; Nausea; Pain; Purulent Discharge; Scar Tissue; Seroma; Unspecified Infection; Unspecified Tissue Injury; Vomiting

  MAUDE report 9504202 ↗
• InjuryDec 13, 2019Adverse 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 VENTRAL INCARCERATED HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED ADHESIONS, RECURRENCE, AND SMALL BOWL OBSTRUCTION. POST-OPERATIVE PATIENT TREATMENT INCLUDED LAPAROSCOPIC LYSIS OF ADHESIONS, REMOVAL OF FOREIGN BODY FROM THE ABDOMINAL WALL AND REMOVAL SURGERY. THE PRODUCT HAD BEEN USED WITH STRAP25 SECURE STRAP (X2), LOT # JJ6970.

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

  MAUDE report 9465069 ↗
• DeathJul 21, 2019Mechanics 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 NON-HEALING WOUND, ABSCESS, INFECTION, BOWEL PERFORATION, FISTULA, LEUKOCYTOSIS, ADHESIONS, LARGE AMOUNT OF BILIOUS FLUID MATERIAL AND SUCCUS IN ABDOMEN, SEROMA, DEFECTIVE DEVICE, MENTAL PAIN, DISABILITY, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, AND PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED BOWEL RESECTION/TRANSECTED, TRANSFERRED TO ICU, MESH REMOVAL, AND REVISION SURGERY.

  Patient problems: Abscess; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Ascites; Bowel Perforation; Emotional Changes; Fistula; Impaired Healing; Injury; No Code Available; Pain; Seroma; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 8810106 ↗