CURE ULTRA MALE CATHETER ULTRA M14Recalls & reported problems

Summary

The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 00815947021069), received between Apr 5, 2019 and Dec 2, 2025 — classified as 35 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Device Handling Problem” (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.

Most reported problems

Recent adverse event reports

The 25 most recent of 39 reports, in the reporter's own words as published by the FDA.

• InjuryDec 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED "PATIENT HAS HAD ONGOING UTI FOR THE LAST 1-2 YEARS. INFECTIOUS DISEASE DOCTOR TOLD PATIENT IT'S FROM ON GOING CATHETER USE THAT HAS CAUSED BUILDUP OF BACTERIA. DOCTOR PUT PATIENT ON A LOW DOSE OF ANTIBIOTICS WHICH SEEMS TO BE HELPING."

  Patient problems: Urinary Tract Infection

  MAUDE report 23692082 ↗
• MalfunctionJan 23, 2025Sharp Edges; Sharp Edges

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

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21217704 ↗
• InjuryMar 29, 2024Device Handling Problem; Device Handling Problem

  END USER REPORTS HE WAS FOUND TO HAVE A "KIDNEY INFECTION" UTI WITH RECENT CATHETER USE. CONSUMER IS AN 87 YEAR OLD MALE, SAID HE HAS BEEN CATCHING FOR 4 - 5 YEARS, 3 X A DAY FOR BPH. HE REPORTS THIS ONE IS HIS ONLY INFECTION SINCE SWITCHING TO THIS ULTRA PRE-LUBBED CATHETER. HE CANNOT REMEMBER WHEN HE STARTED USING THE ULTRA BUT IT HAS BEEN A WHILE. HE SAID HE HAS NEARLY COMPLETED THE ANTIBIOTICS (ORAL) HE WAS GIVEN DOES NOT KNOW NAMES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Urinary Tract Infection

  MAUDE report 19004481 ↗
• InjuryMar 27, 2024Device Handling Problem; Device Handling Problem

  END USER REPORTED, HE RECENTLY WAS DIAGNOSED WITH A UTI AS HE HAD BLEEDING WITH CATHING THAT LASTED SAID 4 -5 DAYS. HE SAID HE HAD BLEEDING AFTER MEETING SOME RESISTANCE RIGHT BEFORE ENTERING HIS BLADDER WITH THE CATHETER AND IT GOT IRRITATED STARTED BLEEDING. HE WENT INTO MD OFFICE AFTER THOSE 4 OR 5 DAYS OF BLEEDING AND THEY DID A CYSTOSCOPY AND HE SAID THEY CAUTERIZED THE AREA THAT WAS BLEEDING. THEY ALSO DIAGNOSED HIM WITH A UTI. HIS MD STARTED HIM ON DAILY GENTAMICIN INSTALLATIONS HE PLACES HIS IN BLADDER. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Urinary Tract Infection

  MAUDE report 18985776 ↗
• MalfunctionJun 15, 2023Sharp Edges; Sharp Edges

  END USER STATES WITH THESE CATHETERS HE WOULD NOTE HURT WITH INSERTION AND HE WOULD SEE BLOOD AT THE TIP OF THE CATHETER UPON RETRACTION. IT WAS A SMALL AMOUNT ON ON CATHETER TIP AND WOULD STOP IMMEDIATELY. HE SAID THE TIPS OF THOSE FELT "TOO SHARP ON THE END" COMPARED TO THE OTHERS HE HAD USED AND THINKS THEY CUT HIM INSIDE URETHRA. HE SAID THE DEFECT WAS VISIBLE AFTER EXAMINATION. THIS EMDR IS TO ADDRESS SHARP EDGES.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Tissue Breakdown

  MAUDE report 17135509 ↗
• InjuryJun 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  END USER REPORTS "DISCOMFORT WITH EACH USE DUE TO THICKER LUBRICATION WHICH COULD HAVE POSSIBLY ATTRIBUTED TO DIAGNOSED UTI THIS MONTH WHILE USING THIS THE LAST MONTH'S TIME - HE IS ON HIS 2ND MU BOX HE SAID." HE SAID HE "CATHS 3 X A DAY FOR THE LAST COUPLE YEARS FROM RETENTION FROM BLADDER ENLARGEMENT/ MUSCLE DYSFUNCTION. HE WAS ALWAYS USED TO USING THE BARD MAGIC 3 GO. HE SAID HE JUST STARTED USING THE ULTRAM14 AND SAID THEY FEEL MORE UNCOMFORTABLE FEELING LIKE THEY SOMETIMES "SNAG" AND FEEL HARDER TO PUSH THROUGH THE THICKER LUBRICANT MAKES THEM FEEL LARGER/HARDER FOR TO HIM TO INSERT DESPITE HIM USING ALWAYS THE 14FR SIZE IN HIS USUAL CATHETER. HE SAID IT IS SLOWER PROCESS AND IT TAKES HIM LONGER TIME TO PLACE AND OVERALL MORE UNCOMFORTABLE BUT STATES THEY ARE USABLE. HE SAID HE NEVER HAD THIS DIFFICULTY WITH THE BARD MAGIC 3 GOS. HE DOES NOT THINK THE ULTRAM14 IS DEFECTED IN ANY WAY, JUST NOT HIS PREFERENCE. HE IS NOT SURE THIS DISCOMFORT WITH USE COULD HAVE LEAD TO A RECENT UTI BUT IT COULD HAVE. HE SAID EARLIER THIS MONTH WHILE HE WAS USING THE ULTRAM14 HE STARTED FEELING PAIN IN HIS KIDNEY AND SO HE WENT TO HIS PRIMARY CARE MD WHO CHECKED HIS URINE WITH UA/ URINE CULTURE AN

  Patient problems: Urinary Tract Infection

  MAUDE report 17133891 ↗
• InjuryJun 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  END USER REPORTS "DISCOMFORT WITH EACH USE DUE TO THICKER LUBRICATION WHICH COULD HAVE POSSIBLY ATTRIBUTED TO DIAGNOSED UTI THIS MONTH WHILE USING THIS THE LAST MONTH'S TIME - HE IS ON HIS 2ND MU BOX HE SAID." HE SAID HE "CATHS 3 X A DAY FOR THE LAST COUPLE YEARS FROM RETENTION FROM BLADDER ENLARGEMENT/ MUSCLE DYSFUNCTION. HE WAS ALWAYS USED TO USING THE BARD MAGIC 3 GO. HE SAID HE JUST STARTED USING THE ULTRAM14 AND SAID THEY FEEL MORE UNCOMFORTABLE FEELING LIKE THEY SOMETIMES "SNAG" AND FEEL HARDER TO PUSH THROUGH THE THICKER LUBRICANT MAKES THEM FEEL LARGER/HARDER FOR TO HIM TO INSERT DESPITE HIM USING ALWAYS THE 14FR SIZE IN HIS USUAL CATHETER. HE SAID IT IS SLOWER PROCESS AND IT TAKES HIM LONGER TIME TO PLACE AND OVERALL MORE UNCOMFORTABLE BUT STATES THEY ARE USABLE. HE SAID HE NEVER HAD THIS DIFFICULTY WITH THE BARD MAGIC 3 GOS. HE DOES NOT THINK THE ULTRAM14 IS DEFECTED IN ANY WAY, JUST NOT HIS PREFERENCE. HE IS NOT SURE THIS DISCOMFORT WITH USE COULD HAVE LEAD TO A RECENT UTI BUT IT COULD HAVE. HE SAID EARLIER THIS MONTH WHILE HE WAS USING THE ULTRAM14 HE STARTED FEELING PAIN IN HIS KIDNEY AND SO HE WENT TO HIS PRIMARY CARE MD WHO CHECKED HIS URINE WITH UA/ URINE CULTURE AN

  Patient problems: Urinary Tract Infection

  MAUDE report 17133832 ↗
• InjuryJun 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  END USER STATES "HE WAS USED TO USING THE MAGIC 3 GO CATHETERS AND THOSE WENT ON BACKORDER. HE IS NOT NEW TO CATHING AND HAS BEEN CATHING 3 X A DAY FOR ABOUT 1.5 YRS DUE TO RETENTION FROM AN UNKNOWN CAUSE. HE HAS HAD MULTIPLE UTIS IN THE PAST EVEN WHILE CATHING WITH HIS BARD MAGIC 3 GO CATHETERS. HE WAS SENT THE ULTRAM14 TO USE INSTEAD AND HAD BEEN USING THEM FOR A LITTLE OVER A MONTH OK BUT A FEW TIMES, ABOUT "2 OR 3 TIMES" WITH THESE CATHETERS HE WOULD NOTE HURT WITH INSERTION AND HE WOULD SEE BLOOD AT THE TIP OF THE CATHETER UPON RETRACTION. IT WAS A SMALL AMOUNT ON ON CATHETER TIP AND WOULD STOP IMMEDIATELY. HE SAID THE TIPS OF THOSE FELT "TOO SHARP ON THE END" COMPARED TO THE OTHERS HE HAD USED AND THINKS THEY CUT HIM INSIDE URETHRA. HE SAID THE DEFECT WAS VISIBLE AFTER EXAMINATION. HE DOES NOT HAVE THEM ANYMORE, LOTS UNAVAILABLE. HE SAID SHORTLY AFTER THIS HAPPENED HIS URINE STARTED TO SMELL VERY BAD AND THEN HIS SYMPTOMS PROGRESSED TO A HIGH FEVER ( COULD NOT RELAY HOW HIGH), VOMITING, DIARRHEA AND PAIN. HE WAS HOSPITALIZED AND TREATED AT BETHESDA HOSPITAL IN OHIO FOR 7 DAYS, DIAGNOSED WITH A UTI AND CURRENTLY HAS BEEN WEARING A FOLEY CATHETER FOR ABOUT A MONTH NOW AND HAS V

  Patient problems: Urinary Tract Infection

  MAUDE report 17133786 ↗
• InjuryJun 2, 2023Device Handling Problem; Device Handling Problem

  END USER REPORTS "HE HAS BEEN CATHING 3-4 TIMES A DAY FOR THE LAST 4.5 YRS. HE WAS USED TO USING THE BARD MAGIC 3 GO FOR THE LAST 3.5 YEARS HOWEVER, IT WAS RECALLED/ UNAVAILABLE SO IN (B)(6) 2023 HIS SUPPLIER SENT HIM A SHIPMENT OF THESE ULTRA CATHETERS. HE SAID THEY WERE VERY HARD FOR HIM TO KEEP HIS HAND ON THE SMALLER LENGTH GRIPPER COMPARED TO WHAT HE WAS USE TO USING. HARD FOR HIM TO HOLD ONTO AS HE WOULD PLACE THEM INTO HIS URETHRA TO DRAIN HIS BLADDER. OFTEN, HE WOULD SLIP DESPITE "TRYING HIS BEST NOT TO TOUCH IT" AND HIS HAND WOULD TOUCH THE CATHETER AND CONTAMINATE THE CATHETER WHILE INSERTING. HE SAID HIS PREVIOUS CATHETER HAD A LONGER SLEEVE ABOUT 1.5 INCHES LONG THAT WAS EASIER FOR HIM TO HOLD ONTO. HE SAID HE NORMALLY GETS UTIS ABOUT 1-2 X A YEAR EVEN WITH OTHER CATHETERS. HE SAID 3 DAYS AFTER USING THIS ULTRA CATHETER FOR THE FIRST TIME IN (B)(6) HE STARTED HAVING HIS USUAL UTI SYMPTOMS OF URGENCY, FREQUENCY, "FLU-LIKE SYMPTOMS OF LOW GRADE FEVERS 100.4F", CHILLS, CLOUDY URINE. HE WENT TO MD AND THEY DID URINE TESTING AND IT WAS DEEMED HE HAD A UTI WAS GIVEN LEVOFLOXACIN AND WITHIN A FEW DAYS HIS SYMPTOMS WERE GONE. AGAIN THIS MONTH IN (B)(6) 2023, AT THE BEGINNING OF

  Patient problems: Urinary Tract Infection

  MAUDE report 17051166 ↗
• InjuryJun 2, 2023Device Handling Problem; Device Handling Problem

  END USER REPORTS "HE HAS BEEN CATHING 3-4 TIMES A DAY FOR THE LAST 4.5 YRS. HE WAS USED TO USING THE BARD MAGIC 3 GO FOR THE LAST 3.5 YEARS HOWEVER, IT WAS RECALLED/ UNAVAILABLE SO IN (B)(6) 2023 HIS SUPPLIER SENT HIM A SHIPMENT OF THESE ULTRA CATHETERS. HE SAID THEY WERE VERY HARD FOR HIM TO KEEP HIS HAND ON THE SMALLER LENGTH GRIPPER COMPARED TO WHAT HE WAS USE TO USING. HARD FOR HIM TO HOLD ONTO AS HE WOULD PLACE THEM INTO HIS URETHRA TO DRAIN HIS BLADDER. OFTEN, HE WOULD SLIP DESPITE "TRYING HIS BEST NOT TO TOUCH IT" AND HIS HAND WOULD TOUCH THE CATHETER AND CONTAMINATE THE CATHETER WHILE INSERTING. HE SAID HIS PREVIOUS CATHETER HAD A LONGER SLEEVE ABOUT 1.5 INCHES LONG THAT WAS EASIER FOR HIM TO HOLD ONTO. HE SAID HE NORMALLY GETS UTIS ABOUT 1-2 X A YEAR EVEN WITH OTHER CATHETERS. HE SAID 3 DAYS AFTER USING THIS ULTRA CATHETER FOR THE FIRST TIME IN (B)(6) HE STARTED HAVING HIS USUAL UTI SYMPTOMS OF URGENCY, FREQUENCY, "FLU-LIKE SYMPTOMS OF LOW GRADE FEVERS 100.4F", CHILLS, CLOUDY URINE. HE WENT TO MD AND THEY DID URINE TESTING AND IT WAS DEEMED HE HAD A UTI WAS GIVEN LEVOFLOXACIN AND WITHIN A FEW DAYS HIS SYMPTOMS WERE GONE. AGAIN THIS MONTH IN (B)(6) 2023, AT THE BEGINNING OF

  Patient problems: Urinary Tract Infection

  MAUDE report 17050345 ↗
• InjuryMay 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  END USER REPORTS THIS YEAR, 'HE HAD A FEW TIMES THAT HE FELT LIKE HE WAS IN RETENTION / COULD FEEL HE WAS DISTENDED WITH URINE AND NEEDED TO CATH. FOLLOWING EACH CATH HE DID, HE SAID HE GOT A UTI. HE GOT HIS FIRST UTI IN (B)(6) 2023 AND NOW RECENTLY JUST A FEW WEEKS AGO A SECOND ONE. HE SAID HE DID GET URINE TESTING DONE EACH TIME, FIRST IN FEBRUARY AND IT WAS DEEMED A UTI AND GIVEN ANTIBIOTICS, NAME UNKNOWN. HE SAID A RECHECK OF HIS URINE SHOWED HE HAD CLEARED THE UTI AFTER THE ANTIBIOTIC COURSE. THE SECOND UTI RECENTLY WAS AGAIN SAME SYMPTOMS AND SAME THING HE WENT TO DO URINE TESTING, IT WAS ALSO DEEMED A UTI WAS FOUND AND HE SAID HE GOT ANOTHER ROUND OF ANTIBIOTICS NAME UNKNOWN HE JUST COMPLETED. HE SAID BOTH TIMES THE ANTIBIOTICS MADE HIS SYMPTOMS GO AWAY RATHER QUICKLY. HE HAS SINCE STOPPED CATHING, HAS NOT NEEDED TO, HE SAID MD AWARE.' THIS EMDR COVERS THE 2ND UTI FROM UNKNOWN LOT.

  Patient problems: Urinary Tract Infection

  MAUDE report 16966401 ↗
• InjuryMay 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  END USER REPORTS THIS YEAR, 'HE HAD A FEW TIMES THAT HE FELT LIKE HE WAS IN RETENTION / COULD FEEL HE WAS DISTENDED WITH URINE AND NEEDED TO CATH. FOLLOWING EACH CATH HE DID, HE SAID HE GOT A UTI. HE GOT HIS FIRST UTI IN (B)(6) 2023 AND NOW RECENTLY JUST A FEW WEEKS AGO A SECOND ONE. HE SAID HE DID GET URINE TESTING DONE EACH TIME, FIRST IN FEBRUARY AND IT WAS DEEMED A UTI AND GIVEN ANTIBIOTICS, NAME UNKNOWN. HE SAID A RECHECK OF HIS URINE SHOWED HE HAD CLEARED THE UTI AFTER THE ANTIBIOTIC COURSE. THE SECOND UTI RECENTLY WAS AGAIN SAME SYMPTOMS AND SAME THING HE WENT TO DO URINE TESTING, IT WAS ALSO DEEMED A UTI WAS FOUND AND HE SAID HE GOT ANOTHER ROUND OF ANTIBIOTICS NAME UNKNOWN HE JUST COMPLETED. HE SAID BOTH TIMES THE ANTIBIOTICS MADE HIS SYMPTOMS GO AWAY RATHER QUICKLY. HE HAS SINCE STOPPED CATHING, HAS NOT NEEDED TO, HE SAID MD AWARE.'

  Patient problems: Urinary Tract Infection

  MAUDE report 16957030 ↗
• MalfunctionApr 21, 2023Sharp Edges; Sharp Edges

  AN END USER REPORTED THAT "1 OR 2" IN HIS PREVIOUS 3 MONTH ORDER OF CATHETERS HAD ROUGHNESS NOTED NEAR THE TIP AREA IN ONE SPOT BY THE EYELETS AREA. HE SAID HE COULD NOT SEE POSSIBLE DEFECT PRIOR TO USE BUT COULD FEEL IT JUST A LITTLE ROUGH SPOT ONLY UPON INSERTION IN URETHRA AND THEN AFTERWARDS HE FELT THE CATHETER WITH HIS HAND AFTER USE AND NOTED THIS ROUGH SPOT AREA NEAR TIP BY EYELET AREA. NO HARM AT ALL EXPERIENCED, NO PAIN, NO BLEEDING AT ALL WITH USE OF THESE WITH ROUGH SPOT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16792053 ↗
• InjuryApr 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CONSUMER STATED 'SHORTLY AFTER STARTING IN (B)(6) 2022 THESE CATHETERS HE DID DEVELOP A UTI HE WAS SEEN IN ER FOR. HE SAID HE CANNOT BE SURE IF IT WAS THIS CATHETER THAT CAUSED IT OR SOMETIMES ELSE LIKE HIM ACCIDENTLY TOUCHING IT WITH HANDS THAT MAY HAVE BEEN UNCLEAN WHILE CATHING. HE SAID THE MD AT THE ER "ATTRIBUTED IT TO THE FRICTION TO HIS URETHRA FROM THIS CATHETER" HE SAID HIS URINE WAS CHECKED IN ER AND IT WAS POSITIVE FOR BACTERIA AND HE WAS GIVEN ORAL ANTIBIOTICS AND FELT BETTER'.

  Patient problems: Urinary Tract Infection

  MAUDE report 16682795 ↗
• InjuryApr 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  END USER STATES HE HAS USED THIS CATHETER SINCE (B)(6) 2022. HE CATHS 2 X A DAY FOR RETENTION AND PREVENTION OF HYDROPNEHPROSIS. HE STATES "MANY YEARS AGO HE HAD SYSTEMIC VASCULARITIS AND WAS ON A MEDICINE CALLED CYSTOTOXIN WHICH AFFECTED HIS BLADDER LINING AND HE DEVELOPED BLADDER CANCER." HE MENTIONS THAT "SINCE HE HAS STARTED CATHING IN HIS LIFE SINCE (B)(6) 2022 HE HAS GOTTEN "4 OR 5 UTIS". HE SAID IT IS DUE TO RESISTANT BACTERIA HE HAS IN HIS BLADDER. HE SPECIFICALLY SAID HE DOES NOT THINK IT IS THE FAULT OF THIS CATHETER AT ALL. HE SAID LATELY HE HAS BEEN DOING "PRETTY GOOD" RECENTLY AND HIS LAST UTI WAS A FEW WEEKS AGO. HIS SYMPTOMS ARE TYPICALLY BURNING, URGENCY AND LEAKAGE. MOST OF THE TIME HE GOES IN FOR A UA AND URINE CULTURE AND GETS PRESCRIBED AN ANTIBIOTIC. HIS LAST UTI HE SAID THEY DID NOT HAVE HIM DO THAT AND JUST PRESCRIBED HIM MEDICATION ON THE PHONE AS IT WAS A WEEKEND CALL. HE MENTIONED HE HAS HAD THE ANTIBIOTIC BACTRIM TWICE AND THEN THEY HAD TO SWITCH ANTIBIOTICS AFTER ONE OF HIS PAST URINE CULTURES AND HE DIDN'T HAVE PROBLEMS AFTER THAT. HE COULD NOT REMEMBER NAMES OF THE OTHER ANTIBIOTICS. HE SAID HE IS CAREFUL IN WIPING DOWN HIS HANDS AND OUTER PACKAGING OF

  Patient problems: Urinary Tract Infection

  MAUDE report 16664181 ↗
• InjuryApr 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  END USER STATES HE HAS USED THIS CATHETER SINCE (B)(6) 2022. HE CATHS 2 X A DAY FOR RETENTION AND PREVENTION OF HYDRONEPHROSIS. HE STATES "MANY YEARS AGO HE HAD SYSTEMIC VASCULARITIS AND WAS ON A MEDICINE CALLED CYTOTOXIN WHICH AFFECTED HIS BLADDER LINING AND HE DEVELOPED BLADDER CANCER." HE MENTIONS THAT "SINCE HE HAS STARTED CATHING IN HIS LIFE SINCE (B)(6) 2022 HE HAS GOTTEN "4 OR 5 UTIS". HE SAID IT IS DUE TO RESISTANT BACTERIA HE HAS IN HIS BLADDER. HE SPECIFICALLY SAID HE DOES NOT THINK IT IS THE FAULT OF THIS CATHETER AT ALL. HE SAID LATELY HE HAS BEEN DOING "PRETTY GOOD" RECENTLY AND HIS LAST UTI WAS A FEW WEEKS AGO. HIS SYMPTOMS ARE TYPICALLY BURNING, URGENCY AND LEAKAGE. MOST OF THE TIME HE GOES IN FOR A UA AND URINE CULTURE AND GETS PRESCRIBED AN ANTIBIOTIC. HIS LAST UTI HE SAID THEY DID NOT HAVE HIM DO THAT AND JUST PRESCRIBED HIM MEDICATION ON THE PHONE AS IT WAS A WEEKEND CALL. HE MENTIONED HE HAS HAD THE ANTIBIOTIC BACTRIM TWICE AND THEN THEY HAD TO SWITCH ANTIBIOTICS AFTER ONE OF HIS PAST URINE CULTURES AND HE DIDN'T HAVE PROBLEMS AFTER THAT. HE COULD NOT REMEMBER NAMES OF THE OTHER ANTIBIOTICS. HE SAID HE IS CAREFUL IN WIPING DOWN HIS HANDS AND OUTER PACKAGING OF H

  Patient problems: Urinary Tract Infection

  MAUDE report 16664178 ↗
• InjuryDec 21, 2022Off-Label Use; Off-Label Use

  END USER REPORTS RECENT PAIN & UTI WITH UNKNOWN NUMBER OF ULTRAM14 CATHETERS. END USER STATES LATELY "HE HAS HAD PAIN ESPECIALLY WITH INSERTION AND RETRACTION OF THIS CATHETER ONLY RECENTLY LAST FEW WEEKS NOTING SMALL AMOUNT OF BLOOD AT TIP OF CATHETER AT RETRACTION OFTEN. BLEEDING IS LIGHT AND STOPS QUICKLY WITHOUT INTERVENTION. PAIN HOWEVER LASTS. HE HAS HAD PAIN WITH CATHETER USE FOR LAST FEW WEEKS RIGHT AROUND THE TIME HE WAS DIAGNOSED WITH A UTI AS WELL. HE SAID WHEN HE STARTED HAVING PAIN IN BLADDER HE HAD A URINE SAMPLE DONE AND HIS MD SAID HE HAD A UTI TO WHICH HE WAS PRESCRIBED 7 DAYS OF 500MG PILLS (NAME UNKNOWN) HE HAD TO TAKE WHICH HELPED HIS PAIN A LITTLE BUT BUT AS SOON AS HE FINISHED THE COURSE HIS SYMPTOMS OF GREATER PAIN RETURNED. HE SAID HE HAS PAIN IN HIS BLADDER AS WELL AS TESTICLE LAST FEW WEEKS. HE SAID HE ONLY HAS 1 TESTICLE AS IN IN THE REMOTE PAST ONE NEEDED TO BE REMOVED AS IT WAS INFECTED DUE TO A COMPLICATION OF CHLAMYDIA. HE SAID HE IS STILL THIS PAIN AND JUST TOOK A TYLENOL TO HELP WITH THE PAIN." HE SAID HE WAS SUPPOSED TO HAVE CYSTOSCOPY ON DEC 1ST DUE TO THIS RECENT PAIN AND RECENT UTI BUT BECAUSE HE COULD NOT GET A RIDE TO HIS UROLOGIST HE COULD NO

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

  MAUDE report 16025459 ↗
• InjuryOct 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  END USER REPORTS UNKNOWN NUMBER OF ULTRA M14 CATHETERS, UNKNOWN QTY, UNKNOWN NUMBER OF MARKET UNITS WITH UNKNOWN LOT NUMBERS OF THE SAME CATHETER OVER THE LAST "COUPLE SHIPMENTS" THAT HE FEELS UPON INSERTION THAT HAVE LITTLE TO NO LUBRICANT WHICH CAUSES LIGHT BLEEDING AND POSSIBLY CONTRIBUTING TO RECENT RECURRING UTIS." HE RELAYED "IN HIS LAST FEW SHIPMENTS HE HAS NOTICED "A LOT" BUT NOT ALL OF THESE CATHETERS HAD LITTLE LUBRICANT TO SOME "NOT HAVING ANY." HE SAID HE HAS VISION DIFFICULTIES AND SO HE CANNOT SEE IT BUT RATHER FEELS IT. WHEN HE TRIED TO USE THEM HE SAID THEY "WOULD GET STUCK ON HIS SKIN" AND HE FURTHER CLARIFIED HE MEANT THEY WOULD GET STUCK IN HIS URETHRA AS THEY LACKED SUFFICIENT LUBRICATION COMPARED TO THESE CATHETERS HE HAD USED IN THE PAST IN PRIOR SHIPMENTS. HE DOES NOT FORCE THEM BUT REMOVES AND APPLIES ADDITIONAL LUBE TO MAKE THEM WORK. HE ALSO HAS NOTICED SOME BLEEDING STARTING IN THE "LAST FEW WEEKS." HE CAN SEE POST CATH WHEN HE DABS MEATUS WITH A GAUZE LIGHT DROPS OF BLOOD THAT STOP QUICKLY, ONLY OCCURS MAYBE "1 OUT OF EVERY 100" TIMES HE FELT CATHETERS WERE DRY CATHETERS HE USED INITIALLY AND THEN HE HAD TO REMOVE TO APPLY MORE LUBRICANT TO. HE LAST HAD

  Patient problems: Urinary Tract Infection

  MAUDE report 15545641 ↗
• InjurySep 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  END USER REPORTS UNKNOWN NUMBER OF ULTRAMM14 CATHETERS, UNKNOWN QTY, UNKNOWN NUMBER OF MARKET UNITS WITH UNKNOWN LOT NUMBERS OF THE SAME CATHETER OVER THE LAST "COUPLE SHIPMENTS" THAT HE FEELS UPON INSERTION THAT HAVE LITTLE TO NO LUBRICANT WHICH CAUSES LIGHT BLEEDING AND POSSIBLY CONTRIBUTING TO RECENT RECURRING UTIS." HE RELAYED "IN HIS LAST FEW SHIPMENTS HE HAS NOTICED "A LOT" BUT NOT ALL OF THESE CATHETERS HAD LITTLE LUBRICANT TO SOME "NOT HAVING ANY." HE SAID HE HAS VISION DIFFICULTIES AND SO HE CANNOT SEE IT BUT RATHER FEELS IT. WHEN HE TRIED TO USE THEM HE SAID THEY "WOULD GET STUCK ON HIS SKIN" AND HE FURTHER CLARIFIED HE MEANT THEY WOULD GET STUCK IN HIS URETHRA AS THEY LACKED SUFFICIENT LUBRICATION COMPARED TO THESE CATHETERS HE HAD USED IN THE PAST IN PRIOR SHIPMENTS. HE DOES NOT FORCE THEM BUT REMOVES AND APPLIES ADDITIONAL LUBE TO MAKE THEM WORK. HE ALSO HAS NOTICED SOME BLEEDING STARTING IN THE "LAST FEW WEEKS." HE CAN SEE POST CATH WHEN HE DABS MEATUS WITH A GAUZE LIGHT DROPS OF BLOOD THAT STOP QUICKLY, ONLY OCCURS MAYBE "1 OUT OF EVERY 100" TIMES HE FELT CATHETERS WERE DRY CATHETERS HE USED INITIALLY AND THEN HE HAD TO REMOVE TO APPLY MORE LUBRICANT TO. HE LAST HAD

  Patient problems: Urinary Tract Infection

  MAUDE report 15510743 ↗
• InjurySep 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  END USER REPORTS UNKNOWN NUMBER OF ULTRAM14 CATHETERS, UNKNOWN QTY, UNKNOWN NUMBER OF MARKET UNITS WITH UNKNOWN LOT NUMBERS OF THE SAME CATHETER OVER THE LAST "COUPLE SHIPMENTS" THAT HE FEELS UPON INSERTION THAT HAVE LITTLE TO NO LUBRICANT WHICH CAUSES LIGHT BLEEDING AND POSSIBLY CONTRIBUTING TO RECENT RECURRING UTIS." HE RELAYED "IN HIS LAST FEW SHIPMENTS HE HAS NOTICED "A LOT" BUT NOT ALL OF THESE CATHETERS HAD LITTLE LUBRICANT TO SOME NOT HAVING ANY. HE SAID HE HAS VISION DIFFICULTIES AND SO HE CANNOT SEE IT BUT RATHER FEELS IT. WHEN HE TRIED TO USE THEM HE SAID THEY "WOULD GET STUCK ON HIS SKIN" AND HE FURTHER CLARIFIED HE MEANT THEY WOULD GET STUCK IN HIS URETHRA AS THEY LACKED SUFFICIENT LUBRICATION COMPARED TO THESE CATHETERS HE HAD USED IN THE PAST IN PRIOR SHIPMENTS. HE DOES NOT FORCE THEM BUT REMOVES AND APPLIES ADDITIONAL LUBE TO MAKE THEM WORK. HE ALSO HAS NOTICED SOME BLEEDING STARTING IN THE "LAST FEW WEEKS." HE CAN SEE POST CATH WHEN HE DABS MEATUS WITH A GAUZE LIGHT DROPS OF BLOOD THAT STOP QUICKLY, ONLY OCCURS MAYBE "1 OUT OF EVERY 100" TIMES HE FELT CATHETERS WERE DRY CATHETERS HE USED INITIALLY AND THEN HE HAD TO REMOVE TO APPLY MORE LUBRICANT TO. HE LAST HAD THI

  Patient problems: Urinary Tract Infection

  MAUDE report 15510680 ↗
• InjurySep 19, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  END USER REPORTS "HE HAS HAD AT LEAST 4 UTIS WITHIN 12 MONTHS." UNKNOWN LOT NUMBER AND MARKET UNIT. PATIENT HAS USED THIS PRODUCT BEFORE. NO ADDITIONAL INFORMATION PROVIDED.¿

  Patient problems: Urinary Tract Infection

  MAUDE report 15446539 ↗
• InjuryMay 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CONSUMER REPORTS HAVING MULTIPLE UTIS WHILE USING THE ULTRAM14. CONSUMER STATES "HIS ONLY CONCERN WITH THESE CATHETERS IS THAT WHEN HE TEARS THEM HE TRIES HIS BEST TO MAKE SURE THE CATHETER ITSELF DOESN'T TOUCH THE SIDES OF THE TORN OUTER UNSTERILE WRAPPING BUT SOMETIMES IT CAN HAPPEN WHICH CAN POSSIBLY CONTRIBUTE TO HIS RECENT UTIS, ABOUT 5 IN THE LAST 12 MONTHS." HE SAID HE WASHES HIS HANDS THOROUGHLY PRIOR TO PLACING GLOVES AND EVEN USES AN ADDITIONAL PAIR OF CLEAN GLOVES PRIOR JUST FOR OPENING THE PACKAGING OF EVERYTHING. HE SAID HE WASHES HIS HANDS AGAIN PRIOR TO PLACING SECOND PAIR OF GLOVES ON THAT COME IN THE KIT. HE MAKES SURE TO USE THE NO TOUCH SLEEVE ON THE CATHETER ITSELF, KEEPS THE CATHETER ITSELF STERILE PRIOR TO INSERTION AND EVEN HAS BOUGHT ADDITIONAL IODINE SWABS TO ALSO CLEAN ON HIS MEATUS PRIOR TO CATHING, IN ADDITION TO THE BZK WIPE. HE ALSO THINKS HIS MEDICAL CONDITIONS CONTRIBUTE TO HIS RECENT BACK TO BACK UTIS, NAMELY HIS KIDNEY STONES. HIS UROLOGIST JUST DID A LITHOTRIPSY PROCEDURE ON HIS 11MM KIDNEY STONE IN HIS LEFT KIDNEY LAST WEEK. FOR 30 DAYS PRIOR TO THAT PROCEDURE HE WAS ON A LOW DOSE ANTIBIOTIC CEFDINIR 300MG TABS STARTED BY HIS INFECTIOUS DISEASE D

  Patient problems: Urinary Tract Infection

  MAUDE report 14497767 ↗
• InjuryMay 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  END USER REPORTING HAVING A UTI WHILE USING THE ULTRAM14 CATHETERS THAT RESULTED IN A 4 DAY HOSPITALIZATION. HE SAID "HE IS AWARE WITH CATHERIZATION HE CAN PUT HIMSELF AT RISK FOR UTI. HE SAID HE WENT INTO THE ER AND WAS ADMITTED INTO THE HOSPITAL LAST SUNDAY AND STAYED 4 DAYS DIAGNOSED WITH A UTI AFTER URINE TESTING (UA AND URINE C & S) DONE AND CONFIRMED UTI. HE SAID HE KNEW HE HAD A UTI BECAUSE HE HAD FREQUENCY TO CATH ABOUT EVERY 20 MIN AND SUDDEN URGENCY. HIS HEART WAS RACING ABOUT 110 BEATS PER MINUTE AS WELL WHICH WAS ANOTHER REASON HE WAS ADMITTED. HE SAID HIS URINE WAS DARKER LOOKING, DENIES ANY BLOOD, AND HAD A FEVER THAT HE REMEMBERS WAS 100.8F. HE IS IMMUNOCOMPROMISED AS HE HAS STAGE 4 CANCER MULTIPLE MYELOMA AS WELL. HE SAID THEY GAVE HIM IV ANTIBIOTICS WHILE HE WAS IN THE HOSPITAL AND HE IS FEELING BETTER NOW. HE REMEMBERS NO ISSUES WITH THE CATHETERS OUT OF HIS USUAL DISCOMFORT HE FEELS WITH EVERY KIND OF BRAND OF CATHETER PLACEMENT IN HIS URETHRA AT TIMES THAT HAS OCCURRED EVER SINCE HE STARTED CATHING 13 YEARS AGO FOR RETENTION. NOTHING HE FELT WAS UNUSUAL WITH THE CATHETERS THEMSELVES OR HIS EXPERIENCE WITH THEM PRIOR TO CATHING PRIOR TO HIS UTI. NO ABNORMALITIES

  Patient problems: Discomfort; Fever; Tachycardia; Urinary Tract Infection

  MAUDE report 14345249 ↗
• InjuryApr 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CONSUMER STATES "ABOUT 2-3 MONTHS AGO ,WHEN HE LAST USED THE ULTRAM14, HE NOTED LIGHT BLEEDING POST CATHS FROM MEATUS - HE USED SEVERAL QTY UNKNOWN FROM SEVERAL MU FROM UNKNOWN LOT #S ABOUT 2-3 MONTHS AGO. HE CATH'S 3 X A WEEK, NOT TO DRAIN, URINE BUT TO KEEP KNOWN URETHRAL SCAR TISSUE OPEN. HE SAID HE HAD A VERY TRAUMATIC CYSTCOPY A FEW YEARS AGO WHEN HE WAS EXAMINED FOR KIDNEY STONES. HE SAID HE STARTED TO HAVE TROUBLE VOIDING AND HIS NEW UROLOGIST EXAMINED HIM WITH ANOTHER CYSTOSCOPY AND FOUND URETHRAL SCAR TISSUE AND ORDERED HIM TO CATH 3 X A WEEK JUST TO KEEP SCAR TISSUE DILATED. ABOUT 2-3 MONTHS AGO HE DID NOTE BLEEDING AFTER EACH USE WITH THESE CATHETERS, JUST A SMALL SPOT OF BLOOD ON A 4X4 GAUZE HE NOTED AS HE CLEANED HIS PENIS POST CATH THAT WOULD COME OUT OF HIS URETHRA THAT WOULD IMMEDIATELY STOP. HE DID NOTICE MORE "DRAG" ON THE CATHETERS THAN HE HAD BEEN FEELING BEFORE WHEN HE PULLED IT OUT. NO BLOOD IN HIS URINE. HE THINKS THESE SIGNS WERE A RETURN OF HIS URETHRAL SCAR TISSUE AND MADE AN APPOINTMENT WITH HIS UROLOGIST TO BE SEEN WITHIN THE NEXT MONTH. HE IS UNSURE IF THIS IS RELATED BUT ALSO STATES HE WAS IN THE ER "ABOUT A MONTH AGO OR A LITTLE OVER" BECAUSE HE ALSO

  Patient problems: Unspecified Tissue Injury; Urinary Tract Infection

  MAUDE report 14251128 ↗
• InjuryMar 31, 2022Device Handling Problem; Device Handling Problem

  END USER REPORTS ¿THESE CATHETERS DIDN'T HAVE ENOUGH LUBRICANT ON THEM TO MAKE THEM COMFORTABLE AND CAUSED HIM TO HAVE A UTI.¿ HE REPORTS UNKNOWN NUMBER OF CATHETERS, UNKNOWN NUMBER OF MARKET UNITS WITH UNKNOWN LOT NUMBERS OF THE SAME CATHETER OVER THE LAST NEARLY 2 MONTHS. HE STATES ¿THIS IS A NEW CATHETER FOR HIM BECAUSE HE CONTACTED HIS SUPPLIER TO CHECK AND SEE IF HE COULD TRY A READY TO USE PRE-LUBRICATED CATHETER. HE IS A LONGTIME CUREM14 USER BEFORE WITHOUT CONCERNS. INSTEAD OF PRE-LUBRICATED ULTRA SAMPLES, HIS ENTIRE 3 MONTH ORDER WAS SWITCHED TO THE ULTRAM14. HE SAID THEY WEREN'T COMFORTABLE WHEN HE STARTED USING THEM AND "BURNED WHEN HE TOOK IT OUT" BUT HE CONTINUED TO USE THEM. HE DOES NOT HAVE THIS DISCOMFORT WITH THE M14. HE SAID THEY SEEMED STIFF AND ALSO NOTED SOME DIFFICULTY IN GETTING THEM IN HIS URETHRA IN GENERAL AND THINKS THIS WAS CAUSE OF A UTI. ABOUT 1 - 2 WEEKS AFTER USING THEM HE DEVELOPED UTI SYMPTOMS SUCH AS FREQUENCY, DYSURIA. HE WAS SEEN BY HIS DOCTORS' PHYSICIAN ASSISTANT AT HIS UROLOGIST OFFICE AND HE WAS TOLD TO "TAKE SOMETHING OVER THE COUNTER" HE CAN'T REMEMBER WHAT IT WAS BUT HE SAID IT DID NOT WORK. HE DID A URINE SPECIMEN BUT HE WAS NOT CONTACTE

  Patient problems: Discomfort; Urinary Tract Infection

  MAUDE report 13965446 ↗