Parietene DS PPDS1510 (UDI 10884521795396)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10884521795396), received between Aug 3, 2023 and Jul 27, 2026 — classified as 5 injuries, 1 malfunction.

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. 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.

• InjuryJul 27, 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 umbilical hernia. It was reported that after the implant, the patient experienced pain, hernia recurrence, inflammation, adhesions, abdominal pain, burning protrusion of belly button. Post-operative patient treatment included surgical intervention, medication.

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

  MAUDE report 50020418 ↗
• InjuryFeb 5, 2026Migration or Expulsion of Device; 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 A HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED EMOTIONAL DISTRESS, RECURRENCE. 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; Deformity/ Disfigurement; Distress; Hernia; Pain; Unspecified Tissue Injury

  MAUDE report 24274171 ↗
• InjuryDec 17, 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, RECURRENCE, ADHESIONS, ABDOMINAL DISTENTION. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, MEDICATION.

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

  MAUDE report 23830964 ↗
• InjuryDec 12, 2025Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Material Integrity Problem; 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 A HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED MESH SHRINKAGE, MESH FAILURE, ADHESIONS, RECURRENCE, PAIN, EMOTIONAL DISTRESS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, MESH REMOVAL, MESH REVISION, HERNIA REPAIR WITH NEW MESH.

  Patient problems: Adhesion(s); Distress; Hernia; Pain; Unspecified Tissue Injury

  MAUDE report 23794109 ↗
• InjuryJul 1, 2025Mechanics 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED FAILURE, RECURRENCE, PAIN, SEROMA, DISCOMFORT, EMOTIONAL CHANGES. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, HERNIA REPAIR WITH NEW MESH, MEDICATION.

  Patient problems: Discomfort; Emotional Changes; Hernia; Pain; Seroma; Unspecified Tissue Injury

  MAUDE report 22373990 ↗
• MalfunctionAug 3, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING A ROBOTIC LAPAROSCOPIC VENTRAL HERNIA REPAIR, WHILE DOING A INTRAPERITONEAL ONLAY MESH TECHNIQUE FOR MESH PLACEMENT, THE MESH TORE WHILE BEING MANIPULATED IN THE PATIENT¿S ABDOMEN. THE SURGEON REMOVED THE RIPPED MESH AND INSERTED A NEW ONE. THE SURGEON USED A SUTURE TO CLOSE THE WOUND. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17454264 ↗