CURE TWIST T14Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 00815947020390), received between Jan 26, 2018 and Sep 15, 2025 — classified as 28 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Handling Problem” (4 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 30 reports, in the reporter's own words as published by the FDA.

• InjurySep 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  END USER REPORTS "SOME CAPS, SHE CANNOT EVEN GET OPEN, THEY WILL NOT TURN AT ALL AND HAS EVEN ASKED HELP FROM HER SISTER WHO ALSO CANNOT EVEN GET SOME OPEN AND THEY HAVE TO DISCARD WITHOUT USING THEM. SOME OPEN EASILY (AS SHE IS USED TO WITH THIS PRODUCT, DESPITE NOT HAVING THE BEST HAND DEXTERITY) AND OTHERS ARE IMPOSSIBLE TO OPEN HAVING TO STRUGGLE WITH THEM TO GET THEM TO OPEN. SHE SAID SHE ISN'T SURE IF THIS CAUSED IT BUT SHE WAS DIAGNOSED WITH UTI THIS PAST WEEK USING THESE. SHE SAID SHE HASN'T HAD A UTI IN A COUPLE YEARS AND LAST WEEK STARTED TO HAVE FREQUENCY, HER BACK STARTED TO HURT AND SHE FELT "MISERABLE." SHE DID A URINE SAMPLE AS ORDERED BY HER MD AND A UTI WAS CONFIRMED. SHE WAS STARTED ON AN ANTIBIOTIC AND THEN SWITCHED TO A DIFFERENT ONE (NAME/S UNKNOWN WHEN THE URINE CULTURE CAME BACK AND IS ONLY ON DAY 2 OF TAKING THAT NEW TREATMENT COURSE. SHE STATES SHE ALWAYS WASHES HER HANDS, USES 2- 3 WIPES TO CLEANSE HER URETHRA WITH PRIOR TO INSERTION EACH TIME AND ENSURES THE CATHETER STAYS STERILE PRIOR TO USE."

  Patient problems: Urinary Tract Infection

  MAUDE report 23050433 ↗
• MalfunctionAug 28, 2025Product Quality Problem; Product Quality Problem

  "PER CUSTOMER THE CATHETER HAS NO LUBRICATION, THEY WERE DRY." NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22911060 ↗
• InjuryOct 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

  Patient problems: Urinary Tract Infection

  MAUDE report 20407762 ↗
• InjuryOct 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  END USER REPORTS EXPERIENCING "MULTIPLE "BACK TO BACK" DIAGNOSED UTIS WHILE USING THIS PRODUCT." END USER STATES "SHE USED TO CATH REGULARLY IN 2022 FOR URINARY RETENTION. PRIOR TO THIS SHE SAID SHE HAD A FOLEY PLACED. SHE DOES NOT KNOW THE CAUSE OF HER RETENTION BUT WAS DIRECTED TO STOP CATHING AFTER HAVING RECURRENT UTIS WHEN SHE WOULD CATH REGULARLY. THE TIME SHE CATHED REGULARLY WAS IN 2022 FOR A FEW MONTHS SHE THINKS FROM (B)(6) 2022. SHE CALLED TODAY TO ASK IF ANYTHING ABOUT THE T14 CATHETER COULD CONTRIBUTE TO HER PAST UTIS, UNSURE OF HER CAUSE OF SO MANY UTIS WHEN SHE WOULD CATH. VERY DIFFICULT FOR HER TO REMEMBER DETAILS AND DOES NOT KNOW EXACT QTY OF DIAGNOSED UTIS ONLY STATES THEY WERE "BACK TO BACK EACH MONTH SHE CATHED" AS IT WAS SO LONG AGO. SHE SAID AS SOON AS SHE WOULD STOP TAKING THE VARIOUS ANTIBIOTIC TREATMENT COURSES (SHE SAID SHE TRIED A VARIETY OF THEM AS PRESCRIBED ONLY REMEMBERS THE NAME CIPRO - DENIES BEING ON ANY PROPHYLAXIS COURSE) THE SYMPTOMS OF FREQUENCY, URGENCY WOULD COME BACK AND ONCE SHE SAID EXPERIENCED FEVER AND CHILLS. SHE TAKES CRANBERRY PILLS FOR PREVENTION. SHE DOES NOT KNOW IF THE BACTERIA FOUND IN HER URINE EACH TIME SHE HAD A URINE TEST (U

  Patient problems: Urinary Tract Infection

  MAUDE report 20407660 ↗
• InjuryAug 8, 2024Device Handling Problem; Device Handling Problem

  END USER STATES "SHE HAS HAD 3 SURGERIES ON HER SPINE LAST IN AUGUST OF LAST YEAR AND NOW MAY NEED A 4RTH FUSION. SHE SAID THIS HAS AFFECTED HER BLADDERS ABILITY TO EMPTY AND SHE CAN RETAIN ABOUT 600ML. SHE WAS ADVISED TO BEGIN TO CATH 4 X A DAY BUT HAS BEEN DOING IT LESS SOMETIMES 3 - 2 X DUE TO THIS IRRITATION AND PAIN SHE HAS HAD WITH VARIOUS CATHETERS SHE HAS TRIALED. SHE SAID SHE HAS A HISTORY OF BEING ALLERGIC TO "PRESERVATIVES IN GENERAL" DOES NOT KNOW A SPECIFIC NAME BUT STATES SHE IS ALLERGIC TO ANESTHETIC PRESERVATIVES AND ANY PRESERVATIVES IN CHICKEN AS WELL AS THE PRESERVATIVES IN MIRCO-SUTURES. SHE WILL HAVE IRRITATION. SHE SAID SHE THINKS SHE IS HAD A REACTION TO ALL THE CATHETERS SHE HAS TRIED SO FAR DUE TO PRESERVATIVES IN THEM AND SPECIFICALLY THE LUBE IN THE CURE PRODUCTS. SHE HAD PRIMARILY USED T14 BUT AFTER USE SHE WILL HAVE IRRITATION AND PAIN IN HER URETHRA THAT CAN LAST DAYS. NO CONCERNS GETTING THESE IN. SHE SAID SHE WAS ADVISED BY HER MD OFFICE TO INITIALLY WASH AND REUSE THEM (DESPITE HER HAVING THIS IRRITATION) UNTIL HER ORDER ARRIVED AND SHE WAS DOING THAT WHEN SHE GOT A UTI. SHE WOULD CLEANSE THEM WITH HIBACLEANSE AND USE 1 CATHETER FOR THE WHOLE DAY PL

  Patient problems: Urinary Tract Infection

  MAUDE report 19938670 ↗
• InjuryAug 8, 2024Device Handling Problem; Device Handling Problem

  END USER STATES "SHE HAS HAD 3 SURGERIES ON HER SPINE LAST IN AUGUST OF LAST YEAR AND NOW MAY NEED A 4RTH FUSION. SHE SAID THIS HAS AFFECTED HER BLADDERS ABILITY TO EMPTY AND SHE CAN RETAIN ABOUT 600ML. SHE WAS ADVISED TO BEGIN TO CATH 4 X A DAY BUT HAS BEEN DOING IT LESS SOMETIMES 3 - 2 X DUE TO THIS IRRITATION AND PAIN SHE HAS HAD WITH VARIOUS CATHETERS SHE HAS TRIALED. SHE SAID SHE HAS A HISTORY OF BEING ALLERGIC TO "PRESERVATIVES IN GENERAL" DOES NOT KNOW A SPECIFIC NAME BUT STATES SHE IS ALLERGIC TO ANESTHETIC PRESERVATIVES AND ANY PRESERVATIVES IN CHICKEN AS WELL AS THE PRESERVATIVES IN MIRCO-SUTURES. SHE WILL HAVE IRRITATION. SHE SAID SHE THINKS SHE IS HAD A REACTION TO ALL THE CATHETERS SHE HAS TRIED SO FAR DUE TO PRESERVATIVES IN THEM AND SPECIFICALLY THE LUBE IN THE CURE PRODUCTS. SHE HAD PRIMARILY USED T14 BUT AFTER USE SHE WILL HAVE IRRITATION AND PAIN IN HER URETHRA THAT CAN LAST DAYS. NO CONCERNS GETTING THESE IN. SHE SAID SHE WAS ADVISED BY HER MD OFFICE TO INITIALLY WASH AND REUSE THEM (DESPITE HER HAVING THIS IRRITATION) UNTIL HER ORDER ARRIVED AND SHE WAS DOING THAT WHEN SHE GOT A UTI. SHE WOULD CLEANSE THEM WITH HIBACLEANSE AND USE 1 CATHETER FOR THE WHOLE DAY PL

  Patient problems: Urinary Tract Infection

  MAUDE report 19938627 ↗
• InjuryFeb 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED AFTER RECENT CONTINUED USE OF THE CATHETER END USER DEVELOPED A UTI. DAUGHTER SAID HER MOM HAS BEEN CATHING HERSELF FOR 13 YEARS, 6 X DAY FOR RETENTION FROM BLADDER MUSCLE DYSFUNCTION AND IS 92 YEARS OLD. SHE SAID SHE HAD SOME TROUBLE WITH A BATCH OF HER USUAL COMPACT CATHETERS FROM A DIFFERENT SUPPLIER, HOWEVER LAST MONTH BEING HARD TO OPEN SHE WAS SENT SAMPLES OF DIFFERENT CATHETERS AND SHE LIKED THE T14 BY CURE. "THEY ORDERED A FULL MONTHS ORDER AND AFTER SOME CONTINUED USE OF 3 MU BOXES THEY CAUSED HER BURNING AND THEN SHE WAS DIAGNOSED WITH A UTI WHEN SHE WENT INTO THE HOSPITAL FOR CHF AND PNEUMONIA IN EARLY (B)(6) 2023 AND WAS ADMITTED FOR 3-4 DAYS. WHEN SHE WENT IN, SHE TOLD THE DOCTORS THERE THAT SHE ALSO FELT BURNING IN BLADDER/URETHRA AND THEY DID URINE TESTING AND FOUND OUT SHE INDEED DID HAVE A UTI. BURNING WAS HER ONLY UTI SYMPTOM. SHE WAS TREATED WITH ANTIBIOTIC DOXYCYCLINE FOR HER UTI AND IS FEELING MUCH BETTER NOW. DAUGHTER SAID THE ONLY THING THEY HAD CHANGED RECENTLY WAS THE CATHETER SHE HAD BEEN USING PRIOR TO GETTING THIS BURNING AND UTI AND THEY THINK IT WAS THE T14 THAT CAUSED HER UTI. SHE RARELY IF EVER GETS UTIS WITH OTHER CATHETERS BEFORE SW

  Patient problems: Urinary Tract Infection

  MAUDE report 16452153 ↗
• InjuryJan 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE END USER HAS "BEEN CATHING FOR YEARS AS HER BLADDER DOES NOT EMPTY ON IT'S OWN. SHE HAS HISTORY OF MULTIPLE UTIS SINCE SHE WAS 15 YEARS OLD AND SHE IS NOW 74 YEARS OLD. " I DON'T THINK IT'S THE CATHETER'S DOING" PER HUSBAND AND THEY CLARIFIED THEY DO NOT THINK THE T14 CATHETERS ARE TO BLAME FOR HER RECENT UTI AS WELL AS SOME OTHER UTIS SHE HAD IN THE REMOTE PAST WHILE USING THIS CATHETER. NO PROBLEMS/ ABNORMALITY WITH THE CATHETERS AND THEY WORK WELL. SHE HAS ALWAYS HAD UTIS EVEN BEFORE CATHING AND SAID ACTUALLY SINCE SHE HAS SWITCHED TO THE T14 WHICH SHE HAS BEEN USING FOR SOME TIME NOW SHE HASN'T HAD THAT MANY UTIS COMPARED TO HER PAST. SHE TAKES PRECAUTION TO WASH HER HANDS PRIOR TO CATHING, KEEPS THE CATHETER STERILE WHILE INSERTING AND WILL USE A PERSONAL WIPE TO CLEANSE URETHRA PRIOR TO INSERTION. SHE HAS TRIED BZK WIPES THEY BOUGHT OFF AMAZON BUT IT CAUSED HER TO BURN AND STING. I ADVISED THEM TO FOLLOW UP WITH THEIR MD ABOUT DIFFERENT WIPE OPTIONS. HER UTI SYMPTOM BEGAN A FEW WEEKS AGO WHEN SHE WAS NOTING PAIN WITH CATHING AND THEN REDUCED HER CATHING FROM 3 X A DAY TO 1 X A DAY AND SINCE THE PAIN CONTINUED, THEY NOTIFIED MD AND SHE HAD URINE TESTING DON

  Patient problems: Pain; Urinary Tract Infection

  MAUDE report 16132054 ↗
• InjuryJan 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE END USER HAS "BEEN CATHING FOR YEARS AS HER BLADDER DOES NOT EMPTY ON IT'S OWN. SHE HAS HISTORY OF MULTIPLE UTIS SINCE SHE WAS 15 YEARS OLD AND SHE IS NOW 74 YEARS OLD. " I DON'T THINK IT'S THE CATHETER'S DOING" PER HUSBAND AND THEY CLARIFIED THEY DO NOT THINK THE T14 CATHETERS ARE TO BLAME FOR HER RECENT UTI AS WELL AS SOME OTHER UTIS SHE HAD IN THE REMOTE PAST WHILE USING THIS CATHETER. NO PROBLEMS/ ABNORMALITY WITH THE CATHETERS AND THEY WORK WELL. SHE HAS ALWAYS HAD UTIS EVEN BEFORE CATHING AND SAID ACTUALLY SINCE SHE HAS SWITCHED TO THE T14 WHICH SHE HAS BEEN USING FOR SOME TIME NOW SHE HASN'T HAD THAT MANY UTIS COMPARED TO HER PAST. SHE TAKES PRECAUTION TO WASH HER HANDS PRIOR TO CATHING, KEEPS THE CATHETER STERILE WHILE INSERTING AND WILL USE A PERSONAL WIPE TO CLEANSE URETHRA PRIOR TO INSERTION. SHE HAS TRIED BZK WIPES THEY BOUGHT OFF AMAZON BUT IT CAUSED HER TO BURN AND STING. I ADVISED THEM TO FOLLOW UP WITH THEIR MD ABOUT DIFFERENT WIPE OPTIONS. HER UTI SYMPTOM BEGAN A FEW WEEKS AGO WHEN SHE WAS NOTING PAIN WITH CATHING AND THEN REDUCED HER CATHING FROM 3 X A DAY TO 1 X A DAY AND SINCE THE PAIN CONTINUED, THEY NOTIFIED MD AND SHE HAD URINE TESTING DON

  Patient problems: Pain; Urinary Tract Infection

  MAUDE report 16132049 ↗
• InjuryNov 18, 2022Sharp Edges; Sharp Edges

  END USER STATES "SHE HAS BEEN USING THE T14 CATHETERS FOR A WHILE, LONG BEFORE (B)(6) 2022 UP UNTIL AUGUST OF THIS YEAR AFTER A HOSPITALIZATION CAUSED BY A UTI FROM THEM. SHE STARTED CATHING AFTER A BACK SURGERY WHICH RESULTED IN URINARY RETENTION AND SHE WAS INSTRUCTED TO CATH 6 X A DAY. SHE SAID SHE THEN STARTED USING THE T14 CATHETERS AND STARTED GETTING MULTIPLE UTIS AS SHE FELT A FEW WOULD WOULD SCRATCH HER ALWAYS ON THE LEFT SIDE OF HER URETHRA UPON REMOVAL EVERY SO OFTEN. SHE ESTIMATES SHE EXPERIENCED THIS WITH ABOUT 2 OR 3 CATHETERS FROM EVERY CASE QUANTITY SHE WAS SENT. SHE THINKS THE AREA THAT CAUSED THE SCRAPING WAS NEAR THE EYELETS. IT DID NOT FEEL ROUGH OR SHARP GOING IN AT ALL AND IT JUST "SCRATCHED ME WHEN TAKING IT OUT." NOTHING VISUALLY ABNORMAL ABOUT THOSE CATHETERS. SHE SAID SHE COULDN'T REMEMBER IF SHE HAD BLOOD IMMEDIATELY AFTER WITHDRAWAL BUT SHE SAID SHE WOULD THEN SHORTLY GET UTI SYMPTOMS SUCH AS VARYING BLOOD AMOUNTS OFF AND ON IN HER URINE AND SHARP PAINS IN BLADDER AFTER THIS "SCRATCHING" EVENTS. SHE SAID SHE HAD MULTIPLE UTIS WHILE USING THESE CATHETERS DUE TO THIS SHE SOUGHT TREATMENT FOR. SHE SAID SHE LAST HAD A UTI IN (B)(6) 2022 THAT SHE SOUGHT MEDIC

  Patient problems: Urinary Tract Infection

  MAUDE report 15824896 ↗
• InjuryNov 18, 2022Sharp Edges; Sharp Edges

  END USER STATES "SHE HAS BEEN USING THE T14 CATHETERS FOR A WHILE, LONG BEFORE MARCH 2022 UP UNTIL AUGUST OF THIS YEAR AFTER A HOSPITALIZATION CAUSED BY A UTI FROM THEM. SHE STARTED CATHING AFTER A BACK SURGERY WHICH RESULTED IN URINARY RETENTION AND SHE WAS INSTRUCTED TO CATH 6 X A DAY. SHE SAID SHE THEN STARTED USING THE T14 CATHETERS AND STARTED GETTING MULTIPLE UTIS AS SHE FELT A FEW WOULD ALWAYS SCRATCH HER ON THE LEFT SIDE OF HER URETHRA UPON REMOVAL EVERY SO OFTEN. SHE ESTIMATES SHE EXPERIENCED THIS WITH ABOUT 2 OR 3 CATHETERS FROM EVERY CASE QUANTITY SHE WAS SENT. SHE THINKS THE AREA THAT CAUSED THE SCRAPING WAS NEAR THE EYELETS. IT DID NOT FEEL ROUGH OR SHARP GOING IN AT ALL AND IT JUST "SCRATCHED ME WHEN TAKING IT OUT." NOTHING VISUALLY ABNORMAL ABOUT THOSE CATHETERS. SHE SAID SHE COULDN'T REMEMBER IF SHE HAD BLOOD IMMEDIATELY AFTER WITHDRAWAL BUT SHE SAID SHE WOULD THEN SHORTLY GET UTI SYMPTOMS SUCH AS VARYING BLOOD AMOUNTS OFF AND ON IN HER URINE AND SHARP PAINS IN BLADDER AFTER THESE "SCRATCHING" EVENTS. SHE SAID SHE HAD MULTIPLE UTIS WHILE USING THESE CATHETERS DUE TO THIS SHE SOUGHT TREATMENT FOR. SHE SAID SHE LAST HAD A UTI IN MARCH 2022 THAT SHE SOUGHT MEDICAL TREA

  Patient problems: Urinary Tract Infection

  MAUDE report 15824835 ↗
• InjuryOct 26, 2022Device Handling Problem; Device Handling Problem

  END USER REPORTS UNKNOWN NUMBER OF T14 CATHETERS, UNKNOWN NUMBER OF MARKET UNITS WITH UNKNOWN LOT NUMBERS OF THE SAME CATHETER OVER THE LAST 3 MONTHS. LOTS UNKNOWN - THE CAPS ARE VERY DIFFICULT TO UNTWIST AND MADE HER CONCERNED THEY WERE DEFECTED POSSIBLY UNSTERILE AND CONTRIBUTED TO A UTI SHE HAS HAD THIS MONTH. CONSUMER STATES SHE HAS HAD VARIOUS QTY FROM VARIOUS MU BOXES OVER THE LAST 3 MONTHS FROM HER SHIPMENT WHERE "SOME, JUST A FEW ENOUGH TO BE CONCERNING" THE CAPS WHERE REALLY HARD TO UNTWIST. SHE SAID SHE HAS NO MORE LIKE THIS AS THE LAST BOXES SHE HAS USED HAVE NO DEFECTS. SHE SAID SHE WAS EVENTUALLY ABLE TO UNTWIST THEM, ALL BUT 1, AS SHE SAID SHE IS VERY STRONG AND ACTIVE FOR 73 YEARS OLD. SHE SAID SHE HAS BEEN USING THESE CATHETERS FOR A VERY LONG TIME AND PREFERS THEM OVER ANY OTHERS AND HAS NEVER HAD THIS PROBLEM BEFORE. SHE LOVES THE PORTABILITY, THEIR BLUE COLOR, AND THEY ARE PRE-LUBRICATED. SHE CATHS 4 X A DAY FOR BLADDER MUSCLE DYSFUNCTION FROM RETENTION. SHE SAID THERE WERE NO VISUAL ABNORMALITIES ON THESE CATHETERS THAT SHOWED THE DEFECT, IT WAS ONLY WHEN SHE WENT TO UNTWIST THEM. THEY WERE ALSO NORMAL WHEN SHE FINALLY OPENED THEM. SHE SAID SHE IS PRONE TO UTIS

  Patient problems: Urinary Tract Infection

  MAUDE report 15677899 ↗
• InjuryOct 26, 2022Device Handling Problem; Device Handling Problem

  END USER REPORTS UNKNOWN NUMBER OF T14 CATHETERS, UNKNOWN NUMBER OF MARKET UNITS WITH UNKNOWN LOT NUMBERS OF THE SAME CATHETER OVER THE LAST 3 MONTHS. LOTS UNKNOWN - THE CAPS ARE VERY DIFFICULT TO UNTWIST AND MADE HER CONCERNED THEY WERE DEFECTED POSSIBLY UNSTERILE AND CONTRIBUTED TO A UTI SHE HAS HAD THIS MONTH. CONSUMER STATES SHE HAS HAD VARIOUS QTY FROM VARIOUS MU BOXES OVER THE LAST 3 MONTHS FROM HER SHIPMENT WHERE "SOME, JUST A FEW ENOUGH TO BE CONCERNING" THE CAPS WHERE REALLY HARD TO UNTWIST. SHE SAID SHE HAS NO MORE LIKE THIS AS THE LAST BOXES SHE HAS USED HAVE NO DEFECTS. SHE SAID SHE WAS EVENTUALLY ABLE TO UNTWIST THEM, ALL BUT 1, AS SHE SAID SHE IS VERY STRONG AND ACTIVE FOR 73 YEARS OLD. SHE SAID SHE HAS BEEN USING THESE CATHETERS FOR A VERY LONG TIME AND PREFERS THEM OVER ANY OTHERS AND HAS NEVER HAD THIS PROBLEM BEFORE. SHE LOVES THE PORTABILITY, THEIR BLUE COLOR, AND THEY ARE PRE-LUBRICATED. SHE CATHS 4 X A DAY FOR BLADDER MUSCLE DYSFUNCTION FROM RETENTION. SHE SAID THERE WERE NO VISUAL ABNORMALITIES ON THESE CATHETERS THAT SHOWED THE DEFECT, IT WAS ONLY WHEN SHE WENT TO UNTWIST THEM. THEY WERE ALSO NORMAL WHEN SHE FINALLY OPENED THEM. SHE SAID SHE IS PRONE TO UTIS

  Patient problems: Urinary Tract Infection

  MAUDE report 15676352 ↗
• InjuryJun 23, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  END USER REPORTS UNKNOWN NUMBER OF CATHETERS, UNKNOWN NUMBER OF MARKET UNITS, STATING MAYBE "5 OR MORE" WITH UNKNOWN LOT NUMBERS OF THE SAME CATHETER OVER THE LAST MONTH SHIPMENT, LOT/S UNKNOWN. SHE STATES THE CAPS WERE DIFFICULT TO REMOVE AND OF ALL THESE HARD TO OPEN CATHETERS THEY SEEMED LIKE THE LUBRICATION WAS MORE DRIED OUT AT THE TIP, "NOT AS FULL" AS THEY USED TO BE WITH LUBRICANT. SHE HAS BEEN USING THESE CATHETERS FOR A LONG TIME. SHE SAID THE CAPS THAT WERE DIFFICULT TO REMOVE WAS HER "FIRST CLUE" THESE CATHETERS WERE DEFECTED. SHE SAID SHE HAD TO HAVE HER HUSBAND OPEN THEM ALL FOR HER BEFORE HE LEFT ON A WORK TRIP OR ELSE SHE WAS GOING TO "GET A TOOL FROM HIS TOOLBOX TO OPEN THEM" AS SHE COULD NOT OPEN THEM WHICH NORMALLY SHE CAN OPEN THEM HERSELF. NO OTHER ABNORMALITIES ON THE CATHETERS THEMSELVES. SHE MENTIONED SHE IS RECOVERING FROM A UTI THAT WAS DISCOVERED LAST WEEK. SHE SAID YOU "CAN'T BLAME THE CATHETERS." SHE DOES NOT FEEL THE DEFECTED CATHETERS WERE THE CAUSE OF HER UTIS. SHE HAS CATH'D FOR 7 YEARS AND 5 X DURING THE DAY AND 2 X AT NIGHT FOR RETENTION. SHE SAID SHE WIPES GENITAL AREA PRIOR TO PLACEMENT WITH ANTIBACTERIAL WIPE, SHE IS CAUTIOUS TO KEEP THE STERIL

  Patient problems: Urinary Tract Infection

  MAUDE report 14787821 ↗
• InjuryApr 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  END USER STATES "SHE HAS DEVELOPED SEVERAL UTIS OVER THE LAST FEW YEARS STARTING IN (B)(6) 2017 AFTER USING THESE CATHETERS BECAUSE SHE THINKS AT TIMES THEY CUT HER INTERNALLY AFTER CATHING AT TIMES WHICH DEVELOPS INTO A UTI SHORTLY AFTER, COULD NOT QUANTITY ALL THE TIMES THIS OCCURRED. MOST RECENTLY SHE SAID LAST WEEK SHE DEVELOPED A UTI AFTER "DRAWING BLOOD" WITH THE CATHETER. SHE COULD SEE VISIBLE BRIGHT RED BLOOD ON THE CATHETER AS SHE PULLED THE CATHETER OUT, IT STOPPED SHORTLY AFTER THAT AND THEN A FEW DAYS LATER AFTER ANOTHER CATH THE LITTLE QTY OF BLOOD RE-STARTED AGAIN WHICH ALSO QUICKLY STOPPED. SHE IS NOT ON BLOOD THINNERS. SHE DENIES SEEING ANY ABNORMALITY WITH THE CATHETER ITSELF. SHORTLY AFTER THOSE BLEEDING EPISODES HER USUAL UTI SYMPTOMS OCCURRED OF CLOUDY URINE, DIFFICULTY VOIDING ON HER OWN, FREQUENCY, URGENCY, MALODOROUS URINE AND PAIN IN BLADDER AND URETHRA. SHE CALLED HER DOCTOR AND SHE DID GO DO A URINE SPECIMEN AT THE LAB AND THEY DEEMED SHE DID HAVE A UTI. SHE WAS ON A COURSE OF MACROBID ANTIBIOTICS BUT THEN THEY "SWITCHED HER TO SOMETHING STRONGER" AND SHE JUST FINISHED THAT ANTIBIOTIC 2 DAYS AGO AND FEELS MUCH BETTER." SHE ALSO SAID "SHE HAS NOTED BLEEDING

  Patient problems: Tissue Breakdown; Urinary Tract Infection

  MAUDE report 14103319 ↗
• InjuryApr 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  END USER STATES "SHE HAS DEVELOPED SEVERAL UTIS OVER THE LAST FEW YEARS STARTING IN (B)(6) 2017 AFTER USING THESE CATHETERS BECAUSE SHE THINKS AT TIMES THEY CUT HER INTERNALLY AFTER CATHING AT TIMES WHICH DEVELOPS INTO A UTI SHORTLY AFTER, COULD NOT QUANTITY ALL THE TIMES THIS OCCURRED. MOST RECENTLY SHE SAID LAST WEEK SHE DEVELOPED A UTI AFTER "DRAWING BLOOD" WITH THE CATHETER. SHE COULD SEE VISIBLE BRIGHT RED BLOOD ON THE CATHETER AS SHE PULLED THE CATHETER OUT, IT STOPPED SHORTLY AFTER THAT AND THEN A FEW DAYS LATER AFTER ANOTHER CATH THE LITTLE QTY OF BLOOD RE-STARTED AGAIN WHICH ALSO QUICKLY STOPPED. SHE IS NOT ON BLOOD THINNERS. SHE DENIES SEEING ANY ABNORMALITY WITH THE CATHETER ITSELF. SHORTLY AFTER THOSE BLEEDING EPISODES HER USUAL UTI SYMPTOMS OCCURRED OF CLOUDY URINE, DIFFICULTY VOIDING ON HER OWN, FREQUENCY, URGENCY, MALODOROUS URINE AND PAIN IN BLADDER AND URETHRA. SHE CALLED HER DOCTOR AND SHE DID GO DO A URINE SPECIMEN AT THE LAB AND THEY DEEMED SHE DID HAVE A UTI. SHE WAS ON A COURSE OF MACROBID ANTIBIOTICS BUT THEN THEY "SWITCHED HER TO SOMETHING STRONGER" AND SHE JUST FINISHED THAT ANTIBIOTIC 2 DAYS AGO AND FEELS MUCH BETTER." SHE ALSO SAID "SHE HAS NOTED BLEEDING

  Patient problems: Tissue Breakdown; Urinary Tract Infection

  MAUDE report 14103317 ↗
• InjuryApr 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CONSUMER REPORTS "THIS CATHETER WAS TOO SHORT FOR HER ANATOMY." SHE STATES "ABOUT 6 MONTHS AGO SHE THOUGHT THIS PRODUCT COULD HAVE GIVEN HER A UTI BECAUSE IT WAS SHORT FOR HER ANATOMY AND SHE ENDED UP TOUCHING HER HAND TO HER URETHRAL OPENING OFTEN TO GET IT TO WORK TO DRAIN HER BLADDER AS IT WAS SHORTER TO HER PREVIOUS CATHETERS. SHE REPORTS USE OF SEVERAL CATHETERS, FROM UNKNOWN LOT NUMBERS FROM MULTIPLE UNKNOWN MU ABOUT 6 MONTHS AGO, SHE NO LONGER HAS. SHE STATES "SHE GETS UTIS MORE THAN A NORMAL PERSON" BUT THOUGHT THE CATHETERS WERE THE CAUSE 6 MONTHS AGO BECAUSE THE INFECTION WAS SO HARD TO CLEAR WHICH IS NOT NORMAL FOR HER WHILE SHE WAS USING THESE CATHETERS. SHORTLY AFTER GETTING THESE CATHETERS, HER UTI SYMPTOMS BEGAN, SHE HAD FREQUENCY, URGENCY, PRESSURE IN BLADDER AND DYSURIA AND KNEW SHE HAD A UTI. SHE WENT INTO IMMEDIATE CARE AND IT WAS DEEMED SHE HAD A UTI AFTER URINE TESTING AND SHE WAS PRESCRIBED A COURSE OF ANTIBIOTICS. THAT COURSE OF ANTIBIOTICS DIDN'T WORK SHE SAID SHE WAS SWITCHED TO ANOTHER ONE AND THEN STILL HER SYMPTOMS DIDN'T CLEAR SO SHE HAD ANOTHER UA AND URINE C&S DONE BY HER DOCTOR AND SHE GOT A NEW ANTIBIOTIC WHICH FINALLY CLEARED THE INFECTION. SHE THE

  Patient problems: Urinary Tract Infection

  MAUDE report 14014327 ↗
• MalfunctionMar 2, 2022Sharp Edges; Sharp Edges

  IT WAS REPORTED "THE EYELETS MADE IT FEEL LIKE THE CATHETER WAS GOUGING HER. NO INJURIES OR MEDICAL INTERVENTION WERE REPORTED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13654655 ↗
• InjuryDec 7, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED BY THE PRODUCT END USER THAT "HER DOCTOR SUGGESTED CHANGING CATHETERS AFTER 2 URINARY TRACT INFECTIONS AND 2 DAYS IN THE HOSPITAL. MEDICAL INTERVENTION WERE REPORTED". END USER DID NOT PROVIDE ANY DETAILS REGARDING THE CATHETER RELATED TO THE URINARY TRACT INFECTIONS. NO PHOTOS WERE RECEIVED DEPICTING ANY COMPLAINT ISSUES.

  Patient problems: Urinary Tract Infection

  MAUDE report 12952839 ↗
• InjuryJun 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INTERMITTENT CATHETER PATIENT (USER) SAID SHE THINKS SHE GOT A URINARY TRACT INFECTION (UTI) FROM A CATHETER, AS SHE HASN'T HAD A UTI SINCE 2014. SHE NOW HAS HAD TWO UTI'S IN THE LAST MONTH AND IS ON MEDICATION. SHE THINKS IT COULD BE SOMETHING IN THE LUBRICANT THAT MAY HAVE CAUSED THE UTI. DURING FOLLOW-UP, THE PATIENT SAID SHE WAS PRESCRIBED AN ANTIBIOTIC AND TOOK THE FULL COURSE, BUT THE INFECTION WAS NOT RESOLVED. SHE WAS PRESCRIBED ANOTHER ANTIBIOTIC AND JUST FINISHED THE DOSE. SHE FEELS FINE AND WILL VISIT HER DOCTOR TO CONFIRM THE INFECTION WAS RESOLVED.

  Patient problems: Urinary Tract Infection

  MAUDE report 11986843 ↗
• InjuryFeb 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INTERMITTENT CATHETER PATIENT (USER) SAID SHE HAD A URINARY TRACT INFECTION (UTI) CONCURRENT WITH CATHETER USE, AND THINKS IT WAS CAUSED BY THE CATHETER BEING TOO SHORT AND DOESN'T DRAIN HER BLADDER COMPLETELY. DURING FOLLOW-UP, THE PATIENT SAID SHE WAS PRESCRIBED AN ANTIBIOTIC, TOOK THE FULL COURSE, BUT DID NOT FULLY RECOVER. SHE WAS PRESCRIBED A SECOND DOSE, AND FULLY RECOVERED AFTER THE TAKING THE SECOND DOSE.

  Patient problems: Urinary Tract Infection

  MAUDE report 11346050 ↗
• InjuryJan 15, 2021Adverse Event Without Identified Device or Use Problem

  INTERMITTENT CATHETER PATIENT (USER) SAID THE PRE-LUBRICATION OF THE CATHETER IS CAUSING URINARY TRACT INFECTIONS (UTI). DURING FOLLOW-UP, THE PATIENT SAID SHE WAS PRESCRIBED AN ANTIBIOTIC, TOOK THE FULL COURSE, BUT DID NOT RECOVER FROM THE INFECTION. SHE WAS GIVEN A SECOND COURSE OF A DIFFERENT ANTIBIOTIC, AND RECOVERED FULLY.

  Patient problems: Urinary Tract Infection

  MAUDE report 11181734 ↗
• InjuryJun 26, 2020Sharp Edges; Sharp Edges

  INTERMITTENT CATHETER PATIENT (USER) SAID SHE GOT A URINARY TRACT INFECTION (UTI) WHILE USING THE T14 CATHETER, ALTHOUGH SHE DIDN'T SPECIFY IT WAS THE CATHETER THAT CAUSED THE UTI. DURING FOLLOW-UP, THE PATIENT REPORTED SHE TOOK THE FULL COURSE OF ANTIBIOTICS AND RECOVERED FULLY.

  Patient problems: Urinary Tract Infection

  MAUDE report 10201629 ↗
• InjuryDec 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT (USER) REPORTED SHE CONTRACTED A URINARY TRACT INFECTION (UTI). SHE WAS PRESCRIBED A 7 DAY COURSE OF KEFLEX TO TREAT THE INFECTION. NO DEFECT OR MALFUNCTION WAS REPORTED WITH THE CATHETER. THE PATIENT SAID SHE IS FORCED TO REUSE SOME CATHETERS BECAUSE HER INSURANCE DOES NOT COVER THE QUANTITY REQUIRED FOR HER NEEDS. SHE SAID SHE THINKS THE REUSE IS THE CONTRIBUTING FACTOR FOR HER ACQUIRING INFECTIONS. SHE IS WORKING WITH HER DOCTOR TO GET DOCUMENTATION SUBMITTED TO INSURANCE WITH THE HOPE OF BEING APPROVED FOR ADDITIONAL SUPPLIES.

  Patient problems: Urinary Tract Infection

  MAUDE report 9453371 ↗
• InjurySep 19, 2019Difficult to Remove; Difficult to Remove

  INTERMITTENT CATHETER PATIENT (USER) REPORTED A FEW CATHETER UNITS STUCK IN HER URETHRA AND SHE HAD A DIFFICULT TIME REMOVING THEM. SHE REPORTED ONE CAUSED BLEEDING AFTER REMOVAL, RESULTING IN A URINARY TRACT INFECTION (UTI). HER DOCTOR PRESCRIBED A 5 DAY COURSE OF ANTIBIOTICS AND THE PATIENT HAS RECOVERED. NO SPECIFIC DEFECT WITH THE CATHETERS WAS REPORTED.

  Patient problems: Hematuria; Urinary Tract Infection

  MAUDE report 9090046 ↗