Parietex TCM3030Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10884521178922), received between May 9, 2018 and Oct 24, 2021 — classified as 6 injuries.

The most frequently reported specific device problem is “Mechanics Altered” (2 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.

• InjuryOct 24, 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 LAPAROSCOPIC THERAPEUTIC TREATMENT OF A VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED HERNIA RECURRENCE AND ABDOMINAL PAIN, PAIN, ADHESIONS, BOWEL PROBLEMS, INFECTIONS, DEFECTIVE DEVICE, MESH FAILURE, MENTAL ANGUISH, EMOTIONAL DISTRESS, PERMANENT IMPAIRMENT, DISABILITY, MENTAL PAIN, SUFFERING, AND LOSS OF ENJOYMENT OF LIFE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, MESH REVISION AND ADDITIONAL HERNIA REPAIR WITH MESH.

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

  MAUDE report 12686963 ↗
• InjuryJul 30, 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 AN INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, ADHESIONS, OBSTRUCTION, ENTEROTOMY, PURULENT MATERIAL, OPEN WOUND, MESH EROSION, INFECTION, ABDOMINAL PAIN, REDNESS, PAIN, NAUSEA, VOMITING, FLUID COLLECTION, AND ABSCESS. POST-OPERATIVE PATIENT TREATMENT INCLUDED HERNIA REPAIR WITH NEW MESH, MESH REVISION, REMOVAL OF MESH, DRAIN PLACEMENT, SMALL BOWEL RESECTION WITH PRIMARY ANASTOMOSIS, LYSIS OF ADHESIONS, REMOVAL OF DRAIN, WOUND VAC, PURULENT MATERIAL EXPRESSED, ADMISSION TO HOSPITAL, REPAIR OF ENTEROTOMY, WOUND PACKED WITH KERLIX GAUZE, ANTIBIOTICS, AND INCISION/DRAINAGE OF ABSCESS.

  Patient problems: Abdominal Pain; Abscess; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Ascites; Erosion; Hernia; Impaired Healing; Nausea; Obstruction/Occlusion; Pain; Purulent Discharge; Unspecified Infection; Unspecified Tissue Injury; Vomiting

  MAUDE report 12254047 ↗
• InjuryJan 25, 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 VENTRAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, FIBROADIPOSE TISSUE, FIBROSIS, CONGESTION, INFLAMMATION, FOREIGN GIANT CELL REACTION, NAUSEA, VOMITING, ADHESIONS, AND OBSTRUCTION. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY AND HERNIA REPAIR WITH NEW MESH.

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Distress; Emotional Changes; Fibrosis; Foreign Body Reaction; Hernia; Inflammation; Nausea; Obstruction/Occlusion; Pain; Unspecified Infection; Unspecified Tissue Injury; Vomiting

  MAUDE report 11222362 ↗
• InjuryDec 9, 2018Material Perforation; Adverse Event Without Identified Device or Use Problem; Material Perforation; 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 FLANK HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED SEVERE PAIN AND HERNIA RECURRENCE IN THE CENTER OF THE MESH. TREATMENT PROVIDED FOR THESE CONDITIONS INCLUDE PORTIONS OF MUSCLE REMOVED TO MOBILIZE THE MESH OFF THE DIAPHRAGM.

  Patient problems: Hernia; Injury; Pain; Perforation

  MAUDE report 8145349 ↗
• InjuryOct 16, 2018Migration or Expulsion of Device; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Patient Device Interaction Problem; Migration or Expulsion of Device; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; 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 RECURRENT HERNIA DUE TO FAILURE OF THE MESH, CONTRACTION, FAILURE TO INCORPORATE AND PAIN. TREATMENT PROVIDED FOR THESE CONDITIONS INCLUDE REVISION AND REMOVAL SURGERY.

  Patient problems: Distress; Failure of Implant; Hernia; Injury; Pain; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 7970673 ↗
• InjuryMay 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. IT WAS REPORTED THAT AFTER A HERNIA PROCEDURE WHERE THIS DEVICE WAS IMPLANTED, THE PATIENT EXPERIENCED REMOVAL OR REVISION SURGERY RESULTING FROM COMPLICATIONS FROM MESH. AFTER THE ORIGINAL PROCEDURE, ADDITIONAL POTENTIALLY RELATED PROCEDURES WERE PERFORMED, INCLUDING REVISION.

  Patient problems: Abdominal Distention; Abdominal Pain; Adhesion(s); Constipation; Hernia; Injury; Nausea; No Code Available; Obstruction/Occlusion; Vomiting

  MAUDE report 7499135 ↗