Parietex PCO8VP (UDI 10884521165724)Recalls & reported problems

Summary

The FDA's MAUDE database contains 172 adverse event reports that list this exact device (DI 10884521165724), received between Sep 12, 2017 and Sep 19, 2025 — classified as 1 death, 169 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (47 reports).

1 other recall cover devices cleared under the same FDA submission (K120506, K142908); they may or may not involve this specific model.

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

• MalfunctionSep 19, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING AN OPEN UMBILICAL HERNIA PROCEDURE, TWO MESH PRODUCTS, A VENTRAL PATCH 6.6CM AND A VENTRAL PATCH 8CM WERE FOUND TO BE DAMAGED IN THE OPERATING ROOM PRIOR TO USE. SPECIFICALLY BREAKING IF NOT UNFOLDED IN ONE GO. BOTH DEVICES WERE NEVER IMPLANTED AND THE APPEARANCE OF THE MESH WAS DESCRIBED AS NORMAL. THE PRODUCT WAS REPLACED BY ANOTHER MANUFACTURER'S PRODUCT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23093243 ↗
• InjuryAug 22, 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 A VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED NUMBNESS, PAIN, RECURRENCE, ADHESIONS, SEROMA. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, PARTIAL REMOVAL OF MESH, LOSS OF UMBILICUS, MEDICATION.

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

  MAUDE report 22874312 ↗
• InjuryJun 4, 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, ADHESIONS, INFLAMMATION, SEROMA, INFECTION. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICATION.

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

  MAUDE report 22144764 ↗
• InjuryMar 31, 2025Migration 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 EMOTIONAL DISTRESS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

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

  MAUDE report 21731667 ↗
• InjuryMar 4, 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, ADHESIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

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

  MAUDE report 21517402 ↗
• InjuryDec 13, 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 RECURRENCE, ADHESIONS, PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Adhesion(s); Discomfort; Fever; Hernia; Nausea; Pain; Unspecified Tissue Injury; Vomiting

  MAUDE report 20928327 ↗
• InjuryDec 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE LITERATURE, AN OBESE 60-YEAR-OLD GENTLEMAN UNDERWENT EMERGENCY SURGERY FOR PORT SITE HERNIA AND BOWEL OBSTRUCTION, WHICH DEVELOPED THREE DAYS FOLLOWING LAPAROSCOPIC SMALL BOWEL RESECTION. A COMPOSITE VENTRAL PATCH 8.6 CM WAS PLACED IN THE INTRA-PERITONEAL LAYER DUE TO A 4 CM FASCIAL DEFECT. THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH PAIN, FEVER, AND ABNORMAL LABORATORY VALUES AND UNDERWENT COMPUTED TOMOGRAPHY (CT), WHICH SHOWED AN EXTENSIVE INFECTION SURROUNDING THE MESH. URGENT PERCUTANEOUS DRAINAGE AND INTRAVENOUS ANTIBIOTICS WERE REQUIRED, FOLLOWED BY DILUTION AND WASHOUT OF THE CAVITY WITH LARGE VOLUMES OF SALINE SOLUTION. A CT SCAN PERFORMED AT THE END OF THE TREATMENT CONFIRMED RESOLUTION OF THE INFECTION, AND THE PATIENT REMAINED WELL.

  Patient problems: Fever; Pain; Unintended Radiation Exposure; Unspecified Infection

  MAUDE report 20905940 ↗
• InjurySep 23, 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 RECURRENCE, INFECTION, ADHESIONS, PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, WOUND VAC.

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

  MAUDE report 20280765 ↗
• InjuryAug 6, 2024Migration or Expulsion of Device; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; 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 DEFECTIVE MESH, FAILURE OF MESH, MESH MIGRATION, RECURRENCE, ADHESIONS,SCARRING, PAIN, MENTAL PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, ABDOMINAL PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REMOVAL OF MESH, HERNIA REPAIR WITH NEW MESH.

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

  MAUDE report 19918899 ↗
• InjuryJul 10, 2024Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Migration or Expulsion of Device; 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED MESH FAILURE, DISABILITY, EMOTIONAL CHANGES, SCARRING, DRAINAGE, PAIN, INFLAMMATION, ADHESIONS, OBSTRUCTION, SEROMA, VOMITING, DIARRHEA, ANXIETY, MESH MIGRATION, MESH ROLLED UP, AND BOWEL ISSUES. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, MESH REMOVAL, EXPLORATORY LAPAROTOMY, LYSIS OF ADHESIONS, BOWEL RESECTION, AND MEDICATION.

  Patient problems: Adhesion(s); Anxiety; Diarrhea; Emotional Changes; Fluid Discharge; Inflammation; Obstruction/Occlusion; Pain; Scar Tissue; Seroma; Unspecified Gastrointestinal Problem; Unspecified Tissue Injury; Vomiting

  MAUDE report 19716188 ↗
• InjuryJul 10, 2024Mechanics Altered; Adverse Event Without Identified Device or Use Problem; 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 DEFECTIVE MESH, FAILURE OF MESH, ADHESIONS, INFLAMMATION, INFECTION, NERVE DAMAGE, SCARRING, PAIN, MENTAL PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, DISABILITY. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, REMOVAL OF MESH.

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

  MAUDE report 19710274 ↗
• InjuryMar 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 THERAPEUTIC TREATMENT OF AN INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, RECURRENCE, ABDOMINAL BULGING, AND ABDOMINAL PAIN.

  Patient problems: Abdominal Distention; Abdominal Pain; Hernia; Pain; Unspecified Tissue Injury

  MAUDE report 18922689 ↗
• InjuryNov 13, 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 VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DEFECTIVE MESH, FAILURE OF MESH, RECURRENCE, ADHESIONS, SCARRING, PAIN,MENTAL PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REMOVAL OF MESH, HERNIA REPAIR WITH NEW MESH, EXPLORATORY LAPAROTOMY, LYSIS OF ADHESIONS, ABDOMINAL WALL RECONSTRUCTION, CREATION OF BILATERAL FASCIAL FLAPS.

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

  MAUDE report 18123040 ↗
• InjurySep 14, 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, SMALL BOWEL OBSTRUCTION, AND PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

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

  MAUDE report 17751046 ↗
• InjuryJun 16, 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, PAIN, AND FOREIGN BODY REACTION. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

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

  MAUDE report 17148364 ↗
• InjuryMay 17, 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 FAILURE OF MESH, DEFECTIVE MESH, PAIN, RECURRENCE, ADHESIONS, INFLAMMATION, INFECTION, SCARRING, NERVE DAMAGE, MENTAL PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, DISABILITY, ALLERGIC REACTION. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, REMOVAL OF MESH, LAPAROSCOPIC CHOLECYSTECTOMY WITH CHOLANGIOGRAM, COMPLETE HYSTERECTOMY, PANNICULECTOMY AND FLEUR-DE-LIS ABDOMINOPLASTY, HERNIA REPAIR WITH NEW MESH,

  Patient problems: Adhesion(s); Emotional Changes; Hernia; Hypersensitivity/Allergic reaction; Inflammation; Nerve Damage; Pain; Scar Tissue; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 16948189 ↗
• InjuryMay 10, 2023Mechanics 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 DEFECTIVE MESH, FAILURE OF MESH, ADHESIONS, RECURRENCE, PAIN, SCARRING,MENTAL PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REMOVAL OF MESH, HERNIA REPAIR WITH NEW MESH, LYSIS OF ADHESIONS.

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

  MAUDE report 16905457 ↗
• InjuryApr 13, 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 VENRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED FAILURE OF MESH, DEFECTIVE MESH, RECURRENCE, ADHESIONS, BOWEL OBSTRUCTION, PERFORATION, INFECTION, PAIN, SEPSIS, INFLAMMATION, SCARRING, NERVE DAMAGE, MENTAL PAIN, DISABILITY, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, REMOVAL OF MESH, LYSIS OF ADHESIONS.

  Patient problems: Adhesion(s); Emotional Changes; Hernia; Inflammation; Nerve Damage; Obstruction/Occlusion; Pain; Perforation; Scar Tissue; Sepsis; Unspecified Gastrointestinal Problem; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 16733034 ↗
• InjuryFeb 15, 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 VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED FAILURE OF MESH, DEFECTIVE MESH, PAIN, EMOTIONAL DISTRESS, ADHESIONS, INFLAMMATION, INFECTION, DISABILITY, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, MENTAL PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Adhesion(s); Distress; Emotional Changes; Inflammation; Pain; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 16382255 ↗
• InjuryFeb 14, 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 VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED FAILURE OF MESH, DEFECTIVE MESH, PAIN, EMOTIONAL DISTRESS, ADHESIONS, INFLAMMATION, INFECTION, DISABILITY, MENTAL PAIN, LOSS OF ENJOYMENT OF LIFE, IMPAIRMENT. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Adhesion(s); Distress; Emotional Changes; Inflammation; Pain; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 16375430 ↗
• InjuryFeb 8, 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 DEFECTIVE MESH, PAIN, DISABILITY, MENTAL PAIN, LOSS OF ENJOYMENT OF LIFE, IMPAIRMENT. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICAL TREATMENT.

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

  MAUDE report 16329334 ↗
• InjuryOct 4, 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 AN UMBILICAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, EMOTIONAL DISTRESS, ADHESIONS, DEFECTIVE DEVICE, PREMATURE RESORPTION OF COLLAGEN COATING, INFLAMMATORY RESPONSE, BOWEL PROBLEMS, INFECTIONS, MENTAL ANGUISH, DISABILITY, IMPAIRMENT, AND LOSS OF ENJOYMENT OF LIFE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REMOVAL OF MESH, INTERVENTION SURGERY, AND REPAIR OF MESH.

  Patient problems: Abdominal Pain; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Distress; Emotional Changes; Fibrosis; Hemorrhage/Blood Loss/Bleeding; Hernia; Inflammation; Nausea; Obstruction/Occlusion; Pain; Swelling/ Edema; Unspecified Infection; Unspecified Tissue Injury; Vomiting

  MAUDE report 15540836 ↗
• InjurySep 28, 2022Material Deformation; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Material Deformation; 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 THE IMPLANT, THE PATIENT EXPERIENCED PAIN, SUFFERING, EMOTIONAL DISTRESS, DIMINISHED QUALITY OF LIFE, DEVICE DEFECTIVE, MENTAL PAIN, SUFFERING, HERNIA RECURRENCE, HERNIA SAC CONTAINED MESH, ADHESIONS, CHRONIC INFLAMMATORY RESPONSE, BOWEL PROBLEMS, INFECTIONS, MENTAL ANGUISH, DISABILITY, PERMANENT IMPAIRMENT, <(>&<)> LOSS OF ENJOYMENT OF LIFE. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICAL TREATMENT, SMALL BOWEL RESECTION WITH ANASTOMOSIS, MESH REVISION, AND REMOVAL OF MESH.

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Distress; Emotional Changes; Fibrosis; Foreign Body Reaction; Hematoma; Hernia; Inflammation; Internal Organ Perforation; Muscle Weakness/Atrophy; Obstruction/Occlusion; Pain; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 15498529 ↗
• InjurySep 24, 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 DEVICES. THE PRODUCTS WERE USED FOR THERAPEUTIC TREATMENT OF AN UMBILICAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DISLODGED MESH, AND RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICATION, AND BLAKE DRAIN.

  Patient problems: Hernia; Unspecified Tissue Injury

  MAUDE report 15476311 ↗
• MalfunctionSep 12, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  ACCORDING TO THE REPORTER, DURING AN OPEN UMBILICAL HERNIOPLASTY WITH INTRAPERITONEAL MESH, AFTER INSERTION INTO THE PATIENT, THE MESH WAS PLACED CORRECTLY BASED ON MANUFACTURER'S INSTRUCTION BUT WITH A DIRECT VIEW OF THE OPTIMAL ONE. IT WAS VERIFIED THAT THE SCREEN ALWAYS BENDS ON ONE SIDE, SHOWING THAT THE EXPANDERS AND HANDLES CANNOT KEEP THE SCREEN OPEN IN OVERLAP COVERING THE HERNIARY DEFECT. HERNIOPLASTY WAS PERFORMED WITH A POLYPROPYLENE FABRIC COMMON TO THE HOSPITAL. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15402781 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K120506, K142908. One submission often covers many models, so check the product and lot details in each record.

• Z-0461-2019 · Oct 5, 2018 · Terminated
  Parietex Composite Parastomal Mesh (Product Number PCOPM15 / PCOPM20) Product Usage: The PCOPM15 and PCOPM20 reorder codes are circular in shape, made from a three-dimensional mon