Parietex PCO3020XRecalls & reported problems

Summary

The FDA's MAUDE database contains 110 adverse event reports that list this exact device (DI 10884521179851), received between Sep 19, 2017 and Jul 14, 2025 — classified as 3 deaths, 107 injuries.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (34 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 110 reports, in the reporter's own words as published by the FDA.

• InjuryJul 14, 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 PAIN, RECURRENCE, AND ADHESIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY AND REMOVAL OF MESH.

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

  MAUDE report 22501961 ↗
• InjuryJun 17, 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, ADHESIONS, PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

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

  MAUDE report 22234316 ↗
• InjuryJun 12, 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 ABSCESS, ADHESIONS, RECURRENCE, INFECTION, PAIN, SUFFERING, EMOTIONAL DISTRESS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, LYSIS OF ADHESIONS, MESH REMOVAL, HERNIA REPAIR AND EXPLORATORY LAPAROTOMY.

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

  MAUDE report 22199656 ↗
• InjuryDec 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 THERAPEUTIC TREATMENT OF HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, RECURRENCE, ADHESIONS, SEROMA, INFECTION. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, EXPLORATORY LAPAROTOMY, MESH REMOVAL, ADHESIOLYSIS, COMPONENT SEPARATION, ABDOMINAL HERNIOPLASTY, HERNIA REPAIR WITH NEW MESH, SMALL BOWEL RESECTION, CHOLECYSTECTOMY.

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

  MAUDE report 21044605 ↗
• InjuryJun 28, 2024Migration 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, INFECTION, ABSCESS, ADHESIONS, PAIN, OPEN WOUND. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, REMOVAL OF MESH, WOUND VAC.

  Patient problems: Abdominal Distention; Abscess; Adhesion(s); Emotional Changes; Fluid Discharge; Hemorrhage/Blood Loss/Bleeding; Hernia; Impaired Healing; Necrosis; Pain; Perforation; Seroma; Thrombosis/Thrombus; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 19639353 ↗
• InjuryJun 14, 2024Mechanics 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED FAILURE OF MESH, RECURRENCE, ADHESIONS, BOWEL OBSTRUCTION, PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

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

  MAUDE report 19540720 ↗
• InjuryApr 30, 2024Degraded; Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem; Degraded; 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED OBSTRUCTION, ADHESIONS, RECURRENCE, MESHOMA, CALCIFICATION OF MESH, PAIN, RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION OF MESH, BOWEL REMOVAL, HERNIA REPAIR WITH NEW MESH.

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

  MAUDE report 19217243 ↗
• InjuryOct 9, 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 THE IMPLANT, THE PATIENT EXPERIENCED EMOTIONAL DISTRESS. POST-OPERATIVE PATIENT TREATMENT INCLUDED SURGICAL INTERVENTION.

  Patient problems: Distress; Unspecified Tissue Injury

  MAUDE report 17897241 ↗
• InjuryAug 14, 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 IMPLANT, THE PATIENT EXPERIENCED ABSCESS, ADHESIONS, PAIN, AND PERFORATED POSTERIOR GASTRIC ULCER. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Abscess; Adhesion(s); Discomfort; Fluid Discharge; Hernia; Internal Organ Perforation; Pain; Ulcer; Unspecified Tissue Injury

  MAUDE report 17547096 ↗
• InjuryJun 30, 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, INFECTION, ABSCESS, FISTULA, ADHESIONS, PAIN, AND MESH EROSION. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, SMALL BOWEL RESECTION, AND REMOVAL OF MESH.

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

  MAUDE report 17238422 ↗
• InjuryFeb 15, 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, INFECTION, ABSCESS, ADHESIONS, PAIN, SEROMA, UNINCORPORATED MESH, AND MESH FAILURE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, DRAINAGE OF SEROMA BY INTERVENTIONAL RADIOLOGY, AND WOUND VAC.

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

  MAUDE report 16382759 ↗
• DeathFeb 9, 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 VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED OBSTRUCTION, ABDOMINAL PAIN, PAIN, INFLAMMATION, INFECTION, SCARRING, NERVE DAMAGE, DEFECTIVE DEVICE, MESH FAILURE, ADHESIONS, PERFORATED BOWELS, MENTAL PAIN, SUFFERING, DISABILITY, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, SEPTIC SHOCK, DEATH. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICATION, EXPLORATORY LAPAROTOMY, EMERGENCY SURGERY, REVISION SURGERY, PARTIAL MESH REMOVAL, MESH REMOVAL, LYSIS OF ADHESIONS, RECTOSIGMOIDECTOMY WITH END-COLOSTOMY AND BOWEL RESECTION. INFORMATION RECEIVED INDICATES THE PATIENT IS NOW DECEASED, DUE TO THE RESULT OF THEIR INJURIES.

  Patient problems: Abdominal Pain; Adhesion(s); Emotional Changes; Inflammation; Nerve Damage; Obstruction/Occlusion; Pain; Perforation; Scar Tissue; Septic Shock; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 16340510 ↗
• InjuryJan 4, 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 VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, INFLAMMATION, ADHESIONS, NON-HEALING, SINUS TRACT, SKIN EROSION. POST-OPERATIVE PATIENT TREATMENT INCLUDED USE OF RELIAVAC DRAIN, AND REVISION SURGERY.

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Erosion; Hernia; Impaired Healing; Inflammation; Unspecified Tissue Injury

  MAUDE report 16099464 ↗
• InjuryDec 27, 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 HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, ADHESIONS, SMALL BOWEL OBSTRUCTION, <(>&<)> CHRONIC PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

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

  MAUDE report 16057473 ↗
• InjuryDec 22, 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, ADHESION, SEROMA, AND SCARRING. POST-OPERATIVE PATIENT TREATMENT INCLUDED JP DRAINS AND MEDICATION.

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

  MAUDE report 16035034 ↗
• InjurySep 22, 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 AN INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, ADHESIONS, PAIN, INFLAMMATION, SEROMA, INCARCERATED HERNIA, AND MESH EROSION. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICATION.

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

  MAUDE report 15464016 ↗
• InjuryApr 8, 2022Migration 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 INFECTION, PAIN, ABSCESS, FISTULA, ADHESIONS, SMALL BOWEL OBSTRUCTION, MESH EROSION, MESH MIGRATION, UNINCORPORATED MESH, DRAINAGE OF ABDOMINAL WALL ABSCESS, SMALL BOWEL DENSELY ADHERED TO MESH, AND MESH SURROUNDED BY FOUL SMELLING MATERIAL . POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY AND SMALL BOWEL RESECTION.

  Patient problems: Abscess; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Erosion; Fistula; Fluid Discharge; Obstruction/Occlusion; Pain; Purulent Discharge; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 14059687 ↗
• InjuryApr 8, 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 RECURRENCE, ADHESIONS, AND PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED ADDITIONAL SURGERY AND REVISION.

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

  MAUDE report 14056557 ↗
• 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 THE IMPLANT, THE PATIENT EXPERIENCED ADHESIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

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

  MAUDE report 13315724 ↗
• InjuryAug 16, 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 INCISIONAL HERNIAS. IT WAS REPORTED THAT AFTER THE INLAY IMPLANT, THE PATIENT EXPERIENCED OBSTRUCTION, ADHESIONS, NAUSEA, PAIN, HYPOKALEMIA, HYPOMAGNESEMIA, ABDOMINAL DISTRESS, DIARRHEA, VOMITING, MESH ENCAPSULATED, DEHYDRATION, AND RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED SMALL BOWEL RESECTION, LYSIS OF ADHESIONS, MESH EXPLANTATION, HOSPITALIZATION, CONTINUE CIPRO, ANTICOAGULATION THERAPY, PAIN MEDICATION, AND HERNIA REPAIR WITH SUTURES.

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Dehydration; Diarrhea; Distress; Foreign Body Reaction; Hernia; Nausea; Obstruction/Occlusion; Pain; Unspecified Tissue Injury; Vomiting

  MAUDE report 12329336 ↗
• InjuryAug 16, 2021Migration or Expulsion of Device; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Migration or Expulsion of Device; 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 INCISIONAL VENTRAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED INFECTION, MESH FAILURE, MESH DISLODGED, ABSCESS, ADHESIONS, COLONIC FISTULA, PURULENT MATERIAL, MUCH OF THE MESH NOT INCORPORATED, MESH MIGRATION, MESH EROSION INTO VISCERA, BACTERIAL INFECTION, INFLAMMATION, PHLEGMON, NECROSIS, FLUID COLLECTION, INFECTION, PAIN, SMALL BOWEL OBSTRUCTION, MESH SURROUNDED BY FOUL SMELLING MATERIAL, RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED PLACEMENT OF CATHETER AND PERCUTANEOUS DRAINAGE TUBE, MEDICATION, INCISION AND DRAINAGE OF ABSCESS, CATHETER PLACEMENT, BOWEL RESECTION, MESH REMOVAL, LYSIS OF ADHESIONS, TAKEN DOWN OF FISTULA, CYSTOSCOPY WITH URETERAL STENT PLACEMENT, REVISION SURGERY, CT SCAN.

  Patient problems: Abscess; Adhesion(s); Ascites; Bacterial Infection; Discomfort; Emotional Changes; Erosion; Fistula; Fluid Discharge; Hernia; Inflammation; Necrosis; Obstruction/Occlusion; Pain; Purulent Discharge; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 12327150 ↗
• InjuryAug 13, 2021Migration or Expulsion of Device; Material Deformation; Adverse Event Without Identified Device or Use Problem; Migration or Expulsion of Device; Material Deformation; 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 ADHESIONS, MESH BULGING INTO HERNIA DEFECT, BULGE DEFECT IN CENTER OF MESH, DISCOMFORT, PAIN, MESH MIGRATION AND RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED LYSIS OF ADHESIONS, HERNIA REPAIR WITH MESH, REMOVAL OF MESH, AND REMOVAL OF TISSUE.

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

  MAUDE report 12321491 ↗
• InjuryJul 29, 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 INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED ADHESIONS, ABDOMINAL PAIN, FISTULA, DRAINAGE, IRRITATION ON SKIN, INFECTION, STOMACH ADHESED TO ABDOMINAL WALL, AND HERNIA RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICATION, LYSIS OF ADHESIONS, REVISION SURGERY, MESH REMOVAL, DIAGNOSTIC LAPAROSCOPY, G-TUBE FOR FEEDING, FISTULA WAS RESECTED, CLOSURE OF GASTROCUTANEOUS FISTULA OF HIS OLD SITE USING A GIA STAPLER, BILATERAL TRANSVERSUS ABDOMINIS PLANE BLOCK, AND HERNIA REPAIR WITH MESH (NON-MEDTRONIC PRODUCT).

  Patient problems: Abdominal Pain; Adhesion(s); Fistula; Fluid Discharge; Hernia; Skin Inflammation/ Irritation; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 12249139 ↗
• InjuryJun 18, 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 A LAPAROSCOPIC THERAPEUTIC TREATMENT OF A VENTRAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED HERNIA RECURRENCE, SCAR, WEAKNESS, PAIN, MESH EROSION, BOWEL STUCK TO MESH AND ADHESIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED LYSIS OF ADHESIONS, HERNIA REPAIR WITH NEW MESH, AND REVISION SURGERY.

  Patient problems: Adhesion(s); Constipation; Erosion; Hemorrhage/Blood Loss/Bleeding; Hernia; Muscle Weakness/Atrophy; Pain; Scar Tissue; Unspecified Tissue Injury

  MAUDE report 12025097 ↗
• InjuryMay 13, 2021Migration 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 AN UMBILICAL HERNIA AND AN INCISIONAL HERNIA BY LAPAROSCOPIC SURGERY. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, RECURRENCE, ADHESIONS, ABDOMINAL PAIN, AND MESH SEPARATION FROM WALL. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICATION, REVISION SURGERY, HERNIA REPAIR WITH NEW MESH, AND LYSIS OF ADHESIONS.

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

  MAUDE report 11822047 ↗