Parietene DS PPDS3530Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884521795426), received between Dec 1, 2023 and Dec 1, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryDec 1, 2023Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Patient Device Interaction Problem; Mechanics Altered; 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 AN INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED UNINCORPORATED MESH, DEFECTIVE MESH, FAILURE OF MESH, ABDOMINAL PAIN, RECURRENCE, SEROMA, NECROSIS, ABSCESS, PAIN, MENTAL PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, DISABILITY. POST-OPERATIVE PATIENT TREATMENT INCLUDED PARTIAL REMOVAL OF MESH, DRAINED/IRRIGATED SEROMA, DRAIN PLACED, WOUND PACKED, DEBRIDEMENT, WOUND VAC, ABSCESS DRAINED.

  Patient problems: Abdominal Pain; Abscess; Discomfort; Emotional Changes; Hernia; Necrosis; Pain; Seroma; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 18247594 ↗