CURE CATHETER M14Recalls & reported problems

Summary

The FDA's MAUDE database contains 83 adverse event reports that list this exact device (DI 00815947020031), received between Sep 22, 2017 and Apr 15, 2026 — classified as 23 injuries, 60 malfunctions.

The most frequently reported specific device problem is “Defective Device” (40 reports).

1 other recall cover devices cleared under the same FDA submission (K072539); they may or may not involve this specific model.

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 83 reports, in the reporter's own words as published by the FDA.

• InjuryApr 15, 2026Device Handling Problem

  CONSUMER'S WIFE REPORTS HER HUSBAND HAS HAD "MULTIPLE UTIS IN THE 13 YRS HE HAS USED THIS PRODUCT." SHE STATES HE "HAS HAD UTIS OVER THE YEARS HE HAS CATHED BUT THEY WERE NOT OFTEN. STARTING THIS PAST ON (B)(6) 2025, IS WHEN THEY BECAME RECURRENT. HE RECENTLY HAD A CT WITH CONTRAST WHICH FOUND A DIVERTICULUM AND HE IS GOING TO DISCUSS THIS WITH HIS UROLOGIST AT AN UPCOMING APPT LATER THIS MONTH. MOST RECENTLY OF THIS PAST TUESDAY HIS INTERNIST CHECKED HIS URINE AS HE STATED IT LOOKED VERY "TRASHY" AND THEY FOUND >100CFU OF KLEBSIELLA IN THE URINE CULTURE. HE IS ON A TREATMENT COURSE RIGHT NOW OF KEFLEX FOR 5 DAYS. PRIOR TO DECEMBER WIFE STATES HE HAS HAD MULTIPLE UTIS WITH VARIOUS BACTERIA NOTING A >100 CFU OF ENTEROCOCCUS UTI IN MARCH AND IN FEBRUARY HAD A >100K OF PSEUDOMONAS INFECTION SHE ACTUALLY ADMINISTERED IV ANTIBIOTICS TO HIM FOR 7 DAYS OF MEROPENEM. SHE STATES SINCE DEC - MARCH HE HAS BEEN ON VARIOUS TREATMENT DOSES FROM 5- 7 DAYS OF EITHER MACROBID, KEFLEX AND AMPICILLIN. DURING THAT TIME WAS ALSO ON A LOW DOSE 20 DAY ANTIBIOTIC TREATMENT DOSE (NAME UNKNOWN). HE GETS RELIEF BUT THEN TYPICALLY JUST 4 DAYS OR SO LATER BEING OFF ANTIBIOTICS, HE GETS SYMPTOMATIC ONCE AGAIN.

  Patient problems: Urinary Tract Infection

  MAUDE report 24886235 ↗
• InjuryApr 15, 2026Device Handling Problem

  CONSUMER'S WIFE REPORTS HER HUSBAND HAS HAD "MULTIPLE UTIS IN THE 13 YRS HE HAS USED THIS PRODUCT." SHE STATES HE "HAS HAD UTIS OVER THE YEARS HE HAS CATHED BUT THEY WERE NOT OFTEN. STARTING THIS PAST ON (B)(6) 2025, IS WHEN THEY BECAME RECURRENT. HE RECENTLY HAD A CT WITH CONTRAST WHICH FOUND A DIVERTICULUM AND HE IS GOING TO DISCUSS THIS WITH HIS UROLOGIST AT AN UPCOMING APPT LATER THIS MONTH. MOST RECENTLY OF THIS PAST TUESDAY HIS INTERNIST CHECKED HIS URINE AS HE STATED IT LOOKED VERY "TRASHY" AND THEY FOUND >100CFU OF KLEBSIELLA IN THE URINE CULTURE. HE IS ON A TREATMENT COURSE RIGHT NOW OF KEFLEX FOR 5 DAYS. PRIOR TO DECEMBER WIFE STATES HE HAS HAD MULTIPLE UTIS WITH VARIOUS BACTERIA NOTING A >100 CFU OF ENTEROCOCCUS UTI IN MARCH AND IN FEBRUARY HAD A >100K OF PSEUDOMONAS INFECTION SHE ACTUALLY ADMINISTERED IV ANTIBIOTICS TO HIM FOR 7 DAYS OF MEROPENEM. SHE STATES SINCE DEC - MARCH HE HAS BEEN ON VARIOUS TREATMENT DOSES FROM 5- 7 DAYS OF EITHER MACROBID, KEFLEX AND AMPICILLIN. DURING THAT TIME WAS ALSO ON A LOW DOSE 20 DAY ANTIBIOTIC TREATMENT DOSE (NAME UNKNOWN). HE GETS RELIEF BUT THEN TYPICALLY JUST 4 DAYS OR SO LATER BEING OFF ANTIBIOTICS, HE GETS SYMPTOMATIC ONCE AGAIN.

  Patient problems: Urinary Tract Infection

  MAUDE report 24886232 ↗
• MalfunctionFeb 4, 2026Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED "THE BACKING OFTEN PEELS OFF IN PIECES, RATHER THAN ONE LONG PIECE, MAKING THE PROCESS OF CAUTERIZATION MORE COMPLICATED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24257179 ↗
• MalfunctionJan 9, 2026Sharp Edges

  IT WAS REPORTED "THE PATIENT HAD A CATHETER WHERE THE EYELETS WERE NOT POLISHED AND CUT HIM DURING INSERTION AND CAUSED BLEEDING."

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Laceration(s)

  MAUDE report 24020036 ↗
• MalfunctionAug 21, 2025Sharp Edges; Sharp Edges

  END USER REPORTS HE HAS BEEN USING THIS CATHETER FOR YEARS NOW 2 X DAY FOR RETENTION. HE SAID IN HIS RECENT 3 MONTH ORDER HE FOUND A FEW, ESTIMATES ABOUT 5-10% FROM 6 MU BOXES THAT WERE STICKING TO THE PACKAGING, SPECIFICALLY THE PLASTIC SIDE NEAR THE TIP. HE SAID HE WOULD HAVE TO PULL HARD TO GET THEM OUT. HE STILL USED THEM. HE SAID SOME WOULD FEEL ROUGH, SHARP AT THE SPOT WHERE THEY STUCK TO PACKAGING. HE WOULD ALWAYS APPLY LUBRICANT LIKE HE NORMALLY DOES. HE HAD SOME LIGHT BLEEDING, ONLY AT TIMES WITH USE OF THESE WITH THE ISSUE. NO ADDITIONAL MEDICATIONS/INTERVENTIONS FOR THIS. HE ALSO MENTIONED HE ALSO RECENTLY HAD A LASER PROCEDURE FOR KIDNEY STONES AND HAD A FOLEY FOR A SHORT TIME FOLLOWING THAT PROCEDURE AND SO THOUGHT MAYBE SOME OF THE BLEEDING/ IRRITATION COULD HAVE BEEN FROM THAT AS WELL. HE DID SAY THAT HE WAS USING CATHETERS WITH THIS DEFECT JUST BEFORE AND AFTER FOLEY REMOVAL WHEN HE RESTARTED CIC. NO PHOTO AVAILABLE (THEY WERE USED AND DISCARDED).

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22862084 ↗
• InjuryMar 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  END USER STATES "HE RECENTLY SWITCHED MDS A WEEK OR 2 AGO AND HAD TO DO A ROUTINE ¿URINE SAMPLE¿ WHICH DID SHOW HE HAD A UTI, HOWEVER HE DENIED HAVING ANY OTHER SYMPTOMS OF A UTI OTHER THAN DARKER COLORED URINE. HE SAID HE ALSO HAS A HEAD COLD AND IS RECOVERING FROM THAT NOW. HE WAS GIVEN ANTIBIOTICS (NAME UNKNOWN) FOR THE UTI. HE SAID HE IS NOT BLAMING THIS DEFECT FOR THE FOUND UTI STATING ¿I DON¿T THINK ITS FROM THAT¿ AS HE IS NOT SURE WHAT IT WAS FROM. HE IS PUSHING FLUIDS AND SOME CRANBERRY JUICE STATING HIS URINE IS A BETTER COLOR NOW BUT STILL RECOVERING FROM THE HEAD COLD." END USER SAYS "HE DOES WASH HIS HANDS AND CLEANSES MEATUS WITH A ANTISEPTIC WIPE PRIOR TO INSERTION. HE HAS NEVER HAD A UTI BEFORE." END USER FURTHER STATES "HE IS A C5-6 INCOMPLETE SCI STATES HE IS A ¿WALKING QUAD.¿ HE HAS SENSATION WHEN HE INSERTS CATHETER. HE CATHS 3 X A DAY REGULARLY. HE REGULARLY MEASURES HIS VOLUME OUTPUT AND HIS USUAL VOLUMES ARE 900-1000ML IN AM / 400-500ML IN AFTERNOON AND 400-500ML IN PM. HE IS AWARE HE HAS A LARGE BLADDER CAPACITY DUE TO HIS OVERSTRETCHED BLADDER. HE HAS NOT RELAYED THESE VOLUMES TO HIS MD."

  Patient problems: Urinary Tract Infection

  MAUDE report 21642881 ↗
• MalfunctionSep 23, 2024Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THE "PACKAGE NOT SEALED PROPERLY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20278383 ↗
• InjuryMay 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DISTRIBUTER REPORTS AN END USER GOT A UTI THAT CAUSED HIM TO GO TO THE ER. NO FURTHER INFORMATION OBTAINED/AVAILABLE.

  Patient problems: Urinary Tract Infection

  MAUDE report 16970248 ↗
• MalfunctionMar 29, 2023Difficult to Open or Remove Packaging Material; Difficult to Open or Remove Packaging Material

  CONSUMER REPORTS "HE HAS NOTICED IN HIS MOST RECENT BOX OF M14 CATHETERS THE PAPER IS RIPPING UNEVENLY IN ABOUT QTY 4 IN HIS MOST RECENT MU BOX, LOT UNKNOWN. CONSUMER WANTED TO REMAIN ANONYMOUS TO SUBMIT THIS COMPLAINT, NO FURTHER CONTACT INFO ABLE TO BE OBTAINED OTHER THAN HIS PHONE NUMBER. HE IS NOT NEW TO CATHING AND STATE HE IS PARAPLEGIC. HE SAID HE USED TO USE THE M14 IN THE PAST BUT NEVER HAD ISSUES WITH PAPER PACKAGING TEARING UNEVENLY LIKE NOW." RECENTLY, HE ORDERED MORE M14S AND HE SAID IN HIS NEWEST BOX OF M14 THE PAPER TEARS UNEVENLY ABOUT 1/3RD TO 1/2 WAY DOWN THE THE CATHETER. THE PAPER SIDES ARE STICKING AND NOT LIFTING AND HE IS ONLY LEFT WITH THE UNEVENLY TORN PAPER IN HIS HAND. HE SAID OF THE FIRST 4 HE USED IN THIS NEW BOX THEY ALL TORE THIS WAY AND FINALLY AT HIS 5TH ONE HE SAID IT TORE WELL EVENLY. HE THINKS MAYBE THEY WERE GLUED TO TIGHTLY HE IS NOT SURE. HE SAID HE ALWAYS RIPS THE PACKAGING FROM RIGHT TO LEFT HORIZONTALLY. HE SAID HE DID NOT USE CATHETERS THAT RIPPED UNEVENLY AS HE DIDN'T WANT THE INVISIBLE "PAPER PARTICLES" TO GET ON CATHETER CONTAMINATING IT OR RISK OF CATHETER TOUCHING OUTSIDE UNEVENLY RIPPED PACKAGING UPON REMOVAL PUTTING HIM AT RISK FOR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16639294 ↗
• MalfunctionMar 29, 2023Difficult to Open or Remove Packaging Material; Difficult to Open or Remove Packaging Material

  CONSUMER REPORTS "HE HAS NOTICED IN HIS MOST RECENT BOX OF M14 CATHETERS THE PAPER IS RIPPING UNEVENLY IN ABOUT QTY 4 IN HIS MOST RECENT MU BOX, LOT UNKNOWN. CONSUMER WANTED TO REMAIN ANONYMOUS TO SUBMIT THIS COMPLAINT, NO FURTHER CONTACT INFO ABLE TO BE OBTAINED OTHER THAN HIS PHONE NUMBER. HE IS NOT NEW TO CATHING AND STATE HE IS PARAPLEGIC. HE SAID HE USED TO USE THE M14 IN THE PAST BUT NEVER HAD ISSUES WITH PAPER PACKAGING TEARING UNEVENLY LIKE NOW." RECENTLY, HE ORDERED MORE M14S AND HE SAID IN HIS NEWEST BOX OF M14 THE PAPER TEARS UNEVENLY ABOUT 1/3RD TO 1/2 WAY DOWN THE THE CATHETER. THE PAPER SIDES ARE STICKING AND NOT LIFTING AND HE IS ONLY LEFT WITH THE UNEVENLY TORN PAPER IN HIS HAND. HE SAID OF THE FIRST 4 HE USED IN THIS NEW BOX THEY ALL TORE THIS WAY AND FINALLY AT HIS 5TH ONE HE SAID IT TORE WELL EVENLY. HE THINKS MAYBE THEY WERE GLUED TO TIGHTLY HE IS NOT SURE. HE SAID HE ALWAYS RIPS THE PACKAGING FROM RIGHT TO LEFT HORIZONTALLY. HE SAID HE DID NOT USE CATHETERS THAT RIPPED UNEVENLY AS HE DIDN'T WANT THE INVISIBLE "PAPER PARTICLES" TO GET ON CATHETER CONTAMINATING IT OR RISK OF CATHETER TOUCHING OUTSIDE UNEVENLY RIPPED PACKAGING UPON REMOVAL PUTTING HIM AT RISK FOR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16639285 ↗
• MalfunctionMar 29, 2023Difficult to Open or Remove Packaging Material; Difficult to Open or Remove Packaging Material

  CONSUMER REPORTS "HE HAS NOTICED IN HIS MOST RECENT BOX OF M14 CATHETERS THE PAPER IS RIPPING UNEVENLY IN ABOUT QTY 4 IN HIS MOST RECENT MU BOX, LOT UNKNOWN. CONSUMER WANTED TO REMAIN ANONYMOUS TO SUBMIT THIS COMPLAINT, NO FURTHER CONTACT INFO ABLE TO BE OBTAINED OTHER THAN HIS PHONE NUMBER. HE IS NOT NEW TO CATHING AND STATE HE IS PARAPLEGIC. HE SAID HE USED TO USE THE M14 IN THE PAST BUT NEVER HAD ISSUES WITH PAPER PACKAGING TEARING UNEVENLY LIKE NOW." RECENTLY, HE ORDERED MORE M14S AND HE SAID IN HIS NEWEST BOX OF M14 THE PAPER TEARS UNEVENLY ABOUT 1/3RD TO 1/2 WAY DOWN THE THE CATHETER. THE PAPER SIDES ARE STICKING AND NOT LIFTING AND HE IS ONLY LEFT WITH THE UNEVENLY TORN PAPER IN HIS HAND. HE SAID OF THE FIRST 4 HE USED IN THIS NEW BOX THEY ALL TORE THIS WAY AND FINALLY AT HIS 5TH ONE HE SAID IT TORE WELL EVENLY. HE THINKS MAYBE THEY WERE GLUED TO TIGHTLY HE IS NOT SURE. HE SAID HE ALWAYS RIPS THE PACKAGING FROM RIGHT TO LEFT HORIZONTALLY. HE SAID HE DID NOT USE CATHETERS THAT RIPPED UNEVENLY AS HE DIDN'T WANT THE INVISIBLE "PAPER PARTICLES" TO GET ON CATHETER CONTAMINATING IT OR RISK OF CATHETER TOUCHING OUTSIDE UNEVENLY RIPPED PACKAGING UPON REMOVAL PUTTING HIM AT RISK FOR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16639284 ↗
• MalfunctionMar 29, 2023Difficult to Open or Remove Packaging Material; Difficult to Open or Remove Packaging Material

  CONSUMER REPORTS "HE HAS NOTICED IN HIS MOST RECENT BOX OF M14 CATHETERS THE PAPER IS RIPPING UNEVENLY IN ABOUT QTY 4 IN HIS MOST RECENT MU BOX, LOT UNKNOWN. CONSUMER WANTED TO REMAIN ANONYMOUS TO SUBMIT THIS COMPLAINT, NO FURTHER CONTACT INFO ABLE TO BE OBTAINED OTHER THAN HIS PHONE NUMBER. HE IS NOT NEW TO CATHING AND STATE HE IS PARAPLEGIC. HE SAID HE USED TO USE THE M14 IN THE PAST BUT NEVER HAD ISSUES WITH PAPER PACKAGING TEARING UNEVENLY LIKE NOW." RECENTLY, HE ORDERED MORE M14S AND HE SAID IN HIS NEWEST BOX OF M14 THE PAPER TEARS UNEVENLY ABOUT 1/3RD TO 1/2 WAY DOWN THE CATHETER. THE PAPER SIDES ARE STICKING AND NOT LIFTING AND HE IS ONLY LEFT WITH THE UNEVENLY TORN PAPER IN HIS HAND. HE SAID OF THE FIRST 4 HE USED IN THIS NEW BOX THEY ALL TORE THIS WAY AND FINALLY AT HIS 5TH ONE HE SAID IT TORE WELL EVENLY. HE THINKS MAYBE THEY WERE GLUED TO TIGHTLY HE IS NOT SURE. HE SAID HE ALWAYS RIPS THE PACKAGING FROM RIGHT TO LEFT HORIZONTALLY. HE SAID HE DID NOT USE CATHETERS THAT RIPPED UNEVENLY AS HE DIDN'T WANT THE INVISIBLE "PAPER PARTICLES" TO GET ON CATHETER CONTAMINATING IT OR RISK OF CATHETER TOUCHING OUTSIDE UNEVENLY RIPPED PACKAGING UPON REMOVAL PUTTING HIM AT RISK FOR UTI.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16639282 ↗
• InjurySep 1, 2022Device Handling Problem; Device Handling Problem

  END USER REPORTS THE CATHETERS "ALL HAD A FILM ON THEM." END USER DESCRIBED THE "FILM ON THE CATHETERS TO LOOK LIKE CONDENSATION OR LIKE OIL. HE SAID THEY WERE ALL LIKE THAT HE RECEIVED IN VARYING AMOUNTS ON EACH CATHETER." HE KNEW THAT THEY SHOULDN'T LOOK THIS WAY AS HE WAS USING THESE M14 CATHETERS FOR YEARS PRIOR. "HE SAID HE USED THESE DEFECTED CATHETERS WITHOUT PROBLEMS, STATING HE PLACED LUBE ON THEM PRIOR TO INSERTION AND USED THEM LIKE HE ALWAYS DID. HE SAID HE COULD SEE WHAT LOOKED LIKE THE OIL RESIDUE IN THE TOILET AFTER HE CATHED. HE SAID HE RECENTLY DID GET DIAGNOSED AND TREATED FOR A UTI AND HAS SWOLLEN LEFT TESTICLE BUT HE SAID HE GOT THIS UTI BECAUSE HE WAS WASHING AND REUSING THESE CATHETERS AND IS NOT ALLEGING THE DEFECT CAUSED HIS RECENT UTI. I ADVISED HIM TO NOT WASH AND RE-USE ANY INTERMITTENT CATHETERS. HE CATHS 12-14 X A DAY FOR MANY YEARS. HE HAD A SPINAL CORD DISEASE IN 2001 THAT AFFECTED HIS BLADDER AND HE HAD RETENTION. HE HAD A SNS IMPLANT BUT THAT WAS REMOVED AND NOW HE JUST CATHS HE SAID."

  Patient problems: Urinary Tract Infection

  MAUDE report 15335711 ↗
• InjuryJun 16, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  END USER STATES "I CONTRACTED A UTI AS A RESULT OF CARE MEDICAL'S CATHETERS, IN WHICH SUFFERED HEAT DAMAGES AND BECAME NON STERILE. I HAVE BEEN USING STRAIGHT CATHETERS FOR 4-20 YEARS." NO PHOTO PROVIDED. PER ADDITIONAL INFORMATION PROVIDED FROM THE SUPPLIER, IT WAS STATED "WE WOULD NOT SHIP ANYTHING THAT IS DAMAGED, DUE TO HEAT OR IN ANY OTHER FORM."

  Patient problems: Urinary Tract Infection

  MAUDE report 14713107 ↗
• InjuryMar 31, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  END USER¿S MOM REPORTS TWO DIFFERENT LOTS OF CATHETERS ¿HAVE A WATERY GLUE OR STICKY SYRUP" TYPE OF FILM TOWARDS THE MIDDLE OF THE CATHETERS THAT HAVE CAUSED HER DAUGHTER TO HAVE 2 UTIS. SHE SAID SHE GOT ALL THESE BOXES IN (B)(6) 2021 AND THEY WERE USING THEM THROUGH (B)(6) 2021 BEFORE THEY NOTED THE DEFECT ON ALL OF THEM. IT IS HARD TO SEE AND YOU HAVE TO HOLD THEM TO THE LIGHT TO SEE, SO THIS IS WHY IT WASN'T CAUGHT EARLIER. THEY HAVE BEEN USING THESE CATHETERS FOR THE LAST 6-8 YEARS AND HAVE NEVER HAD THIS ISSUE.¿ SHE SAID ¿RIGHT AFTER THEY GOT THIS SHIPMENT AND SHE STARTED USING THEM SHE NOTED HER DAUGHTER HAD A UTI IN (B)(6) 2021. AT FIRST SHE THOUGHT IT COULD HAVE BEEN THE SOAP TYPE SHE HAD CHANGED TO AS SHE CLEANS HER IRRIGATION SYRINGES SO SHE CHANGED THAT. HER DAUGHTER "IS ALLERGIC TO THE WORLD" SHE SAID. NOTING ALLERGIES TO CORN, DIFFERENT LUBRICANTS THAT HAVE PRESERVATIVES AND HYDROPHILIC CATHETER COATINGS. THEY WENT TO THE LAB AND DID A URINE SPECIMEN AS ORDERED BY THE UROLOGIST AND IT WAS POSITIVE FOR INFECTION. HER SYMPTOMS WERE NAUSEA, CRAMPING, MALODOROUS URINE, HEADACHES AND BACKACHES, NO PAIN AS HER DAUGHTER DOES NOT HAVE MUCH SENSATION BELOW HER WAIST. AN ANTIBIO

  Patient problems: Abdominal Cramps; Headache; Nausea; Urinary Tract Infection

  MAUDE report 13965138 ↗
• InjuryMar 31, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  END USER¿S MOM REPORTS TWO DIFFERENT LOTS OF CATHETERS ¿HAVE A "WATERY GLUE OR STICKY SYRUP" TYPE OF FILM TOWARDS THE MIDDLE OF THE CATHETERS THAT HAVE CAUSED HER DAUGHTER TO HAVE 2 UTIS. SHE SAID SHE GOT ALL THESE BOXES IN (B)(6) 2021 AND THEY WERE USING THEM THROUGH (B)(6) 2021 BEFORE THEY NOTED THE DEFECT ON ALL OF THEM. IT IS HARD TO SEE AND YOU HAVE TO HOLD THEM TO THE LIGHT TO SEE SO THIS IS WHY IT WASN'T CAUGHT EARLIER. THEY HAVE BEEN USING THESE CATHETERS FOR THE LAST 6-8 YEARS AND HAVE NEVER HAD THIS ISSUE.¿ SHE SAID ¿RIGHT AFTER THEY GOT THIS SHIPMENT AND SHE STARTED USING THEM SHE NOTED HER DAUGHTER HAD UTI IN (B)(6) 2021. AT FIRST SHE THOUGHT IT COULD HAVE BEEN THE SOAP TYPE SHE HAD CHANGED TO AS SHE CLEANS HER IRRIGATION SYRINGES SO SHE CHANGED THAT. HER DAUGHTER "IS ALLERGIC TO THE WORLD" SHE SAID. NOTING ALLERGIES TO CORN, DIFFERENT LUBRICANTS THAT HAVE PRESERVATIVES AND HYDROPHILIC CATHETER COATINGS. THEY WENT TO THE LAB AND DID A URINE SPECIMEN AS ORDERED BY THE UROLOGIST AND IT WAS POSITIVE FOR INFECTION. HER SYMPTOMS WERE NAUSEA, CRAMPING, MALODOROUS URINE, HEADACHES AND BACKACHES, NO PAIN AS HER DAUGHTER DOES NOT HAVE MUCH SENSATION BELOW HER WAIST. AN ANTIBIOTI

  Patient problems: Abdominal Cramps; Headache; Nausea; Urinary Tract Infection

  MAUDE report 13965129 ↗
• MalfunctionMar 24, 2022Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED "ONE CATHETER FROM EACH MARKET UNIT WITH THE INDIVIDUAL PACKAGE OPENED. END USER DID NOT USE THE OPENED PRODUCT. HE DISCARDED THEM." EACH MARKET UNIT WAS SEALED UPON RECEIPT. NO LOT NUMBER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13894324 ↗
• MalfunctionMar 24, 2022Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED "ONE CATHETER FROM EACH MARKET UNIT WITH THE INDIVIDUAL PACKAGE OPENED. END USER DID NOT USE THE OPENED PRODUCT. HE DISCARDED THEM." EACH MARKET UNIT WAS SEALED UPON RECEIPT. NO LOT NUMBER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13890361 ↗
• InjuryFeb 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PRODUCT DISTRIBUTOR THAT A PRODUCT END USER HAD EMAILED THAT PATIENT ADVISED THAT HE GOT A "UTI AND WAS HOSPITALIZED". MULTIPLE ATTEMPTS TO COLLECT MORE INFORMATION REGARDING COMPLAINT, PRODUCT LOT NUMBER, AND HARM WITHOUT ANY SUCCESS.

  Patient problems: Urinary Tract Infection

  MAUDE report 13496848 ↗
• MalfunctionFeb 9, 2022Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED BY PARENT OF PATIENT TO THE MEDIAL DEVICE SUPPLIER THAT THE CATHETERS WERE "ROUGH AND BUMPY NOT SMOOTH". A PHOTOGRAPH DEPICTING THE REPORTED COMPLAINT ISSUE WAS RECEIVED BY THE COMPLAINANT. NO HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13496806 ↗
• InjuryJan 20, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  PRODUCT END USER WITH NEOBLADDER AND CATHETERIZES FOUR OR MORE TIMES PER DAY. PRODUCT END USER REPORTS THAT HE DEVELOPED A URINARY TRACT INFECTION AND WAS PRESCRIBED TWO ORAL ANTIBIOTICS. END USER FOLLOWED UP WITH HIS UROLOGIST AND A CYSTOSCOPY WAS PERFORMED AND PER THE END USER THE DOCTOR USED A "SPOON TO CLEAN OUT HIS URETHRA". THE END USER REPORTS DIFFICULTY INSERTING THE PRODUCT. ACCORDING TO THE END USER AFTER THE CYSTOSCOPY AND ANTIBIOTICS HIS URINE WAS TESTED AGAIN AND WAS "FINE". UNABLE TO DETERMINE EXACT MALFUNCTION THAT COULD HAVE LEAD TO THE ALLEGED URINARY TRACT INFECTIONS. NO PHOTOGRAPHS RECEIVED DEPICTING THE REPORTED COMPLAINT ISSUE.

  Patient problems: Urinary Tract Infection

  MAUDE report 13308963 ↗
• InjuryJan 20, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  PRODUCT END USER WITH NEOBLADDER AND CATHETERIZES FOUR OR MORE TIMES PER DAY. PRODUCT END USER REPORTS THAT HE DEVELOPED A URINARY TRACT INFECTION AND WAS PRESCRIBED TWO ORAL ANTIBIOTICS. END USER FOLLOWED UP WITH HIS UROLOGIST AND A CYSTOSCOPY WAS PERFORMED AND PER THE END USER THE DOCTOR USED A "SPOON TO CLEAN OUT HIS URETHRA". THE END USER REPORTS DIFFICULTY INSERTING THE PRODUCT. ACCORDING TO THE END USER AFTER THE CYSTOSCOPY AND ANTIBIOTICS HIS URINE WAS TESTED AGAIN AND WAS "FINE". UNABLE TO DETERMINE EXACT MALFUNCTION THAT COULD HAVE LEAD TO THE ALLEGED URINARY TRACT INFECTIONS. NO PHOTOGRAPHS RECEIVED DEPICTING THE REPORTED COMPLAINT ISSUE.

  Patient problems: Urinary Tract Infection

  MAUDE report 13308596 ↗
• InjuryJan 20, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  PRODUCT END USER WITH NEOBLADDER AND CATHETERIZES FOUR OR MORE TIMES PER DAY. PRODUCT END USER REPORTS THAT HE DEVELOPED A URINARY TRACT INFECTION AND WAS PRESCRIBED TWO ORAL ANTIBIOTICS. END USER FOLLOWED UP WITH HIS UROLOGIST AND A CYSTOSCOPY WAS PERFORMED AND PER THE END USER THE DOCTOR USED A "SPOON TO CLEAN OUT HIS URETHRA". THE END USER REPORTS DIFFICULTY INSERTING THE PRODUCT. ACCORDING TO THE END USER AFTER THE CYSTOSCOPY AND ANTIBIOTICS HIS URINE WAS TESTED AGAIN AND WAS "FINE". UNABLE TO DETERMINE EXACT MALFUNCTION THAT COULD HAVE LEAD TO THE ALLEGED URINARY TRACT INFECTIONS. NO PHOTOGRAPHS RECEIVED DEPICTING THE REPORTED COMPLAINT ISSUE.

  Patient problems: Urinary Tract Infection

  MAUDE report 13308591 ↗
• MalfunctionJan 13, 2022Sharp Edges; Sharp Edges

  THE PRODUCT END USER STATES "SOMETIMES THE CATHETERS ALSO THEN FEEL SHARP AND ARE PAINFUL AS A RESULT". UNKNOWN QUANTITY. NO PHOTOGRAPHS RECEIVED DEPICTING THE REPORTED COMPLAINT ISSUE. NO MEDICAL TREATMENT SOUGHT.

  Patient problems: Pain

  MAUDE report 13256805 ↗
• InjuryJan 10, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  PRODUCT END USER REPORTS DIFFICULTY WITH INSERTION OF CATHETER. THE END USER STATES HE HAS BEEN CATHETERIZING FOR 14 YEARS. HE REPORTS HE BEGAN TO DEVELOP FEVERS AS HIGH AS 102.5 AND FELT ACHY AND HAD BLOOD CLOTS AND TISSUE COMING FROM HIS CATHETERS. HE STATES HE WENT TO MD WHO OBTAINED URINALYSIS WITH CULTURE AND SENSITIVITY, HE BEGAN TAKING A PRESCRIPTION OF SULFA THAT WAS ORDERED FOR ANOTHER ISSUE. THE RESULTS CAME BACK AND HE WAS DIAGNOSED WITH UTI WITH E. COLI AND MACROBID ORAL COURSE WAS ORDERED. NO PHOTOGRAPH DEPICTING THE REPORTED COMPLAINT ISSUE WAS RECEIVED.

  Patient problems: Genital Bleeding; Pain; Urinary Tract Infection

  MAUDE report 13208634 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K072539. One submission often covers many models, so check the product and lot details in each record.

• Z-0004-2013 · Sep 19, 2012 · Terminated
  Male, 16Fr, Straight-tip Intermittent Urinary Catheters M16. The product is distributed individually or in intermediate boxes containing 30 individual, sterile packaged catheters (