PureWick Female External Catheter PWF030Recalls & reported problems

Summary

The FDA's MAUDE database contains 66 adverse event reports that list this exact device (DI 00801741143083), received between Oct 26, 2017 and Jul 25, 2025 — classified as 50 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (33 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 25 most recent of 66 reports, in the reporter's own words as published by the FDA.

• InjuryJul 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT CUSTOMER SAID THAT THEY GOT SOME WICKS FROM AMAZON THAT CAUSED RASH AND SORENESS, NOT OUR FLEX WICKS, THE BLUE ONES. THE PATIENT HAD STATED THEY REPORTED OR MAILED US A SAMPLE OF IT BACK IN APRIL. ADVISED WILL REPORT AND THEY MAY FOLLOW UP WITH THEM. CONFIRMED NO ISSUES WITH FLEX WICKS. IT'S UNCLEAR IF THE LOT NUMBER WAS REQUESTED. USED WITH FEMALE WICKS. NO ADDITIONAL INFORMATION WAS PROVIDED. IT WAS REPORTED VIA PHONE ON (B)(6)2025 THAT PATIENT HAD PURCHASED WICKS THROUGH AMAZON, AND STATED THEY GAVE PATIENT A URINARY TRACT INFECTION, BUT THEY CALLED AND GOT MONEY BACK FROM AMAZON AND JUST WANTED LIBERATOR TO KNOW THEY THOUGHT THE WICKS WERE BOOTLEGGED, NO ADDITIONAL INFORMATION FURTHER ON IS AVAILABLE. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED.

  Patient problems: Urinary Tract Infection

  MAUDE report 22620659 ↗
• InjuryJul 24, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED FOR SEVERAL DAYS AND CONFINED TO BED. DURING THAT TIME, THE HOSPITAL PROVIDED THEM WITH A PUREWICK EXTERNAL CATHETER WHILE PATIENT INITIALLY APPRECIATED THE CONVENIENCE IT SEEMED TO OFFER, BUT BEGAN NOTICING A TROUBLING CHANGE: A CONSTANT, URGENT NEED TO URINATE SOMETHING THEY HAD NOT EXPERIENCED PRIOR TO MY HOSPITALIZATION. UPON DISCHARGE, THE SITUATION WORSENED CONSIDERABLY AND WAS UNABLE TO CONTROL THE URGE TO URINATE AND BEGAN EXPERIENCING FREQUENT ACCIDENTS. THE URGENCY WAS SO SEVERE AND UNPREDICTABLE THAT PATIENT HAD TO WEAR DOUBLE PROTECTIVE UNDERGARMENTS AND, FOR A TIME, COULD NOT LEAVE HOME. EVENTUALLY, PATIENT WAS DIAGNOSED WITH A URINARY TRACT INFECTION, WHICH MY MEDICAL TEAM BELIEVES MAY HAVE BEEN CAUSED BY THE USE OF THE PUREWICK PRODUCT. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR URINARY TRACT INFECTION.

  Patient problems: Urinary Tract Infection

  MAUDE report 22587332 ↗
• MalfunctionApr 1, 2025Increase in Suction; Increase in Suction

  IT WAS REPORTED THAT PUREWICK FEMALE EXTERNAL CATHETER SUCTIONED TO PATIENT'S SKIN. DURING ASSESSMENT NOTICED PATIENT HAD 2 ROUND RED BLISTERS FROM PUREWICK SUCTIONING IN DIFFERENT AREAS OF THE PUBLIC REGION. NOTIFIED CHARGE NURSE AND PLACED PUREWICK PROPERLY. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Blister

  MAUDE report 21739581 ↗
• InjuryJan 25, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE PUREWICK FEMALE EXTERNAL CATHETER CAUSED BRUSH BURNS AFTER A COUPLE OF DAYS OF USE. PATIENT MENTIONED SOME ADMINISTERS OF THE DEVICE WERE MORE SKILLED, LESS SKILLED ADMINISTERS CAUSED MAJOR LEAKAGE OR MESS MAYBE ALSO THE ABOVE NOTED BRUSH BURNS. HAD TO STOP USING THE PUREWICK AND APPLY DIAPER CREAM TO RELIEVE THE PAIN.

  Patient problems: Abrasion; Pain

  MAUDE report 18581270 ↗
• MalfunctionAug 28, 2023Material Invagination; Material Invagination

  IT WAS REPORTED THAT THE CUSTOMER WAS HAVING AN ISSUE WHEN THE BALLOON WAS BEING DEFLATED THE BALLOON MATERIAL WAS NOT FLATTENING OUT AND THERE WAS A HARD RIDGE/RING.(PR# 8598349) IT CAUSED SIGNIFICANT PAIN WHEN REMOVING THE CATHETER. THEY HAD THIS HAPPEN IN 3 PATIENTS WITH 3 DIFFERENT NURSES OVER 24 HOURS.(PR# 8597490) THEY WERE ABLE TO REPLICATE IT WITH A NEW CATHETER FOR A FEW TIMES AND THEN ONCE THE BALLOON WAS STRETCHED OUT WELL, THEY WERE NO LONGER ABLE TO REPLICATE. THEY HAD USED THESE CATHETERS FOR A LONG TIME AND NONE OF THE NURSES REMEMBER THIS HAPPENING BEFORE. PER FOLLOW UP VIA EMAIL ON (B)(6) 2023, CUSTOMER STATED THAT ONE PATIENT WAS A LOT MORE DIFFICULT TO REMOVE AND THE OTHERS JUST HAD THE PAIN. ALSO STATED THAT THEY WERE NOT SURE IF ALL OF THE CATHETERS WERE FROM THE SAME LOT. THE STAFF PULLED BACK ON THE SYRINGE TO DEFLATE THE BALLOON AND HAD ONE SAMPLE SAVED TO SEND FOR EVALUATION. ALSO HAD 2 OF THE PATIENTS INFORMATION.

  Patient problems: Pain

  MAUDE report 17630540 ↗
• MalfunctionMay 8, 2023Missing Information; Missing Information

  IT WAS REPORTED THAT THE PUREWICK FEMALE EXTERNAL CATHETER WAS NOT PROPERLY LABELED. IT DID NOT STATED THAT THIS PRODUCT DID HAVE LATEX IN IT AND WAS ALMOST USED ON PATIENT THAT WAS ALLERGIC TO LATEX. PER FOLLOW UP VIA EMAIL ON 19APR2023, AT PRESENT THE PWF030 BAG MENTIONS DRY NATURAL RUBBER, WITHOUT SAYING LATEX. IT NEEDS TO INCLUDE THAT WORD, SO THAT NURSES WILL NOT FIT PWF030 TO A PATIENT THEY KNOW TO HAVE "LATEX ALLERGY".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16885458 ↗
• MalfunctionSep 26, 2022Increase in Suction; Patient Device Interaction Problem; Increase in Suction; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE CUSTOMER HAD AN INCREASE IN CATHETER ASSOCIATED URINARY TRACT INFECTION (CAUTI¿S), SO THEY WERE REFRESHING EDUCATION ON INCONTINENCE MANAGEMENT WITHOUT THE USE OF AN INDWELLING CATHETER. COMPANY REPRESENTATIVE FROM SOME OF THEIR OTHER INCONTINENCE MANAGEMENT PRODUCTS WERE SCHEDULING TIMES TO MAKE BRIEF ROUNDS ON INPATIENT UNITS TO REFRESH KNOWLEDGE OF AVAILABLE PRODUCTS AND PROPER USE OF THE INCONTINENCE PRODUCTS. AND STATED THAT THEY HAD A FEW INCIDENTS OF PATIENT HARM IN THE FORM OF BRUISING IN THE PERI AREA BY USING PUREWICK URINE COLLECTION SYSTEM. BOTH TIMES THERE WAS SIGNIFICANT BRUISING AND THERE WAS ALSO NOTED TO BE HIGHER AMOUNTS OF SUCTION 150-200 MMHG. STAFF HAVE SAID THAT IT TAKES OVER 100 MMHG TO MAKE THE URINE MOVE THROUGH THE TUBING UP TO THE SUCTION CANISTER. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR CATHETER ASSOCIATED URINARY TRACT INFECTION. PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 13-SEP-2022, IT WAS REPORTED THAT ONE OF THE PATIENT EXPERIENCED BLEEDING AND BRUISING FROM THE PUREWICK FEMALE EXTERNAL CATHETER AND THE CATHETER WAS TAKEN OFF AND WOUND NURSES SAW IT. STATED THAT THE PATIENT UNDERWENT TREATMENT WHICH

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

  MAUDE report 15485424 ↗
• MalfunctionSep 20, 2022Decrease in Suction; Increase in Suction; Decrease in Suction; Increase in Suction

  IT WAS REPORTED THAT THE CUSTOMER HAD AN INCREASE IN CATHETER ASSOCIATED URINARY TRACT INFECTION (CAUTI¿S), SO THEY WERE REFRESHING EDUCATION ON INCONTINENCE MANAGEMENT WITHOUT THE USE OF AN INDWELLING CATHETER. COMPANY REPRESENTATIVE FROM SOME OF THEIR OTHER INCONTINENCE MANAGEMENT PRODUCTS WERE SCHEDULING TIMES TO MAKE BRIEF ROUNDS ON INPATIENT UNITS TO REFRESH KNOWLEDGE OF AVAILABLE PRODUCTS AND PROPER USE OF THE INCONTINENCE PRODUCTS. AND STATED THAT THEY HAD A FEW INCIDENTS OF PATIENT HARM IN THE FORM OF BRUISING IN THE PERI AREA BY USING PUREWICK URINE COLLECTION SYSTEM. BOTH TIMES THERE WAS SIGNIFICANT BRUISING AND THERE WAS ALSO NOTED TO BE HIGHER AMOUNTS OF SUCTION 150-200 MMHG. STAFF HAVE SAID THAT IT TAKES OVER 100 MMHG TO MAKE THE URINE MOVE THROUGH THE TUBING UP TO THE SUCTION CANISTER . IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR CATHETER ASSOCIATED URINARY TRACT INFECTION.

  Patient problems: Bruise/Contusion; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15455083 ↗
• MalfunctionNov 24, 2021Increase in Suction; Increase in Suction

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED BLEEDING AT THE LABIA AREA ON (B)(6) 2021 WHILE IN THE INTENSIVE CARE UNIT. ANOTHER INCIDENT OCCURRED ON (B)(6) 2021 IN THE TELE UNIT, WHERE THE PATIENT EXPERIENCED BRUISING AT THE LABIA AREA. BD SR. SPECIALIST REVIEWED PUREWICK WITH CUSTOMER THAT SUCTION WAS NOT OCCURRING ON THE LABIA BUT WAS ON THE DISTAL END OF PUREWICK. THEY ALSO REVIEWED SUCTION, SKIN CHECKS EVERY 2 HOURS, AND CHANGING THE PUREWICK EVERY SHIFT OR PRN. COMPLAINANT ALSO ASKED IF PUREWICK NEEDED TO BE REMOVED WHEN PATIENTS WERE USING A BED PAN. COMPLAINANT THOUGHT THE SUCTION OCCURRED ON THE LABIA, CAUSING BLEEDING IF THE SUCTION WAS HIGH. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Abrasion

  MAUDE report 12868928 ↗
• MalfunctionNov 23, 2021Increase in Suction; Increase in Suction

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED BLEEDING AT THE LABIA AREA ON 28OCT2021 WHILE IN THE INTENSIVE CARE UNIT. ANOTHER INCIDENT OCCURRED ON 02NOV2021 IN THE TELE UNIT, WHERE THE PATIENT EXPERIENCED BRUISING AT THE LABIA AREA. BD SR. SPECIALIST REVIEWED PUREWICK WITH CUSTOMER THAT SUCTION WAS NOT OCCURRING ON THE LABIA BUT WAS ON THE DISTAL END OF PUREWICK. THEY ALSO REVIEWED SUCTION, SKIN CHECKS EVERY 2 HOURS, AND CHANGING THE PUREWICK EVERY SHIFT OR PRN. COMPLAINANT ALSO ASKED IF PUREWICK NEEDED TO BE REMOVED WHEN PATIENTS WERE USING A BED PAN. COMPLAINANT THOUGHT THE SUCTION OCCURRED ON THE LABIA, CAUSING BLEEDING IF THE SUCTION WAS HIGH. NO MEDICAL INTERVENTION WAS REPORTED. PER FOLLOW UP VIA PHONE ON 30NOV2021, THE COMPLAINANT REPORTED THE PATIENT DIED FROM ISSUES UNRELATED TO THE PUREWICK DEVICE, AS THE PATIENT WAS IN HOSPICE CARE.

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

  MAUDE report 12860072 ↗
• InjuryMar 15, 2021Fluid/Blood Leak; Biocompatibility; Fluid/Blood Leak; Biocompatibility

  IT WAS REPORTED THAT TWO PURE WICK FEMALE EXTERNAL CATHETERS WERE IN PLACE FOR ROUGHLY 2 TO 3 HOURS EACH TIME AND REPEATEDLY USED FOR URINATION. WHERE ITS SPONGE MADE IN CONTACT WITH THE PUREWICK CAUSED THE SKIN BREAKDOWN ON THE LABIA AND A SKIN LESION ON THE POSTPARTUM LABIAL SCAR. AN INFECTION MAY BE YEAST LATER SET IN WHERE THE SKIN WAS BROKEN DOWN. CURRENTLY THE DIRECTIONS FOR PUREWICK STATE IT SHOULD BE CHANGED FOR EVERY 8 HOURS. THE NURSING STAFF STATED THAT THE DEVICE WAS GOOD FOR REPEATED USE OVER THE TIME SINCE THE SUCTION DRIES THE URINE IN THE SPONGE. REPEATED USE MAY BE CAUSING THE URIC ACID TO BECOME MORE CONCENTRATED IN EACH USE AND MAY BE ACCELERATING THE SKIN BREAKDOWN. THE URINE WAS NOT STERILE. THE PATHOGENS MAY BE ACCUMULATING ON THE SURFACE. OVER THE COUNTER MONISTAT USED FOR THE ACQUIRED INFECTION. IT WAS NOTED THAT THE CATHETERS NEED TO BE REEVALUATED AND CONSIDER LIMITING IT TO SINGLE USE ONLY AND TO BE CHANGED SHORTLY AFTER THE USE OR IN THE CASE OF LEAK INCONTINENCE SHORTLY AFTER BECOMING WET.

  Patient problems: Fungal Infection; Tissue Breakdown

  MAUDE report 11487622 ↗
• InjuryJun 15, 2020Biocompatibility; Biocompatibility; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED URINARY TRACT INFECTION BUT WASN'T SURE OF THE CAUSE. NO MEDICAL INTERVENTION REPORTED.

  Patient problems: Urinary Tract Infection

  MAUDE report 10155428 ↗
• InjuryMay 4, 2020Biocompatibility; Biocompatibility; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED A URINARY TRACT INFECTION.

  Patient problems: Urinary Tract Infection

  MAUDE report 10021200 ↗
• InjuryApr 27, 2020Biocompatibility; Biocompatibility; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S HUSBAND SAID THE PATIENT WAS IN A NURSING HOME AND GOT AN URINARY TRACT INFECTION AND HE THINKS IT¿S BECAUSE THE NURSES WERE NOT CLEANING THE PUREWICK. IT IS UNKNOWN IF MEDICAL TREATMENT WAS PROVIDED FOR THE UTI.

  Patient problems: Urinary Tract Infection

  MAUDE report 10001799 ↗
• InjuryApr 21, 2020Biocompatibility; Biocompatibility; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN UTI WITH USE OF THE WICKS. IT IS UNKNOWN WHAT MEDICAL INTERVENTIONS WERE GIVEN FOR THE UTI.

  Patient problems: Urinary Tract Infection

  MAUDE report 9980971 ↗
• InjuryMar 26, 2020Biocompatibility; Adverse Event Without Identified Device or Use Problem; Biocompatibility

  IT WAS REPORTED THAT THE PATIENT DEVELOPED TWO URINARY TRACT INFECTIONS WHILE USING THE PUREWICK CATHETERS. IT WAS NOTED THAT LAB RESULTS SHOWED THE CAUSE OF THE URINARY TRACT INFECTION WAS PROTEUS MIRABILIS.

  Patient problems: Urinary Tract Infection

  MAUDE report 9886305 ↗
• InjuryMar 19, 2020Biocompatibility; Adverse Event Without Identified Device or Use Problem; Biocompatibility

  IT WAS REPORTED THAT THE AUTHORIZED REPRESENTATIVE SAID THE PATIENT WAS HAVING A UTI, AND IT MAY HAVE BEEN DUE TO THE WICKS. IT WAS UNKNOWN IF INTERVENTION WAS REQUIRED.

  Patient problems: Urinary Tract Infection

  MAUDE report 9856126 ↗
• MalfunctionMar 17, 2020Labelling, Instructions for Use or Training Problem; Device Slipped; Labelling, Instructions for Use or Training Problem

  IT WAS REPORTED THAT THE PATIENT¿S DAUGHTER STATED HER MOM WAS NOT USING PUREWICK. SHE MOVED AROUND A LOT SO THE WICKS CAME OUT, AND THE MACHINE DID NOT SAY PUREWICK.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 9841583 ↗
• InjuryMar 14, 2020Use of Device Problem; Improper or Incorrect Procedure or Method; Use of Device Problem

  IT WAS REPORTED THAT THE PATIENT WOKE UP WITH AN INFECTION AND WAS ADVISED BY THE DOCTOR THAT IT WAS DUE TO THE WICK. THE PATIENT HAD REPORTEDLY USED THE PRODUCT AT ANOTHER HOSPITAL BEFORE, BUT THEY CHANGED IT EVERY 6 HOURS. AT THE HOSPITAL (B)(6), THEY CHANGED IT ONLY 1 ONCE A DAY. AUTHORIZED STATED SHE HAD BEEN USING IT FOR ABOUT 3 WEEKS.

  Patient problems: Unspecified Infection

  MAUDE report 9832797 ↗
• InjuryMar 5, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A UTI (URINARY TRACT INFECTIONS) AFTER THE USE OF THE PUREWICK CATHETER. THE PATIENT HAD A UTI GOING INTO THE HOSPITAL, AND BEFORE BEING RELEASED A TEST WAS DONE AND THE URINE WAS CLEAR.

  Patient problems: Urinary Tract Infection

  MAUDE report 9792751 ↗
• InjuryMar 3, 2020Fluid/Blood Leak; Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED LEAKAGE WITH THE USE OF THE WICK AND DEVELOPED A URINARY TRACT INFECTION. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED.

  Patient problems: Urinary Tract Infection

  MAUDE report 9780675 ↗
• InjuryFeb 28, 2020Break; Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PURE WICK IN THE HOSPITAL CAUSED THE PATIENT TO DEVELOP AN E.COLI/UTI INFECTION. THE PURE WICK REPORTEDLY DAMAGED THE PATIENTS VAGINAL SKIN.

  Patient problems: Bacterial Infection; Unspecified Infection; Urinary Tract Infection

  MAUDE report 9769985 ↗
• InjuryFeb 13, 2020Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED A UTI WITH PAIN, IRRITATION AND SWELLING WITH USE OF THE PURE WICK. THE PATIENT WAS HOSPITALIZED AND GIVEN ANTIBIOTICS FOR THE UTI.

  Patient problems: Irritation; Pain; Swelling; Urinary Tract Infection

  MAUDE report 9706681 ↗
• InjuryFeb 7, 2020Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Patient-Device Incompatibility

  IT WAS REPORTED THAT AFTER FOUR DAYS OF USE THE PATIENT EXPERIENCED EXTREME PAIN IN HER VAGINA AND CLITORIS.

  Patient problems: Pain

  MAUDE report 9681115 ↗
• InjuryJan 31, 2020Decrease in Suction; Fluid/Blood Leak

  IT WAS REPORTED THAT THE PATIENT¿S MOTHER STATED THE MACHINE DOESN'T HAVE ENOUGH SUCTION AND IT WAS LEAKING DURING THE NIGHT. SHE ALSO STATED SHE HAS POSITIONED THE WICK HERSELF, WHEN HER DAUGHTER WAS IN THE HOSPITAL, SO SHE KNOWS HOW TO DO IT. PER ADDITIONAL INFORMATION RECEIVED ON 15JAN2020, THE CUSTOMER STATED THAT THEY DEVELOPED SORES WHILE USING THERE PUREWICK. IT IS CURRENTLY UNKNOWN IF THE PATIENT RECEIVED MEDICAL INTERVENTION.

  Patient problems: Ulcer

  MAUDE report 9654827 ↗