Parietene DS PPDS2520 (UDI 10884521553484)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10884521553484), received between Oct 17, 2018 and Apr 28, 2023 — classified as 4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryApr 28, 2023Mechanics 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 IMPLANT, THE PATIENT EXPERIENCED DEFECTIVE MESH, FAILURE OF MESH, ABDOMINAL PAIN, RECURRENCE, PAIN, SCARRING, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, MENTAL PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED MESH REVISION, HERNIA REPAIR WITH NEW MESH, MOBILIZED THE SMALL BOWEL, THE OMENTUM AND THE LEFT LOBE OF THE LOVER.

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

  MAUDE report 16834764 ↗
• InjuryJun 16, 2022Mechanics 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 AN INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, MENTAL PAIN, EMOTIONAL DISTRESS, MESH FAILURE, DISABILITY, IMPAIRMENT, AND LOSS OF ENJOYMENT OF LIFE.

  Patient problems: Abdominal Distention; Abdominal Pain; Abscess; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Ascites; Cellulitis; Distress; Emotional Changes; Erythema; Fever; Fluid Discharge; Pain; Swelling/ Edema; Unspecified Tissue Injury

  MAUDE report 14717800 ↗
• InjuryJun 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THE PATIENT EXPERIENCED A SMALL SEROMA FOLLOWING A VENTRAL HERNIA REPAIR PROCEDURE.

  Patient problems: Seroma

  MAUDE report 8700642 ↗
• InjuryOct 17, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, FOLLOWING A LAPAROSCOPIC HERNIA REPAIR FOR INCISIONAL MIDLINE HERNIA REPAIR, THE PATIENT PRESENTED WITH PAIN AND NAUSEA. CT SCANS AND X-RAY IMAGING WAS DONE AND SHOWED IMAGING CONSISTENT WITH POST-OPERATIVE ILEUS. THE PATIENT WAS ADMITTED AND BOWEL REST WAS PROVIDED AND THE PATIENT WAS TREATED WITH INTRAVENOUS FLUID HYDRATION ALONG WITH MEDICATIONS FOR THE PAIN AND NAUSEA.

  Patient problems: Nausea; No Code Available; Pain

  MAUDE report 7975854 ↗