Parietex PCO2015FXRecalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10884521179752), received between Jan 2, 2018 and Nov 7, 2024 — classified as 14 injuries.

The most frequently reported specific device problem is “Mechanics Altered” (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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryNov 7, 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 EPIGASTRIC HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED HEMORRHAGIC COLLECTION, FAT NECROSIS, FLUID COLLECTION, INFECTION, STAPH AUREUS; ANAEROBIC ORGANISM, SMALL LOCULE OF GAS, ABSCESS, INFECTED HEMATOMA, DRAINING WOUND, CELLULITIS, SWELLING, ERYTHEMA, PURULENT FLUID, HERNIA RECURRENCE, & LEAKING SINUSES. POST-OPERATIVE PATIENT TREATMENT INCLUDED CT SCAN, HOSPITALIZATION, EXPLORATION OF WOUND, WASH-OUT AND EVACUATION OF HEMATOMA, USE OF DRAIN, IV ANTIBIOTICS, INCISION DRAINAGE OF ABSCESS, WOUND CARE, WOUND VAC, MESH REVISION, MESH REMOVAL.

  Patient problems: Abscess; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Ascites; Bacterial Infection; Cellulitis; Erythema; Fluid Discharge; Hematoma; Hemorrhage/Blood Loss/Bleeding; Hernia; Impaired Healing; Necrosis; Purulent Discharge; Swelling/ Edema; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 20635535 ↗
• InjuryOct 24, 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 PARAUMBILICAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED STAPH AUREUS, GREEN SCAB ON WOUND WITH CRUST GREEN DISCHARGE, DOES NOT FEEL WELL, FEVER, SHIVERS, WOUND INFECTION, BELLY BUTTON LEAKING/SMELLY, PURULENT FLUID DISCHARGING FROM STITCH SINUS, PUS, INFLAMMATION, <(>&<)> ERYTHEMA. POST-OPERATIVE PATIENT TREATMENT INCLUDED ULTRASOUND, ANTIBIOTICS, WOUND CARE, <(>&<)> MEDICATION.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Bacterial Infection; Chills; Erythema; Fever; Fluid Discharge; Impaired Healing; Inflammation; Malaise; Purulent Discharge; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 20530076 ↗
• InjurySep 20, 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 A LAPAROSCOPIC THERAPEUTIC TREATMENT OF A LEFT LUMBAR HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, ABDOMINAL PAIN, BACK PAIN, FULLNESS/BULGE, SCARRING, DISCOMFORT, NERVE IRRITATION, BLOATING, ABDOMINAL DISCOMFORT, MALAISE, FEVERS, SWEATS, NEURALGIC PAIN, MUSCLE SPASMS, AND ENTRAPMENT NEUROPATHY. POST-OPERATIVE PATIENT TREATMENT INCLUDED HOSPITALIZATION, CT SCAN, AND MRI.

  Patient problems: Abdominal Distention; Abdominal Pain; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Cramp(s) /Muscle Spasm(s); Diaphoresis; Discomfort; Fever; Malaise; Neuralgia; Neuropathy; Pain; Scar Tissue; Unspecified Tissue Injury

  MAUDE report 20271514 ↗
• InjuryMar 13, 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 A LAPAROSCOPIC THERAPEUTIC TREATMENT OF A INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED NAUSEA, LUMP, NERVE PAIN, LOSS OF APPETITE, INABILITY TO EAT, ABDOMINAL PAIN, DISTRESS, PREVENTED FROM HAVING A LIFE, LESION, GRANULOMA, PAIN, RECURRENCE, INFLAMMATION, SCARRING, SWELLING, ADHESIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED IV MEDICATION, PT, ORAL MEDICATIONS, STEROID INJECTIONS, REMOVAL OF GRANULOMA, SUTURE/CLIP REMOVAL, DIAGNOSTIC LAP, LYSIS OF ADHESIONS, MESH REMOVAL, LOCAL EXPLORATION OF ABDOMINAL WALL. CONCOMITANT DEVICES: ABSORBATACK.

  Patient problems: Abdominal Pain; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Decreased Appetite; Distress; Granuloma; Hernia; Inflammation; Localized Skin Lesion; Nausea; Nodule; Pain; Scar Tissue; Swelling/ Edema; Unspecified Tissue Injury

  MAUDE report 18896317 ↗
• InjuryFeb 16, 2024Mechanics 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 AN UMBILICAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DEFECTIVE MESH, ABDOMINAL PAIN, RECURRENCE, ADHESIONS, SCARRING, PAIN, MENTAL PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REMOVAL OF MESH, EXPLORATORY LAPAROTOMY, SMALL BOWEL RESECTION WITH ENTEROENTEROSTOMY.

  Patient problems: Abdominal Pain; Adhesion(s); Cramp(s) /Muscle Spasm(s); Depression; Diarrhea; Emotional Changes; Fatigue; Hernia; Inflammation; Obstruction/Occlusion; Pain; Scar Tissue; Unspecified Tissue Injury

  MAUDE report 18725400 ↗
• InjuryAug 30, 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED INFECTION, SEROMA, WOUND DEHISCENCE, PAIN, MENTAL PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, DISABILITY, DEPRESSION, DEFECTIVE MESH, PSYCHOLOGICAL STRESS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, REMOVAL OF MESH, HERNIA REPAIR WITH NEW MESH, HOSPITALIZATION, WOUND VAC, DEBRIDEMENT OF MESH.

  Patient problems: Depression; Distress; Emotional Changes; Pain; Seroma; Unspecified Infection; Unspecified Tissue Injury; Wound Dehiscence

  MAUDE report 17653332 ↗
• InjuryMar 31, 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 IMPLANT, THE PATIENT EXPERIENCED ABDOMINAL PAIN, DISCOMFORT, RECURRENCE, ADHESIONS, AND PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, MEDICATION, LYSIS OF ADHESIONS, AND HERNIA REPAIR WITH NEW MESH.

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

  MAUDE report 16660681 ↗
• InjuryAug 19, 2021Degraded; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Degraded; 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 BROKEN DOWN MESH, MESH FAILURE, HERNIA RECURRENCE, ADHESIONS, BOWEL COMPLICATIONS, PAIN, DEFECTIVE MESH, SCARRING, DISFIGUREMENT, PSYCHOLOGICAL AND EMOTIONAL INJURIES, SUFFERING, LOSS OF ENJOYMENT OF LIFE, DISABILITY, AND LOSS OF MENTAL AND EMOTIONAL HEALTH. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Adhesion(s); Deformity/ Disfigurement; Emotional Changes; Failure of Implant; Hernia; Pain; Scar Tissue; Unspecified Tissue Injury

  MAUDE report 12345032 ↗
• InjuryAug 19, 2021Degraded; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Degraded; 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 BROKEN DOWN MESH, HERNIA RECURRENCE, ADHESIONS, GASTROINTESTINAL COMPLICATIONS, PAIN, DEFECTIVE MESH, SCARRING, DISFIGUREMENT, PSYCHOLOGICAL AND EMOTIONAL INJURIES, SUFFERING, LOSS OF ENJOYMENT OF LIFE, DISABILITY, AND LOSS OF MENTAL AND EMOTIONAL HEALTH. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

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

  MAUDE report 12344530 ↗
• InjuryJun 18, 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 THERAPEUTIC TREATMENT OF A VENTRAL INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, MESH EROSION, ADHESIONS, ABDOMINAL PAIN, UNPLEASANT ODOR, LEAKAGE, INFECTED MESH, PHYSICAL PAIN, MENTAL ANGUISH, DISABILITY, PSYCHOLOGICAL STRESS, DEPRESSION, INFLAMMATION, GRANULATION TISSUE, ABSCESS, PURULENT MATERIAL, ADHESIONS, MESH MIGRATION, AND LOSS OF ENJOYMENT OF LIFE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REMOVAL OF INFECTED ABDOMINAL WALL MESH, ADDITIONAL SURGERY, ANTIBIOTICS, LYSIS OF ADHESIONS, HERNIA REPAIR WITH NEW MESH, AND HOSPITALIZATION.

  Patient problems: Abdominal Pain; Abscess; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Depression; Distress; Emotional Changes; Erosion; Fluid Discharge; Hernia; Inflammation; Pain; Purulent Discharge; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 12028266 ↗
• InjuryFeb 19, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THE PATIENT EXPERIENCED POST OPERATIVE PAIN. IT WAS STATED THAT THE PATIENT HAD BOWEL ISSUES WITH BOWEL BLOCKING UP AND A LOT OF CONSTIPATION DESPITE PLENTY OF FLUID AND FIBER INTAKE. THE PATIENT DEVELOPED SEVERE GLUTEN INTOLERANCE, NUMBNESS. IT WAS ALSO STATED THAT THE PAIN VARIES FROM STABBING, SHARP, DULL, FORCEFUL LIKE A PUNCH, ELECTRIC SHOCKED, A DEEP THROBBING ACHE IN AND AROUND THE HERNIA REPAIR.

  Patient problems: Constipation; No Code Available; Numbness

  MAUDE report 9728063 ↗
• InjuryJan 3, 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 VENTRAL INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED HERNIA RECURRENCE, CHRONIC PAIN, PSYCHOLOGICAL STRESS, DEPRESSION, AND SEVERE/PERMANENT INJURY. POST-OPERATIVE PATIENT TREATMENT INCLUDED RECURRENT HERNIA REPAIR SURGERY, MESH REMOVAL, AND IMPLANT OF NEW MESH. CONCOMITANT MEDICAL DEVICE: VENTRALEX 002011552 ST MESH.

  Patient problems: Abdominal Distention; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Depression; Discomfort; Distress; Emotional Changes; Hernia; Hypoxia; Injury; Muscle Weakness/Atrophy; Pain; Tachycardia; Unspecified Tissue Injury

  MAUDE report 9544720 ↗
• InjuryDec 9, 2018Loss of or Failure to Bond; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Loss of or Failure to Bond; 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 MULTIPLE REDUCIBLE INCISIONAL HERNIAS. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, SMALL BOWEL OBSTRUCTION, SEVERE PAIN, NECROTIC INFECTION, UNINCORPORATED MESH, NECROSIS, ORGAN DAMAGE, AND OPEN WOUND. POST-OPERATIVE PATIENT TREATMENT INCLUDED WOUND VAC, SMALL BOWEL ENTEROTOMY, DEBRIDEMENT, REMOVAL OF INFECTED MESH, DEFECTS WERE CLOSED WITH MYOCUTANEOUS ADVANCEMENT FLAPS, AND REVISION SURGERIES.

  Patient problems: Abdominal Distention; Discomfort; Hernia; Impaired Healing; Inflammation; Injury; Necrosis; Nerve Damage; No Code Available; Obstruction/Occlusion; Pain; Swelling/ Edema; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 8145163 ↗
• InjuryJan 2, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC HERNIAL PROCEDURE FOR AN UMBILICAL HERNIA, WHILE BEING APPLIED AT THE INTRA-PERITONEAL, AFTER THE TROCAR WAS INSERTED, THE MESH HAD A 4CM DEFECT. THEY USED AN IPOM APPROACH AND ALSO UTILIZED ABSORBABLE TACKERS AND TRANSFASCIAL SUTURES AS A FIXATION SYSTEM WITH 4 SUTURES AND 25 TACKS AS FIXATION POINTS. THE MESH WAS FOUND TO BE WET AND TRANSPARENT AS A 10-5-5 TROCAR WAS USED. PATIENT HAD TO BE OPERATED AGAIN TO REMOVE THE INFECTED MESH AND HE ALSO STAYED IN THE HOSPITAL FOR 2 WEEKS. THEY COMPLETELY REMOVED THE INFECTED MESH AFTER 2-3 WEEKS. AN ADDITIONAL OPERATION WILL BE PERFORMED TO CORRECT THE ISSUE. THE PATIENT WAS ALIVE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 7156665 ↗