Parietene PPMK1508X3Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884521214903), received between Jun 11, 2018 and Dec 15, 2025 — classified as 3 injuries.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryDec 15, 2025Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; 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. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

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

  MAUDE report 23809329 ↗
• InjuryMay 28, 2021Adverse 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 RIGHT GROIN HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED INFECTION AND PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Pain; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 11901079 ↗
• InjuryJun 11, 2018Adverse 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 LEFT INGUINAL HERNIA. IT WAS REPORTED THAT AFTER A PROCEDURE WHERE THIS DEVICE WAS IMPLANTED, THE PATIENT EXPERIENCED INCARCERATED LEFT INGUINAL HERNIA, INTERMITTENT SMALL-BOWEL OBSTRUCTION DUE TO ADHESIONS, INFECTED PROSTHETIC MESH THE ABDOMINAL WALL; RECURRENCE; PAIN; EXTENSIVE ENTEROLYSIS WITH ENTERECTOMY; FISTULA; SEROSAL TEARS; MULTIPLE ABSCESS; SMALL BOWEL RESECTION. AFTER THE ORIGINAL PROCEDURE ADDITIONAL SURGERIES WERE PERFORMED, INCLUDING REVISION.

  Patient problems: Abscess; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Ascites; Bacterial Infection; Confusion/ Disorientation; Electrolyte Imbalance; Emotional Changes; Fibrosis; Fistula; Fluid Discharge; Foreign Body Reaction; Hematoma; Hemorrhage/Blood Loss/Bleeding; Hernia; Impaired Healing; Inflammation; Injury; Muscle Weakness/Atrophy; No Code Available; Obstruction/Occlusion; Pain; Purulent Discharge; Scar Tissue; Ulcer; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 7586992 ↗