Parietex PCO3728XRecalls & reported problems

Summary

The FDA's MAUDE database contains 82 adverse event reports that list this exact device (DI 10884521179653), received between Dec 5, 2017 and Jan 16, 2026 — classified as 3 deaths, 79 injuries.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (27 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 82 reports, in the reporter's own words as published by the FDA.

• InjuryJan 16, 2026Adverse 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 ADHESIONS, PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

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

  MAUDE report 24098916 ↗
• InjuryMar 7, 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 PAIN, RECURRENCE, INFLAMMATION, ADHESIONS, FOREIGN BODY GIANT CELL REACTION, SCARRING, AND HERNIA ENLARGEMENT. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICATION.

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

  MAUDE report 21549493 ↗
• InjuryAug 9, 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED SEROMA, CELLULITIS, ABSCESS, RECURRENCE, ADHESIONS, MESH FAILURE, MESH MIGRATION. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICATION.

  Patient problems: Abscess; Adhesion(s); Cellulitis; Hernia; Seroma; Unspecified Tissue Injury

  MAUDE report 19954594 ↗
• InjuryJul 12, 2024Adverse 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 A LAPAROSCOPIC THERAPEUTIC TREATMENT OF A VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED FLUID COLLECTION, INFECTION, ABSCESS, PURULENT DISCHARGE, ADHESIONS, FISTULA, SEROSAL INJURIES, MENTAL PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, DISABILITY, LOW LUNG VOLUMES, ATELECTASIS, ASPIRATION, LABS ABNORMAL FOR LACTATE; HEMOGLOBIN; WBC; SODIUM; HEMATOCRIT; TOTAL BILIRUBIN; AST; ALT; CALCIUM; POTASSIUM; GLUCOSE; PROTHROMBIN TIME; INR; FIBRINOGEN; PLATELETS; C-REACTIVE PROTEIN; MAGNESIUM; PHOSPHORUS; ALBUMIN, HERNIA RECURRENCE, SMALL BOWEL PERFORATION, GASEOUS/AIR COLLECTION, FIBROUS CONNECTIVE TISSUE, INFLAMMATION, PNEUMOPERITONEUM, MYCOBACTERIUM FORTUITUM, STREP, HAEMOPHILIS PARAINFLUENZAE, KLEBSIELLA AEROGENES, LACTOSE FERMENTING GRAM NEGATIVE RODS, ACTINOMYCES SPECIES, CEFTRIAXONE, SERRATIA, BACILLUS, BACTEREMIA, FIBROUS SEROSAL ADHESIONS, EDEMA, FISTULOUS TRACT, HYPEREMIA, TRANSVERSE COLITIS, ILEUS, SCARRING, ISCHEMIC CHANGES, CANDIDA ALBICANS, TACHYCARDIA, FEVER, ABDOMINAL PAIN, BLEEDING, PERITONITIS, LEUKOCYTOSIS, DIAPHORESIS, ABDOMINAL SORENESS/TENDERNESS, DISTEN

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

  MAUDE report 19735815 ↗
• InjuryMay 7, 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 INFECTION, ADHESIONS, PAIN, WOUND DRAINAGE, DRAINING SINUS TRACT. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Fluid Discharge; Hypersensitivity/Allergic reaction; Impaired Healing; Pain; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 19261116 ↗
• InjuryMar 15, 2024Migration or Expulsion of Device; Material Deformation; Adverse Event Without Identified Device or Use Problem; Migration or Expulsion of Device; 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 AN INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED MESH DEFORMATION, MESH FOLDED, MESH MIGRATION, RECURRENCE, ADHESIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, REMOVAL OF MESH.

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

  MAUDE report 18910174 ↗
• InjuryDec 27, 2023Migration 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 IMPLANT, THE PATIENT EXPERIENCED PAIN, INFECTION, INFLAMMATION, RECURRENCE, HEMATOMA, ADHESIONS, ABSCESS, SINUS TRACT, CURLED MESH. POST-OPERATIVE PATIENT TREATMENT INCLUDED ORGAN LOSS, SKIN REMOVAL, BLAKE DRAIN, HERNIA REPAIR WITH NEW MESH.

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

  MAUDE report 18402285 ↗
• InjuryNov 17, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, ON POST OPERATIVE LAPAROSCOPIC VENTRAL HERNIA REPAIR, A RECURRENT VENTRAL HERNIA APPEAR 2 YEARS AFTER THE MESH IMPLANTATION. THE MESH WAS DAMAGED. THERE WAS A 2.5 CM. CENTRAL HOLE IN THE MESH, INVOLVING A VENTRAL HERNIA. THE PATIENT HAD TEMPORARY INJURY AND TISSUE DAMAGE AS A RESULT. THE EVENT HAS LEAD TO PATIENT HOSPITALIZATION. THE PATIENT HAD TO UNDERGO ANOTHER VENTRAL HERNIA REPAIR AS PART OF THE INTERVENTION. THERE WAS NO PROBLEM ON THE FIXATION POINTS USING SUTURE.

  Patient problems: Hernia; Tissue Breakdown

  MAUDE report 18160826 ↗
• InjurySep 20, 2023Degraded; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Degraded; 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, ADHESIONS, PAIN, AND MESH EROSION. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Adhesion(s); Constipation; Deformity/ Disfigurement; Erosion; Hernia; Hypersensitivity/Allergic reaction; Inflammation; Obstruction/Occlusion; Pain; Perforation; Unspecified Tissue Injury

  MAUDE report 17783696 ↗
• InjuryMar 7, 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, ADHESIONS, AND PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED ADDITIONAL SURGERY AND REVISION.

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

  MAUDE report 16499142 ↗
• InjuryAug 22, 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 RECURRENCE, INFECTION, ABSCESS, FISTULA, ADHESIONS, AND CHRONIC PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Abscess; Adhesion(s); Discomfort; Fistula; Hernia; Pain; Scar Tissue; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 15271952 ↗
• InjuryJul 5, 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, INFECTION, OBSTRUCTION, PAIN, AND SEROMA. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

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

  MAUDE report 14917583 ↗
• InjuryApr 22, 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 RECURRENCE, INFECTION, ADHESIONS, PAIN, ABSCESS, FISTULA, SMALL BOWEL OBSTRUCTION, MEH EROSION, SEROSAL INJURY, AND PERFORATED BOWEL. POST-OPERATIVE PATIENT TREATMENT INCLUDED SMALL BOWEL RESECTION AND REVISION SURGERIES.

  Patient problems: Abdominal Pain; Abscess; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Ascites; Bacterial Infection; Bowel Perforation; Cellulitis; Confusion/ Disorientation; Cyst(s); Decreased Appetite; Discomfort; Dyspnea; Erosion; Erythema; Fistula; Fluid Discharge; Fungal Infection; Hematoma; Hemorrhage/Blood Loss/Bleeding; Hernia; Hypoxia; Inflammation; Malaise; Muscle Weakness/Atrophy; Nodule; Obstruction/Occlusion; Pain; Peritonitis; Swelling/ Edema; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 14189399 ↗
• InjuryApr 22, 2022Migration 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, ADHESIONS, PAIN, MESH CONTRACTION, MESH DETACHMENT, SCARRING, AND MESH SEPARATION. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Abdominal Distention; Abdominal Pain; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Constipation; Diarrhea; Fatigue; Hernia; Muscle Weakness/Atrophy; Nausea; Pain; Scar Tissue; Unspecified Infection; Unspecified Tissue Injury; Vomiting

  MAUDE report 14189345 ↗
• InjuryApr 22, 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 AN INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, ADHESIONS, PAIN, AND DISEASED ABDOMINAL WALL. POST-OPERATIVE PATIENT TREATMENT INCLUDED EXTENSIVE LYSIS OF ADHESIONS AND REMOVAL OF PREVIOUS MESH.

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

  MAUDE report 14187873 ↗
• InjuryMar 21, 2022Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; 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 A HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, ADHESIONS, AND RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Abdominal Distention; Adhesion(s); Erosion; Hemorrhage/Blood Loss/Bleeding; Hernia; Incontinence; Inflammation; Obstruction/Occlusion; Pain; Unspecified Tissue Injury

  MAUDE report 13840500 ↗
• InjuryJan 21, 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 A HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED INFECTION, ABSCESS, ADHESIONS, AND MESH MIGRATION. POST-OPERATIVE PATIENT TREATMENT INCLUDED SMALL BOWEL RESECTION AND WOUND VAC.

  Patient problems: Abscess; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Fibrosis; Fistula; Fluid Discharge; Foreign Body Reaction; Impaired Healing; Inflammation; Muscle Weakness/Atrophy; Necrosis; Nodule; Obstruction/Occlusion; Seroma; Unspecified Infection; Unspecified Tissue Injury; Wound Dehiscence

  MAUDE report 13324582 ↗
• InjuryNov 12, 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 MESH FAILED, SCARRING, PAIN, RECURRENCE, MENTAL AND PHYSICAL PAIN, DISABILITY, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, AND DEFECTIVE DEVICE. POST-OPERATIVE PATIENT TREATMENT INCLUDED ABDOMINAL WALL RECONSTRUCTION AND REVISION SURGERY.

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

  MAUDE report 12805182 ↗
• InjuryJul 29, 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 LAPAROSCOPIC THERAPEUTIC TREATMENT OF VENTRAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED ADHESIONS, RECURRENCE (INCISIONAL HERNIA ATTENUATED), CHRONIC SINUS ABDOMINAL WALL, OPEN WOUND, INFECTED MESH, ABSCESS, FISTULA, CHRONIC PAIN, AND INFLAMMATION. POST-OPERATIVE PATIENT TREATMENT INCLUDED HERNIA REPAIR WITH NEW MESH, LYSIS OF ADHESIONS, TOTAL COLECTOMY, ILEORECTAL ANASTOMOSIS, MESH REAPPROXIMATED USED FOR REPAIR, DRAINAGE OF ABSCESS, PARTIAL REMOVAL OF MESH, REPAIR OF SMALL BOWEL FISTULA, EXPLORATION OF CHRONIC SINUS, REMOVAL OF MESH, EXPLORATORY LAPAROTOMY, REVISION SURGERY, AND MEDICATION.

  Patient problems: Abscess; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Fistula; Hernia; Impaired Healing; Inflammation; Muscle Weakness/Atrophy; Pain; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 12247775 ↗
• InjuryJul 15, 2021Mechanics 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 DEVICE DEFECT, INFECTION, ADHESIONS, SMALL BOWEL OBSTRUCTION AND SEROMA. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, SMALL BOWEL RESECTION, DEBRIDEMENT AND HERNIA REPAIR WITH MESH.

  Patient problems: Abdominal Distention; Abdominal Pain; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Ascites; Hematoma; Hernia; Inflammation; Obstruction/Occlusion; Pain; Perforation; Seroma; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 12178809 ↗
• InjuryJul 15, 2021Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Material Split, Cut or Torn; Migration or Expulsion of Device; 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 LAPAROSCOPIC THERAPEUTIC TREATMENT OF AN INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, RECURRENCE, MESH SPLITTING, MESH MIGRATION, AND ADHESIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, MESH REMOVAL, AND HERNIA REPAIR WITH MESH.

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

  MAUDE report 12173919 ↗
• 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 VENTRAL INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED BOWEL OBSTRUCTION, INFECTIONS, SEROMA, ADHESIONS, INFLAMMATION, EVENTRATION, HERNIA RECURRENCE, PURULENT MATERIAL, DEGENERATING DEBRIS, SCATTERED GIANT CELLS, HISTIOCYTES, PERITONEAL FLUID, AND PAIN/SUFFERING. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, LYSIS OF ADHESIONS, PARTIAL RESECTION OF INFECTED MESH, RELEASE OF SMALL BOWEL OBSTRUCTION, DRAIN PLACEMENT, PERITONEAL LAVAGE, CYTOLOGY, HERNIA REPAIR WITH MESH, AND DRAINAGE OF INFECTED SEROMA.

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Ascites; Burning Sensation; Hernia; Inflammation; Numbness; Obstruction/Occlusion; Pain; Purulent Discharge; Seroma; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 12138340 ↗
• DeathMay 20, 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 THE IMPLANT, THE PATIENT EXPERIENCED EXPOSED MESH, WOUND DEHISCENCE, NON-HEALING WOUND, CHRONIC ABDOMINAL WOUND, EROSION OF MESH INTO BOWEL, MESH INFECTION, FISTULA, RECURRENCE, ADHESIONS, ABSCESS, SEROMA, POORLY INCORPORATED MESH, MESH MIGRATION, LOSS OF DOMAIN, POSITIVE FOR PYODERMA GANGRENOSUM, SEPSIS, DEATH, AND NECROTIC TISSUE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERIES, MESH RESUTURED, WOUND VAC, WOUND DEBRIDEMENT, REMOVAL OF MESH, SPLIT-THICKNESS SKIN GRAFT, AND HERNIA REPAIR WITH NEW MESH, INCISION/DRAINAGE OF ABSCESS, EVACUATION OF SEROMA, TAKEDOWN OF ADHESIONS, SMALL BOWEL RESECTION, ANASTOMOSIS, RIGHT FLANK ABDOMINOPLASTY WITH ADVANCEMENT FLAPS OF MUSCLE AND SKIN, TRANSPORTED TO THE ICU, REMAINED INTUBATED BECAUSE OF LONG DURATION OF OPEN ABDOMEN/COMORBIDITIES, AND EXCISION OF NECROTIC TISSUE. INFORMATION RECEIVED INDICATES THE PATIENT IS NOW DECEASED, DUE TO SEPSIS.

  Patient problems: Abscess; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Bacterial Infection; Erosion; Fistula; Hernia; Impaired Healing; Necrosis; Sepsis; Seroma; Unspecified Infection; Unspecified Tissue Injury; Wound Dehiscence

  MAUDE report 11859998 ↗
• DeathMay 20, 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 THE IMPLANT, THE PATIENT EXPERIENCED EXPOSED MESH, WOUND DEHISCENCE, NON-HEALING WOUND, CHRONIC ABDOMINAL WOUND, EROSION OF MESH INTO BOWEL, MESH INFECTION, FISTULA, RECURRENCE, ADHESIONS, ABSCESS, SEROMA, POORLY INCORPORATED MESH, MESH MIGRATION, LOSS OF DOMAIN, POSITIVE FOR PYODERMA GANGRENOSUM, SEPSIS, DEATH, AND NECROTIC TISSUE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERIES, MESH RESUTURED, WOUND VAC, WOUND DEBRIDEMENT, REMOVAL OF MESH, SPLIT-THICKNESS SKIN GRAFT, AND HERNIA REPAIR WITH NEW MESH, INCISION/DRAINAGE OF ABSCESS, EVACUATION OF SEROMA, TAKEDOWN OF ADHESIONS, SMALL BOWEL RESECTION, ANASTOMOSIS, RIGHT FLANK ABDOMINOPLASTY WITH ADVANCEMENT FLAPS OF MUSCLE AND SKIN, TRANSPORTED TO THE ICU, REMAINED INTUBATED BECAUSE OF LONG DURATION OF OPEN ABDOMEN/COMORBIDITIES, AND EXCISION OF NECROTIC TISSUE. INFORMATION RECEIVED INDICATES THE PATIENT IS NOW DECEASED, DUE TO SEPSIS.

  Patient problems: Abscess; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Bacterial Infection; Erosion; Fistula; Hernia; Impaired Healing; Necrosis; Sepsis; Seroma; Unspecified Infection; Unspecified Tissue Injury; Wound Dehiscence

  MAUDE report 11859944 ↗
• InjuryMay 7, 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 AN ABDOMINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED ADHESIONS, FAILED MESH, SEROMA, ABSCESS, AND SMALL BOWEL EROSION. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY AND MESH REMOVAL SURGERY.

  Patient problems: Abscess; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Erosion; Failure of Implant; Hernia; Obstruction/Occlusion; Pain; Seroma; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 11792343 ↗