Parietene DS PPDS2015 (UDI 10884521784116)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10884521784116), received between Jan 27, 2023 and Aug 7, 2026 — classified as 6 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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.

• InjuryAug 7, 2026Migration or Expulsion of Device; 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 umbilical incisional hernia. It was reported that after the implant, the patient experienced recurrence, pain, mesh migration, failure of mesh to incorporate, acute cystitis, mesh failure, device defective, mental pain, suffering, disability, loss of enjoyment of life. Post-operative patient treatment included trigger point injections, medical treatment, revision surgery.

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

  MAUDE report 50180407 ↗
• InjuryFeb 5, 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 EMOTIONAL DISTRESS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Distress; Unspecified Tissue Injury

  MAUDE report 24274224 ↗
• InjuryJul 29, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED MESH FAILURE, DISCOMFORT, PAIN, RECURRENCE, ADHESIONS, EMOTIONAL HARM. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, REMOVAL OF MESH, HERNIA REPAIR WITH NEW MESH, MEDICATION.

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

  MAUDE report 22652509 ↗
• InjuryJun 16, 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 A PARASTOMAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, RECURRENCE, ADHESIONS, AND OBSTRUCTIONS.

  Patient problems: Adhesion(s); Hernia; Obstruction/Occlusion; Pain; Unspecified Tissue Injury

  MAUDE report 22215194 ↗
• InjuryNov 17, 2023Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Mechanics Altered; 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 IMPLANT, THE PATIENT EXPERIENCED DEFECTIVE MESH, FAILURE OF MESH, RECURRENCE, INFECTION, INFLAMMATION, BLEEDING, PERFORATION, NERVE DAMAGE, SCARRING, PAIN, MENTAL PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, DISABILITY. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, REMOVAL OF MESH, HERNIA REPAIR WITH NEW MESH.

  Patient problems: Emotional Changes; Hemorrhage/Blood Loss/Bleeding; Hernia; Inflammation; Muscle Weakness/Atrophy; Nerve Damage; Pain; Perforation; Scar Tissue; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 18161315 ↗
• InjuryJan 27, 2023Migration 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 AN INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED MESH MIGRATION, PAIN, INFECTION, RECURRENCE, INFLAMMATION, FISTULA, AND ABSCESS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REMOVAL OF MESH, MEDICATION, AND WOUND VAC.

  Patient problems: Abscess; Fistula; Hernia; Inflammation; Pain; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 16254091 ↗