TULSA-PRO PAD-105Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07540281000014), received between May 31, 2024 and May 31, 2024 — 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 31, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADVERSE EVENT REPORTED: "PROLONGED INCREASED PAIN POST-TULSA" PATIENT HAS BEEN SUFFERING WITH SEVERE BLADDER NECK AND RECTAL SPASMS SINCE SHORTLY AFTER CATHETER REMOVAL POST TULSA PROCEDURE. TULSA PROCEDURE: ON (B)(6) 2023, CATHETER REMOVED: ON (B)(6) 2023, BLADDER NECK SPASMS: UNKNOWN (B)(6) 2023, RECTAL SPASMS: ON (B)(6) 2023. PATIENT RECEIVED MULTIPLE INTERVENTIONS, INCLUDING BLADDER NECK RESECTION (B)(6) 2024.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Pelvic Pain

  MAUDE report 19439595 ↗