Parietex PCOPM20Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 10884521177789), received between Aug 30, 2017 and Apr 2, 2026 — classified as 1 death, 22 injuries.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (9 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• InjuryApr 2, 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 PAIN, ABSCESS, INFECTION, SEROMA. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, MESH REVISION.

  Patient problems: Abscess; Pain; Seroma; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 24769053 ↗
• InjuryMay 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 THERAPEUTIC TREATMENT OF A HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED ADHESIONS, RECURRENCE, ENTEROTOMY, MESH EROSION, PAIN, INFECTION, INFLAMMATION, OBSTRUCTIONS, SCAR TISSUE, ENTEROTOMY, AND SUCCUS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, GORE-TEX PATCH REPAIR OF HERNIA, CHOLECYSTECTOMY, REMOVAL OF MESH, REPAIR OF ENTEROTOMY CAUSED BY MESH EROSION, REPAIR OF ILEAL CONDUIT OPENING, EXPLORATORY LAPAROTOMY, LYSIS OF ADHESIONS, SUCCUS REMOVED FROM BOWEL, AND MEDICATION. IT WAS NOTED THAT DURING IMPLANT PROCEDURE THE MESH WAS CUT THROUGH.

  Patient problems: Abdominal Distention; Abdominal Pain; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Ascites; Bacterial Infection; Constipation; Dehydration; Electrolyte Imbalance; Erosion; Fistula; Fluid Discharge; Foreign Body Reaction; Hernia; Hyponatremia; Hypovolemic Shock; Inflammation; Liver Damage/Dysfunction; Low Blood Pressure/ Hypotension; Nausea; Obstruction/Occlusion; Pain; Purulent Discharge; Renal Failure; Renal Impairment; Scar Tissue; Sleepiness/Drowsiness/Somnolence; Stenosis; Tachycardia; Unspecified Infection; Unspecified Tissue Injury; Vomiting

  MAUDE report 11846123 ↗
• InjuryApr 21, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, A PARASTOMAL MESH WAS USED TO REPAIR A PARASTOMAL HERNIA OCCURRED A FEW YEARS AGO. SINCE THE PARASTOMAL HERNIA RECURRED, A RE-OPERATION WAS PERFORMED ON THE REPORT DAY. IT WAS FOUND THAT THE CENTRAL PART OF THE PARASTOMAL MESH WAS DAMAGED.

  Patient problems: Hernia

  MAUDE report 11700228 ↗
• InjuryMar 26, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, POST-OPERATIVE LAPAROSCOPIC HERNIA REPAIR, THE PATIENT INITIAL MESH IMPLANTED BROKE AT THE CENTER AND PATIENT HAD RECURRENCE OF PARA-STOMA HERNIA. THE PATIENT UNDERWENT RE-OPERATION AND NEW MESH DEVICE WAS USED TO REINFORCE THE INITIAL MESH. THE TISSUE ADHERING TO THE HERNIA PHYLUM HAD TO BE RESECTED AND DISSECTED.

  Patient problems: Failure of Implant; Hernia; Unspecified Tissue Injury

  MAUDE report 11574356 ↗
• InjuryJan 6, 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 PARASTOMAL HERNIA. IT WAS REPORTED THAT AFTER THE UNDERLAY IMPLANT, THE PATIENT EXPERIENCED AN UNSPECIFIED ADVERSE OUTCOME.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 11124494 ↗
• InjuryApr 6, 2020Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, 1-2 YEARS FOLLOWING A LAPAROSCOPIC PARASTOMAL HERNIA REPAIR, THE PATIENT'S HERNIA RELAPSED. DURING THE REOPERATION, A HOLE WAS FOUND IN THE MIDDLE OF THE MESH. A NEW MESH WAS INSERTED TO COVER THE DEFECT.

  Patient problems: Hernia; No Code Available

  MAUDE report 9928517 ↗
• InjuryJan 21, 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 THERAPEUTIC TREATMENT OF A PARASTOMAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED MESH FAILURE, RECURRENCE, SCARRING, DRAINING SINUS TRACT, PURULENT MATERIAL, ADHESIONS, GRANULATION, ABDOMINAL PAIN, PAIN, SEROSAL TEAR, SMALL BOWEL OBSTRUCTION, AND INFECTION. POST-IMPLANT TREATMENT INCLUDED REVISION SURGERY, CATHETER PLACEMENT, EXTENDED HOSPITAL STAY, HERNIA REPAIR WITH NEW MESH, SCAR REVISION, PICC LINE PLACED, NASOGASTRIC TUBE WITH 2 LITERS OUTPUT, LYSIS OF ADHESIONS, SEROSAL TEAR REPAIRED, WOUND PACKED, AND REMOVAL SURGERY.

  Patient problems: Abdominal Pain; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discharge; Distress; Failure of Implant; Fluid Discharge; Hernia; Injury; No Code Available; Obstruction/Occlusion; Pain; Purulent Discharge; Scar Tissue; Scarring; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 9610284 ↗
• InjuryOct 3, 2019Migration 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 A PARASTOMAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED ADHESIONS TO BOWEL AND SMALL INTESTINE, RECURRENCE, MESH DETACHMENT, HEMATOMA, SWELLING, MESH FORMED SLING CONFIGURATION, LIQUIFIED BLOOD, PAIN, AND ABDOMINAL PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Abdominal Pain; Adhesion(s); Hematoma; Hemorrhage/Blood Loss/Bleeding; Hernia; Injury; Pain; Swelling; Swelling/ Edema; Unspecified Tissue Injury

  MAUDE report 9153493 ↗
• InjuryJul 11, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, THE PATIENT WAS RE-OPERATED FOR ILEUS SYMPTOMS AND HERNIA SYMPTOMS FOLLOWING A LAPAROSCOPIC PARASTOMAL HERNIA REPAIR. IT WAS NOTED THAT THE MESH WAS DAMAGED. THE MESH HAD A 3X3 CM HOLE CLOSE TO THE FIELD WHEN IT'S GOING FROM 3D TO 2D STRUCTURE. THE INCISION WAS EXTENDED BY MORE THAN 1 INCH. THEY HAD TO SUTURE THE HOLE IN THE MESH.

  Patient problems: No Code Available

  MAUDE report 8783200 ↗
• InjuryJul 3, 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 PARASTOMAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED AN INFECTION, AN ABSCESS, FISTULA, AND AN OPEN WOUND. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Abdominal Pain; Abscess; Chills; Fever; Fistula; Impaired Healing; Injury; Swelling; Unspecified Infection

  MAUDE report 8759405 ↗
• InjuryJun 12, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PARASTOMAL HERNIA ON THE ABDOMINAL WALL, THERE WAS A HOLE IN THE MESH. RE OPERATION WAS DONE TO COMPLETE THE CASE.

  Patient problems: No Code Available

  MAUDE report 8693756 ↗
• InjuryMar 27, 2019Material Erosion; Adverse Event Without Identified Device or Use Problem; Material Erosion; 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 ABDOMINAL PAIN, A SKIN RASH NEAR THE INCISION, HERNIA RECURRENCE, MESH EXTRUDING FROM HER BODY, MESH EROSION, AND SMALL BOWEL OBSTRUCTION. POST-OPERATIVE PATIENT TREATMENT INCLUDED REMOVAL SURGERY.

  Patient problems: Abdominal Pain; Erosion; Hernia; Injury; No Code Available; Obstruction/Occlusion; Rash

  MAUDE report 8457866 ↗
• DeathJan 18, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  ACCORDING TO THE REPORTER, FOLLOWING A PARASTOMAL HERNIA PROCEDURE, REOPERATION WAS PERFORMED. THE SURGEON WAS CUTTING THE MESH TOWARD THE LOWER ABDOMEN, AND NOTED THE INTESTINAL TRACT WAS INCARCERATED FROM THE INTERSPACE WHICH IS LOCATED FURTHER OUTSIDE OF THE INTESTINAL TRACT WHICH BECAME RED DUE TO HEMATOMA. THE SURGEON COMPRESSED THE INCARCERATED INTESTINAL TRACT AND TRIED TO RETURN IT IN THE ABDOMINAL CAVITY, BUT COULD NOT. AS IT WAS ABOUT 4 CM FROM THE HERNIA ORIFICE TO THE INSIDE, THE SURGEON RESECTED AND OPENED THE HERNIA ORIFICE. THE SMALL INTESTINE WAS INCARCERATED BY A LENGTH OF ABOUT 10CM. THE INTESTINAL TRACT WAS HYPEREMIC, BUT THE SEROUS DID NOT BECOME ISCHEMIC, AND IT SEEMED THAT THE INTESTINAL TRACT COULD BE PRESERVED WITHOUT RESECTION. THE STATE OF THE MESH WAS CHECKED AND IT WAS SEEN THAT THE ENTIRE CIRCUMFERENCE OF THE MESH WAS FIXED TO THE ABDOMINAL WALL AND THERE WAS NO ADHESION. THE MESH'S CLEAVAGE WAS AROUND THE CENTER AND IT HAD NOT REACHED THE EDGE. IT WAS UNCERTAIN THE MESH IN QUESTION ACTUALLY CRACKED, BUT THE SURGEON CLOSED THE CLEAVAGE AND THE INCISED ORIFICE BY INTERRUPTING SUTURE, FOR TOTAL 7CM WITH NYLON 2-0, TO LET KNOTS MOVE OUTSIDE OF THE MESH (AB

  Patient problems: Adhesion(s); Death; Hematoma; No Code Available

  MAUDE report 8262066 ↗
• InjuryDec 4, 2018Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC PARASTOMAL HERNIA PROCEDURE, WHEN RE OPERATING RECURRENCE, THE DEVICE WAS BROKEN IN THE SEEM. RE-OPERATION WAS DONE TO RESOLVE THE ISSUE.

  Patient problems: Hernia; No Code Available; No Known Impact Or Consequence To Patient

  MAUDE report 8131320 ↗
• InjuryDec 4, 2018Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC PARASTOMAL HERNIA PROCEDURE, WHEN RE OPERATING RECURRENCE, THE DEVICE WAS BROKEN IN THE SEEM. RE-OPERATION WAS DONE TO RESOLVE THE ISSUE.

  Patient problems: Hernia; No Code Available; No Known Impact Or Consequence To Patient

  MAUDE report 8131301 ↗
• InjuryOct 30, 2018Degraded; Degraded

  ACCORDING TO THE REPORTER, FOLLOWING A LAPAROSCOPIC PARASTOMAL HERNIA REPAIR PROCEDURE, THE IMPLANTED MESH WAS DAMAGED. A RE-OPERATION WAS DONE TO RESOLVE THE ISSUE AND THE PATIENT'S HOSPITAL STAY WAS EXTENDED.

  Patient problems: No Code Available; Pain

  MAUDE report 8019615 ↗
• InjurySep 17, 2018Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PARASTOMAL HERNIA REPAIR FOR RECURRENT PARASTOMAL HERNIA, IT WAS FOUND THAT THE MESH APPLIED TO THE ABDOMINAL WALL HAD A HOLE. DURING EXPLANTATION, THE MESH WAS CUT IN PIECES SO THAT IT CAN BE TAKEN OUT. THE PATIENT'S HOSPITALIZATION WAS EXTENDED BY 7 DAYS.

  Patient problems: Hernia; No Code Available

  MAUDE report 7881141 ↗
• InjuryJul 20, 2018Fracture; Defective Device; Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, FOLLOWING PARASTOMAL HERNIA REPAIR, THE PATIENT HAD AN INCARCERATED - BUT VITAL - BOWEL LOOP THROUGH THE MESH FRACTURE. PATIENT CAME AS EMERGENCY PATIENT DUE TO BOWEL "UPSTRUCTION". A NEW MESH REPAIR WAS PERFORMED TO CLOSE THE DEFECT. THIS RESULTED IN DELAY OF SURGERY.

  Patient problems: No Code Available; Obstruction/Occlusion

  MAUDE report 7706376 ↗
• InjuryJun 26, 2018Torn Material; Torn Material

  ACCORDING TO THE REPORTER, FOLLOWING A LAPAROSCOPIC REPAIR OF A PARASTOMAL HERNIA PROCEDURE USING A MODIFIED SUGARBAKER OPERATIVE APPROACH, THE MESH WAS DAMAGED. THE SURGEON OBSERVED A FRACTURE OF THE MESH CORRESPONDING TO THE TRANSLUCENT STRIPE, WHERE THIS ORIGINALLY COVERED THE HERNIA DEFECT. THERE WAS TISSUE DAMAGE AND THE PATIENT EXPERIENCED BOWEL OBSTRUCTION AS A RESULT OF THE PRODUCT PROBLEM. THE SURGICAL TIME WAS EXTENDED 30 MINUTES OR MORE AND THE EVENT ALSO RESULTED TO AN EXTENDED PATIENT HOSPITAL STAY. THE PATIENT UNDERWENT REOPERATION FOR PARASTOMAL HERNIA TO RESOLVE THE ISSUE AND TO PREVENT PERMANENT IMPAIRMENT.

  Patient problems: No Code Available; Obstruction/Occlusion; Tissue Damage

  MAUDE report 7639304 ↗
• InjuryJun 26, 2018Torn Material; Torn Material

  ACCORDING TO THE REPORTER,FOLLOWING A LAPAROSCOPIC REPAIR OF A PARASTOMAL HERNIA PROCEDURE USING A MODIFIED SUGARBAKER OPERATIVE APPROACH, THE MESH WAS DAMAGED. THE SURGEON OBSERVED A FRACTURE OF THE MESH CORRESPONDING TO THE TRANSLUCENT STRIPE, WHERE THIS ORIGINALLY COVERED THE HERNIA DEFECT. THERE WAS TISSUE DAMAGE AND THE PATIENT EXPERIENCED BOWEL OBSTRUCTION AS A RESULT OF THE PRODUCT PROBLEM. THE SURGICAL TIME WAS EXTENDED 30 MINUTES OR MORE AND THE EVENT ALSO RESULTED TO AN EXTENDED PATIENT HOSPITAL STAY. THE PATIENT UNDERWENT REOPERATION FOR PARASTOMAL HERNIA TO RESOLVE THE ISSUE AND TO PREVENT PERMANENT IMPAIRMENT.

  Patient problems: No Code Available; Obstruction/Occlusion; Tissue Damage

  MAUDE report 7638025 ↗
• InjuryJun 26, 2018Torn Material; Torn Material

  ACCORDING TO THE REPORTER,FOLLOWING A LAPAROSCOPIC REPAIR OF A PARASTOMAL HERNIA PROCEDURE USING A MODIFIED SUGARBAKER OPERATIVE APP ROACH, THE MESH WAS DAMAGED. THE SURGEON OBSERVED A FRACTURE OF THE MESH CORRESPONDING TO THE TRANSLUCENT STRIPE, WHERE THIS ORIGINALLY COVERED THE HERNIA DEFECT. THERE WAS TISSUE DAMAGE AND THE PATIENT EXPERIENCED BOWEL OBSTRUCTION AS A RESULT OF THE PRODUCT PROBLEM. THE SURGICAL TIME WAS EXTENDED 30 MINUTES OR MORE AND THE EVENT ALSO RESULTED TO AN EXTENDED PATIENT HOSPITAL STAY. THE PATIENT UNDERWENT REOPERATION FOR PARASTOMAL HERNIA TO RESOLVE THE ISSUE AND TO PREVENT PERMANENT IMPAIRMENT.

  Patient problems: No Code Available; Obstruction/Occlusion; Tissue Damage

  MAUDE report 7637652 ↗
• InjuryNov 20, 2017Failure To Adhere Or Bond; Adverse Event Without Identified Device or Use Problem; Failure To Adhere Or Bond; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER: THE PATIENT UNDERWENT AN OPEN PARASTOMAL HERNIA PROCEDURE. POST OPERATIVELY, THE MESH WAS STUCK TO THE INTESTINE AND CAUSED A PROLONGED FEVER OF THE PATIENT. THE MESH WAS NOT FOLDED AT THE TWO VIOLET EXPANDER JUNCTIONS AND WAS NOT FOLDED FACIAL SIDE AGAINST FACIAL SIDE. THE MESH WAS NOT CUT PRIOR TO IMPLANTATION. THE APPEARANCE OF THE MESH WAS NORMAL. THE FIXATION SYSTEM WAS A TACKER WITH SIXTY FIXATION POINTS AND A 12 MM TROCAR WAS USED. THE WOUND WAS CLOSED WITH SUTURES. POST PROCEDURE THE PATIENT HAD A PROLONGED FEVER AND THE DOCTOR THEREFORE PERFORMED CT SCAN AND DISCOVERED THE BOWEL IS STICKING TO THE MESH. THE SURGEON RE-OPENED THE WOUND AND CONFIRMED THE STICKING AND CORRECTED THE ISSUE. THE COLLAGEN SIDE OF THE MESH WAS FACING THE VISCERAL. NO OTHER SYMPTOMS HAVE BEEN REPORTED. NO INFECTION WAS REPORTED. THE PATIENT HAD NO FURTHER INJURY.

  Patient problems: Adhesion(s); Fever; Radiation Exposure, Unintended

  MAUDE report 7045587 ↗
• InjuryAug 30, 2017Torn Material; Torn Material

  ACCORDING TO THE REPORTER: OCCURRED POST-OPERATIVELY, APPROXIMATELY 1 YEAR AND 8 MONTHS AFTER RECEIVING A COMPOSITE PARASTOMAL MESH AS PART OF A MODIFIED SUGARBAKER REPAIR FOR A RECTAL EXTIRPATION FOR CANCER. THE ORIGINAL REPAIR INCLUDED COMPOSITE PARASTOMAL MESH FIXED WITH PERMANENT TACKERS AND SUTURES. THE PATIENT DID NOT PRESENT WITH ANY IMMEDIATE PROBLEMS FOLLOWING THE PROCEDURE. HE RETURNED TO THE HOSPITAL DUE TO AN ACUTELY DEVELOPED SMALL BOWEL OBSTRUCTION. HE UNDERWENT EMERGENCY LAPAROSCOPIC SURGERY WHERE A SMALL BOWEL LOOP WAS DISCOVERED INSIDE A FRACTURE HOLE IN THE MESH. THE BOWEL LOOP WAS VITAL AND WAS REPOSITIONED FOLLOWING REPAIR OF THE MESH HOLE WITH NYLON SUTURE. THE MESH APPEARED NORMAL BESIDES THE FRACTURE HOLE. THE ISSUE CAUSED TEMPORARY INJURY AND TISSUE DAMAGE AND REQUIRED SURGICAL INTERVENTION. PATIENT STATUS REPORTED AS ALIVE, NO INJURY. RELEVANT MEDICAL HISTORY: RECTAL EXTIRPATION FOR CANCER

  Patient problems: Injury; No Code Available; Obstruction/Occlusion; Tissue Damage

  MAUDE report 6831993 ↗