Parietene DS PPDS2520 (UDI 10884521795419)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10884521795419), received between Apr 6, 2023 and Aug 22, 2024 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Degraded” (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. 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.

• InjuryAug 22, 2024Adverse 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 HERNIA, PAIN, ADHESIONS, ABDOMINAL PAIN, DISCOMFORT, DISTENTION, INFLAMMATION. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, MEDICATION, AND LYSIS OF ADHESIONS.

  Patient problems: Abdominal Distention; Abdominal Pain; Adhesion(s); Discomfort; Hernia; Inflammation; Pain; Unspecified Tissue Injury

  MAUDE report 20026772 ↗
• MalfunctionSep 5, 2023Degraded; Degraded

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC VENTRAL HERNIA REPAIR PROCEDURE, DURING MESH PLACEMENT, THE PRODUCT WAS USED AS INDICATED, BUT THE SURGEON WAS CONCERNED ABOUT THE INTEGRITY AND STRENGTH OF THE MESH.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17685867 ↗
• InjuryMay 9, 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 MULTIPLE INCISIONAL HERNIAS. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED ABDOMINAL PAIN, INFECTED MESH, FISTULA, INFLAMMATION, SCARIFICATION, RECURRENCE, DEFECTIVE DEVICE, MENTAL PAIN, PHYSICAL PAIN, SUFFERING, DISABILITY, IMPAIRMENT, AND LOSS OF ENJOYMENT OF LIFE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, EXCISION OF SKIN AND SUBCUTANEOUS TISSUE, REMOVAL OF MESH, EXCISION OF FISTULA, AND PLACEMENT OF JACKSON-PRATT DRAIN.

  Patient problems: Abdominal Pain; Discomfort; Emotional Changes; Fistula; Hernia; Inflammation; Pain; Scar Tissue; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 16895694 ↗
• InjuryApr 6, 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 A LAPAROSCOPIC THERAPEUTIC TREATMENT OF A VENTRAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED AN UNSPECIFIED ADVERSE OUTCOME. POST-OPERATIVE PATIENT TREATMENT INCLUDED USE OF PREVENA WOUND DRESSING & JP DRAIN.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 16690829 ↗