Parietex PCO3020FXRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10884521179844), received between Dec 19, 2017 and Sep 27, 2024 — classified as 12 injuries.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (3 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjurySep 27, 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED FLUID COLLECTION, INFECTED MESH, INFLAMMATION, SEROMA, ABSCESS, HERNIA RECURRENCE, STAPH AUREUS, SCARRING, YELLOW SEROUS FLUID, ABDOMINAL PAIN, VOMITING, DISCHARGING SINUSES, PAIN, CHRONIC ABDOMINAL WOUND WITH PURULENT DISCHARGE, UTI, BLADDER FISTULA, ERYTHEMA, SWELLING, FUNGAL INFECTION, SEVERE PAIN WITH WALKING, SKIN IRRITATION, WOUND INFECTION, THRUSH, SMALL BOWEL OBSTRUCTION, ADHESIONS, AGITATION, PHYSICAL AGGRESSION, DELIRIUM, HALLUCINATIONS, & INCONTINENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED CT SCAN, USE OF INDWELLING DRAIN, MULTIPLE HOSPITALIZATIONS, ANTIBIOTICS, INCISION <(>&<)> DRAINAGE OF ABDOMINAL WOUND ABSCESS, YELLOW SEROUS FLUID ASPIRATED, IMAGING, PAIN MEDICATION, EXPLORATION OF ABDOMINAL WALL SINUS, WOUND CARE, WOUND VAC, DEBRIDEMENT OF ABDOMINAL WOUND SINUS, MESH REMOVAL, REPAIR OF BLADDER FISTULA, RECONSTRUCTION OF ABDOMINAL WALL, TACKERS REMOVED, ULTRASOUND GUIDED DRAINAGE OF SEROMA, ANTIFUNGAL MEDICATION, SEROMA WALL EXCISION, EXCESS SKIN EXCISED, MULTIPLE HERNIA REPAIR WITH

  Patient problems: Abdominal Pain; Abscess; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Ascites; Bacterial Infection; Confusion/ Disorientation; Emotional Changes; Erythema; Fistula; Fluid Discharge; Fungal Infection; Hallucination; Hernia; Impaired Healing; Incontinence; Inflammation; Obstruction/Occlusion; Pain; Purulent Discharge; Scar Tissue; Seroma; Swelling/ Edema; Unspecified Infection; Unspecified Tissue Injury; Urinary Tract Infection; Vomiting

  MAUDE report 20323416 ↗
• InjurySep 18, 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 A LAPAROSCOPIC THERAPEUTIC TREATMENT OF AN INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED FLUID COLLECTIONS, STAPH, ABDOMINAL PAIN, DISCHARGE FROM PORT SITE, & WOUND INFECTION. POST-OPERATIVE PATIENT TREATMENT INCLUDED CT SCAN, HOSPITALIZATION, & ANTIBIOTICS.

  Patient problems: Abdominal Pain; Ascites; Bacterial Infection; Fluid Discharge; Impaired Healing; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 20252427 ↗
• InjurySep 16, 2024Migration 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 INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED HERNIA RECURRENCE, SMALL BOWEL DILATION, ADHESIONS, STENOSIS OF SMALL BOWEL, INDURATION, LUMP, MESH INFECTION, FLUID FILLED TRACT, SCARRING, THICKENING AT THE ABDOMINAL WALL, STAPH, ABDOMINAL PAIN, MESH MOVEMENT, PAIN WITH SIGNIFICANT IMPACT ON ALL DAILY ACTIVITIES, UNABLE TO WALK ANY DISTANCE FROM PAIN, NAUSEA, LIGHT HEADEDNESS, INCISION LEAKING HAEMOSEROUS FLUID, DISCHARGE OF BLOOD, <(>&<)> VOMITING. POST-OPERATIVE PATIENT TREATMENT INCLUDED CT SCAN, ULTRASOUND, ABDOMINAL SPLIT, <(>&<)> ANTIBIOTICS.

  Patient problems: Abdominal Pain; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Ascites; Bacterial Infection; Dizziness; Fluid Discharge; Hemorrhage/Blood Loss/Bleeding; Hernia; Impaired Healing; Nausea; Nodule; Obstruction/Occlusion; Pain; Scar Tissue; Stenosis; Unspecified Infection; Unspecified Tissue Injury; Vomiting

  MAUDE report 20232637 ↗
• InjurySep 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 AN INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED ATROPHIC LATERAL MUSCLES, FEVER, SEROMA, ANXIETY, LABS ABNORMAL FOR CRP, EMESIS, OPEN WOUND WITH BLEEDING, INFLAMMATION WITH SWELLING, HERNIA RECURRENCE, UNABLE TO HAVE BOWEL MOTION, DIAPHORETIC, ABDOMINAL PAIN, DISCOMFORT, & PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED CT SCAN, ANTIBIOTICS, EPIDURAL PCA, IV/ORAL PAIN MEDICATION, IV FLUIDS, ANTIEMETICS, DIAZEPAM, WOUND CARE, PHYSIOTHERAPY, & HOSPITALIZATION.

  Patient problems: Abdominal Pain; Anxiety; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Diaphoresis; Discomfort; Fever; Hemorrhage/Blood Loss/Bleeding; Hernia; Impaired Healing; Inflammation; Muscle Weakness/Atrophy; Pain; Seroma; Swelling/ Edema; Unspecified Tissue Injury; Vomiting

  MAUDE report 20183408 ↗
• InjuryJul 14, 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 AN INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED INFECTION, EROSION, DEPRESSION, PAIN, MENTAL PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, DISABILITY, OPEN WOUND. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, REMOVAL OF MESH, MEDICATION, HOSPITALIZATION, WOUND VAC.

  Patient problems: Depression; Emotional Changes; Erosion; Impaired Healing; Pain; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 17326495 ↗
• InjuryApr 21, 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 ABDOMINAL SINUS, PAIN, INFECTION, RECURRENCE, PAIN, DISCOMFORT, LOW MOOD, ANXIETY, MOBILITY RESTRICTED. POST-OPERATIVE PATIENT TREATMENT INCLUDED REMOVAL OF MESH.

  Patient problems: Abdominal Distention; Abdominal Pain; Abscess; Adhesion(s); Anxiety; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Ascites; Cellulitis; Cough; Depression; Discomfort; Emotional Changes; Erythema; Fistula; Fluid Discharge; Foreign Body Reaction; Hematoma; Hemorrhage/Blood Loss/Bleeding; Hernia; Impaired Healing; Inflammation; Necrosis; Nodule; Pain; Pneumonia; Purulent Discharge; Scar Tissue; Seroma; Suicidal Ideation; Swelling/ Edema; Ulcer; Unspecified Infection; Unspecified Tissue Injury; Vomiting

  MAUDE report 14167286 ↗
• InjuryJul 15, 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 AND INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED INFLAMMATION, CUTTING SENSATION UNDER CHEST WHEN SITTING, INFECTION, BLEEDING, SEROMA, PROTRUDING ABDOMEN, DIARRHEA, ABDOMINAL PAIN, DENSE ADHESIONS, HERNIA RECURRENCE, BURNING SENSATION, SEVERE AND CHRONIC PAIN AND DISCOMFORT. POST-OPERATIVE PATIENT TREATMENT INCLUDED ADDITIONAL SURGERY.

  Patient problems: Abdominal Distention; Abdominal Pain; Adhesion(s); Burning Sensation; Diarrhea; Discomfort; Fluid Discharge; Hemorrhage/Blood Loss/Bleeding; Hernia; Inflammation; Pain; Seroma; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 12178669 ↗
• InjuryOct 16, 2019Material Erosion; Material Perforation; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Material Erosion; Material Perforation; 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 VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED ABSCESS, FISTULA, MESH ERODED INTO THE SMALL BOWEL, SCARRING, CHRONIC DRAINING SINUS, INFECTED MALODOROUS MESH WITH SURROUNDING PURULENCE/ABSCESS, RECURRENCE, OPEN WOUND, SEROSITIS, ULCERATION, FLUID COLLECTION, FIBROADIPOSE AND CONNECTIVE TISSUE, INFLAMMATION, SINUS TRACT, SCAR TISSUE, ISCHEMIA, PERFORATION, HOT/COLD SPELLS, AND ADHESIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDES REVISION SURGERY, SMALL BOWEL RESECTION, WOUND VAC, HERNIA REPAIR, MESH REMOVAL, JP DRAINS, INCISION AND DRAINAGE OF ABSCESS, PURULENCE DRAINED, ADMITTED TO HOSPITAL, OPEN WOUND DEBRIDEMENT AND PACKING AND BULLET REMOVAL.

  Patient problems: Abscess; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Ascites; Bowel Perforation; Discharge; Erosion; Fistula; Fluid Discharge; Foreign Body In Patient; Hernia; Impaired Healing; Inflammation; Injury; Ischemia; No Code Available; Pain; Perforation; Purulent Discharge; Scar Tissue; Scarring; Seroma; Ulcer; Ulceration; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 9199412 ↗
• InjuryApr 22, 2019Material Erosion; Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Material Erosion; 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 HISTIOCYTE AGGREGATES, MIGRATION, ADHESIONS, PAIN, SEROMA, MESH EROSION INTO VISCERA, FIBROSIS, NECROSIS, INFLAMMATION, PELVIC MASS AND RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED CT SCAN, REVISION SURGERY, REPAIR OF HERNIA WITH MESH, EXPLORATORY LAPAROTOMY, LAPAROSCOPIC HERNIA REPAIR REMOVAL OF MESH, BILATERAL TRUNK ADVANCEMENT FLAPS, DRAINAGE OF SEROMA, DECORTICATION/CAPSULECTOMY.

  Patient problems: Abdominal Pain; Abscess; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Ascites; Erosion; Fibrosis; Hernia; Inflammation; Injury; Necrosis; No Code Available; Nodule; Obstruction/Occlusion; Pain; Renal Failure; Scar Tissue; Seroma; Unspecified Tissue Injury

  MAUDE report 8538285 ↗
• InjuryMar 7, 2019Degraded; Adverse Event Without Identified Device or Use Problem; Degraded; Adverse Event Without Identified Device or Use Problem

  INCISION WAS EXTENDED MORE THAN 1 INCH DUE TO THE PROBLEM. PATIENT REMAINS IN THE HOSPITAL.

  Patient problems: No Code Available; Tissue Damage

  MAUDE report 8399377 ↗
• InjuryApr 2, 2018Migration 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

  ACCORDING TO THE REPORTER, THIS WAS A HERNIA PROCEDURE MIDLINE OVHR. THE MESH MIGRATED AND ROLLED UP INTO SMALL BOWEL, THIS PART HAD TO BE REMOVED. THE PATIENT PRESENTED WITH AN ENTEROCUTANEOUS FISTULA. SUPPLEMENTARY INTERVENTION WAS NEEDED DUE TO THE ENTEROCUTANEOUS FISTULA. A END-TO-END ANASTOMOSES WAS PERFORMED WITH STANDARD SURGICAL PROCEDURE FOR PARTIAL REMOVAL OF THE AFFECTED SMALL BOWEL, REMOVAL OF THE ENTEROCUTANEOUS FISTULA WITH THE ROLLED UP MESH. THE SURGICAL TIME WAS EXTENDED 30 MINUTES OR MORE DUE TO REMOVAL OF ROLLED UP MESH. THE INCISION WAS EXTENDED MORE THAN ONE INCH. THE WOUND WAS CLOSED WITH SUTURES AND STANDARD ABDOMINAL WALL CLOSURE. THE PATIENT OUTCOME IS ALIVE WITH INJURY. THE SPECIMEN WAS COLLECTED AN SENT TO PATHOLOGY (B)(6) TO CLARIFY IF THERE ARE PATHOLOGICAL CHANGES OF THE SMALL BOWEL. THERE WILL BE AN ADDITIONAL OPERATION TO CORRECT THE ISSUE. THE MESH WAS IMPLANTED (B)(6) 2015 AND PARTIAL EXPLANT (B)(6) 2018 (28.1 MONTHS).

  Patient problems: Fistula; Injury

  MAUDE report 7388581 ↗
• InjuryDec 19, 2017Adverse 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 RESULTING IN AN UNSPECIFIED ADVERSE OUTCOME. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT. THE PATIENT UNDERWENT A LAPAROSCOPIC VENTRAL HERNIA AND LAPAROSCOPIC ADHESIOLYSIS. HE HAD REVISION SURGERY 8 MONTHS POST-SURGERY. THE PATIENT UNDERWENT A OPEN REPAIR RECURRENT VENTRAL LEFT LOWER QUADRANT HERNIA WITH MESH AND OPEN VENTRAL HERNIA REPAIR, PRIMARY RIGHT MID ABDOMINAL HERNIA. THE PATIENT UNDERWENT ANOTHER REVISION SURGERY 2 YEARS AND 7 MONTHS. THE PATIENT UNDERWENT A EXPLORATORY LAPAROTOMY, EXTENSIVE LYSIS OF ADHESIONS AND RESECTION OF TWO ENTEROCUTANEOUS FISTULAE WITH CREATION OF SMALL BOWEL TO SMALL BOWEL ANASTOMOSIS, EXCISION OF INFECTED ABDOMINAL WALL, INCISIONAL HERNIA REPAIR AND COMPLEX CLOSURE OF THE ABDOMINAL WALL. THE PATIENT EXPERIENCED PAIN, SEROMA, ADHESIONS, INFECTION, HERNIA RECURRENCE AND FISTULA.

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

  MAUDE report 7129328 ↗