CURE ULTRA MALE CATHETER ULTRA M14CRecalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 00815947021113), received between Dec 14, 2021 and Jan 29, 2026 — classified as 16 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Sharp Edges” (7 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 28 reports, in the reporter's own words as published by the FDA.

• InjuryJan 29, 2026Adverse Event Without Identified Device or Use Problem

  CONSUMER STATES HE "HAS BEEN CATHING SINCE (B)(6) 2025 WITH THE ULTRAM14C CATHETER. HE JUST PREVIOUSLY HAD PAE PROCEDURE FOR HIS BPH ON (B)(6) 2025. HE HAD A FOLEY POST OP, IT WAS REMOVED AFTER A FEW DAYS AND HE ENDED UP FAILING THAT VOIDING TRIAL. HE SAID A NEW FOLEY WAS PLACED HOWEVER HE ENDED UP GETTING A BAD UTI END OF OCTOBER WITH SHAKING CHILLS AND FEVER FROM IT. HE SAID THAT WAS SUCCESSFULLY TREATED HIS SYMPTOMS OF THAT UTI AND REMOVED AND HE STARTED CIC. HE SAID SINCE HE STARTED CIC HE HAS HAD 2 ADDITIONAL UTIS WITH HIS INTERMITTENT CATHETERS FOLLOWING THE FIRST ONE POST OP WITH THE FOLEY. HIS SYMPTOMS POST FOLEY INFECTION CLEARED WITH ANTIBIOTIC TREATMENT. THEN END OF (B)(6) 2025 HE NOTICED HE HAD CLOUDY URINE THAT WAS FOUL SMELLING AND A URINE CULTURE WAS CHECKED WHICH WAS POSITIVE FOR ENTEROCOCCUS AND HE WAS TREATED WITH MACROBID. HE SAID THE ANTIBIOTIC HELPED A LOT TO CLEAR HIS URINE CLOUDINESS BUT NOT SURE IF IT EVER FULLY CLEARED UP POST TREATMENT. HE SAID HE WENT INTO SEE HIS UROLOGIST LAST THURSDAY BECAUSE HE HAD AN EPISODE WEDNESDAY NIGHT WHERE HE PLACED THE CATHETER IN HIM AND URINE SPRAYED OUT ALL AROUND THE CATHETER AND IT WAS HARD TO INSERT AND UNCOMFORTABLE. H

  Patient problems: Urinary Tract Infection

  MAUDE report 24208631 ↗
• InjuryJan 29, 2026Adverse Event Without Identified Device or Use Problem

  CONSUMER STATES HE "HAS BEEN CATHING SINCE (B)(6) 2025 WITH THE ULTRAM14C CATHETER. HE JUST PREVIOUSLY HAD PAE PROCEDURE FOR HIS BPH ON (B)(6) 2025. HE HAD A FOLEY POST OP, IT WAS REMOVED AFTER A FEW DAYS AND HE ENDED UP FAILING THAT VOIDING TRIAL. HE SAID A NEW FOLEY WAS PLACED HOWEVER HE ENDED UP GETTING A BAD UTI END OF (B)(6) WITH SHAKING CHILLS AND FEVER FROM IT. HE SAID THAT WAS SUCCESSFULLY TREATED HIS SYMPTOMS OF THAT UTI AND REMOVED AND HE STARTED CIC. HE SAID SINCE HE STARTED CIC HE HAS HAD 2 ADDITIONAL UTIS WITH HIS INTERMITTENT CATHETERS FOLLOWING THE FIRST ONE POST OP WITH THE FOLEY. HIS SYMPTOMS POST FOLEY INFECTION CLEARED WITH ANTIBIOTIC TREATMENT. THEN END OF (B)(6) 2025 HE NOTICED HE HAD CLOUDY URINE THAT WAS FOUL SMELLING AND A URINE CULTURE WAS CHECKED WHICH WAS POSITIVE FOR ENTEROCOCCUS AND HE WAS TREATED WITH MACROBID. HE SAID THE ANTIBIOTIC HELPED A LOT TO CLEAR HIS URINE CLOUDINESS BUT NOT SURE IF IT EVER FULLY CLEARED UP POST TREATMENT. HE SAID HE WENT INTO SEE HIS UROLOGIST LAST THURSDAY BECAUSE HE HAD AN EPISODE WEDNESDAY NIGHT WHERE HE PLACED THE CATHETER IN HIM AND URINE SPRAYED OUT ALL AROUND THE CATHETER AND IT WAS HARD TO INSERT AND UNCOMFORTABLE.

  Patient problems: Urinary Tract Infection

  MAUDE report 24208630 ↗
• InjuryOct 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  END USER STATES "HE CATHS DUE TO RETENTION HIS AS HIS BLADDER CANNOT EMPTY ON IT'S OWN NOTING POSSIBLY THE MUSCLE SPHINCTER/ MUSCULAR ISSUE COULD BE THE CAUSE. HE DOES NOT HAVE AN ENLARGED PROSTATE. HE STARTED CATHING ABOUT 3- 4 YRS AGO FOR RETENTION AND HAS USED THIS CATHETER SINCE THEN. HE SAID WHEN HE FIRST STARTED CATHING HE STARTED HAVING FEW UTIS BUT NOT VERY MANY. HE SAID THIS YEAR HE HAS MORE UTIS THAN EVER AND HIS UROLOGIST DOES NOT KNOW WHY HE SAID. HE SAID HE HAD ONE IN (B)(6), THEN (B)(6) (BOTH DIAGNOSED BY URINE SAMPLE AND TREATED WITH ANTIBIOTICS) AND MOST RECENTLY HAD ONE DIAGNOSED ON (B)(6). HE SAID ABOUT 20 DAYS OR SO BEFORE THAT HE HAD BEEN DIAGNOSED WITH A UTI AS WELL. HE SAID HE WAS SYMPTOM FREE FOR 2-3 DAYS AFTER BEING ON 10 DAY COURSE OF BACTRIM (HE KNOWS HE HAS A UTI WHEN SYMPTOM OF MALODOROUS SMELLING URINE, URINE HAS A FISHY VERY STRONG SMELL HE SAID) BEFORE THE SMELL CAME BACK. AS OF ON (B)(6), HIS MD HAS PLACED HIM ON ANOTHER COURSE OF ANTIBIOTICS (NAME CNO) HE IS TAKING NOW, FEELING BETTER. HE SAID WITH THIS CATHETER, MORE RECENTLY THIS STARTED COULD NOT PINPOINT WHEN, OFTEN HAS A FEELING OF "BURNING" AT THE TIP OF HIS PENIS AND POSSIBLY DEVELOPING A SEN

  Patient problems: Urinary Tract Infection

  MAUDE report 23414465 ↗
• InjuryOct 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  END USER STATES "HE CATHS DUE TO RETENTION HIS AS HIS BLADDER CANNOT EMPTY ON IT'S OWN NOTING POSSIBLY THE MUSCLE SPHINCTER/ MUSCULAR ISSUE COULD BE THE CAUSE. HE DOES NOT HAVE AN ENLARGED PROSTATE. HE STARTED CATHING ABOUT 3- 4 YRS AGO FOR RETENTION AND HAS USED THIS CATHETER SINCE THEN. HE SAID WHEN HE FIRST STARTED CATHING HE STARTED HAVING FEW UTIS BUT NOT VERY MANY. HE SAID THIS YEAR HE HAS MORE UTIS THAN EVER AND HIS UROLOGIST DOES NOT KNOW WHY HE SAID. HE SAID HE HAD ONE IN JANUARY, THEN FEBRUARY (BOTH DIAGNOSED BY URINE SAMPLE AND TREATED WITH ANTIBIOTICS) AND MOST RECENTLY HAD ONE DIAGNOSED OCT 22. HE SAID ABOUT 20 DAYS OR SO BEFORE THAT HE HAD BEEN DIAGNOSED WITH A UTI AS WELL. HE SAID HE WAS SYMPTOM FREE FOR 2-3 DAYS AFTER BEING ON 10 DAY COURSE OF BACTRIM ( HE KNOWS HE HAS A UTI WHEN SYMPTOM OF MALODOROUS SMELLING URINE, URINE HAS A FISHY VERY STRONG SMELL HE SAID) BEFORE THE SMELL CAME BACK. AS OF OCT 22ND, HIS MD HAS PLACED HIM ON ANOTHER COURSE OF ANTIBIOTICS (NAME CNO) HE IS TAKING NOW, FEELING BETTER. HE SAID WITH THIS CATHETER, MORE RECENTLY THIS STARTED COULD NOT PINPOINT WHEN, OFTEN HAS A FEELING OF "BURNING" AT THE TIP OF HIS PENIS AND POSSIBLY DEVELOPING A SEN

  Patient problems: Urinary Tract Infection

  MAUDE report 23414463 ↗
• MalfunctionJun 26, 2025Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED " ONE OF THE CATHETERS TIP WAS STICKING OUT OF THE INDIVIDUAL CATHETER PACKAGING AS IT WAS ALREADY OPENED." THE CATHETER WAS NOT USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22342695 ↗
• MalfunctionApr 4, 2025Sharp Edges; Sharp Edges

  END USER REPORTS QTY 1 AFFECTED FROM 1 MU BOX, PART AT THE TIP/ BEGINNING OF CATHETER THAT IS NOT SMOOTH, SCRATCHING HIM WITH USE. HE STATES HE FOUND ANOTHER CATHETER IN A NEW MU FROM HIS 90 DAY SHIPMENT HE JUST GOT WITH THE CONTINUED ISSUE. HE SAID IT SEEMS TO BE ROUGH SCRATCHY PART ON THE RIGHT SIDE OF THE CATHETER NEAR THE TIP AREA OF THE CATHETER. HE DID NOT USE TO PLACE THE LENGTH OF HIS URETHRA TO DRAIN HIS BLADDER AFTER FEELING THIS ISSUE AT THE START OF URETHRA. HE SAID IT FELT SCRATCHY AND HE REMOVED IT, PAIN DISSIPATED QUICKLY WITHOUT INTERVENTION. HE DID NOT KEEP IT AND IT HAS BEEN DISCARDED. END USER REPORTS PAIN OF A SCRATCHY FEELING WITH ATTEMPTED USE. DID NOT CONTINUE TO PLACE AND REMOVED, PAIN DISSIPATED QUICKLY WITHOUT INTERVENTION. NO PHOTO AVAILABLE.

  Patient problems: Pain

  MAUDE report 21773465 ↗
• MalfunctionMar 7, 2025Sharp Edges; Sharp Edges

  END USER REPORTS "PART AT THE TIP/ BEGINNING OF CATHETER THAT IS NOT SMOOTH, SCRATCHING HIM WITH USE." "HE SAID IT FEELS LIKE A "STONE ON THE SIDE GOING INTO" HIM. ONE HE DID NOT USE TO PLACE THE LENGTH OF HIS URETHRA TO DRAIN HIS BLADDER AFTER FEELING THIS ISSUE AT THE START OF URETHRA AND THE OTHER ONE HE DID HAVE TO USE TO FULLY DRAIN/ PLACE THE LENGTH OF HIS URETHRA AS HE WAS AT THE GROCERY STORE, HAD NOTHING ELSE TO CATH WITH/ NEED TO VOID AND HE SAID AFTER USE THE PAIN DID "ALLEVIATE" QUICKLY AFTERWARDS. HE SAID HE WENT REALLY SLOWLY PLACING IT AS WELL AND IS AWARE OF COUDE TIP PROPER PLACEMENT."

  Patient problems: Pain

  MAUDE report 21546331 ↗
• MalfunctionFeb 13, 2025Sharp Edges; Sharp Edges

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

  Patient problems: Unspecified Tissue Injury

  MAUDE report 21373862 ↗
• InjuryJan 17, 2024Off-Label Use; Off-Label Use

  CONSUMERS WIFE STATES SHE CATHS HIM. "HE HAS BEEN CATHING FOR THE LAST 2-3 YRS AND WHEN HE FIRST STARTED CATHING , CATHED EVERY DAY NOW ONLY NEEDED 2-3 X A WEEK. HE HAS AN ENLARGED PROSTATE, SCAR TISSUE IN HIS URETHRA. SHE STATES "HE HAD NOT RECEIVED SUPPLIES FOR SOME TIME NOW SO THEY HAD SOME OLD STOCK OF HIS USUAL ULTRAM14C CATHETERS. THEY USED SOME BEFORE NOTICING THEY WERE EXPIRED AS NOTED THAT THE LUBRICANT WAS NOT VERY LUBRICOUS BUT USED THEM ANYWAY. AFTER USING A FEW FROM THE EXPIRED BOX, HE DEVELOPED UTI SYMPTOMS. HE HAD SOME PAIN WHEN CATHING WITH THESE, ESPECIALLY THROUGH THE SCAR TISSUE AREA IN HIS URETHRA AND THEN BLEEDING/ CLOTS OFF AND ON FOR A FEW DAYS BEFORE SEEKING TREATMENT. SOMETIMES THE BLEEDING WAS UP TO "QUITE A BIT" IN QUANTITY. " SHE STATES "SHE ALWAYS PLACES COUDE TIP IN CORRECTLY." SHE STATED "THEY WENT TO MD AND GOT HIS URINE TESTED WHICH SHOWED A UTI AND HE WAS GIVEN A ROCPHIN INJECTION AND SOME ORAL ANTIBIOTICS FOR 12 DAYS FEELING BETTER NOW, BLEEDING HAS COMPLETELY STOPPED. THE DOCTOR SAID IT WAS LIKELY BECAUSE HE WAS USING THE EXPIRED CATHETERS HE GOT THE UTI." SHE WAS ADVISED TO NEVER USED EXPIRED CATHETERS AND TO CHECK THE DATES PRIOR TO USE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Urinary Tract Infection

  MAUDE report 18527120 ↗
• InjuryOct 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CONSUMER REPORTS HAVING "2 SEPARATE UTIS WITH USE OF THE ULTRAM14C DURING THE BEGINNING OF THIS YEAR (B)(6) 2023, UNKNOWN QTY, UNKNOWN MU, UNKNOWN LOTS." HE STATES EARLIER THIS YEAR HE WAS SENT THE ULTRAM14C INSTEAD AS HE HAD AN ISSUE WITH QUALIFYING FOR HIS CLOSED SYSTEM KITS AND HE GOT 2 UTIS RIGHT AFTER STARTING TO USE THEM. HE THEN QUALIFIED BACK AGAIN FOR THE CLOSED SYSTEMS BUT JUST GOT MORE ULTRAM14C NOW AS HE WAS TOLD BY HIS SUPPLIER HIS CLOSED SYSTEMS ARE "BACKORDERED." HE IS USING THEM NOW AND HAS NO UTI SYMPTOMS BUT WORRIED HE WILL GET MORE UTIS WITHOUT HIS CLOSED SYSTEMS. WHEN HE FIRST USED THESE HE SAID HE GOT A UTI IN (B)(6) 2023 AND THEN ANOTHER IN (B)(6) 2023 WITH TOTAL RESOLVE OF SYMPTOMS IN BETWEEN THESE UTIS FOR ABOUT A MONTH. HE SAID HIS UTI SYMPTOMS ARE HE STARTS TO "FEEL SICK, GETS FREQUENCY VOIDING SMALL AMTS FREQUENTLY." HE GOT HIS URINE TESTED EACH TIME AND ANTIBIOTIC TREATMENTS EACH TIME." HE SAID "HE HAS NO IDEA WHY HE GETS MORE UTIS WHILE USING THE CURE ULTRA AS HE AND HIS WIFE WHO CATH HIM OTHER THAN THE CLOSED SYSTEMS ARE BETTER FOR UTI PREVENTION AND HE "JUST DOESN'T LIKE THEM". EVEN WITH USE OF THE CATHETER THEY ARE CAREFUL WITH HYGIENE AND WEAR GLOVE

  Patient problems: Urinary Tract Infection

  MAUDE report 17984487 ↗
• InjuryOct 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CONSUMER REPORTS HAVING "2 SEPARATE UTIS WITH USE OF THE ULTRAM14C DURING THE BEGINNING OF THIS YEAR (B)(6) AND (B)(6) 2023, UNKNOWN QTY, UNKNOWN MU, UNKNOWN LOTS." HE STATES EARLIER THIS YEAR HE WAS SENT THE ULTRAM14C INSTEAD AS HE HAD AN ISSUE WITH QUALIFYING FOR HIS CLOSED SYSTEM KITS AND HE GOT 2 UTIS RIGHT AFTER STARTING TO USE THEM. HE THEN QUALIFIED BACK AGAIN FOR THE CLOSED SYSTEMS BUT JUST GOT MORE ULTRAM14C NOW AS HE WAS TOLD BY HIS SUPPLIER HIS CLOSED SYSTEMS ARE "BACKORDERED." HE IS USING THEM NOW AND HAS NO UTI SYMPTOMS BUT WORRIED HE WILL GET MORE UTIS WITHOUT HIS CLOSED SYSTEMS. WHEN HE FIRST USED THESE HE SAID HE GOT A UTI IN (B)(6) 2023 AND THEN ANOTHER IN (B)(6) 2023 WITH TOTAL RESOLVE OF SYMPTOMS IN BETWEEN THESE UTIS FOR ABOUT A MONTH. HE SAID HIS UTI SYMPTOMS ARE HE STARTS TO "FEEL SICK, GETS FREQUENCY VOIDING SMALL AMTS FREQUENTLY." HE GOT HIS URINE TESTED EACH TIME AND ANTIBIOTIC TREATMENTS EACH TIME." HE SAID "HE HAS NO IDEA WHY HE GETS MORE UTIS WHILE USING THE CURE ULTRA AS HE AND HIS WIFE WHO CATH HIM OTHER THAN THE CLOSED SYSTEMS ARE BETTER FOR UTI PREVENTION AND HE "JUST DOESN'T LIKE THEM". EVEN WITH USE OF THE CATHETER THEY ARE CAREFUL WITH HYGIENE AND

  Patient problems: Urinary Tract Infection

  MAUDE report 17984485 ↗
• MalfunctionSep 15, 2023Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping

  IT WAS REPORTED, THE BLUE LINE NOT LINING UP TO COUDE TIP, OFF BY ABOUT "20 DEGREES."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17761596 ↗
• MalfunctionSep 15, 2023Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping

  IT WAS REPORTED, THE BLUE LINE NOT LINING UP TO COUDE TIP, OFF BY ABOUT "20 DEGREES."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17761595 ↗
• MalfunctionSep 15, 2023Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping

  IT WAS REPORTED, THE BLUE LINE NOT LINING UP TO COUDE TIP, OFF BY ABOUT "20 DEGREES."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17761594 ↗
• InjuryJun 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  END USER'S WIFE REPORTED HE USED THE ULTRAM14C, QTY 1 FROM 1 MU BOX, LOT UNKNOWN WHICH CAUSED HIM A UTI WHICH LEAD TO SEPSIS AND A 3 DAY HOSPITALIZATION. CONSUMER IS A 70 YEAR OLD MAN AND HAS BEEN CATHING 4-5 X A DAY FOR 4 YRS FROM RETENTION FROM BPH. HE WAS ALWAYS USED TO USING THE BARD MAGIC 3 GO 14 FR COUDE AND HE WAS SENT THE ULTRAM14C AS HIS USUAL CATHETER IS UNAVAILABLE. THIS WAS HIS FIRST AND ONLY TIME USING THIS CATHETER AND HE NOTED IT WAS DIFFICULT TO INSERT DUE TO LUBE FEELING "VERY DRY". WIFE STATED HE HAD A LITTLE BIT OF BLEEDING WITH THAT CATH; FELT LIKE "IT SCRATCHED HIM" DUE TO IT'S DRYNESS IN URETHRA WITH USE AND THEN A "FEW DAYS LATER HE STARTED WITH UTI SYMPTOMS" WHICH PROGRESSED QUICKLY TO CHILLS AND HIGH FEVER. HE WAS BROUGHT TO THE HOSPITAL AND ADMITTED FOR 3 DAYS DIAGNOSED WITH UTI AND SEPSIS FROM IT. SHE SAID THEY KEPT HIM IN HOSPITAL FOR 3 DAYS AS HE HAS SOME OTHER MEDICAL ISSUES. SHE SAID HE THINKS THE USE OF THIS CATHETER, THE URETHRAL INJURY WITH USE COULD HAVE ATTRIBUTED TO THE SEPSIS. SHE SAID THEY KEPT HIM IN THE HOSPITAL AND GAVE HIM IV ANTIBIOTICS AND HE WAS PRESCRIBED AN ORAL ANTIBIOTIC.

  Patient problems: Urinary Tract Infection

  MAUDE report 17139741 ↗
• MalfunctionMay 22, 2023Sharp Edges; Sharp Edges

  CONSUMER STATED "HE HAS USED THIS CATHETER EVER SINCE HE STARTED TO CATH ABOUT 12-14 MONTHS AGO. HE CATHS 2 X DAY, MORNING AND NIGHT FOR RETENTION AS HIS MD EXPLAINED IT IS LIKE HIS "BLADDER COLLAPSED." HE SAID RARELY IN PAST, HE HAS FELT DISCOMFORT AT TIP OF THIS CATHETER WHILE PASSING THROUGH URETHRA BUT NOTHING THAT EVER FELT SHARP LIKE THESE THAT CAUSED BLEEDING FROM THIS BOX WHICH HE SUSPECTED TO BE A DEFECT. HE SAID IT WAS IN NEW YORK RECENTLY FOR TRAVEL AND HE TOOK SOME OF HIS CATHETERS WITH HIM. HE SAID 3 FELT VERY SHARP AT THE VERY TIPS LIKE THEY HAD EXTRA PLASTIC ON THE END THAT WASN'T SMOOTHED OVER. HE "COULD NOT SEE THE DEFECT WITH HIS NAKED EYE" AT ALL BUT HE SAID HE FELT IT WITH USE GOING IN AND IT WAS AT THE "VERY TIP" OF THIS CATHETER AT THE COUDE TIP. HE SAID HE EXPERIENCED BLEEDING WITH 2 OUT OF THE 3 THAT FELT SHARP. WHEN HE REMOVED THE CATHETER IT WAS LIKE HE WAS "CUT INSIDE" AND "BLOOD SQUIRTED ONTO THE FLOOR" UPON REMOVAL. HE DID SAY IT STOPPED RATHER QUICKLY WITHOUT INTERVENTION, DID NOT NEED TO SEEK MEDICAL INTERVENTION. HE IS ALWAYS MINDFUL TO KEEP THE COUDE TIP UPWARDS WHEN HE PASSES THIS CATHETER. HE DOES TAKE CLOPIDOGREL 75MG DAILY AS WELL A BLOOD THINNE

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16975711 ↗
• MalfunctionMay 22, 2023Sharp Edges; Sharp Edges

  CONSUMER STATED "HE HAS USED THIS CATHETER EVER SINCE HE STARTED TO CATH ABOUT 12-14 MONTHS AGO. HE CATHS 2 X DAY, MORNING AND NIGHT FOR RETENTION AS HIS MD EXPLAINED IT IS LIKE HIS "BLADDER COLLAPSED." HE SAID RARELY IN PAST, HE HAS FELT DISCOMFORT AT TIP OF THIS CATHETER WHILE PASSING THROUGH URETHRA BUT NOTHING THAT EVER FELT SHARP LIKE THESE THAT CAUSED BLEEDING FROM THIS BOX WHICH HE SUSPECTED TO BE A DEFECT. HE SAID IT WAS IN NEW YORK RECENTLY FOR TRAVEL AND HE TOOK SOME OF HIS CATHETERS WITH HIM. HE SAID 3 FELT VERY SHARP AT THE VERY TIPS LIKE THEY HAD EXTRA PLASTIC ON THE END THAT WASN'T SMOOTHED OVER. HE "COULD NOT SEE THE DEFECT WITH HIS NAKED EYE" AT ALL BUT HE SAID HE FELT IT WITH USE GOING IN AND IT WAS AT THE THE "VERY TIP" OF THIS CATHETER AT THE COUDE TIP. HE SAID HE EXPERIENCED BLEEDING WITH 2 OUT OF THE 3 THAT FELT SHARP. WHEN HE REMOVED THE CATHETER IT WAS LIKE HE WAS "CUT INSIDE" AND "BLOOD SQUIRTED ONTO THE FLOOR" UPON REMOVAL. HE DID SAY IT STOPPED RATHER QUICKLY WITHOUT INTERVENTION, DID NOT NEED TO SEEK MEDICAL INTERVENTION. HE IS ALWAYS MINDFUL TO KEEP THE COUDE TIP UPWARDS WHEN HE PASSES THIS CATHETER. HE DOES TAKE CLOPIDOGREL 75MG DAILY AS WELL A BLOOD TH

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16975710 ↗
• MalfunctionMay 22, 2023Sharp Edges; Sharp Edges

  CONSUMER STATED "HE HAS USED THIS CATHETER EVER SINCE HE STARTED TO CATH ABOUT 12-14 MONTHS AGO. HE CATHS 2 X DAY, MORNING AND NIGHT FOR RETENTION AS HIS MD EXPLAINED IT IS LIKE HIS "BLADDER COLLAPSED." HE SAID RARELY IN PAST, HE HAS FELT DISCOMFORT AT TIP OF THIS CATHETER WHILE PASSING THROUGH URETHRA BUT NOTHING THAT EVER FELT SHARP LIKE THESE THAT CAUSED BLEEDING FROM THIS BOX WHICH HE SUSPECTED TO BE A DEFECT. HE SAID IT WAS IN NEW YORK RECENTLY FOR TRAVEL AND HE TOOK SOME OF HIS CATHETERS WITH HIM. HE SAID 3 FELT VERY SHARP AT THE VERY TIPS LIKE THEY HAD EXTRA PLASTIC ON THE END THAT WASN'T SMOOTHED OVER. HE "COULD NOT SEE THE DEFECT WITH HIS NAKED EYE" AT ALL BUT HE SAID HE FELT IT WITH USE GOING IN AND IT WAS AT THE "VERY TIP" OF THIS CATHETER AT THE COUDE TIP. HE SAID HE EXPERIENCED BLEEDING WITH 2 OUT OF THE 3 THAT FELT SHARP. WHEN HE REMOVED THE CATHETER IT WAS LIKE HE WAS "CUT INSIDE" AND "BLOOD SQUIRTED ONTO THE FLOOR" UPON REMOVAL. HE DID SAY IT STOPPED RATHER QUICKLY WITHOUT INTERVENTION, DID NOT NEED TO SEEK MEDICAL INTERVENTION. HE IS ALWAYS MINDFUL TO KEEP THE COUDE TIP UPWARDS WHEN HE PASSES THIS CATHETER. HE DOES TAKE CLOPIDOGREL 75MG DAILY AS WELL A BLOOD THINNE

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16975707 ↗
• InjuryDec 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  END USER REPORTS "HE HAS BEEN CATHING FOR 1-2 YEARS FOR RESULTING COMPLICATIONS FROM BACK SURGERY AFFECTING HIS BLADDER'S NERVES ABILITY TO EMPTY. CATHS ABOUT 6 X A DAY. HE SAID HE HAS BEEN DEALING WITH UTIS FOR "SEVERAL MONTHS." HE ALSO KNOWS HE HAS A VERY AGGRESSIVE PROSTATE CANCER, STATING HE HAS A GLEASON SCORE OF 10 AND HE FINISHED 45 ROUNDS OF RADIATION TREATMENT FOR IT THIS PAST JANUARY. HE SAID HE RECENTLY FIRST STARTED HAVING TROUBLE WITH UTIS AND DIFFICULTY PLACING CATHETERS IN URETHRA AND BLEEDING WITH THE BARD MAGIC 3 GO STRAIGHT TIP CATHETERS HE WAS USING AND UNDER HIS MD GUIDANCE THEY SWITCHED HIM TO A COUDE TIP CATHETER, THE ULTRAM14C. HE SAID HE USED "SEVERAL BOXES" OF THIS CATHETER ONLY RECENTLY. HE WAS VERY AWARE ON HOW TO PLACE COUDE TIP PROPERLY IN URETHRA. HE SAID THE ULTRAM14C "WORKED FOR A LITTLE" WHILE BUT THEN HE STARTED NOTICING OFF AND ON BLEEDING WITH CATHING A FEW DAYS AGO WITH USE. MOST NOTABLY, HE SAID LAST SATURDAY WAS WHEN HE NOTICED DIFFICULTY PLACING THE ULTRAM14C AND HE HAD "SEVERE" BLEEDING WITH THAT CATHETERIZATION TO THE POINT OF ALMOST HAVING CLOTS BIG ENOUGH TO CAUSE HIM DIFFICULTY TO VOID NATURALLY WHICH WORRIED HIM ABOUT GOING INTO RETENTI

  Patient problems: Bruise/Contusion; Pain; Urinary Tract Infection

  MAUDE report 16064223 ↗
• InjuryOct 5, 2022Device Handling Problem; Device Handling Problem

  THIS EMDR IS TO ADDRESS THE UNKNOWN LOT NUMBERS. END USER REPORTS "HE HAD A MONTH LONG UTI WHILE USING THESE CATHETERS, THE ULTRAM14C." HE REPORTS UNKNOWN NUMBER OF CATHETERS, UNKNOWN NUMBER OF MARKET UNITS WITH UNKNOWN LOT NUMBERS OF THE SAME CATHETER OVER THE LAST MONTH. HE STATES HE DOESN'T THINK THE CATHETERS ARE THE CAUSE OF HIS UTI HE THINKS HIS TECHNIQUE NEEDS TO GET BETTER TO REDUCE HIS RISK FOR UTI. OVERALL, HE SAID THEY ARE "REALLY GOOD CATHETERS" AND HAS NO COMPLAINTS ABOUT THEM." HE SAID HE HAS RECENTLY TRIED TO GET BETTER ABOUT WASHING HIS HANDS PRIOR TO CATHING AS HE DIDN'T ALWAYS USED TO. HE USES THE NO TOUCH SLEEVE TO KEEP STERILITY OF THE CATHETER BUT HE DOESN'T CLEAN HIS MEATUS PRIOR TO CATHETER INSERTION. HE SAID THIS IS THE WORST UTI HE HAS HAD IN HIS LIFE. HE SAID HE HAD A VERY "LIGHT UTI" WHEN HE FIRST STARTED CATHING THAT JUST HAD MALODOROUS URINE AND THE COLOR WAS OFF. THIS UTI ABOUT A MONTH AGO STARTED OFF WITH INCREASED DRIBBLING, FELT A LOT OF PRESSURE IN BLADDER AND "GOBS OF MUCOUS" WOULD COME OUT. HE SAID HIS TESTICLES ALSO WERE VERY INFLAMED AND SWOLLEN AT BEGINNING OF UTI SYMPTOMS AS WELL HOWEVER THAT IS GETTING BETTER NOW TOO. HE DID SEEK MEDICAL ATT

  Patient problems: Urinary Tract Infection

  MAUDE report 15543556 ↗
• InjuryOct 5, 2022Device Handling Problem; Device Handling Problem

  END USER REPORTS "HE HAD A MONTH LONG UTI WHILE USING THESE CATHETERS, THE ULTRAM14C." HE REPORTS UNKNOWN NUMBER OF CATHETERS, UNKNOWN NUMBER OF MARKET UNITS WITH UNKNOWN LOT NUMBERS OF THE SAME CATHETER OVER THE LAST MONTH. HE STATES HE DOESN'T THINK THE CATHETERS ARE THE CAUSE OF HIS UTI HE THINKS HIS TECHNIQUE NEEDS TO GET BETTER TO REDUCE HIS RISK FOR UTI. OVERALL, HE SAID THEY ARE "REALLY GOOD CATHETERS" AND HAS NO COMPLAINTS ABOUT THEM." HE SAID HE HAS RECENTLY TRIED TO GET BETTER ABOUT WASHING HIS HANDS PRIOR TO CATHING AS HE DIDN'T ALWAYS USED TO. HE USES THE NO TOUCH SLEEVE TO KEEP STERILITY OF THE CATHETER BUT HE DOESN'T CLEAN HIS MEATUS PRIOR TO CATHETER INSERTION. HE SAID THIS IS THE WORST UTI HE HAS HAD IN HIS LIFE. HE SAID HE HAD A VERY "LIGHT UTI" WHEN HE FIRST STARTED CATHING THAT JUST HAD MALODOROUS URINE AND THE COLOR WAS OFF. THIS UTI ABOUT A MONTH AGO STARTED OFF WITH INCREASED DRIBBLING, FELT A LOT OF PRESSURE IN BLADDER AND "GOBS OF MUCOUS" WOULD COME OUT. HE SAID HIS TESTICLES ALSO WERE VERY INFLAMED AND SWOLLEN AT BEGINNING OF UTI SYMPTOMS AS WELL HOWEVER THAT IS GETTING BETTER NOW TOO. HE DID SEEK MEDICAL ATTENTION, URINE TESTING DONE. HE SAID HE HAS BEEN P

  Patient problems: Urinary Tract Infection

  MAUDE report 15543459 ↗
• MalfunctionApr 22, 2022Sharp Edges; Sharp Edges

  END USER'S WIFE STATES ONLY IN THE LAST MONTH SOME OF THE ULTRAM14C CATHETERS, QTY UNKNOWN, FROM SEVERAL MU, UNKNOWN LOT #/S HAD SHARP EDGES AT THE TIP OF THEM, SHE DESCRIBES "LIKE IF YOU WERE TO CUT A LITTLE PIECE OF PLASTIC, LIKE A NIB ON THERE." HER AND HER HUSBAND DID THINK IT WAS A MANUFACTURE DEFECT AFTER THEY REALIZED THIS. SHE SAID SOMETIMES HE WOULD NOTICE A FEW "DROPS OF BLOOD" IN HIS UNDERWEAR AFTER CATHING WITH THE AFFECTED CATHETERS. HE ALSO SAID IT WAS A LITTLE PAINFUL GOING IN IN URETHRA WITH THE AFFECTED CATHETERS BUT HE STILL USED THE CATHETERS SINCE IT WASN'T EVERY SINGLE ONE AND BEFORE USE "YOU COULDN'T SEE IT (THE DEFECT) BUT YOU COULD FEEL IT AT THE EDGE." HE IS ON BABY ASPIRIN DAILY 81MG NIGHTLY AS WELL. SHE SAID HE ALSO KNOWS ALWAYS TO PLACE THE COUDE TIP UPWARDS IN PROPER POSITION WHEN CATHING. HE WAS AT THE UROLOGIST LAST WEEK FRIDAY FOR REGULAR FOLLOW UP. HE GETS HIS LUPRON INJECTION EVERY 3 MONTHS AND PROLIA INJECTION FROM HIS UROLOGIST AS HE HAD A PROSTATE CANCER DIAGNOSIS IN 2018 AND HAD UNDERGONE RADIATION FOR THIS WHICH SHE SAID NEGATIVELY AFFECTED "MANY OF HIS INTERNAL ORGANS." SHORTLY AFTER THIS HE WAS DIAGNOSED WITH BLADDER CANCER AND MOST RECE

  Patient problems: Tissue Breakdown

  MAUDE report 14187253 ↗
• MalfunctionMar 4, 2022Degraded; Degraded

  IT WAS REPORTED "PATIENT ADVISED THAT THEY HAVE NO GRIPPER AND ARE NOT LUBRICATE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13668267 ↗
• InjuryMar 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  END USER REPORTS HE "PERFORMS INTERMITTENT URINARY SELF-CATHETERIZATION SEVERAL TIMES A DAY FOR THE PAST SEVERAL YEARS DUE TO NEUROGENIC BLADDER AFTER HE BROKE HIS NECK. HE USES THE MAGC GO CATHETER WHICH IS ON BO AND HE IS CURRENTLY USING SUB ULTRAM14C. UNKNOWN QUANTITY OF ULTRAM14C." END USER STATES "THE COUDE TIP IS AT A DIFFERENT ANGLE THAN THE MAGIC GO AND THE LUBRICANT IS "VERY STICKY" AND THIS CAUSES DISCOMFORT WHEN INSERTED INTO HIS URETHRA. HE DEVELOPED A BURNING FEELING TO THE URETHRA WITH CATHETERIZATION AND VOIDING. HE SAW HIS HCP WHO DID A URINE CULTURE WHICH SHOWED A URINARY TRACT INFECTION UTI" FOR WHICH END USER WAS PRESCRIBED CIPRO ORAL ANTIBIOTIC X 10 DAYS. END USER FURTHER STATES HE IS "WELL AWARE OF HYGENIC STANDARDS" WITH THE CATHETERIZATION PROCEDURE AND DOES NOT FEEL HIS TECHNIQUE RESULTED IN THE UTI. THE BURNING HAS RESOLVED.

  Patient problems: Burning Sensation; Urinary Tract Infection

  MAUDE report 13636884 ↗
• InjuryFeb 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PRODUCT END USER REPORTS URINARY TRACT INFECTION WITH THE USE OF CATHETER. HE STATES HE IS "VERY HAPPY WITH THIS CATHETER", DOES NOT MENTION ANY TECHNIQUE ISSUES WITH CATHETERIZATION. END USER STATES HE "WASHES HIS HANDS WITH SOAP AND WATER PRIOR TO USE AND WHEN HE IS AT HOME AND IT IS CONVENIENT HE USES BETADINE TO CLEANSE URETHRAL OPENING FIRST HE DOES, BUT HAS NOT CONSISTENTLY USED A CLEANSER'. IT IS UNCLEAR IF THE END USER DEVELOPED THESE ALLEGED URINARY TRACT INFECTIONS WHILE NOT USING A CLEANSER? NO MALFUNCTION NOTED WITH THE PRODUCT. PATIENT STATES HE RECEIVED ORAL ANTIBIOTICS TO TREAT THE URINARY TRACT INFECTION. NO PHOTOS RECEIVED.

  Patient problems: Urinary Tract Infection

  MAUDE report 13555154 ↗