Parietex PCO20XRecalls & reported problems

Summary

The FDA's MAUDE database contains 106 adverse event reports that list this exact device (DI 10884521179677), received between Jan 9, 2018 and Jan 6, 2026 — classified as 3 deaths, 103 injuries.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (29 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 106 reports, in the reporter's own words as published by the FDA.

• InjuryJan 6, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT ON POST OPERATIVE LAPAROSCOPIC INCISIONAL HERNIORRHAPHY, THE PATIENT EXPERIENCED A RECURRENCE OF HERNIA. THE PATIENT WAS TAKEN BACK TO SURGERY TO PERFORMED ROBOTIC REPAIR WITH REDUCTION AND REPAIR OF INCARCERATED VENTRAL HERNIA WITH MESH. THE PATIENT HAD A LOT OF ADHESIONS AROUND THE PREVIOUSLY PLACED MESH. THE SURGEON FOUND THAT THERE WAS ABOUT A 3 CM. TO 4 CM. DEFECT IN THE MESH RIGHT IN THE MIDLINE. IT LOOKED LIKE THE MESH HAD JUST TORN RIGHT IN THE MIDLINE OR FAILED. TISSUE DAMAGE WAS NOTED AS THE PATIENT HAD A RECURRENCE. THE SURGEON CLOSED THE MESH, AFTER INCORPORATING THE HERNIA SAC INTO THAT CLOSURE, THE SURGEON REINFORCED IT WITH ANOTHER PIECE OF MESH FROM ANOTHER COMPANY.

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

  MAUDE report 23972958 ↗
• InjuryDec 3, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED MESH FAILURE, PAIN, RECURRENCE, EMOTIONAL CHANGES, DISCOMFORT. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, REMOVAL OF MESH, HERNIA REPAIR WITH NEW MESH, MEDICATION.

  Patient problems: Discomfort; Emotional Changes; Hernia; Pain; Unspecified Tissue Injury

  MAUDE report 23705574 ↗
• InjuryMar 5, 2025Migration 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 IMPLANT, THE PATIENT EXPERIENCED MESH MIGRATION, INFECTION, ADHESIONS, PAIN, ABDOMINAL PAIN, DISCOMFORT. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, REMOVAL OF MESH.

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

  MAUDE report 21532383 ↗
• InjuryJan 22, 2025Adverse 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, RECURRENCE, ADHESIONS, OBSTRUCTION, INFECTION, FISTULA, SEROMA, PERFORATION, SEPSIS, ABSCESS, SEROSITIS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, EXPLORATORY LAPAROTOMY, SMALL BOWEL RESECTION, REMOVAL OF INFECTED MESH.

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

  MAUDE report 21209326 ↗
• InjurySep 16, 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 INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, RECURRENCE, INFLAMMATION, ADHESIONS, AND OBSTRUCTIONS.

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

  MAUDE report 20233321 ↗
• InjuryApr 15, 2024Material 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED INFECTION, ABSCESS, ADHESIONS, PAIN, SEROMA, INFLAMMATION, AND ORGAN PERFORATION. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERIES, WOUND VAC PLACEMENT AND SMALL BOWEL RESECTION.

  Patient problems: Abscess; Adhesion(s); Erosion; Hemorrhage/Blood Loss/Bleeding; Hypersensitivity/Allergic reaction; Impaired Healing; Inflammation; Internal Organ Perforation; Pain; Purulent Discharge; Seroma; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 19106650 ↗
• InjuryMar 11, 2024Migration or Expulsion of Device; Material Deformation; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Migration or Expulsion of Device; Material Deformation; 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 MESH SHRINKAGE, MESH BALLING UP, MESH EVENTRATION, MESH CONTRACTION, RECURRENCE, PAIN, AND DISCOMFORT. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

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

  MAUDE report 18876959 ↗
• InjuryFeb 14, 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 THERAPEUTIC TREATMENT OF HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PERFORATION, PAIN, RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICATION.

  Patient problems: Hernia; Pain; Perforation; Unspecified Tissue Injury

  MAUDE report 18706333 ↗
• DeathFeb 9, 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 INFECTION, FISTULA, ADHESIONS, AND DEATH. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICAL INTERVENTION. INFORMATION RECEIVED INDICATES THE PATIENT IS DECEASED. NO INFORMATION WAS PROVIDED REGARDING THE CIRCUMSTANCES OF EXPIRATION.

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

  MAUDE report 18679551 ↗
• InjuryJun 28, 2023Adverse 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, ADHESIONS, CHRONIC PAIN, MESH EROSION, RECURRENT DRAINING SINUSES, SINUS TRACT, INFLAMMATION. POST-OPERATIVE PATIENT TREATMENT INCLUDED SMALL BOWEL RESECTION, WOUND DEBRIDEMENT, WOUND VAC PLACEMENT, REVISION SURGERY.

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Erosion; Fluid Discharge; Hemorrhage/Blood Loss/Bleeding; Hernia; Inflammation; Pain; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 17221261 ↗
• InjuryMay 10, 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 DEFECTIVE MESH, ABDOMINAL PAIN, RECURRENCE, ADHESIONS, PAIN, INFLAMMATION, SCARRING, MENTAL PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, HERNIA REPAIR WITH NEW MESH, LYSIS OF ADHESIONS, RESECTION OF JEJUNUM.

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

  MAUDE report 16906291 ↗
• InjuryApr 6, 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 VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED INCARCERATED HERNIA, MESENTERIC ADENOPATHY, SEROSAL TEAR, CONSTANT PULLING, PAIN, INFECTION, RECURRENCE, INFLAMMATION, ADHESIONS, OBSTRUCTION, ABSCESS, MUSCLE SPASMS, WEAK FASCIA. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICATION, OPEN REPAIR OF RECURRENT INCARCERATED INCISIONAL HERNIA WITH MESH, OPEN REPAIR OF SECOND INCISIONAL HERNIA, CT SCAN.

  Patient problems: Abscess; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Cramp(s) /Muscle Spasm(s); Discomfort; Hernia; Inflammation; Muscle Weakness/Atrophy; Obstruction/Occlusion; Pain; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 16693840 ↗
• InjuryMar 30, 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 AN INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, INFECTION, AND RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICATION.

  Patient problems: Hernia; Pain; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 16649004 ↗
• InjuryFeb 24, 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 A HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, ABSCESS, ADHESIONS, SMALL BOWEL OBSTRUCTION, & MESH MIGRATION. POST-OPERATIVE PATIENT TREATMENT INCLUDED MESH REMOVAL.

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

  MAUDE report 16437114 ↗
• InjuryFeb 14, 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 FAILURE OF MESH, DEFECTIVE MESH, PAIN, EMOTIONAL DISTRESS, MENTAL PAIN,INFLAMMATION, DISABILITY, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, ADHESIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, REMOVAL OF MESH.

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

  MAUDE report 16375198 ↗
• InjuryJan 3, 2023Material Integrity Problem; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Material Integrity 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 THE IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, INFECTION, ADHESIONS, CHRONIC PAIN, & MESH CONTRACTION. POST-OPERATIVE PATIENT TREATMENT INCLUDED SMALL BOWEL RESECTION, MESH REMOVAL, ADDITIONAL SURGERY, WOUND VAC, & DEBRIDEMENT.

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

  MAUDE report 16091474 ↗
• InjuryOct 1, 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 A VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, PAIN, ADHESIONS, INFLAMMATION, INFECTION, BOWEL PROBLEMS, SUFFERING, MENTAL ANGUISH, MENTAL PAIN, EMOTIONAL DISTRESS, DISCOMFORT, DEFECTIVE DEVICE, MESH FAILURE, DISABILITY, IMPAIRMENT, AND LOSS OF ENJOYMENT OF LIFE. POST-OPERATIVE PATIENT TREATMENT INCLUDED SMALL BOWEL RESECTION, REVISION SURGERY, HERNIA REPAIR WITH NEW MESH.

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Distress; Emotional Changes; Hemorrhage/Blood Loss/Bleeding; Hernia; Inflammation; Pain; Seroma; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 15525719 ↗
• InjurySep 26, 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, RECURRENCE, INFLAMMATION, ADHESIONS, OBSTRUCTION, SEROMA, AND INCARCERATED HERNIA. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICATION.

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

  MAUDE report 15486860 ↗
• InjurySep 16, 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 VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, INFECTION, RECURRENCE, INFLAMMATION, ADHESIONS, SEROMA, SCARIFICATION, MESH ENCAPSULATION, CURRENTLY UNABLE TO BEND OR LIFT COMFORTABLY AND IS ALSO UNABLE TO LIFT ANYTHING OVER 20 LBS, AND LACK OF ADEQUATE INGROWTH. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICATION, OPEN RECURRENT INCARCERATED INCISIONAL HERNIA WITH BILATERAL COMPONENT SEPARATION AND BILATERAL TRANSVERSE ABDOMINIS POSTERIOR RELEASE AND TISSUE TRANSFER, EXCISION OF OLD MESH, AND HERNIA REPAIR WITH NEW MESH.

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

  MAUDE report 15440692 ↗
• InjuryMay 3, 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 HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, ADHESIONS, PAIN, INFLAMMATION, SCARIFICATION, MESH ENCAPSULATION, LACK OF ADEQUATE INGROWTH AND MESH DEFORMATION. POST-OPERATIVE PATIENT TREATMENT INCLUDED SMALL BOWEL RESECTION.

  Patient problems: Abdominal Distention; Adhesion(s); Constipation; Foreign Body Reaction; Hemorrhage/Blood Loss/Bleeding; Hernia; Inflammation; Obstruction/Occlusion; Pain; Scar Tissue; Unspecified Tissue Injury; Vomiting

  MAUDE report 14269062 ↗
• InjuryMar 9, 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 CHRONIC PAIN, ADHESIONS, RECURRENCE, AND MESH EROSION. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

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

  MAUDE report 13711622 ↗
• InjuryMar 9, 2022Material Deformation; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Material Deformation; 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 CHRONIC PAIN, ADHESIONS, RECURRENCE, AND MESH EROSION. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

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

  MAUDE report 13711585 ↗
• InjuryJan 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 A HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED ADHESIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

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

  MAUDE report 13314460 ↗
• InjuryJan 2, 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 INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED ADHESIONS, MENTAL PAIN/ANGUISH, PAIN, DISABILITY, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, EMOTIONAL DISTRESS, DEFECTIVE MESH, AND RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICAL TREATMENT, HERNIA REPAIR WITH NEW MESH, AND LYSIS OF ADHESIONS.

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

  MAUDE report 13139278 ↗
• InjurySep 9, 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED ABDOMINAL PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, REVISION OF MESH, AND REMOVAL OF MESH.

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

  MAUDE report 12449040 ↗