Parietex TET3030Recalls & reported problems

Summary

The FDA's MAUDE database contains 61 adverse event reports that list this exact device (DI 10884521180185), received between Nov 15, 2017 and Oct 28, 2025 — classified as 1 death, 60 injuries.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 61 reports, in the reporter's own words as published by the FDA.

• InjuryOct 28, 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 INFECTION, ABSCESS, SEROMA, OPEN DRAINING WOUND, POOR HEALING, INFLAMMATION, EXPOSED MESH, DRANING SINUS TRACTS, PAIN, AND DISCOMFORT. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, REMOVAL OF MESH.

  Patient problems: Abscess; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Fluid Discharge; Impaired Healing; Inflammation; Pain; Seroma; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 23406342 ↗
• InjuryJun 10, 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, INFECTION, PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, REMOVAL OF MESH.

  Patient problems: Abdominal Pain; Abscess; Fistula; Hernia; Inflammation; Pain; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 19499787 ↗
• InjuryMay 28, 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 AN INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED CHRONIC PAIN, INFECTION, RECURRENCE, HEMATOMA, INFLAMMATION, ADHESIONS, OBSTRUCTIONS, SEROMA, INCARCERATION, MESH FAILURE BY DETACHED MESH, ABSCESS, NECROSIS, SEPSIS, ACUTE RENAL FAILURE, LIMITED MOBILITY, ABDOMINAL PAIN, BULGING, FEELS LIKE CARRYING A 50 POUND WEIGHT BAG, BOWEL ISSUES, CONSTIPATION, IRRITABLE BOWEL SYNDROME, RESTLESS LEG SYNDROME, DEPRESSION, LOWER BACK PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED JP DRAIN, INCISION AND DRAINAGE, DEBRIDEMENT, WOUND VAC, WOUND CARE, 13 DAYS HOSPITALIZATION, MEDICATION.

  Patient problems: Abdominal Distention; Abdominal Pain; Abscess; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Constipation; Depression; Hematoma; Hernia; Inflammation; Necrosis; Obstruction/Occlusion; Pain; Renal Failure; Sepsis; Seroma; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 19403019 ↗
• InjuryApr 26, 2024Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Patient Device Interaction Problem; 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, INFECTION, ABSCESS, FISTULA, PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, REMOVAL OF MESH, DEBRIDEMENT.

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

  MAUDE report 19194603 ↗
• InjuryOct 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 A HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED INFECTION, ABSCESS,CHRONIC PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, MESH REMOVAL, DEBRIDEMENT.

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

  MAUDE report 17897125 ↗
• InjuryMay 26, 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 IMPLANT, THE PATIENT EXPERIENCED PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Inflammation; Pain; Unspecified Tissue Injury

  MAUDE report 17012686 ↗
• InjuryApr 4, 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 IMPLANT, THE PATIENT EXPERIENCED RECURRENCE AND PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED ADDITIONAL SURGERY AND REVISION.

  Patient problems: Hernia; Pain; Unspecified Tissue Injury

  MAUDE report 16677869 ↗
• InjuryFeb 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 FAILURE OF MESH, DEFECTIVE MESH, PAIN, EMOTIONAL DISTRESS, INFLAMMATION, INFECTION, DISABILITY, MENTAL PAIN, LOSS OF ENJOYMENT OF LIFE, IMPAIRMENT. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

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

  MAUDE report 16381911 ↗
• InjuryOct 11, 2022Migration 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 THE IMPLANT, THE PATIENT EXPERIENCED CHRONIC PAIN, INFECTION, HERNIA RECURRENCE, INFLAMMATION, ADHESIONS, OBSTRUCTIONS, PERFORATION, CELLULITIS, INCARCERATED HERNIA, & DISLODGED MESH. POST-OPERATIVE PATIENT TREATMENT INCLUDED 12 DAYS HOSPITALIZATION, & USE OF BLAKE DRAIN.

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

  MAUDE report 15584646 ↗
• InjuryOct 4, 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 AN ABDOMINAL INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED MRSA, DRAINING SINUS, PAIN, INFECTION, RECURRENCE, INFLAMMATION, FISTULAS, SCARRING, MESH ENCAPSULATION, ABSCESS, AND LACK OF INGROWTH. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, MESH REVISION, MEDICATION, WOUND VAC, AND DEBRIDEMENT.

  Patient problems: Abdominal Pain; Abscess; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Bacterial Infection; Erythema; Fever; Fistula; Fluid Discharge; Foreign Body Reaction; Hemorrhage/Blood Loss/Bleeding; Hernia; Impaired Healing; Inflammation; Pain; Scar Tissue; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 15538807 ↗
• 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 INFECTION, HEMATOMA, FLUID COLLECTION AND POCKET OF PUS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Ascites; Hematoma; Inflammation; Purulent Discharge; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 15017397 ↗
• InjuryMar 28, 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 THE IMPLANT, THE PATIENT EXPERIENCED INFECTION, ADHESIONS, PAIN, INFLAMMATION, SCARIFICATION, MESH ENCAPSULATION AND LACK OF ADEQUATE INGROWTH. POST-OPERATIVE PATIENT TREATMENT INCLUDED SMALL BOWEL RESECTION AND HERNIA REPAIR WITH MESH.

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Bacterial Infection; Discomfort; Erythema; Fever; Fibrosis; Fistula; Fluid Discharge; Foreign Body Reaction; Hernia; Impaired Healing; Inflammation; Nausea; Obstruction/Occlusion; Pain; Scar Tissue; Ulcer; Unspecified Infection; Unspecified Tissue Injury; Vomiting

  MAUDE report 13930049 ↗
• InjuryDec 9, 2021Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Material Split, Cut or Torn; 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 INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, ADHESIONS, SMALL BOWEL OBSTRUCTION, CHRONIC PAIN, MESH EROSION, DEHISCENCE OF MESH, SEPARATED FASCIA, ILEUS, ABDOMINAL PAIN, BLOATING, OBSTIPATION, CONSTIPATION, DEPRESSED, NAUSEA, VOMITING, SCARRING, & STRESS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, CT SCAN, EXPLORATORY LAPAROTOMY, SMALL BOWEL RESECTION, GASTROJEJUNOSTOMY, INSERTION GASTROSTOMY, HOSPITALIZATION, IV FLUIDS, PAIN MEDICATION, PSYCHOLOGICAL ASSISTANCE, REDUCTION AND REPAIR OF DEHISCED FASCIA, HERNIA REPAIR WITH MESH, LYSIS OF ADHESIONS, MESH REAPPROXIMATED, & NERVE BLOCK.

  Patient problems: Abdominal Distention; Abdominal Pain; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Constipation; Depression; Distress; Erosion; Fistula; Hernia; Nausea; Obstruction/Occlusion; Pain; Scar Tissue; Unspecified Tissue Injury; Vomiting; Wound Dehiscence

  MAUDE report 12973278 ↗
• InjuryDec 9, 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED HERNIA RECURRENCE, INFECTION, ABSCESS, AND PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

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

  MAUDE report 12969108 ↗
• InjurySep 2, 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 ADHESIONS, HERNIA RECURRENCE, OPEN DRAINING WOUND, MESH CONTRACTION, WEIGHT GAIN, MOBILITY ISSUES, PAIN, AND DISCOMFORT. POST-OPERATIVE PATIENT TREATMENT INCLUDED ABDOMINAL WALL RECONSTRUCTION, REVISION SURGERY, <(>&<)> CT SCAN.

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Constipation; Discomfort; Fluid Discharge; Hematoma; Hernia; Impaired Healing; Inflammation; Nausea; Obstruction/Occlusion; Pain; Scar Tissue; Unspecified Infection; Unspecified Tissue Injury; Urinary Retention; Weight Changes

  MAUDE report 12416205 ↗
• InjuryAug 19, 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 AN ABDOMINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED ADHESIONS AND PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED EXCISION OF MESH, LYSIS OF ADHESIONS AND ABDOMINAL WALL RECONSTRUCTION.

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

  MAUDE report 12341698 ↗
• InjuryJul 15, 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 VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED ADHESIONS, OPEN DRAINING WOUND, WADDED UP MESH, HERNIA RECURRENCE, FOREIGN BODY GIANT CELL REACTION, CHRONIC INFLAMMATION, SCARRING, SEVERE AND CHRONIC PAIN AND DISCOMFORT. POST-OPERATIVE PATIENT TREATMENT INCLUDED SURGERY TO REMOVE MESH AND REVISION SURGERY.

  Patient problems: Adhesion(s); Discomfort; Fluid Discharge; Foreign Body Reaction; Hernia; Impaired Healing; Inflammation; Pain; Scar Tissue; Unspecified Tissue Injury

  MAUDE report 12178813 ↗
• InjuryJul 15, 2021Migration 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 PAIN, ADHESIONS, DESIGN DEFECT, BULGING, ADHESIONS, RECURRENCE, AND INFOLDING/PARTIAL DETACHMENT OF MESH. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, CT-SCAN, AND HERNIA REPAIR WITH NEW MESH. RELEVANT TESTS/LABORATORY DATA: (B)(6) 2020: CT SCAN OF ABDOMEN/PELVIS SHOWED INTERVAL WORSENING OF A LARGE WIDE NECK BULGE OF THE UPPER ABDOMINAL WALL CONTAINING N ONOBSTRUCTED SMALL BOWEL LOOPS, MESH FROM PRIOR VENTRAL HERNIA APPEARS LARGELY INTACT; HOWEVER, A COMPONENT AT THE INFERIOR MEDIAL ASPECT SHOWS INFOLDING SUGGESTIVE OF PARTIAL DETACHMENT.

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

  MAUDE report 12175700 ↗
• InjuryJul 8, 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 FLANK ABDOMINAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED HERNIA RECURRENCE, CORD LIPOMA, SCARRING, HETEROGENOUS RIGHT TESTIS WITH LOW FLOW, AND INFECTION. POST-OPERATIVE PATIENT TREATMENT INCLUDED MESH REMOVAL AND HERNIA REPAIR WITH NEW MESH.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hernia; Inflammation; Scar Tissue; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 12134809 ↗
• InjuryJul 2, 2021Migration or Expulsion of Device; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Migration or Expulsion of Device; Detachment of Device or Device Component; 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 LARGE VENTRAL HERNIA. IT WAS REPORTED THAT AFTER THE ONLAY IMPLANT, THE PATIENT EXPERIENCED ADHESIONS, ROLLED UP MESH, BOWEL OBSTRUCTION, COMPONENT SEPARATION, HEMATOMA, SEROMA, AND PAIN AND SUFFERING. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

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

  MAUDE report 12112158 ↗
• InjuryJun 18, 2021Migration or Expulsion of Device; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Migration or Expulsion of Device; Detachment of Device or Device Component; 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 INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED SINUS TRACT, INFLAMMATION, HUMILIATION, PAIN, UNINCORPORATED MESH, WHICH WAS OPENED, AND THIS APPEARED TO BE INTO THE PERITONEAL CAVITY, INFECTION/INFECTED MESH, INDURATED TISSUE BENEATH IT APPEARED TO BE A RIND OVER THE SURFACE OF THE BOWEL, CHRONIC GRANULATION TISSUE, PURULENT MATERIAL, ADHESIONS, DRAINING WOUND, MESH EROSION, FISTULOUS COMMUNICATION TO THE SMALL BOWEL, BOWEL INJURY, MURKY FLUID, ATTENUATED TISSUE, FOREIGN BODIES IN THE ANTERIOR ABDOMINAL WALL, LARGE SQUAMOUS CELL CANCER, RECURRENCE, DENSELY ADHERED MASS, BOWEL SHOWED LESS TENDENCY TO EVISCERATE FROM THE ABDOMINAL CAVITY, ABSCESS, OPEN WOUND, MESH FRAGMENTED, AREA OF FLUCTUANCE, CHRONIC SEROSITIS, HEMORRHAGE, NECROSIS, CHRONIC DRAINING TRACTS, FISTULA, AND FLUID COLLECTION. POST-OPERATIVE PATIENT TREATMENT INCLUDED WEARING BAGS AND DRESSINGS ON ABDOMEN FOR MORE THAN 18 YEARS, USE OF DRAIN, BLAKE DRAIN, REVISION SURGERY, EXCISION OF EXTENSIVE DISSECTION OF THE VISCERA, FREE THIS DENSELY ADHERENT MASS FROM THE ANTERIOR

  Patient problems: Abscess; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Ascites; Cancer; Emotional Changes; Erosion; Fistula; Fluid Discharge; Foreign Body In Patient; Hemorrhage/Blood Loss/Bleeding; Hernia; Impaired Healing; Inflammation; Muscle Weakness/Atrophy; Necrosis; Nodule; Pain; Purulent Discharge; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 12029274 ↗
• InjuryMay 21, 2021Degraded; Adverse Event Without Identified Device or Use Problem; Degraded; 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 ABDOMINAL PAIN, ABSCESS, DETERIORATING MESH, CALCIFIED BOWEL, AND ADHESIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED BOWEL RESECTION, AND REVISION SURGERY.

  Patient problems: Abdominal Pain; Abscess; Adhesion(s); Calcium Deposits/Calcification; Fistula; Fluid Discharge; Pain; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 11861287 ↗
• InjuryMay 18, 2021Material 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 PARASTOMAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED MESH CONTRACTION, THE MESH WAS SOMEWHAT TIGHT AT STOMA SITE WHICH WAS LIKELY LEADING TO A PARTIAL BOWEL OBSTRUCTION, RECURRENCE, ADHESIONS, & CHRONIC PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, AND SMALL BOWEL RESECTION.

  Patient problems: Adhesion(s); Cramp(s) /Muscle Spasm(s); Hemorrhage/Blood Loss/Bleeding; Hernia; Nausea; Obstruction/Occlusion; Pain; Unspecified Infection; Unspecified Tissue Injury; Vomiting

  MAUDE report 11843842 ↗
• InjuryMay 17, 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 IMPLANT, THE PATIENT EXPERIENCED A HERNIA, PAIN, AND ADHESIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

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

  MAUDE report 11837042 ↗
• InjuryApr 23, 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 IMPLANT, THE PATIENT EXPERIENCED DRAINAGE, INFECTION, DEFORMED ABDOMEN, CONFIDENCE AND MENTAL HEALTH IMPACTED, CHRONICALLY DRAINING SINUS TRACT WOUNDS, ADHESIONS, STITCH GRANULOMA, ABSCESS, OSSIFICATION OF SOFT TISSUE, RECURRENCE, MENTAL PAIN, PAIN, DISABILITY, PERMANENT IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, DEFECTIVE MESH, AND FISTULA. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICATION, EXPLORATORY LAPAROTOMY, REVISION SURGERY, CLOSURE OF ENTEROCUTANEOUS FISTULA, REMOVAL OF MESH, LYSIS OF ADHESIONS, REMOVAL OF SUTURE MATERIAL, IMPLANTATION OF NEW MESH, AND ADMISSION TO HOSPITAL.

  Patient problems: Abscess; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Deformity/ Disfigurement; Emotional Changes; Fistula; Fluid Discharge; Granuloma; Hernia; Impaired Healing; Pain; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 11715700 ↗