SpeediCath Compact 28584Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05708932020572), received between Sep 12, 2016 and Apr 4, 2023 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (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.

• InjuryApr 4, 2023Separation Failure; Separation Failure

  ACCORDING TO THE AVAILABLE INFORMATION, THIS COMPLAINT DESCRIBES AN EVENT WHERE THE CATHETER DETACHES AND IS STUCK INSIDE THE END USER. IN THIS EVENT, THE END USER¿S SISTER/CARETAKER IS AIDING THE END USER IN THE INSERTION OF THE CATHETER. THIS EVENT IS NARRATED BY THE SISTER. WHEN THE CATHETER DETACHED, THE END USER WAS ADMITTED TO A WALK-IN CLINIC WHERE A HEALTH CARE PROVIDER REMOVED THE CATHETER. THE END USER HAD UNDERGONE SOME SCANS, WHICH HAVE REVEALED A ¿FOREIGN OBJECT¿ PRESUMABLY A BROKEN CATHETER TIP. FROM THE LATEST INFORMATION, THE END USER IS STILL AWAITING FURTHER SCANS AND SURGERY DATE TO REMOVE THE FOREIGN OBJECT. THE END USER IS STILL CATHETERIZING 4 TIMES PER DAY. THE END USER EXPERIENCES ABDOMINAL AND PELVIC PAINS. HOWEVER, THERE HAS NOT BEEN ANY SIGNS OF BLOOD OR ADDED DISCOMFORT WHEN CATHETERIZING. NO MORE INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Foreign Body In Patient; Pain; Tissue Breakdown

  MAUDE report 16673787 ↗
• InjurySep 21, 2021Sharp Edges; Sharp Edges

  THIS CASE INVOLVES A FEMALE END-USER WHO IS AN EXPERIENCED CATHETER USER (MORE THAN 40 YEARS). SHE DESCRIBES THAT THE EYELETS ON THE SPEEDICATH COMPACT FEMALE CATHETER ARE CUTTING AND HURTING HER AND THAT BECAUSE OF THIS SHE HAS SUFFERED FROM AN INFECTION WHICH NECESSITATED A HOSPITAL STAY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Urinary Tract Infection

  MAUDE report 12507145 ↗
• MalfunctionSep 12, 2016Inadequacy of Device Shape and/or Size; Packaging Problem

  ACCORDING TO THE INFORMATION RECEIVED, THE CUSTOMER WAS PRESCRIBED 8FR CATHETERS FOR USE IN VOIDING. A SAMPLE ORDER WAS ENTERED TO SHIP SAMPLES OF THE 28578. THE DC PICKED THE ORDER AND SHIPPED OUT THE MAJORITY OF THE ORDER AS 28578 BUT THERE WERE INADVERTENTLY SEVERAL 28584 (14FR) CATHETERS THAT WERE INCLUDED IN THE SHIPMENT. THE CUSTOMER DID NOT NOTICE THAT THE FRENCH SIZE WAS INCORRECT AND ATTEMPTED TO USE ONE OF THE 28584 (14FR) CATHETERS. THIS RESULTED IN TRAUMA TO THE PATIENT INCLUDING BLEEDING IN THE URETHRA. THE CUSTOMER DID NOT SEEK IMMEDIATE MEDICAL ATTENTION. THE CUSTOMER SUBSEQUENTLY USED A SAMPLE OF THE 28578 (8FR) CATHETER LATER IN THE DAY AND WAS ABLE TO VOID WITH NO PAIN OR BLEEDING.

  Patient problems: Blood Loss; Injury; Pain

  MAUDE report 5943794 ↗