Parietex TET1309Recalls & reported problems

Summary

The FDA's MAUDE database contains 67 adverse event reports that list this exact device (DI 10884521180147), received between Nov 7, 2017 and Aug 15, 2025 — classified as 67 injuries.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (20 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 67 reports, in the reporter's own words as published by the FDA.

• InjuryAug 15, 2025Migration 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 AN INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED HYDROCELE, MESH MIGRATION, FAILED INCORPORATION, PAIN, INFECTION, RECURRENCE, INFLAMMATION, ADHESIONS, BLEEDING, FISTULA, SEROMA, PERFORATION, ABSCESS, SCARRING, SEROUS FLUID DRAINAGE, CYST, FOREIGN BODY GIANT CELL REACTION, ABDOMINAL PAIN, BOIL. POST-OPERATIVE PATIENT TREATMENT INCLUDED DEBRIDEMENT OF ABSCESS, OPEN HERNIA REPAIR, TISSUE REPAIR, PARTIAL PUNCTURE ASPIRATION OF HYDROCELE, REMOVAL OF MESH, REMOVAL OF MESH, MEDICATION, HOSPITALIZATION, DEBRIDEMENT AND WOUND VAC.

  Patient problems: Abdominal Pain; Abscess; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Cyst(s); Fistula; Fluid Discharge; Foreign Body Reaction; Hemorrhage/Blood Loss/Bleeding; Hernia; Inflammation; Pain; Perforation; Scar Tissue; Seroma; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 22817351 ↗
• InjuryAug 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 BILATERAL INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY AND HERNIA REPAIR WITH NEW MESH.

  Patient problems: Hernia; Unspecified Tissue Injury

  MAUDE report 22783826 ↗
• InjurySep 10, 2024Degraded; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Degraded; Material Integrity 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED MESH CONTRACTION, MESH HARDENING, ADHESIONS, EROSION, PAIN, DISCOMFORT. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

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

  MAUDE report 20182967 ↗
• InjuryMay 22, 2024Adverse 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 RECURRENCE, ADHESIONS, PAIN, SEROMA. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, SMALL BOWEL RESECTION, AND MESH REMOVAL.

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

  MAUDE report 19378201 ↗
• InjuryFeb 28, 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 AN INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, RECURRENCE, ADHESIONS, BLEEDING, SCARRING, ABDOMINAL DISCOMFORT, NERVE PAIN, AND SWOLLEN GROIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, REMOVAL OF MESH, HERNIA REPAIR WITH NEW MESH, AND MEDICATION.

  Patient problems: Adhesion(s); Discomfort; Hemorrhage/Blood Loss/Bleeding; Hernia; Pain; Scar Tissue; Swelling/ Edema; Unspecified Tissue Injury

  MAUDE report 18804742 ↗
• InjuryDec 12, 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, INFECTION, ADHESIONS, PAIN, AND MESH FOLDING. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, HERNIA REPAIR WITH MESH, AND MESH REVISION.

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

  MAUDE report 18315431 ↗
• InjuryDec 12, 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, INFECTION, ADHESIONS, PAIN, AND MESH FOLDING. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, HERNIA REPAIR WITH MESH, AND MESH REVISION.

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

  MAUDE report 18315428 ↗
• InjuryDec 1, 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 HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, INFECTION, <(>&<)> CHRONIC PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED ADDITIONAL SURGERY.

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

  MAUDE report 18252890 ↗
• InjurySep 14, 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, INFECTION, ADHESIONS, AND PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY AND MESH REVISION.

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

  MAUDE report 17751217 ↗
• InjuryAug 17, 2023Adverse 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, INFECTION, PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY AND REMOVAL OF MESH.

  Patient problems: Fistula; Hematoma; Hemorrhage/Blood Loss/Bleeding; Hernia; Inflammation; Pain; Perforation; Seroma; Sexual Dysfunction; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 17565790 ↗
• InjuryAug 17, 2023Adverse 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, INFECTION, PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Fistula; Hematoma; Hemorrhage/Blood Loss/Bleeding; Hernia; Inflammation; Pain; Perforation; Seroma; Sexual Dysfunction; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 17565769 ↗
• InjuryDec 6, 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 HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED DEVICE DEFECTIVE, PAIN, MENTAL PAIN, SUFFERING, DISABILITY, PERMANENT IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICAL TREATMENT, HERNIA REPAIR WITH MESH.

  Patient problems: Emotional Changes; Erectile Dysfunction; Hernia; Pain; Unspecified Tissue Injury

  MAUDE report 15926029 ↗
• InjuryJul 14, 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Hernia; Unspecified Tissue Injury

  MAUDE report 15017375 ↗
• InjuryJun 16, 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED INFECTION AND PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Fibrosis; Fistula; Fluid Discharge; Foreign Body Reaction; Hematoma; Hernia; Hypersensitivity/Allergic reaction; Impaired Healing; Inflammation; Nausea; Obstruction/Occlusion; Pain; Purulent Discharge; Ulcer; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 14717863 ↗
• InjuryMar 21, 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED SHORT TERM PAIN, RECURRENCE, MESH EROSION, AND SPERMATIC CORD INVOLVEMENT. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

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

  MAUDE report 13840670 ↗
• InjuryFeb 28, 2022Migration 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 HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, INFECTION, PAIN, NERVE DAMAGE, WADDED MESH. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Hernia; Nerve Damage; Pain; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 13619970 ↗
• InjuryNov 8, 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 HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED DISCOMFORT, ALL ASPECTS OF LIFE NEGATIVELY IMPACTED, MESH FAILURE, EMOTIONAL HARM, NERVE PAIN, RECURRENCE, PAIN, AND NERVE DAMAGE. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICATION, EXPLORATORY SURGERY, HERNIA REPAIR, ADDITIONAL SURGERY, AND MESH REMOVAL.

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

  MAUDE report 12770289 ↗
• InjuryOct 26, 2021Migration or Expulsion of Device; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Migration or Expulsion of Device; 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 VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED HERNIA RECURRENCE, PAIN, AND ABDOMINAL PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Abdominal Pain; Emotional Changes; Hernia; Inflammation; Pain; Scar Tissue; Seroma; Swelling/ Edema; Unspecified Tissue Injury

  MAUDE report 12699147 ↗
• InjurySep 30, 2021Adverse 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 UMBILICAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED INFECTION, INFECTED MESH, ABSCESS, AND LACK OF INCORPORATION. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Abscess; Fibrosis; Hernia; Obstruction/Occlusion; Purulent Discharge; Scar Tissue; Seroma; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 12558781 ↗
• InjuryJul 29, 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 ALL ASPECTS OF LIFE NEGATIVELY IMPACTED, MESH FAILURE, EMOTIONAL HARM, DISCOMFORT, HERNIA RECURRENCE AD PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED HERNIA REPAIR WITH NEW MESH, MEDICATION, ADDITIONAL SURGERY AND REVISION SURGERY.

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

  MAUDE report 12246083 ↗
• InjuryJul 29, 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 ALL ASPECTS OF LIFE NEGATIVELY IMPACTED, MESH FAILURE, EMOTIONAL HARM, DISCOMFORT, HERNIA RECURRENCE AD PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED HERNIA REPAIR WITH NEW MESH, MEDICATION, ADDITIONAL SURGERY AND REVISION SURGERY.

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

  MAUDE report 12246064 ↗
• InjuryJul 2, 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 AN ABDOMINAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED MESH MIGRATION, RECURRENCE, SCAR TISSUE, AND PAIN AND SUFFERING. POST-OPERATIVE PATIENT TREATMENT INCLUDED MESH REMOVAL, AND REVISION SURGERY.

  Patient problems: Erosion; Hernia; Pain; Scar Tissue; Unspecified Tissue Injury

  MAUDE report 12112121 ↗
• InjuryJun 18, 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 AN INGUINAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, CORD LIPOMA, SCAR TISSUE, SPERMATIC CORD INVOLVED, NERVE DAMAGE, ADHESIONS, MESH ENTRAPPED IN RED-PINK FIBROMEMBRANOUS TISSUE, PAIN, SEVERE INGUINAL PAIN AND MESH MIGRATION. POST-OPERATIVE PATIENT TREATMENT INCLUDED REMOVAL OF RETAINED MESH, INJECTION INTO THE ILIOINGUINAL AND GENITAL BRANCH OF THE GENITAL FEMORAL NERVE, PHYSICAL THERAPY, INJECTION THERAPY, CORD LIPOMA REMOVAL AND HERNIA REPAIR WITH SUTURES.

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

  MAUDE report 12026005 ↗
• InjuryJun 11, 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 AN INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, BOWEL OBSTRUCTION, ADHESIONS, AND MESH MIGRATION. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, HERNIA REPAIR WITH MESH, REMOVAL OF MESH, SMALL BOWEL ANASTOMOSIS, ADMISSION TO HOSPITAL, SMALL BOWEL RESECTION, MECKEL¿S DIVERTICULECTOMY, OPERATIONS TO REDO THE ANASTAMOSIS, AND BILATERAL RECTUS ABDOMINIS MYOFASCIAL RELEASE.

  Patient problems: Adhesion(s); Cramp(s) /Muscle Spasm(s); Foreign Body Reaction; Hemorrhage/Blood Loss/Bleeding; Hernia; Inflammation; Muscle Weakness/Atrophy; Obstruction/Occlusion; Pain; Scar Tissue; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 11985182 ↗
• InjuryJun 11, 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 AN INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, BOWEL OBSTRUCTION, ADHESIONS, INFECTION, PAIN, CHRONIC INFLAMMATION, SCARIFICATION, MESH ENCAPSULATION, LACK OF ADEQUATE INGROWTH, AND MESH MIGRATION. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, HERNIA REPAIR WITH MESH, REMOVAL OF MESH, SMALL BOWEL ANASTOMOSIS, ADMISSION TO HOSPITAL, SMALL BOWEL RESECTION, MECKEL¿S DIVERTICULECTOMY, OPERATIONS TO REDO THE ANASTAMOSIS, AND BILATERAL RECTUS ABDOMINIS MYOFASCIAL RELEASE.

  Patient problems: Adhesion(s); Cramp(s) /Muscle Spasm(s); Foreign Body Reaction; Hemorrhage/Blood Loss/Bleeding; Hernia; Inflammation; Muscle Weakness/Atrophy; Obstruction/Occlusion; Pain; Scar Tissue; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 11983421 ↗