Parietex TET5050Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10884521180369), received between Nov 7, 2017 and Aug 29, 2022 — classified as 6 injuries.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryAug 29, 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 INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED EXTENSIVE ADHESIONS, RECURRENT INCISIONAL HERNIA, SEROMA, SEROSAL TEAR OF BOWEL, AND INFLAMMATION. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, ADHESIOLYSIS, AND DRAINING.

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

  MAUDE report 15312588 ↗
• InjuryJun 2, 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 A HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED INFECTION AND ABSCESS. POST-OPERATIVE PATIENT TREATMENT INCLUDED EXCISIONAL DEBRIDEMENT OF ABDOMEN AND EVACUATION OF ASSOCIATED ABSCESS COMPLEX, EXCISION OF INFECTED TISSUE AND PARTIAL EXCISION OF MESH.

  Patient problems: Abscess; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Ascites; Bacterial Infection; Chills; Discomfort; Erythema; Fever; Fluid Discharge; Hernia; Impaired Healing; Nausea; Necrosis; Pain; Purulent Discharge; Scar Tissue; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 14578633 ↗
• InjuryMay 28, 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, AND A PARASTOMAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED FISTULA, INFECTION, ABSCESS, PAIN, HERNIA RECURRENCE, ADHESIONS, LIMITATIONS ON PHYSICAL ACTIVITY, AND EMOTIONAL INJURIES WITHOUT TREATMENT. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, BOWEL RESECTION, TRANSFERRED TO BARIATRIC BED AND TAKEN DIRECTLY TO ICU, INTUBATED/VENTILATED, AND WOUND VAC.

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

  MAUDE report 11900529 ↗
• InjuryNov 8, 2019Adverse 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 INFECTION, OPEN DRAINING WOUND, FLUID COLLECTION, LEUKOCYTOSIS, MRSA, ABSCESS, LEG SWELLING, RASH ON LEFT LEG, FEVER, ABDOMINAL PAIN, MALAISE, PAIN, LEUKOCLASTIC VASCULITIS, ERYTHEMA, ADHESIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERIES, CT SCAN, WOUND VAC, ANTIBIOTICS, HOSPITALIZATION, IV ANTIBIOTICS, IRRIGATION OF FLUID COLLECTION, PAIN MEDICATION, PICC LINE PLACEMENT, WOUND EXPLORATION, DRAIN PLACEMENT, SINOGRAM.

  Patient problems: Abdominal Pain; Abscess; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Ascites; Bacterial Infection; Erythema; Fever; Fluid Discharge; Hernia; Impaired Healing; Injury; Malaise; Pain; Perforation; Rash; Scar Tissue; Swelling/ Edema; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 9294411 ↗
• InjuryMar 3, 2018Degraded; Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Material Split, Cut or Torn; Degraded; Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Material Split, Cut or Torn

  THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE RESULTING IN AN UNSPECIFIED ADVERSE OUTCOME. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT. THE PATIENT HAS EXPERIENCED REMOVALS, INFECTION, AND FISTULA.

  Patient problems: Abdominal Pain; Adhesion(s); Anemia; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Ascites; Dehydration; Dizziness; Edema; Erythema; Fever; Fistula; Fluid Discharge; Headache; Hematoma; Hemorrhage/Blood Loss/Bleeding; Hernia; Impaired Healing; Inflammation; Injury; Loss of consciousness; Muscle Weakness/Atrophy; Necrosis; No Code Available; Obstruction/Occlusion; Pain; Pallor; Pneumonia; Purulent Discharge; Renal Failure; Scar Tissue; Sepsis; Seroma; Sleep Dysfunction; Swelling/ Edema; Tachycardia; Thrombosis/Thrombus; Ulcer; Unspecified Infection; Unspecified Tissue Injury; Urinary Retention; Urinary Tract Infection

  MAUDE report 7311990 ↗
• InjuryNov 7, 2017Migration 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 HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED ADHESIONS, INFECTION, ABSCESS, CHRONIC PAIN AND MESH MIGRATION. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY AND MESH REMOVAL.

  Patient problems: Abscess; Adhesion(s); Hernia; Hypersensitivity/Allergic reaction; Inflammation; No Code Available; Pain; Seroma; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 7007142 ↗