Parietex PCOPM15H35Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10884521177765), received between Apr 23, 2018 and Aug 12, 2026 — classified as 1 death, 11 injuries.

The most frequently reported specific device problem is “Mechanics Altered” (3 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 16, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryAug 12, 2026Adverse 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 emotional distress. Post-operative patient treatment included revision surgery.

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

  MAUDE report 50227394 ↗
• InjuryJan 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A CLINICAL STUDY, HEMORRHAGE NEAR THE MESH DURING SURGERY WAS NOTED. A DRAIN WAS PLACED BESIDE THE MESH, RESULTING IN DRAINAGE OF 450 MILLIMETERS IN THE FIRST 12 HOURS AND AN ADDITIONAL 400 MILLIMETERS IN THE NEXT 12 HOURS. INTERVENTIONS MENTIONED INCLUDED THE REVISION OF THE WOUND, EVACUATION OF HEMATOMA, AND HEMOSTASIS. HEMORRHAGE AT THE IMPLANTATION SITE FROM THE BRANCHES OF THE LEFT INFERIOR EPIGASTRIC ARTERY AND VEIN. ALSO, THERE WAS SOME HEMORRHAGE FROM THE MUSCLES. THE PATIENT HAD A MEDICAL HISTORY OF ANEURYSMAL DISEASE, ANTIPLATELET AND/OR ANTICOAGULANT THERAPY, CHRONIC KIDNEY DISEASE, HYPERTENSION, A HISTORY OF AAA (ABDOMINAL AORTIC ANEURYSM), AND AN AMERICAN SOCIETY OF ANESTHESIOLOGISTS (ASA) GRADE OF III, INDICATING A PATIENT WITH SEVERE SYSTEMIC DISEASE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18446100 ↗
• InjuryOct 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO CLINICAL STUDY, POST-OPERATIVELY, LAPAROSCOPIC PARASTOMAL HERNIA REPAIR WITH KEY HOLE, MESH FIXATION, THE PATIENTS THAT WAS  READMITTED WITHIN 90 DAYS AND WAS OBSERVE THAT THERE  7 UNSPECIFIED CONDITIONS, ABDOMINAL PAIN 3, DEEP WOUND INFECTION 1, HEMATOMA / POSTOPERATIVE BLEEDING 1, POST-OPERATIVE CARE AND REHABILITATION 10 , SMALL BOWEL OBSTRUCTION 3, OTHER GASTROINTESTINAL DISEASE 4, PULMONARY DISEASE 1, RENAL OR UROGENITAL DISEASE 3, HEPATOBILIARY DISEASE 1, PAIN IN BACK OR EXTREMITIES  1. REOPERATION WAS ALSO DONE  FOR SUPERFICIAL WOUND COMPLICATION 1, EXPLORATORY LAPAROTOMY 1 , EXPLORATORY LAPAROSCOPY 3, STOMA RELATED SURGERY 1, OTHER UNSPECIFIED 2, 3 DEATH AND IT WAS NOT RELATED TO THE DEVICE. IT WAS NOTED THAT HERNIA RECURRENCE WITH REOPERATION WAS REQUIRED FOR TREATMENT.

  Patient problems: Hematoma; Hemorrhage/Blood Loss/Bleeding; Hernia; Obstruction/Occlusion; Pain; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 18014745 ↗
• InjuryOct 28, 2020Migration or Expulsion of Device; Material Integrity Problem; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Migration or Expulsion of Device; Material Integrity 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 PARASTOMAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, MENTAL ANGUISH, DISABILITY (UNABLE TO PARTICIPATE IN EMPLOYMENT, RECREATIONAL, SOCIAL, AND HOUSEHOLD ACTIVITIES), PSYCHOLOGICAL STRESS, DEPRESSION, LOSS OF ENJOYMENT OF LIFE, DEFECTIVE MESH, AND SUFFERING. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, HERNIA REPAIR, MESH REMOVAL, AND HOSPITALIZATION.

  Patient problems: Abscess; Adhesion(s); Depression; Disability; Distress; Emotional Changes; Fistula; Hematoma; Hemorrhage/Blood Loss/Bleeding; Hernia; Injury; Obstruction/Occlusion; Pain; Perforation; Scar Tissue; Seroma; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 10751617 ↗
• InjuryJul 10, 2020Mechanics 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 PARASTOMAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED SMALL BOWEL OBSTRUCTION, MESH GROWN INTO BOWEL, ADHESIONS, CONTAMINATION, DIARRHEA, NAUSEA, INFLAMMATION, DISTENTION, RECURRENCE, MESH EROSION INTO VISCERA, AND PAIN/SUFFERING. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, ADMITTED TO HOSPITAL, NG TUBE PLACED, LYSIS OF ADHESIONS, SMALL BOWEL RESECTION WITH PRIMARY ANASTAMOSIS, HERNIA REPAIR, AND REMOVAL OF MESH.

  Patient problems: Abdominal Distention; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Diarrhea; Emotional Changes; Erosion; Hernia; Inflammation; Injury; Nausea; No Code Available; Obstruction/Occlusion; Pain; Scar Tissue; Unspecified Tissue Injury

  MAUDE report 10261095 ↗
• InjuryJun 19, 2020Mechanics 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 LAPAROSCOPIC TREATMENT OF AN UMBILICAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED RECURRENT HERNIA, PAIN AND ADHESIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

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

  MAUDE report 10174220 ↗
• InjuryJan 27, 2020Adverse 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 PARASTOMAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED SEROSAL TEARS, INFECTION, EROSION, ABSCESS, ADHESIONS, FLUID COLLECTION, BACTERIAL INFECTION, TACHYCARDIA, ABDOMINAL PAIN, NAUSEA, BLOATING, DISCOMFORT, REDNESS, SWELLING, PURULENT BLOODY DRAINAGE, BILIOUS FECULENT MATERIAL, FIBRINOUS EXUDATE, SMALL BOWEL OBSTRUCTION, AND RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED SMALL BOWEL RESECTION, INCISION AND DRAINAGE OF ABDOMINAL WALL ABSCESS, LYSIS OF ADHESIONS, RELOCATION OF ILEOSTOMY, REPAIR OF ENTEROTOMY, DEBRIDEMENT OF WOUND, REMOVAL OF PORTION OF MESH, DRAIN PLACEMENT, TRANSFERRED TO ICU, AND REVISION SURGERY.

  Patient problems: Abdominal Distention; Abdominal Pain; Abscess; Adhesion(s); Ascites; Bacterial Infection; Blood Loss; Discharge; Discomfort; Erosion; Hernia; Injury; Nausea; No Code Available; Obstruction/Occlusion; Purulent Discharge; Swelling; Tachycardia; Unspecified Infection

  MAUDE report 9630956 ↗
• DeathAug 15, 2019Adverse 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 PAIN, ADHESIONS, INFECTION, PERITONITIS, SMALL BOWEL OBSTRUCTION AND INTESTINAL ISCHEMIA. POST-OPERATIVE PATIENT TREATMENT INCLUDED RESECTION OF SMALL INTESTINE, PARTIAL COLECTOMY AND ADDITIONAL SURGERY. INFORMATION RECEIVED INDICATES THE PATIENT IS DECEASED.

  Patient problems: Adhesion(s); Injury; Ischemia; Obstruction/Occlusion; Pain; Peritonitis; Unspecified Infection

  MAUDE report 8898813 ↗
• InjuryJun 11, 2019Adverse 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 RECURRENT PARASTOMAL HERNIA AND A SEPARATE VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED AN ADVERSE OUTCOME. THE DEVICE HAD BEEN USED WITH BARD VENTRIO HERNIA PATCH.

  Patient problems: Injury

  MAUDE report 8687968 ↗
• InjuryJun 10, 2019Adverse 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 AN ADVERSE OUTCOME.

  Patient problems: Injury

  MAUDE report 8683512 ↗
• InjuryApr 25, 2018Adverse 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 RESULTING IN AN UNSPECIFIED ADVERSE OUTCOME. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT. THE PATIENT UNDERWENT A LAPAROSCOPIC LYSIS OF ADHESIONS LAPAROSCOPIC PARASTOMAL HERNIA REPAIR WITH MESH. HE HAD REVISION SURGERY 1 YEARS AND 7 MONTHS POST-SURGERY. THE PATIENT EXPERIENCED PAIN, ADHESIONS, RE-HERNIATION, EXPOSED MESH, SCARRING.

  Patient problems: Adhesion(s); Failure of Implant; Hernia; Injury; No Code Available; Pain; Scarring

  MAUDE report 7457774 ↗
• InjuryApr 23, 2018Adverse 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 RESULTING IN AN UNSPECIFIED ADVERSE OUTCOME. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT. THE PROCEDURE PERFORMED WAS LAPAROSCOPIC VENTRAL HERNIA REPAIR WITH MESH. THE PATIENT EXPERIENCE REVISION, AND RECURRENCE.

  Patient problems: Abdominal Pain; Adhesion(s); Hernia; Injury; No Code Available

  MAUDE report 7451624 ↗