Parietex PCOPM15Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10884521177758), received between Jan 8, 2018 and Jul 18, 2023 — classified as 17 injuries.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (4 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryJul 18, 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, ADHESIONS, BOWEL OBSTRUCTION, PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, REMOVAL OF MESH.

  Patient problems: Adhesion(s); Emotional Changes; Hernia; Hypersensitivity/Allergic reaction; Inflammation; Obstruction/Occlusion; Pain; Unspecified Tissue Injury

  MAUDE report 17344107 ↗
• InjuryJun 25, 2021Migration 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 LAPAROSCOPIC THERAPEUTIC TREATMENT OF A PARASTOMAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED ADHESIONS, PAIN, HERNIA RECURRENCE, BOWEL PERFORATION, SCARRING, FLUID COLLECTION, EXTRALUMINAL AIR, CESSATION OF BOWEL FUNCTION, OBSTRUCTION, SEROMA, HEMATOMA, ABDOMINAL PAIN, SWEATS, PURULENT MATERIAL, BOWEL TOO FRIABLE AND EDEMATOUS, SCARRING, UTI, DEPRESSION, MESH FAILURE, AND MESH PULLED AWAY FROM ABDOMINAL WALL. POST-OPERATIVE PATIENT TREATMENT INCLUDED HERNIA REPAIR WITH MESH, ASPIRATION OF SEROMA/HEMATOMA, ADMISSION TO HOSPITAL, FLUID COLLECTION DRAINAGE, SMALL BOWEL RESECTION WITH REVISION OF ILEOSTOMY, CENTRAL LINE PLACEMENT, TPN [TOTAL PARENTERAL NUTRITION], NG TUBE, MEDICATION, ANTIBIOTICS, LYSIS OF ADHESIONS, PARTIAL REMOVAL OF MESH, REVISION SURGERY.

  Patient problems: Abdominal Pain; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Ascites; Depression; Diaphoresis; Failure of Implant; Hematoma; Hernia; Internal Organ Perforation; Obstruction/Occlusion; Pain; Purulent Discharge; Scar Tissue; Seroma; Swelling/ Edema; Unspecified Tissue Injury; Urinary Tract Infection

  MAUDE report 12071433 ↗
• InjuryApr 16, 2020Migration 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 BUNCHED UP MESH AND ADHESIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

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

  MAUDE report 9968646 ↗
• InjuryFeb 28, 2020Migration 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 LAPAROSCOPIC THERAPEUTIC TREATMENT OF AN INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, BOWEL ADHERENT TO MESH, AND MESH BUNCHED UP. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISIONS SURGERY, ANTICOAGULATION REVERSED BEFORE SURGERY, ADMITTED TO HOSPITAL, AND PORTION OF MESH REMOVED WITH NEW MESH IMPLANTED.

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

  MAUDE report 9769683 ↗
• InjuryNov 8, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, POST-PARASTOMAL HERNIA SURGERY, AS WAS NOTED BY COMPUTED TOMOGRAPHY SCAN, RECURRENCE WAS NOTED FROM THE BROKEN PART ABOUT SIX CM IN THE CENTER OF THE MESH. HERNIA REPAIR WAS PERFORMED BY USING ANOTHER MESH WITHOUT REMOVING THE BROKEN MESH. PATIENT WAS DISCHARGED FROM THE HOSPITAL AND THE PROGRESS WAS UNDER OBSERVATION.

  Patient problems: No Code Available

  MAUDE report 9295915 ↗
• InjuryOct 16, 2019Mechanics 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 THERAPEUTIC TREATMENT OF A PARASTOMAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PHYSICAL AND MENTAL PAIN, DEFECTIVE MESH, SCARRING, PERMANENT IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, NON-HEALING WOUND, INFECTED MESH, ABDOMINAL WOUND DIFFICULTY, RECURRING OBSTRUCTIONS, AND PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDES REVISION SURGERY AND WOUND EXPLORATION WITH REMOVAL OF PARASTOMAL HERNIA MESH

  Patient problems: Adhesion(s); Emotional Changes; Hernia; Impaired Healing; Inflammation; Injury; Obstruction/Occlusion; Pain; Scar Tissue; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 9199805 ↗
• InjuryJun 10, 2019Material Perforation; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Material Perforation; 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 EXTENSIVE ADHESIONS, RECURRENCE, SEROMA AND PERFORATION IN THE CONDUIT WITH URINOMA. POST-OPERATIVE PATIENT TREATMENT INCLUDED LYSIS OF ADHESIONS, EXPLANT OF PREVIOUS MESH AND REPAIR OF HERNIA WITH NEW MESH.

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Distress; Hernia; Injury; Internal Organ Perforation; Perforation; Seroma; Unspecified Tissue Injury

  MAUDE report 8683143 ↗
• InjuryJun 5, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POST-OPERATIVELY, THE PATIENT EXPERIENCE HERNIA RECURRENCE.

  Patient problems: Hernia

  MAUDE report 8672932 ↗
• InjuryMay 29, 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 LAPAROSCOPIC THERAPEUTIC TREATMENT OF A PARASTOMAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED MESH FAILURE, RECURRENCE, SEROMA, OPEN WOUND, SCAR TISSUE, DENSE ADHESIONS, AND ISCHEMIC BOWEL. POST-OPERATIVE PATIENT TREATMENT INCLUDED REMOVAL, REVISION OF ILEOSTOMY, EXCISION OF ANTERIOR ABDOMINAL WOUND, WOUND VAC, AND SMALL BOWEL RESECTION.

  Patient problems: Adhesion(s); Failure of Implant; Hernia; Impaired Healing; Injury; Ischemia; Scar Tissue; Seroma

  MAUDE report 8652190 ↗
• InjuryMar 25, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC HERNIA PROCEDURE, ONLY THE SIDES OF THE MESH WAS LEFT. THE MIDLINE OF THE MESH WAS GONE AND THE INTESTINES HAD ADHERE TO IT. RE SURGERY WAS DONE TO REPAIR THE HERNIA RECURRENCE AND TO FREE THE ADHESIONS. THERE WAS TISSUE DAMAGE OF ADHESIONS AND FIBROTIC TISSUE. THE PATIENT WAS HOSPITALIZED. THE SURGICAL TIME WAS EXTENDED BY THREE TO FIVE HOURS. THE PATIENT HAD TO UNDERGO SURGERY AFTER THIS OPERATION ALSO BECAUSE OF PAIN OCCURRING BECAUSE OF ADHESIONS ONCE AGAIN.

  Patient problems: Adhesion(s); Fibrosis; Hernia; No Code Available; Pain; Tissue Damage

  MAUDE report 8447973 ↗
• InjuryFeb 7, 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 RECURRENCE, HIGH-GRADE SMALL BOWEL OBSTRUCTION, NEAR ISCHEMIC BOWEL, ADHESIONS, INTRA-ABDOMINAL ADHESION TO MESH, OMENTUM ADHESED TO MESH, PAIN AND ABDOMINAL PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

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

  MAUDE report 8318788 ↗
• InjuryJan 30, 2019Mechanics 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 IMPLANT, THE PATIENT EXPERIENCED CHRONIC PAIN, MULTIPLE SMALL BOWEL OBSTRUCTIONS, MULTIPLE ABSCESSES, ADHESIONS AND RECURRENCE. THE DEVICE HAD BEEN USED WITH COVIDIEN TACKING DEVICES (LOT# N0B0513, P9C1251) AND C-QUR V-PATCH MESH 4.3X4.3 CM (REF# (B)(4), LOT# 10580516037). POST-OPERATIVE PATIENT TREATMENT INCLUDED MESH EXPLANT AND MULTIPLE SURGICAL REVISIONS ((B)(6) 2010, (B)(6) 2012, (B)(6) 2012, (B)(6) 2013, (B)(6) 2016, (B)(6) 2017).

  Patient problems: Abdominal Pain; Abscess; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Ascites; Chills; Discharge; Emotional Changes; Fever; Fluid Discharge; Hernia; Injury; Nausea; Necrosis; No Code Available; Obstruction/Occlusion; Pain; Perforation; Seroma; Tachycardia; Unspecified Tissue Injury; Vomiting

  MAUDE report 8290086 ↗
• InjuryNov 30, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, TEMPORARY STOMA WAS ESTABLISHED DUE TO ILEUS. STOMA WAS ESTABLISHED AGAIN DUE TO TRANSVERSE COLON CANCER. PARA-STOMA HERNIA OCCURRED AND REPAIRED. THERE WAS A COMPLAINT OF RECURRENT HERNIA, ILEUS ALSO OCCURRED. COMPUTED TOMOGRAPHY(CT) WAS PERFORMED AND NOTED THAT THE SMALL INTESTINE PROLAPSED FROM ILEUS FROM THE OPPOSITE SIDE THROUGH THE STOMA, ILEUS WAS CONFIRMED. HERNIA WAS TAKEN CARE BY EMERGENCY TREATMENT, WHEN PROLAPSED AGAIN, REOPERATION WAS SCHEDULED, ILEUS WAS RELEASED AFTER AMBROSIA. BECAUSE ONLY CT WAS PERFORMED, IT WAS UNABLE TO CONFIRM IF THERE WAS MESH DAMAGE THAT CAUSED THE RECURRENCE.

  Patient problems: No Code Available

  MAUDE report 8119859 ↗
• InjuryNov 12, 2018Loss of or Failure to Bond; Loss of or Failure to Bond

  ACCORDING TO THE REPORTER, POST PARASTOMAL HERNIA WHEREIN SUGARBAKER TECHNIQUE WAS USED, A REOPERATION WAS PERFORMED FOLLOWING A REOCCURRENCE OF HERNIA OF A PATIENT WHO USED MESH. AT THAT TIME, THERE WAS A ROUND HOLE OF ABOUT 5 CM AROUND THE CENTER OF THE CENTER BAND AND THE HERNIA REOCCURRED. IT WAS CONFIRMED THAT THE MESH WAS UNDER ADHERING TO THE ABDOMINAL WALL AROUND THE HOLE. THE HERNIA WAS CLOSED WITH SUTURE AND THE OPERATION WAS COMPLETED.

  Patient problems: No Code Available; Prolapse

  MAUDE report 8059538 ↗
• InjuryNov 8, 2018Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, A PATIENT WITH A PARASTOMAL HERNIA WAS CURED WITH SUGARBAKER ABOUT 3 YEARS AGO EXPERIENCED A RECURRENCE. WHEN THE DOCTOR OPENED THE SURGICAL SITE, THEY SAW THAT THERE WAS A HOLE IN THE MIDDLE OF THE MESH AND IT HAD BECOME A HERNIA ORIFICE. IT SEEMED THAT THE DOCTOR THOUGHT KEYHOLE TYPE MIGHT HAVE BEEN USED. THE INCARCERATION WAS REMOVED IN THE FIRST REVISION SURGERY, BUT THE HERNIA WAS INCARCERATED AND REOCCURRED, SO THE SECOND REVISION SURGERY WAS PERFORMED AND AT THAT TIME THE DOCTOR DID NOT USE MESH. REOPERATION WAS REQUIRED DUE TO THE ISSUE. THE PROCEDURE WAS CONVERTED TO AN OPEN PROCEDURE. THERE WAS TISSUE DAMAGE.

  Patient problems: No Code Available; Prolapse; Tissue Damage

  MAUDE report 8053075 ↗
• InjuryJul 19, 2018Material Puncture/Hole; Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, AFTER A LAPAROSCOPIC PARASTOMAL HERNIA REPAIR, THE MESH DEVELOPED A CENTRAL HOLE AND A HERNIA OCCURRED THROUGH IT. A NEW MESH WAS IMPLANTED TO REPAIR THE HERNIA THROUGH A SECOND OPERATION.

  Patient problems: Failure of Implant; Hernia; No Code Available; Prolapse

  MAUDE report 7704315 ↗
• InjuryJan 8, 2018Material Perforation; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Material Perforation; 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 UNDERWENT A HERNIORRHAPHY INCISIONAL LAPAROSCOPIC RO. HE HAD REVISION SURGERY 2 DAYS POST-SURGERY. THE PATIENT EXPERIENCED SURGICAL REVISION, EXTENSIVE ADHESIONS, PERFORATION IN THE CONDUIT WITH URINOMA.

  Patient problems: Abdominal Pain; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Ascites; Distress; Hernia; Injury; Internal Organ Perforation; No Code Available; Perforation; Peritonitis; Renal Failure; Seroma; Unspecified Tissue Injury; Urinary Incontinence

  MAUDE report 7171481 ↗