PM-LRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04560224977268), received between May 29, 2025 and May 29, 2025 — classified as 1 injury.

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.

• InjuryMay 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT REMOVAL OF MESH AND REPAIR OF RECURRENT VENTRAL INCISIONAL HERNIA ON (B)(6) 2019 AND A MESH WAS IMPLANTED DURING WHICH THE SURGEON PERFORMED LYSIS OF ADHESIONS, REMOVAL AND MESH PLACEMENT, SEPARATION OF COMPONENTS, ABDOMINAL WALL RECONSTRUCTION AND LIVER BIOPSY. IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN, LUMP ALONG INCISION, DISCOMFORT, NAUSEA EMESIS, SCARS, SLIGHT DIZZINESS AND FATIGUE. IT WAS PREVIOUSLY REPORTED THAT THE PATIENT HAD UMBILICAL INCISIONAL HERNIA ON (B)(6) 2017 AND A MESH WAS IMPLANTED. OTHER PROCEDURE WAS CAPTURED IN A SEPARATE FILE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Dizziness; Fatigue; Nausea; Pain; Scar Tissue

  MAUDE report 22102773 ↗