Parietex TEC3030Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10884521180031), received between Dec 13, 2017 and Feb 7, 2025 — classified as 14 injuries.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (6 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.

• InjuryFeb 7, 2025Adverse 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, INFECTION, ADHESIONS, PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, REMOVAL OF MESH, SMALL BOWEL RESECTION.

  Patient problems: Adhesion(s); Hernia; Hypersensitivity/Allergic reaction; Inflammation; Pain; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 21334602 ↗
• InjuryJun 16, 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 INFECTION, ABSCESS, ADHESIONS, AND PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY AND MESH REMOVAL.

  Patient problems: Abscess; Adhesion(s); Discomfort; Nodule; Pain; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 17148341 ↗
• InjuryMay 14, 2021Migration 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 BILATERAL UMBILICAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED INDURATED TISSUE WITH PURULENCE, PAIN, HERNIA RECURRENCE, ABSCESS, OPEN DRAINING WOUND, MESH SEPARATION, AND INFECTION. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, ABDOMEN WOUND INCISION AND DRAINAGE, DEBRIDEMENT, PLACEMENT OF WOUND VAC, AND MESH REMOVAL SURGERY.

  Patient problems: Abscess; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Fluid Discharge; Hernia; Impaired Healing; Pain; Purulent Discharge; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 11829027 ↗
• InjuryMay 11, 2021Mechanics 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 A LEFT INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED INFECTION AND PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, MEDICATION, AND MESH REMOVAL.

  Patient problems: Pain; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 11807669 ↗
• InjuryMar 20, 2021Migration or Expulsion of Device; Material Deformation; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Migration or Expulsion of Device; Material Deformation; 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 ABDOMINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED INFECTION, ABSCESS, DISCOMFORT, EMOTIONAL HARM, ALL ASPECTS OF LIFE NEGATIVELY IMPACTED, MESH FAILURE, RECURRENCE AND PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, REPAIR OF RECURRENT VENTRAL HERNIA AND MEDICATION.

  Patient problems: Abdominal Distention; Abscess; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Emotional Changes; Hernia; Pain; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 11536681 ↗
• InjuryJan 5, 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 AN INGUINAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, INFECTION, WOUND SINUS, AND OPEN WOUND. POST-OPERATIVE PATIENT TREATMENT INCLUDED HERNIA REPAIR WITH NEW MESH AND REMOVAL OF MESH.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Fluid Discharge; Hernia; Impaired Healing; Inflammation; Pain; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 11118732 ↗
• InjuryDec 21, 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 AN ABDOMINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DRAINING ABDOMINAL WOUND WITH SEROMA SURROUNDING UNINCORPORATED MESH, PURULENT FLUID, CHRONIC MESH INFECTION, AND PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Fluid Discharge; Impaired Healing; Pain; Purulent Discharge; Seroma; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 11046410 ↗
• InjuryOct 13, 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 THE IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, ADHESIONS, SCAR TISSUE, MESH DISRUPTION, PAIN, INFLAMMATION, OBSTRUCTION, SWELLING, VOMITING, AND ABDOMINAL PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICATION, REVISION SURGERY, PARTIAL MESH REMOVAL, AND HERNIA REPAIR WITH NEW MESH.

  Patient problems: Abdominal Pain; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Foreign Body Reaction; Hernia; Inflammation; Injury; Obstruction/Occlusion; Pain; Scar Tissue; Swelling/ Edema; Unspecified Tissue Injury; Vomiting

  MAUDE report 10673449 ↗
• InjurySep 4, 2020Migration 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 PAIN, ADHESIONS, FISTULA, INFECTION, INFLAMMATION, NECROSIS, MESH/TISSUE EROSION, AIR FLUID COLLECTION WITHIN THE RECTUS SHEATH, YELLOW-GREEN MUCINOUS AND EXUDATIVE MATERIAL LOOSELY ADHERED TO THE MESH, FOREIGN BODY REACTION, FIBROSIS, AGGREGATE OF SURGICAL MESH, CELLULITIS, OPENING OF PRIOR INCISION, ABSCESS, BILIOUS CONTENT PRESENT IN WOUND, DEHISCENCE, WOUND TRACTS LATERALLY RIGHT AND LEFT, PURULENCE EXPRESSED FROM WOUND, HERNIA RECURRENCE, AND MESH MIGRATION. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, DEBRIDEMENT OF ABSCESS, PLACEMENT OF NEGATIVE PRESSURE WOUND VAC, REMOVAL OF MESH, IV ANTIBIOTICS, SUBCUTANEOUS DEHISCENCE EVACUATED, REMOVAL OF MESH/TISSUE EROSION, PALPATE BOWEL ADHERED TO ANTERIOR ABDOMINAL WALL WITH REFLUX OF ENTERIC CONTENTS INTO WOUND, NECROSIS DEBRIDED, IRRIGATION AND BLUNT DEBRIDEMENT OF ABDOMINAL WOUND, ADAPTIC SHEET PLACED AT BASE OF WOUND, FISTULA TREATED WITH NUTRITIONAL OPTIMIZATION, FISTULA TAKEDOWN, SMALL BOWEL RESECTION, INFECTE

  Patient problems: Abdominal Distention; Abscess; Adhesion(s); Ascites; Cellulitis; Depression; Discomfort; Emotional Changes; Erosion; Fibrosis; Fistula; Foreign Body Reaction; Hernia; Impaired Healing; Inflammation; Injury; Necrosis; No Code Available; Pain; Purulent Discharge; Swelling/ Edema; Unspecified Infection; Unspecified Tissue Injury; Wound Dehiscence

  MAUDE report 10494547 ↗
• InjuryFeb 4, 2020Adverse 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, INFECTION, NECROTIZING SOFT TISSUE, OPEN WOUND, ABSCESS, DISCHARGE, AND HEMATOMA. POST-OPERATIVE PATIENT TREATMENT INCLUDED REMOVAL SURGERY, EXCISIONAL DEBRIDEMENT OF SKIN, SUBCUTANEOUS TISSUE AND FASCIA, WOUND DEBRIDEMENT/PACKING, WASHOUT, AND WOUND VAC.

  Patient problems: Abscess; Discharge; Hematoma; Impaired Healing; Injury; Necrosis; Pain; Unspecified Infection

  MAUDE report 9668091 ↗
• InjuryDec 9, 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. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF A RECURRENT INCARCERATED INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED ADHESIONS TO BOWEL, ABSCESS, SEROMA FORMATION, WOUND INFECTION WITH INFECTED MESH. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Abdominal Pain; Abscess; Adhesion(s); Cellulitis; Discharge; Fever; Fistula; Fluid Discharge; Foreign Body In Patient; Hematoma; Hernia; Impaired Healing; Inflammation; Injury; Nausea; Necrosis; No Code Available; Pain; Purulent Discharge; Scar Tissue; Scarring; Seroma; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 8145172 ↗
• InjuryFeb 27, 2018Migration 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 RESULTING IN AN UNSPECIFIED ADVERSE OUTCOME. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT. THE PATIENT UNDERWENT A VENTRAL OPEN HERNIA REPAIR WITH MESH. SHE HAD REVISION SURGERY 10 MONTHS POST-SURGERY. THE PATIENT EXPERIENCED SURGICAL REVISION, ABDOMINAL WALL WOUND, AND DENSE ADHESIONS.

  Patient problems: Achalasia; Adhesion(s); Disability; Discharge; Fibrosis; Hematoma; Hernia; Impaired Healing; Injury; Nausea; No Code Available; Syncope

  MAUDE report 7299407 ↗
• InjuryJan 3, 2018Degraded; Material Erosion; Migration or Expulsion of Device; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Degraded; Material Erosion; Migration or Expulsion of Device; Material Integrity Problem; 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 AN EXPLORATORY LAPAROTOMY WITH LYSIS OF ADHESIONS, AND A RECURRENT INCISIONAL HERNIA REPAIR. HE HAD REVISION SURGERY 8 MONTHS POST-OPERATIVE. THE PATIENT EXPERIENCED PAIN, ADHESIONS, MESH SHRINKAGE, AND HERNIA RECURRENCE.

  Patient problems: Adhesion(s); Erosion; Failure of Implant; Hernia; Injury; No Code Available; Obstruction/Occlusion; Pain; Perforation; Unspecified Tissue Injury

  MAUDE report 7161597 ↗
• InjuryDec 13, 2017Adverse 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 RECURRENCE AND ADHESIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REMOVAL OF MESH AND SMALL BOWEL RESECTION.

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Constipation; Discomfort; Foreign Body Reaction; Hernia; Impaired Healing; Inflammation; Injury; Nausea; No Code Available; Nodule; Obstruction/Occlusion; Pain; Scar Tissue; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 7112441 ↗