Parietex PCO2520OSXRecalls & reported problems

Summary

The FDA's MAUDE database contains 58 adverse event reports that list this exact device (DI 10884521179820), received between Sep 12, 2017 and Aug 20, 2025 — classified as 58 injuries.

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 58 reports, in the reporter's own words as published by the FDA.

• InjuryAug 20, 2025Migration 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED EMOTIONAL DISTRESS, RECURRENCE, MESH MIGRATION, DEPRESSION, PAIN, ABSCESS, ADHESIONS, OPEN WOUND, INFECTION. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, EXCISIONAL DEBRIDEMENT OF ABDOMINAL WALL, MESH REMOVAL, MESH REVISION, EXPLORATORY LAPAROTOMY, PARTIAL OMENTECTOMY, LAPAROSCOPIC CHOLECYSTECTOMY WITH CHOLANGIOGRAM.

  Patient problems: Abscess; Adhesion(s); Depression; Distress; Hernia; Impaired Healing; Pain; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 22856740 ↗
• InjuryJun 13, 2024Migration 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 INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED MESH FAILURE, MESH FAILED TO INCORPORATE, MESH MIGRATION, MESH EROSION, PAIN, INFECTION, RECURRENCE, ADHESIONS, SEROMA, DEHISCENCE OF ABDOMINAL WALL. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, MEDICATION, DRAINAGE OF ABDOMINAL WALL INFECTION AND DEHISCENCE OF ABDOMINAL WALL, SUTURE REMOVAL, DEBRIDEMENT, IRRIGATION AND WOUND VAC INSERTION.

  Patient problems: Adhesion(s); Hernia; Pain; Seroma; Unspecified Infection; Unspecified Tissue Injury; Wound Dehiscence

  MAUDE report 19529747 ↗
• InjuryOct 24, 2023Migration 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, INFECTION, ABSCESS, ADHESIONS, AND PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY SMALL BOWEL RESECTION, AND MESH REMOVAL SURGERY.

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

  MAUDE report 17999743 ↗
• InjuryOct 19, 2023Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Material Split, Cut or Torn; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Material Split, Cut or Torn

  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, PAIN, AND MESH BREAKAGE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY AND MESH REVISION.

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

  MAUDE report 17971009 ↗
• InjuryJul 20, 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 REVISION SURGERY, AND SMALL BOWEL RESECTION.

  Patient problems: Hernia; Obstruction/Occlusion; Pain; Unspecified Tissue Injury

  MAUDE report 17360261 ↗
• InjuryJun 22, 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, ADHESIONS, AND PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

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

  MAUDE report 17183341 ↗
• InjuryMay 16, 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 DEFECTIVE MESH, FLUID COLLECTION, INFECTION, ABSCESS, PURULENT DISCHARGE, ADHESIONS, FISTULA, SEROSAL INJURIES, MENTAL PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, DISABILITY, LABS ABNORMAL FOR WBC; HEMOGLOBIN; HEMATOCRIT; GLUCOSE; PLATELETS; C-REACTIVE PROTEIN; MAGNESIUM; PHOSPHORUS; POTASSIUM; AST ; ALT; CALCIUM; ALBUMIN; TOTAL BILIRUBIN; SODIUM, MYCOBACTERIUM FORTUITUM, STREP, HAEMOPHILIS PARAINFLUENZAE, KLEBSIELLA AEROGENES, LACTOSE FERMENTING GRAM NEGATIVE RODS, ACTINOMYCES SPECIES, CEFTRIAXONE, SERRATIA, BACILLUS, BACTEREMIA, FIBROUS SEROSAL ADHESIONS, INFLAMMATION, EDEMA, FISTULOUS TRACT, GASEOUS/AIR COLLECTION, HYPEREMIA, TRANSVERSE COLITIS, ILEUS, SCARRING, ISCHEMIC CHANGES, SMALL BOWEL PERFORATION, CANDIDA ALBICANS, MILD ABDOMINAL/PELVIC WALL THICKENING, BLEEDING, TACHYCARDIA, ABDOMINAL PAIN, HEMATOMA WITH ECCHYMOSIS, BLOOD CLOTS, ABDOMINAL SORENESS, DECREASED ENERGY, DIFFICULTY SLEEPING, WOUND DEHISCENCE, FLUID FILLED BUMP AT EDGE OF INCISION, INDURATION, ERYTHEMA, TENDERNESS, WOUND

  Patient problems: Abdominal Cramps; Abdominal Distention; Abdominal Pain; Abscess; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Ascites; Bacterial Infection; Blister; Chills; Cramp(s) /Muscle Spasm(s); Diaphoresis; Diarrhea; Discomfort; Dyspnea; Ecchymosis; Electrolyte Imbalance; Emotional Changes; Erythema; Fatigue; Fever; Fibrosis; Fistula; Fluid Discharge; Fungal Infection; Headache; Hematoma; Hemorrhage/Blood Loss/Bleeding; Hyperemia; Impaired Healing; Inflammation; Internal Organ Perforation; Ischemia; Itching Sensation; Muscle Weakness/Atrophy; Nausea; Neuropathy; Numbness; Purulent Discharge; Scar Tissue; Sleep Dysfunction; Swelling/ Edema; Tachycardia; Thrombosis/Thrombus; Unspecified Infection; Unspecified Tissue Injury; Vomiting; Wound Dehiscence

  MAUDE report 16940731 ↗
• InjuryMar 16, 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 PAIN, RECURRENCE, INFECTION, INFLAMMATION, SWISS CHEESE FACIAL DEFEC TS/GRANULATION TISSUE BECAUSE OF MESH, MESH FAILURE, SCARRING. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICATION.

  Patient problems: Hernia; Inflammation; Pain; Scar Tissue; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 16555038 ↗
• InjuryFeb 15, 2023Material 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED ADHESIONS, PAIN, AND MESH BULGING. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY AND MESH COMPLETELY REMOVED.

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

  MAUDE report 16382457 ↗
• InjuryFeb 8, 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 INFECTION, ABSCESS, FISTULA, ADHESIONS, PAIN, SEROMA, AND SEPSIS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, WOUND VAC, DRAINS, SMALL BOWEL RESECTION, AND REMOVAL SURGERY.

  Patient problems: Abscess; Adhesion(s); Fistula; Hemorrhage/Blood Loss/Bleeding; Hypersensitivity/Allergic reaction; Inflammation; Pain; Sepsis; Seroma; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 16320927 ↗
• InjuryJan 24, 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 VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED CAN'T LIFT MORE THAN 10LBS, DAILY TASKS ARE CHALLENGING, RECURRENCE ANDPAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, MEDICATION, PANNICULECTOMY, ADVANCEMENT FLAP CLOSURE OF ABDOMEN OVER COMPLEX HERNIA WITH NEW MESH.

  Patient problems: Hernia; Pain; Unspecified Tissue Injury

  MAUDE report 16237115 ↗
• InjuryDec 29, 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 RECURRENCE, INFECTION, ADHESIONS, SMALL BOWEL OBSTRUCTION, MESH FAILURE, DISCOMFORT, EMOTIONAL CHANGES <(>&<)> CHRONIC PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, MESH REMOVAL, MEDICATION, ADHESIOLYSIS, DEBRIDEMENT, EXPLORATORY LAPAROTOMY, HERNIA REPAIR WITH NEW MESH.

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

  MAUDE report 16073042 ↗
• InjuryOct 19, 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 A VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, PAIN, INFLAMMATION, ADHESIONS, MESH MIGRATION, IMPAIRMENT, DEFECTIVE DEVICE, MESH FAILURE, MENTAL PAIN, SUFFERING, SCARRING, AND LOSS OF ENJOYMENT OF LIFE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, MESH REVISION, AND MESH REMOVAL.

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

  MAUDE report 15636127 ↗
• InjuryOct 19, 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 A VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, PAIN, INFLAMMATION, ADHESIONS, MESH MIGRATION, IMPAIRMENT, DEFECTIVE DEVICE, MESH FAILURE, MENTAL PAIN, SUFFERING, SCARRING, AND LOSS OF ENJOYMENT OF LIFE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, MESH REVISION, AND MESH REMOVAL.

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

  MAUDE report 15636106 ↗
• InjuryOct 3, 2022Migration or Expulsion of Device; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Material Split, Cut or Torn; Migration or Expulsion of Device; 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 PREMATURE RESORPTION OF THE COLLAGEN COATING, DEFECTIVE MESH, ADHESIONS, PAIN, INFLAMMATION, BOWEL PROBLEMS, INFECTION, MENTAL PAIN, EMOTIONAL DISTRESS, DISABILITY, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE. POST-OPERATIVE PATIENT TREATMENT INCLUDED MESH REVISION, TAKEDOWN OF ADHESIONS.

  Patient problems: Abdominal Distention; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Distress; Dizziness; Electrolyte Imbalance; Emotional Changes; Erythema; Fatigue; Hernia; Impaired Healing; Inflammation; Muscle Weakness/Atrophy; Nausea; Pain; Unspecified Infection; Unspecified Tissue Injury; Vomiting; Wound Dehiscence

  MAUDE report 15533501 ↗
• InjurySep 7, 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 VENTRAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED PAIN, SUFFERING, MENTAL ANGUISH, EMOTIONAL DISTRESS, DIMINISHED QUALITY OF LIFE, MENTAL PAIN, CHRONIC DRAINING ABDOMINAL WOUND, INFECTION, ADHESIONS, FISTULA WITH MESH INSIDE OF IT, FOUL-SMELLING ODOR, FLUID LEAKAGE, NECROSIS, DEVICE DEFECTIVE, MESH FAILURE, DISABILITY, IMPAIRMENT, & LOSS OF ENJOYMENT OF LIFE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, MESH REMOVAL, REMOVAL OF ADHESIONS TO THE SMALL BOWEL, SMALL BOWEL RESECTION, FASCIA DEBRIDEMENT, & REPAIR OF HERNIA MESH.

  Patient problems: Abscess; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Distress; Emotional Changes; Fistula; Fluid Discharge; Hemorrhage/Blood Loss/Bleeding; Impaired Healing; Necrosis; Nodule; Pain; Purulent Discharge; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 15375557 ↗
• InjuryJul 28, 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 IMPLANT, THE PATIENT EXPERIENCED DEFECTIVE DEVICE, MENTAL PAIN, DISABILITY, PAIN, LOSS OF ENJOYMENT OF LIFE, IMPAIRMENT. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICAL TREATMENT.

  Patient problems: Abdominal Pain; Abscess; Adhesion(s); Bacterial Infection; Cellulitis; Discomfort; Emotional Changes; Erythema; Fever; Hernia; Impaired Healing; Inflammation; Ischemia; Necrosis; Pain; Purulent Discharge; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 15122548 ↗
• InjuryDec 23, 2021Mechanics 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 HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED PHYSICAL/MENTAL PAIN, SUFFERING, DISABILITY, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, AND DEVICE DEFECTIVE.

  Patient problems: Abdominal Distention; Abdominal Pain; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Ascites; Burning Sensation; Deformity/ Disfigurement; Discomfort; Emotional Changes; Hematoma; Hernia; Inflammation; Necrosis; Pain; Purulent Discharge; Swelling/ Edema; Unspecified Infection; Unspecified Tissue Injury; Wound Dehiscence

  MAUDE report 13079155 ↗
• InjuryOct 18, 2021Migration or Expulsion of Device; Material Deformation; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Migration or Expulsion of Device; 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 MESH INFECTION, ADHESIONS, PAIN, AND ABDOMEN FROZEN BENEATH THE FAILED MESH. POST-OPERATIVE PATIENT TREATMENT INCLUDED ABDOMINAL WOUND WASHOUT AND PARTIAL MESH REMOVAL SURGERY, PLACEMENT OF WOUND VAC AND REPEATED DRAINAGE PROCEDURE, AND ADDITIONAL MESH REMOVAL SURGERY TO REMOVE REMAINING MESH.

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Failure of Implant; Fluid Discharge; Impaired Healing; Inflammation; Pain; Purulent Discharge; Scar Tissue; Unspecified Infection; Unspecified Tissue Injury; Wound Dehiscence

  MAUDE report 12647481 ↗
• InjuryAug 19, 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 INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, HERNIA RECURRENCE, SMALL BOWEL OBSTRUCTION, ADHESIONS AND INFECTION. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY AND LYSIS OF ADHESIONS.

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

  MAUDE report 12343467 ↗
• InjuryAug 13, 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 A VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED SEPSIS, ABSCESS, NECROTIC TISSUE, SMALL BOWEL AND OMENTUM DENSELY ADHERENT TO MESH, MACERATED SEGMENT OF MID JEJUNUM ATTACHED TO MESH, PAIN AND INFECTION. POST-OPERATIVE PATIENT TREATMENT INCLUDED SMALL BOWEL RESECTION, WOUND VAC REQUIREMENT, AND REVISION SURGERY.

  Patient problems: Abscess; Adhesion(s); Erosion; Inflammation; Necrosis; Pain; Sepsis; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 12321183 ↗
• InjuryJul 15, 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DENSE AND HARDENED ADHESIONS, CHRONIC OBSTRUCTION, SEVERE AND CHRONIC PAIN AND DISCOMFORT, HERNIA RECURRENCE, MESH FAILURE, FISTULA, NAUSEA, DIARRHEA, URINARY FREQUENCY, DISCOMFORT, AND FOREIGN BODY GIANT CELL REACTION. POST-OPERATIVE PATIENT TREATMENT INCLUDED ADDITIONAL SURGERY AND REMOVAL OF MESH, MEDICATION, HERNIA REPAIR WITH NEW MESH.

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Diarrhea; Discomfort; Failure of Implant; Fistula; Foreign Body Reaction; Hernia; Nausea; Obstruction/Occlusion; Pain; Unspecified Tissue Injury; Urinary Frequency / Polyuria

  MAUDE report 12178658 ↗
• InjuryJul 2, 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 RECURRENCE, INFECTION, NECROTIZING ACUTE INFLAMMATORY CHANGES, AND OPEN DRAINING WOUND. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY AND SURGERY TO REMOVE MESH. INFORMATION RECEIVED INDICATES THE PATIENT IS DECEASED. THE REPORTER STATED THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE EVENT.

  Patient problems: Discomfort; Fluid Discharge; Hernia; Impaired Healing; Inflammation; Necrosis; Pain; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 12112234 ↗
• InjuryMay 7, 2021Degraded; Migration or Expulsion of Device; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Patient Device Interaction Problem; Degraded; Migration or Expulsion of Device; 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 A HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED INFECTED MESH, ADHESIONS, FAILED MESH, RECURRENCE, PAIN, PURULENT DRAINING CAVITY, FOLDED MESH, CALCIFIED MESH, AND MESH EROSION. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, REMOVAL SURGERY, CUTTING INSTRUMENTS TO GET THROUGH ABDOMINAL WALL DUE TO CALCIFIED MESH, PLACEMENT OF WOUND VAC, HERNIA REPAIR WITH MESH, AND WOUND DEBRIDEMENTS.

  Patient problems: Abdominal Distention; Abdominal Pain; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Decreased Appetite; Distress; Emotional Changes; Erosion; Failure of Implant; Fever; Hernia; Inflammation; Nausea; Pain; Perforation; Purulent Discharge; Scar Tissue; Unspecified Gastrointestinal Problem; Unspecified Infection; Unspecified Tissue Injury; Vomiting

  MAUDE report 11794964 ↗
• InjuryMay 7, 2021Degraded; Migration or Expulsion of Device; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Patient Device Interaction Problem; Degraded; Migration or Expulsion of Device; 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 A HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED INFECTED MESH, ADHESIONS, FAILED MESH, RECURRENCE, PAIN, PURULENT DRAINING CAVITY, FOLDED MESH, CALCIFIED MESH, AND MESH EROSION. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, REMOVAL SURGERY, CUTTING INSTRUMENTS TO GET THROUGH ABDOMINAL WALL DUE TO CALCIFIED MESH, PLACEMENT OF WOUND VAC, AND WOUND DEBRIDEMENTS.

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Distress; Erosion; Failure of Implant; Fever; Hernia; Inflammation; Pain; Perforation; Purulent Discharge; Scar Tissue; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 11794960 ↗