Parietex PCO20FXRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10884521179714), received between Nov 2, 2020 and Sep 12, 2024 — classified as 4 injuries.

The most frequently reported specific device problem is “Mechanics Altered” (1 report).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjurySep 12, 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 A VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED LABS ABNORMAL FOR CRP, HERNIA RECURRENCE, CELLULITIS, DISCOMFORT, TENDERNESS, PAIN, POOR QUALITY OF SLEEP, CHRONIC GROIN PAIN, & ABDOMINAL PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED CT SCAN, IV ANTIBIOTICS, PAIN MEDICATION, INJECTIONS, & NERVE INFILTRATION.

  Patient problems: Abdominal Pain; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Cellulitis; Discomfort; Hernia; Pain; Sleep Dysfunction; Unspecified Tissue Injury

  MAUDE report 20205646 ↗
• InjuryJan 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 A HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED PAIN, INFLAMMATION, SWELLING, BOWEL OBSTRUCTION, GASTROINTESTINAL MALFUNCTION, LOSS OF ENJOYMENT OF LIFE, INABILITY TO PARTICIPATE IN PREVIOUS ACTIVITIES, AND HERNIA RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED HOSPITALIZATION, DIAGNOSTIC IMAGING, REVISION SURGERY, SERUM TESTING, ANTIBIOTICS, ANALGESICS, MEDICATION, THERAPY, REHABILITATION, AND REST.

  Patient problems: Abdominal Pain; Abscess; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Ascites; Bacterial Infection; Chills; Discomfort; Emotional Changes; Erythema; Fever; Fluid Discharge; Foreign Body Reaction; Hernia; Inflammation; Muscle Weakness/Atrophy; Nausea; Obstruction/Occlusion; Pain; Purulent Discharge; Scar Tissue; Swelling/ Edema; Unspecified Infection; Unspecified Tissue Injury; Wound Dehiscence

  MAUDE report 13385816 ↗
• InjuryAug 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 VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED HERNIA RECURRENCE, MESH ADHESIONS, BOWEL COMPLICATIONS, CHRONIC PAIN, DEFECTIVE PRODUCT, SCARRING, DISFIGUREMENT, PSYCHOLOGICAL AND EMOTIONAL INJURIES, SUFFERING, LOSS OF ENJOYMENT OF LIFE, DISABILITY, AND LOSS OF PHYSICAL, MENTAL, AND EMOTIONAL HEALTH. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

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

  MAUDE report 12354319 ↗
• InjuryNov 2, 2020Adverse 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 AN INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, PAIN, MENTAL ANGUISH, PSYCHOLOGICAL STRESS, DEPRESSION, DISABILITY (UNABLE TO PARTICIPATE IN EMPLOYMENT, RECREATIONAL, SOCIAL, AND HOUSEHOLD ACTIVITIES), MASS/DISTENTION, DIFFICULTIES SLEEPING, ABDOMINAL PAIN, REDNESS, BULGING OF MIDLINE, AND LOSS OF ENJOYMENT OF LIFE. POST-OPERATIVE PATIENT TREATMENT INCLUDED HERNIA REPAIR WITH NEW MESH, HOSPITALIZATION, X-RAY, AND ADDITIONAL SURGERY.

  Patient problems: Abdominal Distention; Abdominal Pain; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Depression; Disability; Emotional Changes; Erythema; Hernia; Injury; Nodule; Pain; Sleep Dysfunction; Unspecified Tissue Injury

  MAUDE report 10770973 ↗