Parietex PCO9FXRecalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10884521179868), received between Jan 8, 2018 and Sep 30, 2024 — classified as 14 injuries, 1 malfunction.

The most frequently reported specific device problem is “Mechanics Altered” (5 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 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 E PIGASTRIC HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED WOUND INFECTION, ABDOMINAL PAIN, BLOATING, NAUSEA, INCREASED FREQUENCY OF STOOLS, & REDUCED ENERGY LEVELS. POST-OPERATIVE PATIENT TREATMENT INCLUDED ANTIBIOTICS.

  Patient problems: Abdominal Distention; Abdominal Pain; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Fatigue; Nausea; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 20338470 ↗
• MalfunctionAug 8, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPIC ABDOMINAL WALL SCAR HERNIA SURGERY, NINE YEARS AFTER THE INITIAL SURGERY, A SECOND LOOK AT THE REPAIRED AREA REVEALED WHITE DISSEMINATION ON THE ABDOMINAL WALL WHERE THE MESH WAS PLACED. IT WAS NOTED THAT THE SIZES OF THE LESION WERE 10MM X 15MM. AND 10MM.

  Patient problems: Tissue Breakdown

  MAUDE report 19937372 ↗
• InjuryJun 12, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, THE TWO MESHES WERE FRACTURED, SLIGHTLY OVERLAPPED, AND HAD A SPLIT THAT WENT DIRECTLY THROUGH BOTH MESHES. IT WAS NOTED THAT A RE-OPERATION HAD TO BE DONE TO REMOVE THE MESH TO RESOLVE THE ISSUE.

  Patient problems: Tissue Breakdown

  MAUDE report 19519548 ↗
• InjuryJun 12, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, THE TWO MESHES WERE FRACTURED, SLIGHTLY OVERLAPPED, AND HAD A SPLIT THAT WENT DIRECTLY THROUGH BOTH MESHES. IT WAS NOTED THAT A RE-OPERATION HAD TO BE DONE TO REMOVE THE MESH TO RESOLVE THE ISSUE.

  Patient problems: Tissue Breakdown

  MAUDE report 19519410 ↗
• InjuryJul 24, 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 A LAPAROSCOPIC THERAPEUTIC TREATMENT OF A VENTRAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED LAB ABNORMAL FOR HEMOGLOBIN; HEMATOCRIT, DIASTASES AND THINNING OF VENTRAL ABDOMINUS MUSCLES, HERNIA RECURRENCE, SWELLING, FIBROTIC SCARRING, ADHESION, INJURIES, PRODUCT DEFECT, LOSS OF ENJOYMENT OF LIFE, LOST THE ABILITY TO PARTICIPATE IN HIS USUAL SOCIAL, RECREATIONAL, HOUSEHOLD, ATHLETIC, OTHER ACTIVITIES ENJOYED PREVIOUSLY. POST-OPERATIVE PATIENT TREATMENT INCLUDED HERNIA REPAIR WITH MESH, CT SCAN, HOSPITALIZATION, DIAGNOSTIC IMAGING, REVISION SURGERY, SERUM TESTING, ANTIBIOTICS, ANALGESICS, MEDICATION, THERAPY, REHABILITATION, REST.

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Emotional Changes; Fibrosis; Hernia; Muscle Weakness/Atrophy; Scar Tissue; Swelling/ Edema; Unspecified Tissue Injury

  MAUDE report 17384501 ↗
• InjuryOct 11, 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 THE IMPLANT, THE PATIENT EXPERIENCED CHRONIC PAIN, HERNIA RECURRENCE, ADHESIONS, AND SEROMA.

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

  MAUDE report 15584496 ↗
• InjurySep 19, 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 VENTRAL. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE AND ADHESIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICAL TREATMENT.

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

  MAUDE report 15446730 ↗
• InjuryAug 19, 2021Degraded; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Degraded; 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 BROKEN DOWN MESH, MESH FAILURE, HERNIA RECURRENCE, ADHESIONS, BOWEL COMPLICATIONS, PAIN, DEFECTIVE MESH, SCARRING, DISFIGUREMENT, PSYCHOLOGICAL AND EMOTIONAL INJURIES, SUFFERING, LOSS OF ENJOYMENT OF LIFE, DISABILITY, AND LOSS OF MENTAL AND EMOTIONAL HEALTH. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

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

  MAUDE report 12345030 ↗
• InjuryAug 5, 2021Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  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, SWELLING, FIBROTIC SCARRING, ADHESION, DIASTASES OF THE RECTOS MUSCLES AS THE SITE OF REPAIR, BOWEL OBSTRUCTION, INJURIES, PRODUCT DEFECTS, A LOSS OF ENJOYMENT OF LIFE, LOST THE ABILITY TO PARTICIPATE IN HIS USUAL SOCIAL, RECREATIONAL, HOUSEHOLD, ATHLETIC, AND OTHER ACTIVITIES ENJOYED PREVIOUSLY, AND HERNIA RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED HOSPITALIZATION, DIAGNOSTIC IMAGING, REVISION SURGERY, SERUM TESTING, ANTIBIOTICS, ANALGESICS, HERNIA REPAIR WITH NEW MESH, AND REST.

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Emotional Changes; Fibrosis; Hernia; Obstruction/Occlusion; Pain; Scar Tissue; Swelling/ Edema; Unspecified Tissue Injury

  MAUDE report 12285361 ↗
• InjuryAug 5, 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 PAIN, SWELLING, FIBROTIC SCARRING, ADHESION, DIASTASES OF THE RECTOS MUSCLES AS THE SITE OF REPAIR, BOWEL OBSTRUCTION, INJURIES, PRODUCT DEFECTS, A LOSS OF ENJOYMENT OF LIFE, LOST THE ABILITY TO PARTICIPATE IN HIS USUAL SOCIAL, RECREATIONAL, HOUSEHOLD, ATHLETIC, AND OTHER ACTIVITIES ENJOYED PREVIOUSLY, AND HERNIA RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED HOSPITALIZATION, DIAGNOSTIC IMAGING, REVISION SURGERY, SERUM TESTING, ANTIBIOTICS, ANALGESICS, HERNIA REPAIR WITH NEW MESH, AND REST.

  Patient problems: Abdominal Distention; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Emotional Changes; Fibrosis; Hernia; Obstruction/Occlusion; Pain; Scar Tissue; Swelling/ Edema; Unspecified Tissue Injury

  MAUDE report 12285357 ↗
• InjuryMay 17, 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 INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED ABSCESS, SEROMA, OPEN DRAINING WOUND, INFECTION, PAIN, DISCOMFORT, RECURRENCE, ADHESIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED SURGERY TO REMOVE MESH, REVISION SURGERY, HERNIA REPAIR WITH MESH.

  Patient problems: Abdominal Pain; Abscess; Adhesion(s); Bacterial Infection; Burning Sensation; Constipation; Discomfort; Erythema; Fever; Fistula; Fluid Discharge; Foreign Body Reaction; Hernia; Impaired Healing; Inflammation; Muscle Weakness/Atrophy; Pain; Purulent Discharge; Seroma; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 11837388 ↗
• InjuryNov 13, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THE PATIENT HAD AN INITIAL LAPAROSCOPIC HERNIA REPAIR, HOWEVER, THE PATIENT DID NOT HAVE A BOWEL MOVEMENT THREE DAYS POST OP. THE PATIENT WENT AGAIN TO HAVE ANOTHER LOOK AND FOUND THAT BOWEL HAD DEVELOPED AN ILEUS AND WAS ADHERED TO THE MESH WITH ADHESION. ADHESIOLYSIS WAS PERFORMED, RESULTING IN THE PATIENT STAYING IN THE HOSPITAL FOR 3-4 DAYS.

  Patient problems: Adhesion(s); No Code Available

  MAUDE report 9318086 ↗
• InjuryJan 15, 2019Migration 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 LAPAROSCOPIC VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, EXTENSIVE ADHESIONS, BOWEL ATTACHED TO INTRA-ABDOMINAL MESH, CHOLECYSTITIS, CHOLELITHIASIS, DISCOMFORT, AND PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, PARTIAL REMOVAL OF MESH, LAPAROSCOPIC CHOLECYSTECTOMY, LYSIS OF ADHESIONS, REPAIR OF MIDLINE INCISIONAL HERNIA.

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Hernia; Injury; No Code Available; Pain; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 8250887 ↗
• InjuryDec 12, 2018Mechanics 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 MESH FAILURE, ADHESIONS, AND PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REMOVAL SURGERY.

  Patient problems: Abdominal Distention; Abdominal Pain; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Decreased Appetite; Distress; Failure of Implant; Granuloma; Hernia; Inflammation; Injury; Localized Skin Lesion; Nausea; Nodule; Pain; Scar Tissue; Swelling/ Edema; Unspecified Tissue Injury

  MAUDE report 8156238 ↗
• InjuryJan 8, 2018Migration 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 RESULTING IN AN UNSPECIFIED ADVERSE OUTCOME. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT. THE PATIENT HAS HAD MULTIPLE SURGICAL REVISIONS, INFECTIONS, SMALL BOWEL OBSTRUCTIONS, ADHESIONS, INTESTINAL PERFORATION, AND RECURRENCE.

  Patient problems: Abdominal Distention; Abdominal Pain; Abscess; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Bowel Perforation; Cellulitis; Discomfort; Erosion; Fluid Discharge; Hemorrhage/Blood Loss/Bleeding; Hernia; Inflammation; Injury; Muscle Weakness/Atrophy; Nausea; No Code Available; Obstruction/Occlusion; Pain; Perforation; Purulent Discharge; Unspecified Infection; Unspecified Tissue Injury; Vomiting; Weight Changes

  MAUDE report 7173342 ↗