PureWick Female External Catheter PWF030FRecalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00801741163081), received between May 31, 2019 and Dec 1, 2022 — classified as 16 injuries, 1 malfunction.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (9 reports).

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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 1, 2022Incomplete or Missing Packaging; Incomplete or Missing Packaging

  IT WAS REPORTED THAT THE CUSTOMER RECEIVED A BUNCH OF PUREWICK FEMALE EXTERNAL CATHETER IN A ZIP LOCK BAG BUT NOT THE PUREWICK PACKAGE THAT HAD THE DIRECTIONS FOR USE ON IT. PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 23NOV2022, IT WAS REPORTED THAT THE PUREWICK FEMALE EXTERNAL CATHETER CAME IN ZIP-LOG BAGS RATHER THAN PACKAGED INDIVIDUALLY. WHILE THESE WERE NOT STERILE, THEY WERE CONSIDERED CLEAN, AND STORING THEM THIS WAY COULD AFFECT THEIR CLEANLINESS. THIS WAS NOT NORMAL, THERE WAS NO PLAN TO CHANGE THE PACKAGING, AND THEY WERE WORKING WITH MEDLINE TO RETURN THE PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15893439 ↗
• InjuryAug 10, 2021Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED SKIN INFLAMMATION AND IRRITATION WITH THE USE OF PUREWICK FEMALE EXTERNAL CATHETER AND THE PATIENT BEING HOSPITALIZED

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 12305204 ↗
• InjuryJul 22, 2020Biocompatibility; Adverse Event Without Identified Device or Use Problem; Biocompatibility

  IT WAS REPORTED THAT THE PATIENT HAD A BAD REACTION THAT RESULTED IN AN INFECTION AND ALSO STATED THAT THERE WAS LATEX INVOLVED IN THE PRODUCT. THE PATIENT WAS NOW IN HOSPICE. IT IS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR THE INFECTION.

  Patient problems: Reaction; Unspecified Infection

  MAUDE report 10308926 ↗
• InjuryApr 2, 2020Biocompatibility; Material Integrity Problem; Biocompatibility

  IT WAS REPORTED THAT THE PATIENT HAD A URINARY TRACT INFECTION, AND HER NURSE NOTED IT WAS BECAUSE THE WICK WAS LEAVING URINE ON THE PATIENT. THE PATIENT WAS REPORTEDLY NOW USING A CATHETER.

  Patient problems: Urinary Tract Infection

  MAUDE report 9916491 ↗
• InjuryMar 26, 2020Biocompatibility; Adverse Event Without Identified Device or Use Problem; Biocompatibility

  IT WAS REPORTED THAT THE PATIENT GOT A YEAST INFECTION; THEY ARE REPORTEDLY NOT SURE IF IT WAS FROM THE WICKS OR FROM ANOTHER MEDICAL CONDITION (CHEMO).

  Patient problems: Fungal Infection

  MAUDE report 9882758 ↗
• InjuryFeb 14, 2020Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PATIENT STATED THE MACHINE WAS JUST SUCTIONING AIR AND CAUSED IRRITATION. IT ALSO CAUSED SORES IN HER VAGINAL AREA. SHE THOUGHT IT WAS A COMBINATION OF THE URINE AND THE RUBBER WHICH CAUSED THE IRRITATION. SHE STATED SHE AVOIDED USING THE MACHINE DUE TO THIS. THE PATIENT ALSO STATED THE PATIENT HOSE KEPT POPPING OF. IT WAS UNKNOWN IF THE PATIENT RECEIVED INTERVENTION FOR THE SORES.

  Patient problems: Abrasion; Irritation

  MAUDE report 9712493 ↗
• InjuryFeb 12, 2020Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT BROKE OUT IN SORES WHILE USING THE WICKS. PATIENT STATED SHE HAS BEEN HOSPITALIZED FOR 20 DAYS FROM THE RASH.

  Patient problems: Rash

  MAUDE report 9701153 ↗
• InjuryFeb 12, 2020Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED AN UTI WHILE USING THE WICKS. IT WAS UNKNOWN WHAT MEDICAL INTERVENTIONS WERE GIVEN FOR THE UTI.

  Patient problems: Urinary Tract Infection

  MAUDE report 9701152 ↗
• InjuryJan 19, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A UTI WITH USE OF THE WICK. THE PATIENT'S DOCTOR SUGGESTED SHE NO LONGER USE THE DEVICE. IT WAS UNKNOWN WHAT INTERVENTIONS WERE GIVEN FOR THE UTI.

  Patient problems: Urinary Tract Infection

  MAUDE report 9604936 ↗
• InjuryJan 19, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE WICK WAS SUCKING UP FECES, WHICH CAUSED THE PATIENT TO GET URINARY TRACT INFECTIONS.

  Patient problems: Urinary Tract Infection

  MAUDE report 9604912 ↗
• InjuryDec 13, 2019Patient-Device Incompatibility; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENTS HUSBAND SAID THE PATIENT BROKE OUT IN A RASH AND HAD A YEAST INFECTION. HE ALSO SAID THE PACKAGING FOR WICKS SHOULD INDICATE LATEX-FREE ON THE BOX, NOT THAT IT WAS NOT MADE WITH ANY NATURAL LATEX, AS THAT MAY LEAD PEOPLE TO BELIEVE THERE WAS LATEX IN THE WICK. PER ADDITIONAL INFORMATION RECEIVED FROM COMPLAINANT ON 13-DEC-2019 VIA PHONE, THE PATIENT WAS PRESCRIBED AN UNKNOWN ANTIBIOTIC FOR THE YEAST INFECTION. SHE ALSO STATED THAT SHE WAS ALLERGIC TO LATEX.

  Patient problems: Fungus; Hypersensitivity/Allergic reaction; Rash; Unspecified Infection

  MAUDE report 9469338 ↗
• InjuryNov 25, 2019Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT STATED SHE HAD TERRIBLE REACTION TO THE PRODUCT; TOOK HER A MONTH TO RECOVER FROM THE ISSUE. PER ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER, SHE EXPERIENCED BURNING AND ITCHING. SHE USED KETAMINE CREAM AND LIDOCAINE. IN ADDITION, SHE HAD A VAGINAL SUPPOSITORY.

  Patient problems: Burning Sensation; Itching Sensation; Patient Problem/Medical Problem; Reaction

  MAUDE report 9371564 ↗
• InjuryNov 13, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE CUSTOMER STATED THAT THE WICKS WERE TOO BIG AND CAUSED THE PATIENT TO GET A HEMORRHOID, AND THE NURSE TOLD HER TO STOP USING THE PRODUCT. IT IS CURRENTLY UNKNOWN IF THE PATIENT RECEIVED MEDICAL INTERVENTION.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 9315344 ↗
• InjuryOct 31, 2019Leak/Splash

  IT WAS REPORTED THAT THE PATIENT SAID SHE HASN¿T REALLY BEEN USING THE PUREWICK BECAUSE IT WAS LEAKING. SHE SAID SHE HAD A NEOBLADDER AND HAD BEEN GENERATING A LOT OF MUCUS. ALSO, SHE SAID SHE HAD A UTI WHEN THE LEAKING WAS OCCURRING AND WAS AFRAID TO USE DUE TO REINFECTION. PER FOLLOW UP CALL ON (B)(6)2019 , THE PATIENT RECEIVED KEFLEX AND MACROBID. SHE WAS NOT SURE IF THE PURE WICK CAUSED THE UTI.

  Patient problems: Urinary Tract Infection

  MAUDE report 9260922 ↗
• InjuryOct 10, 2019Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE PATIENT'S DAUGHTER SAID HER MOTHER WAS WAKING UP WET AND CONSTANTLY GETTING UTIS, ONE AFTER ANOTHER. IT WAS UNKNOWN IF THE PATIENT RECEIVED MEDICATION FOR THE UTI.

  Patient problems: Urinary Tract Infection

  MAUDE report 9176423 ↗
• InjurySep 27, 2019Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT DEVELOPED AN ABSCESS ON HER LABIA. THE PATIENT'S SPOUSE ALLEGED THAT IT WAS NOT JUST IN THE AREA WHERE THE WICKS TOUCHED. HE ALSO NOTED THAT SHE DEVELOPED AN ABSCESS THAT REQUIRED SURGICAL REMOVAL (JUNE 3RD), BUT THEY APPEARED RANDOMLY SINCE MAY.

  Patient problems: Abscess

  MAUDE report 9129438 ↗
• InjuryMay 31, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE WICKS CAUSED A URINARY TRACT INFECTION. THE PATIENT STATED SHE WAS HOSPITALIZED FOR TWO WEEKS.

  Patient problems: Urinary Tract Infection

  MAUDE report 8658371 ↗