PureWick Female External Catheter PWFX30LRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741215933), received between Jan 8, 2026 and Jan 8, 2026 — 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 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.

• InjuryJan 8, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S FAMILY HAD TO CALL THE DOCTOR ON SATURDAY, AS PATIENT WAS TOTALLY DISORIENTATED. IN THE PAST THIS CONDITION WAS ALWAYS DUE TO A URINE INFECTION. IT USED TO BE BECAUSE THEY WERE USING AN INTERNAL FOLEY CATHETER, BUT ON THIS OCCASION WHEN IT HAPPENED, HAD ONLY USED THE PUREWICK FOR THE PREVIOUS 6 DAYS, AND A NEW CATHETER EVERY NIGHT. WHEN THE DOCTOR SAW THE EQUIPMENT, IT WAS STOPPED USING, TO BE FAIR AS WASN'T PREVIOUSLY AWARE OF YOUR PRODUCT BUT HAD NO DOUBT THAT THE PUREWICK WAS TO BLAME. UTI IDENTIFIED VIA DOCTOR. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED. PER FOLLOW UP INFORMATION RECEIVED VIA RCC ON 07JAN2026, STATED THAT THE PCN#: PWFX30E WITH BATCH#: MYJR1899 HAD THE ISSUE.

  Patient problems: Urinary Tract Infection

  MAUDE report 24005775 ↗