CURE ULTRA MALE CATHETER ULTRA M16Recalls & reported problems
Convatec, Purchasing Department · Ultra Male, 16”, Straight Tip · Class 2
All models of CURE ULTRA MALE CATHETER (10)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 20
- Deaths reported
- 0
- Injuries reported
- 10
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00815947021076), received between Aug 20, 2020 and Jun 26, 2025 — classified as 10 injuries, 10 malfunctions.
The most frequently reported specific device problem is “Difficult to Remove” (5 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.
Reports received per month
Most reported problems
Device problems
- Difficult to Remove5
- Adverse Event Without Identified Device or Use Problem4
- Device Handling Problem4
- Sharp Edges4
- Appropriate Device Problem Term/Code Not Available1
- Coagulation in Device or Device Ingredient1
- Material Too Soft/Flexible1
Patient problems
- Urinary Tract Infection10
- Discomfort7
- Pain2
- No Clinical Signs, Symptoms or Conditions1
- Tissue Breakdown1
Recent adverse event reports
The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.
InjuryJun 26, 2025Device Handling Problem; Device Handling Problem
END USER STATES HE HAS BEEN "CATHING FOR THE PAST 5 YEARS FROM RETENTION, UNKNOWN REASON WHY HE HAD TO BEGIN CIC. HE CATHS EVERY 4-5 HRS. HE SAID HE HAS USED THIS SAME CATHETER BRAND/ TYPE FOR 5YRS AND HAS NO DIFFICULTY USING IT AND LIKES THIS CATHETER. HE DID NOT HAVE UTIS PREVIOUSLY THE FIRST FEW YEARS OF CIC BUT SAYS ONLY MORE RECENTLY STARTED GETTING UTIS WHICH HE IS HOSPITALIZED FOR EACH TIME. HE SAID "SINCE (B)(6) HAS BEEN HOSPITALIZED 3 TIMES" AND PRIOR TO THAT HAD 2 PRIOR UTIS WHERE HE WAS HOSPITALIZED. HE SAID HE IS CURRENTLY IN THE HOSPITAL FOR 4 DAYS ON IV ANTIBIOTICS AND HAS HAD A FOLEY PLACED FOR THE PAST 4-5 DAYS AND IS PLANNING TO HAVE IT REMOVED SO HE CAN START CIC AGAIN. THE UTI JUST PRIOR TO THIS CURRENT UTI WAS ABOUT 5 WEEKS AGO AND SAID HIS SYMPTOMS HAD FULLY RESOLVED AFTER THAT ANTIBIOTIC TREATMENT FOR ABOUT 4 WEEKS. EACH OF HIS UTIS HIS ONLY SYMPTOM IS WHOLE BODY FATIGUE - IT REALLY "KNOCKS HIM OUT" AND HE CAN'T EVEN STAND/ WALK. HE SAID HE IS ALWAYS CARRIED OR BROUGHT BY WHEELCHAIR TO THE HOSPITAL EACH OF HIS 5 DIAGNOSED UTIS AND HE IS FOUND TO HAVE A UTI IN HIS URINE AND TREATED WITH IV ANTIBIOTICS AND SENT HOME ON ORAL ANTIBIOTICS AND HIS SYMPTOMS RESOLVE.
Patient problems: Urinary Tract Infection
MAUDE report 22342700 ↗InjuryJun 26, 2025Device Handling Problem; Device Handling Problem
END USER STATES HE HAS BEEN "CATCHING FOR THE PAST 5 YEARS FROM RETENTION, UNKNOWN REASON WHY HE HAD TO BEGIN CIC. HE CATHS EVERY 4-5 HRS. HE SAID HE HAS USED THIS SAME CATHETER BRAND/ TYPE FOR 5YRS AND HAS NO DIFFICULTY USING IT AND LIKES THIS CATHETER. HE DID NOT HAVE UTIS PREVIOUSLY THE FIRST FEW YEARS OF CIC BUT SAYS ONLY MORE RECENTLY STARTED GETTING UTIS WHICH HE IS HOSPITALIZED FOR EACH TIME. HE SAID "SINCE THANKSGIVING HAS BEEN HOSPITALIZED 3 TIMES" AND PRIOR TO THAT HAD 2 PRIOR UTIS WHERE HE WAS HOSPITALIZED. HE SAID HE IS CURRENTLY IN THE HOSPITAL FOR 4 DAYS ON IV ANTIBIOTICS AND HAS HAD A FOLEY PLACED FOR THE PAST 4-5 DAYS AND IS PLANNING TO HAVE IT REMOVED SO HE CAN START CIC AGAIN. THE UTI JUST PRIOR TO THIS CURRENT UTI WAS ABOUT 5 WEEKS AGO AND SAID HIS SYMPTOMS HAD FULLY RESOLVED AFTER THAT ANTIBIOTIC TREATMENT FOR ABOUT 4 WEEKS. EACH OF HIS UTIS HIS ONLY SYMPTOM IS WHOLE BODY FATIGUE - IT REALLY "KNOCKS HIM OUT" AND HE CAN'T EVEN STAND/ WALK. HE SAID HE IS ALWAYS CARRIED OR BROUGHT BY WHEELCHAIR TO THE HOSPITAL EACH OF HIS 5 DIAGNOSED UTIS AND HE IS FOUND TO HAVE A UTI IN HIS URINE AND TREATED WITH IV ANTIBIOTICS AND SENT HOME ON ORAL ANTIBIOTICS AND HIS SYMPTOMS RE
Patient problems: Urinary Tract Infection
MAUDE report 22342697 ↗MalfunctionFeb 2, 2024Sharp Edges; Sharp Edges
PER ADDITIONAL INFORMATION RECEIVED "HE SAID HE REALLY CANNOT BE SURE IF THE EYELETS CHANGED IN ANY WAY AS HE NEVER PAID ATTENTION TO THEM BEFORE OR IF IT WAS ¿ALL IN HIS MIND.¿ HE THOUGHT THE EYELETS HAD LOOKED AND FELT MORE POLISHED IN THE PAST, BUT HAD NEVER CHECKED THEM BEFORE HE STARTED TO FEEL THE PROBLEMS HE HAD REPORTED TO ME. HE THINKS MAYBE THEY MAY HAVE CHANGED BUT ¿CANNOT PROVE IT.¿ HE OVERALL SAID THE PROBLEM WAS HIM AND HIS ANATOMY ¿ URETHRAL STRICTURE THAT HAD FORMED AS HE NEEDED THIS DILATION PROCEDURE THAT THE UROLOGIST HAD TO PERFORM ON HIM FOR CATHING TO FEEL COMFORTABLE AGAIN FOR HIM WITH THIS SAME PRODUCT. "
Patient problems: Discomfort
MAUDE report 18629104 ↗MalfunctionFeb 1, 2024Sharp Edges; Sharp Edges
END USER REPORTS THE EYELETS AREN'T POLISHED, THEY FEEL "SHARP." CAUSES HIM DISCOMFORT IN HIS URETHRA.
Patient problems: Pain
MAUDE report 18622205 ↗MalfunctionFeb 1, 2024Sharp Edges; Sharp Edges
END USER REPORTS THE EYELETS AREN'T POLISHED, THEY FEEL "SHARP." CAUSES HIM DISCOMFORT IN HIS URETHRA.
Patient problems: Pain
MAUDE report 18622045 ↗MalfunctionDec 28, 2023Sharp Edges; Sharp Edges
END USER REPORTS CURE ULTRA CATHETERS APPEAR TO HAVE BEEN EXPOSED TO HIGH TEMPERATURE CAUSING THE LUBRICANT TO BECOME EXTREMELY STICKY AND JELLY LIKE, THE TIPS ARE SHARP AND CAUSE SCRAPPING INSIDE THE URETHRA WHICH RESULTS IN BLOOD IN MY URINE.
Patient problems: Tissue Breakdown
MAUDE report 18411953 ↗MalfunctionFeb 17, 2023Difficult to Remove; Difficult to Remove
IT WAS REPORTED A CONSUMER USED QUANTITY OF 5 FROM A SAMPLE PACK OF 10 SENT TO HIM. STATES THEY FEEL LIKE UPON REMOVAL THEY FELT "GLUED TO HIS URETHRA." HE IS FOLLOWING IFUS TO PREPARE AND USES THIS GC GLIDE CATHETER RIGHT AWAY AFTER PREPARATION BY ACTIVATING WATER SACHET PRIOR TO INSERTING TO DRAIN HIS BLADDER. HE SAID IT TAKES HIM ABOUT 1 MINUTE 15 SECONDS FOR HIM TO DRAIN BLADDER AND REMOVE BUT WHEN HE GOES TO REMOVE THE CATHETER IT FEELS LIKE IT IS SOMEWHAT "GLUED TO URETHRA" AND IT IS "UNPLEASANT" TO REMOVE IT FROM ENTIRE LENGTH OF URETHRA.
Patient problems: Discomfort
MAUDE report 16400642 ↗MalfunctionFeb 17, 2023Difficult to Remove; Difficult to Remove
IT WAS REPORTED A CONSUMER USED QUANTITY OF 5 FROM A SAMPLE PACK OF 10 SENT TO HIM. STATES THEY FEEL LIKE UPON REMOVAL THEY FELT "GLUED TO HIS URETHRA." HE IS FOLLOWING IFUS TO PREPARE AND USES THIS GC GLIDE CATHETER RIGHT AWAY AFTER PREPARATION BY ACTIVATING WATER SACHET PRIOR TO INSERTING TO DRAIN HIS BLADDER. HE SAID IT TAKES HIM ABOUT 1 MINUTE 15 SECONDS FOR HIM TO DRAIN BLADDER AND REMOVE BUT WHEN HE GOES TO REMOVE THE CATHETER IT FEELS LIKE IT IS SOMEWHAT "GLUED TO URETHRA" AND IT IS "UNPLEASANT" TO REMOVE IT FROM ENTIRE LENGTH OF URETHRA.
Patient problems: Discomfort
MAUDE report 16400614 ↗MalfunctionFeb 17, 2023Difficult to Remove; Difficult to Remove
IT WAS REPORTED A CONSUMER USED QUANTITY OF 5 FROM A SAMPLE PACK OF 10 SENT TO HIM. STATES THEY FEEL LIKE UPON REMOVAL THEY FELT "GLUED TO HIS URETHRA." HE IS FOLLOWING IFUS TO PREPARE AND USES THIS GC GLIDE CATHETER RIGHT AWAY AFTER PREPARATION BY ACTIVATING WATER SACHET PRIOR TO INSERTING TO DRAIN HIS BLADDER. HE SAID IT TAKES HIM ABOUT 1 MINUTE 15 SECONDS FOR HIM TO DRAIN BLADDER AND REMOVE BUT WHEN HE GOES TO REMOVE THE CATHETER IT FEELS LIKE IT IS SOMEWHAT "GLUED TO URETHRA" AND IT IS "UNPLEASANT" TO REMOVE IT FROM ENTIRE LENGTH OF URETHRA.
Patient problems: Discomfort
MAUDE report 16400606 ↗MalfunctionFeb 17, 2023Difficult to Remove; Difficult to Remove
IT WAS REPORTED A CONSUMER USED QUANTITY OF 5 FROM A SAMPLE PACK OF 10 SENT TO HIM. STATES THEY FEEL LIKE UPON REMOVAL THEY FELT "GLUED TO HIS URETHRA." HE IS FOLLOWING IFUS TO PREPARE AND USES THIS GC GLIDE CATHETER RIGHT AWAY AFTER PREPARATION BY ACTIVATING WATER SACHET PRIOR TO INSERTING TO DRAIN HIS BLADDER. HE SAID IT TAKES HIM ABOUT 1 MINUTE 15 SECONDS FOR HIM TO DRAIN BLADDER AND REMOVE BUT WHEN HE GOES TO REMOVE THE CATHETER IT FEELS LIKE IT IS SOMEWHAT "GLUED TO URETHRA" AND IT IS "UNPLEASANT" TO REMOVE IT FROM ENTIRE LENGTH OF URETHRA.
Patient problems: Discomfort
MAUDE report 16400576 ↗MalfunctionFeb 17, 2023Difficult to Remove; Difficult to Remove
IT WAS REPORTED A CONSUMER USED QUANTITY OF 5 FROM A SAMPLE PACK OF 10 SENT TO HIM. STATES THEY FEEL LIKE UPON REMOVAL THEY FELT "GLUED TO HIS URETHRA." HE IS FOLLOWING IFUS TO PREPARE AND USES THIS GC GLIDE CATHETER RIGHT AWAY AFTER PREPARATION BY ACTIVATING WATER SACHET PRIOR TO INSERTING TO DRAIN HIS BLADDER. HE SAID IT TAKES HIM ABOUT 1 MINUTE 15 SECONDS FOR HIM TO DRAIN BLADDER AND REMOVE BUT WHEN HE GOES TO REMOVE THE CATHETER IT FEELS LIKE IT IS SOMEWHAT "GLUED TO URETHRA" AND IT IS "UNPLEASANT" TO REMOVE IT FROM ENTIRE LENGTH OF URETHRA.
Patient problems: Discomfort
MAUDE report 16400515 ↗InjuryOct 19, 2022Device Handling Problem; Device Handling Problem
END USER REPORTS "HE HAS BEEN HAVING BACK TO BACK UTIS IN THE LAST 6-8 WEEKS WHILE HE HAS BEEN USING THE ULTRAM16 CATHETER. HE REPORTS UNKNOWN NUMBER OF CATHETERS, UNKNOWN NUMBER OF MARKET UNITS WITH UNKNOWN LOT NUMBERS OF THE SAME CATHETER OVER THE LAST 6-8 WEEKS. CONSUMER SAID HE HAS BEEN CATHING FOR LAST 2 YEARS AS HIS BLADDER DOES NOT EMPTY. HE SAID ONLY LATELY HE HAS BEEN GETTING BACK TO BACK UTI'S AND HIS URINE TURNS REAL MILKY AND CLOUDY. HE SAID HE HAS HAD 5 UTIS IN THE LAST 6-8 WEEKS. HE SAID HE GOES TO THE MD AND THEY RUN URINE TESTING AND IT IS POSITIVE FOR UTI. HE SAID HE WAS TOLD BY HIS MD HE WASN'T CLEANING HIS MEATUS WELL ENOUGH PRIOR TO CATHETER INSERTION. HE WAS TOLD TO PURCHASE BETADINE SWABS TO WIPE HIS MEATUS WITH PRIOR TO CATHING WHICH HE HAS BEEN USING EVER SINCE THIS WAS SUGGESTED. HE SAID THIS HAS BEEN HELPING A LOT AS HIS UTI HAS NOT RETURNED SINCE HE IMPLEMENTED THIS. HE SAID BEFORE HE WOULD JUST USE ALCOHOL ON HIS MEATUS PRIOR TO CATHING AND HE SAID IT NEVER BOTHERED HIS SKIN. HE ALSO DID SAY HE DOES WASH HIS HANDS PRIOR TO CATHING AS WELL AS USES AN HAND SANITIZER ON HIS HANDS AS WELL. HE DOES NOT EVER USE THE NO TOUCH SLEEVE WHICH HE SAID HE NEVER KNEW
Patient problems: Urinary Tract Infection
MAUDE report 15633161 ↗InjuryOct 19, 2022Device Handling Problem; Device Handling Problem
END USER REPORTS "HE HAS BEEN HAVING BACK TO BACK UTIS IN THE LAST 6-8 WEEKS WHILE HE HAS BEEN USING THE ULTRAM16 CATHETER. HE REPORTS UNKNOWN NUMBER OF CATHETERS, UNKNOWN NUMBER OF MARKET UNITS WITH UNKNOWN LOT NUMBERS OF THE SAME CATHETER OVER THE LAST 6-8 WEEKS. CONSUMER SAID HE HAS BEEN CATHING FOR LAST 2 YEARS AS HIS BLADDER DOES NOT EMPTY. HE SAID ONLY LATELY HE HAS BEEN GETTING BACK TO BACK UTI'S AND HIS URINE TURNS REAL MILKY AND CLOUDY. HE SAID HE HAS HAD 5 UTIS IN THE LAST 6-8 WEEKS. HE SAID HE GOES TO THE MD AND THEY RUN URINE TESTING AND IT IS POSITIVE FOR UTI. HE SAID HE WAS TOLD BY HIS MD HE WASN'T CLEANING HIS MEATUS WELL ENOUGH PRIOR TO CATHETER INSERTION. HE WAS TOLD TO PURCHASE BETADINE SWABS TO WIPE HIS MEATUS WITH PRIOR TO CATHING WHICH HE HAS BEEN USING EVER SINCE THIS WAS SUGGESTED. HE SAID THIS HAS BEEN HELPING A LOT AS HIS UTI HAS NOT RETURNED SINCE HE IMPLEMENTED THIS. HE SAID BEFORE HE WOULD JUST USE ALCOHOL ON HIS MEATUS PRIOR TO CATHING AND HE SAID IT NEVER BOTHERED HIS SKIN. HE ALSO DID SAY HE DOES WASH HIS HANDS PRIOR TO CATHING AS WELL AS USES AN HAND SANITIZER ON HIS HANDS AS WELL. HE DOES NOT EVER USE THE NO TOUCH SLEEVE WHICH HE SAID HE NEVER KNEW
Patient problems: Urinary Tract Infection
MAUDE report 15633088 ↗InjuryJul 7, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
END USER REPORTS "AT THE BEGINNING OF THE MONTH HE HAD A UTI WHICH HE SAID "HE DOESN'T GET MANY OF." HE ALSO THINKS THIS OCCURRED BECAUSE OF HIS ANATOMY AS RECENTLY ALSO HIS CHANNEL HAS BEEN FEELING TIGHTER TO PASS HIS NORMAL 16 FR SIZE CATHETER THROUGH IN GENERAL WHICH STARTED PRIOR TO HIS UTI. SOME RESISTANCE ALSO NOTED AND SOME DISCOMFORT NOTED WHEN CATHING AS WELL IN GENERAL WITH 16FR. DENIES PAIN. HE THINKS HE MAY NEED A SMALLER CATHETER. HE IS NOT SURE IF THIS WAS FURTHER AGGRAVATED BECAUSE NOT ENOUGH LUBRICATION ON SOME CATHETERS HE HAD STARTED USING AT THAT TIME. HIS UTI SYMPTOMS WERE BURNING AND PRESSURE. HE HAD TO DO A URINE TEST AND AN GET ANTIBIOTICS COURSE IN ORDER FOR SYMPTOMS TO GO AWAY." END USER WAS ADVISED NOT TO USE CATHETERS WITHOUT SUFFICIENT LUBRICATION.
Patient problems: Urinary Tract Infection
MAUDE report 14950047 ↗InjuryJun 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
END USER REPORTS "HIS FIRST UTI WHILE CATHING AND WAS USING THIS CATHETER. HE SAID HE WENT INTO HIS PCP FOR REGULAR EXAMINATION LAST WEEK, HAVING NO UTI SYMPTOMS, AND THEY DID A ROUTINE URINALYSIS WHICH WAS POSITIVE FOR UTI HE SAID. HIS PCP CONSULTED WITH HIS UROLOGIST AND HE WAS TOLD THIS INFECTION WAS DUE TO CATHETERIZATION. HE IS UNSURE IF A URINE CULTURE WAS DONE BUT HE WAS PUT ON A TREATMENT COURSE OF CIPROFLOXACIN HE SAID WHICH HE IS STILL FINISHING UP." HE STATES HE HAS "ONLY BEEN USING THE ULTRAM16 FOR THE PAST 2 MONTHS BECAUSE HIS OTHER CATHETERS WERE UNAVAILABLE. HE STARTED CATHING ABOUT 1-2 YEARS AGO HE SAID AFTER A KNEE OPERATION HE WHICH RESULTED IN URINARY RETENTION AS WHILE HE WAS POST OP AND RESULTED IN SEPSIS DUE TO THE URINE HE SAID. EVER SINCE THEN HE CATHS NIGHTLY PER HIS UROLOGIST AND WAS TOLD TO MONITOR SO HE GETS OUT BETWEEN 50-100ML NIGHTLY WHICH HIS UROLOGIST IS HAPPY WITH. THROUGHOUT THE DAY HE VOIDS ON HIS OWN. HE MAKES SURE TO STAY WELL HYDRATED. HE HAS REGULAR BOWEL MOVEMENTS. HIS WIFE TYPICALLY CATHS FOR HIM AND SHE WASHES HER HANDS PRIOR TO CATHING. MAKES SURE THE CATHETER STAYS STERILE AND DOES WIPE MEATUS WITH AN ANTIBACTERIAL WIPE PRIOR TO PLACEMEN
Patient problems: Urinary Tract Infection
MAUDE report 14619741 ↗InjuryMar 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
END USER REPORTS "HE THINKS THE CATHETERS HE WAS USING WAS A POSSIBLE SOURCE OF HIS MULTIPLE UTIS SPANNING THE LENGTH OF A YEAR. HE REPORTS UNKNOWN NUMBER OF CATHETERS, UNKNOWN NUMBER OF MARKET UNITS WITH UNKNOWN LOT NUMBERS OF THE SAME CATHETER OVER THE LAST 1-2 YEARS. HE STATES THAT HE HAD 4 UTIS EVERY FEW MONTHS SPANNING THE LENGTH OF A YEAR. HIS LAST UTI WAS ABOUT 7-8 MONTHS AGO. HE STATES HE HAD BEEN CATHING FOR A TOTAL OF 3 YEARS AND HE STATES ONLY AFTER STARTING USE OF THE ULTRAM16 HE STARTED DEVELOPING THE UTIS." HE WAS UNABLE TO PROVIDE TIMELINE SPECIFICS WHEN HIS FIRST UTI STARTED AFTER USING THE ULTRAM16. "HIS SIGNS OF UTI WERE ALWAYS DYSURIA AND MALODOROUS URINE. HE SOUGHT MEDICAL TREATMENT WITH EACH OF HIS 4 UTIS AND HE WENT TO HIS LOCAL URGENT CARE WHERE THEY DID URINE TESTING, UA AND URINE C & S AND PRESCRIBED ANTIBIOTICS EACH TIME WHICH HELPED HIS SYMPTOMS. HE FOLLOWED UP WITH HIS UROLOGIST AFTER SO MANY REOCCURRING UTIS AND THE UROLOGIST TOLD HIM THE CATHETERS HE WAS USING COULD BE A POSSIBLE CAUSE OF HIS UTIS." HE CONFIRMED HE WAS ALWAYS "DILIGENT ABOUT HYGIENE AND WASHED HIS HANDS, CLEANSED HIS PENIS PRIOR TO CATH INSERTION AND FOLLOWED PRIOR CLEAN INTERMITTENT C
Patient problems: Discomfort; Urinary Tract Infection
MAUDE report 13741792 ↗MalfunctionNov 3, 2021Material Too Soft/Flexible; Material Too Soft/Flexible
IT WAS REPORTED " THAT THE STEMS AREN'T STIFF ENOUGH." NO HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12744695 ↗InjuryDec 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
INTERMITTENT CATHETER PATIENT (USER) SAID HE GETS RECURRING URINARY TRACT INFECTIONS (UTI'S) CONCURRENT WITH CATHETER USE, AND HAS A BACK STOCK OF CATHETERS BECAUSE HE IS NOT CATHETERIZING AT THE MOMENT. DURING FOLLOW-UP, THE PATIENT SAID HE WAS PRESCRIBED AN ANTIBIOTIC (AMOXICILLIN), TOOK THE FULL COURSE, BUT THE INFECTION WAS NOT RESOLVED UNTIL HE WAS GIVEN A DIFFERENT ANTIBIOTIC (OXYCYCLINE). THE PATIENT HAS RECOVERED.
Patient problems: Urinary Tract Infection
MAUDE report 11097660 ↗InjuryNov 20, 2020Coagulation in Device or Device Ingredient; Coagulation in Device or Device Ingredient
INTERMITTENT CATHETER PATIENT (USER) SAID HE'S BEEN GETTING URINARY TRACT INFECTIONS (UTI) CONCURRENT WITH CATHETER USE, AND HIS DOCTOR BELIEVES IT'S DUE TO HIS BLADDER NOT FULLY EMPTYING. HE SAID HE HAS TROUBLE EMPTYING HIS BLADDER WITH THESE CATHETERS BECAUSE IT SEEMS TO HIM THE LUBRICANT BUILDS UP AND BLOCKS IT. DURING FOLLOW-UP, THE PATIENT SAID HE WAS PRESCRIBED ANTIBIOTICS AT AN URGENT CARE CENTER, BUT THE INFECTION WAS NOT RESOLVED AND WAS ADMITTED TO THE HOSPITAL FOR TREATMENT. HE WAS PUT ON INTRAVENOUS (IV) ANTIBIOTICS TO TREAT THE INFECTION, AND THE INFECTION WAS RESOLVED.
Patient problems: Urinary Tract Infection
MAUDE report 10878628 ↗InjuryAug 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
INTERMITTENT CATHETER PATIENT (USER) SAID HE GOT A URINARY TRACT INFECTION (UTI) BACK IN JUNE CONCURRENT WITH CATHETER USE. DURING FOLLOW-UP, THE PATIENT SAID HE WAS PRESCRIBED AN ANTIBIOTIC, TOOK THE FULL COURSE OF 14 DAYS, AND COMPLETELY RECOVERED.
Patient problems: Urinary Tract Infection
MAUDE report 10434153 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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