SpeediCath StandardRecalls & reported problems across all models
Coloplast A/S · 9 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 36
- Deaths reported
- 1
- Injuries reported
- 35
- Recalls
- 0
We found 9 models of SpeediCath Standard by Coloplast A/S in the FDA's device registry (GUDID). Together they are named in 36 adverse event reports in the FDA's MAUDE database, received between Nov 16, 2016 and Oct 15, 2025 — classified as 1 death, 35 injuries.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported SpeediCath Standard problems
Device problems
- Adverse Event Without Identified Device or Use Problem20
- Insufficient Device Problem Information5
- Improper or Incorrect Procedure or Method3
- Partial Blockage2
- Sharp Edges2
- Appropriate Device Problem Term/Code Not Available1
- Device Operates Differently Than Expected1
- Difficult to Insert1
Patient problems
- Hemorrhage/Blood Loss/Bleeding15
- Urinary Tract Infection11
- Pain6
- Sepsis6
- Hematuria5
- Blood Loss2
- Exsanguination2
- No Code Available2
SpeediCath Standard models
9 models, most reported first. Each model has its own page with its reports, recalls and device details.
- SpeediCath Standard 28414CATHETER, URETHRAL13 reports
- SpeediCath Standard 28494CATHETER, URETHRAL9 reports
- SpeediCath Standard 28416CATHETER, URETHRAL5 reports
- SpeediCath Standard 28492CATHETER, URETHRAL3 reports
- SpeediCath Standard 28496CATHETER, URETHRAL2 reports
- SpeediCath Standard 28412CATHETER, URETHRAL1 report
- SpeediCath Standard 28484CATHETER, URETHRAL1 death1 report
- SpeediCath Standard 28512CATHETER, URETHRAL1 report
- SpeediCath Standard 28514CATHETER, URETHRAL1 report
Recent SpeediCath Standard adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryOct 15, 2025Inadequate or Insufficient Training; Inadequate or Insufficient Training
THIS COMPLAINT CONCERNS A MALE END USER WHO HAS USED A SPEEDICATH STANDARD CH12 TIEMANN CATHETER. THE END USER HAD BEEN USING CH12 TIEMANN CATHETERS FOR A FEW WEEKS WITHOUT COMPLICATIONS, HOWEVER ONE DAY, DUE TO NOT BEING CLEAR ON WHICH DIRECTION TO INSERT THE CATHETER, HAD EXPERIENCED A LOT OF BLEEDING. THE END USER MENTIONS THAT IT TOOK APPROXIMATELY A DAY FOR THE BLEEDING TO STOP. THE END USER HAD UNDERGONE A CYSTOSCOPY TO INVESTIGATE IF ANY FURTHER UNDERLYING COMPLICATIONS MIGHT HAVE BEEN ASSOCIATED WITH THE ISSUE. WITHOUT THE BENEFIT OF EXAMINATION AND TESTING, COLOPLAST IS PRECLUDED FROM COMMENTING ON THE CONDITION OF THE DEVICE OR THE CAUSE OF THE OCCURRENCE. SHOULD ADDITIONAL FACTS PROMPT US TO ALTER OR SUPPLEMENT ANY INFORMATION OR CONCLUSIONS CONTAINED IN THE ORIGINAL MDR OR IN ANY PRIOR SUPPLEMENTAL REPORTS, A FOLLOW-UP REPORT WILL BE SUBMITTED.
Patient problems: Hemorrhage/Blood Loss/Bleeding; Syncope/Fainting
MAUDE report 23300015 ↗InjuryJul 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE AVAILABLE INFORMATION, THE END USER RECEIVED A COUPLE SAMPLES OF SPEEDICATH AND AFTER USING THEM, HE WAS BLEEDING AND HAD TO BE ADMITTED TO THE HOSPITAL. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 22519522 ↗InjuryJan 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE AVAILABLE INFORMATION, THIS COMPLAINT CONCERNS AN END USER (EU) WHO HAS BEEN USING SC STANDARD MALE CATHETER FOR A FEW MONTHS. THE EU HAS RECEIVED TRAINING IN SELF-CATHETERISATION BY THE DOCTOR AND CATHETERISES ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE EU HAS EXPERIENCED SOME TROUBLE PASSING THE CATHETER AROUND THE PROSTATE AS WELL AS PAIN/DISCOMFORT WHEN INSERTING. A FEW WEEKS AGO, THE EU EXPERIENCED BLEEDING AND REACHED OUT TO THE UROLOGIST. MORE RECENTLY (DATES NOT SPECIFIED), THE EU GOT A BLOOD INFECTION AND WAS ADMITTED TO THE HOSPITAL FOR AROUND A WEEK, WHERE THE EU WAS TREATED WITH IV ANTIBIOTICS.
Patient problems: Hemorrhage/Blood Loss/Bleeding; Pain; Sepsis
MAUDE report 21065069 ↗InjuryMay 21, 2024Sharp Edges; Sharp Edges
ACCORDING TO THE AVAILABLE INFORMATION, A MALE END-USER WAS HOSPITALIZED DUE TO AN INCIDENT WITH A SPEEDICATH STANDARD MALE URINARY CATHETER. THE INCIDENT WAS DESCRIBED TO BE A PUNCTURED PROSTATE, WHICH CAUSED A BLOOD VESSEL TO BURST. THE END-USER EXPERIENCED BLEEDING, AND DIZZINESS AND WAS TREATED UNDER ANAESTHESIA TO CLEAR UP BLOOD AND DEBRIS. HE WAS HOSPITALIZED FOR 3 DAYS AND WERE DISCHARGED WITH AN INDWELLING CATHETER FOR 10-14 DAYS AS WELL AS ANTIBIOTICS, VITAMINS AND IRON PILLS. THE END-USER IS AN EXPERIENCE CATHETER USER AND HAVE USED INTERMITTENT CATHETERS FOR 4 YEARS AND HAS NOT CHANGED HIS INSERTION ROUTINE. HE HAS BENIGN PROSTATIC HYPERPLASIA (BPH) BUT STATED THAT WHEN INSERTING THE CATHETER BEFORE THE INCIDENT HE DID NOT FEEL ANY RESISTANCE AT ALL. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.
Patient problems: Urethral Stenosis/Stricture
MAUDE report 19361090 ↗InjuryMar 4, 2024Partial Blockage; Partial Blockage
ACCORDING TO THE AVAILABLE INFORMATION, THE COMPLAINT DESCRIBED IN (B)(4) CONCERNS A PATIENT WITH BLADDER CANCER WHO EXPERIENCED A TRAUMATIC CATHETERISATION WITH SC STANDARD MALE. FOLLOWING USE OF THE SPEEDICATH CATHETER TO EMPTY THE BLADDER, THE SPEEDICATH CATHETER WAS USED FOR BCG INSTILLATION (AS A TREATMENT FOR THE BLADDER CANCER), WHICH CAUSED BCG SEPSIS AND HOSPITALIZATION OF THE PATIENT. THE RISK OF HARM IS SHORT-TERM, AND THE PATIENT IS NO LONGER HOSPITALIZED.
Patient problems: Sepsis; Tissue Breakdown
MAUDE report 18827347 ↗InjuryApr 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE AVAILABLE INFORMATION, THIS COMPLAINT CONCERNS A MALE END USER WHO STATED HE GOT INFECTED WITH UTI¿S USING COLOPLAST CATHETERS. THE END USER STATED HE WAS HOSPITALIZED AS A RESULT BUT DID NOT PROVIDE ANY INFORMATION IN REGARDS TO THE DATES ADMITTED, TREATMENT RECEIVED, OR LENGTH OF TIME. HE DOES NOT USE THE CATHETERS ANY LONGER. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.
Patient problems: Urinary Tract Infection
MAUDE report 16777480 ↗InjuryApr 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE AVAILABLE INFORMATION, THIS CASE CONCERNS A MALE PATIENT WHO EXPRESSED THAT HE HAD BEEN EXPERIENCING PAIN BOTH BEFORE AND AFTER RECEIVING COLOPLAST CATHETER SAMPLES. THE PAIN CONTINUED AS HE CATHETERIZED. HIS URINE WAS ALSO GOING AROUND THE CATHETER REGARDLESS OF WHICH SIZE HE USED. THE END USER WAS RUSHED TO THE HOSPITAL DUE TO EXCESSIVE PAIN AND AN INFECTION WAS FOUND. THE DR. IS TRYING TO FIGURE OUT HOW THE INFECTION HAPPENED AND IF IT WAS DUE TO THESE SUPPLIES OR SOMETHING UNDERLYING. THE LENGTH OF HOSPITAL STAY AND AFFECTED QUANTITY WERE NOT REPORTED. IT WAS ESTABLISHED THAT THE PATIENT HAS NOT USED THIS PRODUCT BEFORE. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Pain; Urinary Tract Infection
MAUDE report 16762186 ↗InjuryJun 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE AVAILABLE INFORMATION, THIS CASE CONCERNS A MALE END USER WHO WAS HOSPITALIZED DUE TO URINARY TRACT INFECTIONS THAT WERE THOUGHT TO HAVE BEEN CAUSED BY COLOPLAST SPEEDICATH STANDARD (MALE) CATHETERS. THE END USER IS NOT NEW TO USING THESE CATHETERS, BUT IT APPEARS THAT HE HAS TOUCHED THEM UPON INSERTION AND HAS REQUESTED FOR A DIFFERENT TYPE IN WHICH HE DOESN'T NEED TO DO THIS. ATTEMPTS WERE MADE TO THE END USER ON DURATION OF THE HOSPITAL STAY AND THE OUTCOME OF ANY TREATMENT. THESE ATTEMPTS WERE NOT ANSWERED AND NO FURTHER INFORMATION HAS BEEN PROVIDED IN REGARDS TO THIS CASE. END USER WILL BE SENT NEW CATHETERS TO TRY.
Patient problems: Urinary Tract Infection
MAUDE report 14630483 ↗InjuryApr 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE AVAILABLE INFORMATION, THIS COMPLAINT CONCERNS A MALE END USER WHO SUFFERS FROM CHRONIC URINARY RETENTION AND A SIGNIFICANTLY ENLARGED PROSTATE. HE HAS BEEN CATHETERISING FOR 6 YEARS WITH A STRAIGHT TIP CATHETER, BUT DUE TO HIS ENLARGED PROSTATE, HE STARTED USING SPEEDICATH COUDÉ CATHETERS IN (B)(6) 2021, AFTER BEING TRAINED. HE EXPERIENCED BLEEDING EVERY TIME AND WENT TO THE EMERGENCY ROOM TWO TIMES IN (B)(6) (THE FIRST ON (B)(6)2021). THERE WERE NO APPARENT DEFECTS WITH THE USED PRODUCT (E.G., NO SHARP OR ROUGH EDGES, ADEQUATE LUBRICATION), AND IT IS THUS UNLIKELY THAT THE BLEEDING IS RELATED TO A PRODUCT FAILURE. PRIOR TO THE FIRST VISIT, HE HAD LOST 2 PINTS OF BLOOD, WAS DIZZY, BUT DID NOT FAINT. HE RECEIVED A BLOOD TRANSFUSION AND STAYED IN THE HOSPITAL FOR 4 DAYS. HE RECEIVED MEDICATION IN HOPES OF REGAINING BLADDER FUNCTION, HAD A FOLEY CATHETER PLACED, WHICH WAS LATER REMOVED, AND WENT BACK TO INTERMITTENT CATHETERISATION. THE DATE AND LENGTH OF THE SECOND STAY IS NOT KNOWN. ON (B)(6)2022, HE WENT BACK TO USING SPEEDICATH STANDARD STRAIGHT TIP CATHETERS.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 14014344 ↗InjuryApr 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE AVAILABLE INFORMATION, THIS COMPLAINT CONCERNS A MALE END USER WHO SUFFERS FROM CHRONIC URINARY RETENTION AND A SIGNIFICANTLY ENLARGED PROSTATE. HE HAS BEEN CATHETERISING FOR 6 YEARS WITH A STRAIGHT TIP CATHETER, BUT DUE TO HIS ENLARGED PROSTATE, HE STARTED USING SPEEDICATH COUDÉ CATHETERS IN (B)(6) 2021, AFTER BEING TRAINED. HE EXPERIENCED BLEEDING EVERY TIME AND WENT TO THE EMERGENCY ROOM TWO TIMES IN (B)(6) (THE FIRST ON (B)(6) 2021). THERE WERE NO APPARENT DEFECTS WITH THE USED PRODUCT (E.G., NO SHARP OR ROUGH EDGES, ADEQUATE LUBRICATION), AND IT IS THUS UNLIKELY THAT THE BLEEDING IS RELATED TO A PRODUCT FAILURE. PRIOR TO THE FIRST VISIT, HE HAD LOST 2 PINTS OF BLOOD, WAS DIZZY, BUT DID NOT FAINT. HE RECEIVED A BLOOD TRANSFUSION AND STAYED IN THE HOSPITAL FOR 4 DAYS. HE RECEIVED MEDICATION IN HOPES OF REGAINING BLADDER FUNCTION, HAD A FOLEY CATHETER PLACED, WHICH WAS LATER REMOVED, AND WENT BACK TO INTERMITTENT CATHETERISATION. THE DATE AND LENGTH OF THE SECOND STAY IS NOT KNOWN. ON (B)(6) 2022, HE WENT BACK TO USING SPEEDICATH STANDARD STRAIGHT TIP CATHETERS.
Patient problems: Exsanguination
MAUDE report 14014343 ↗InjuryMar 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE AVAILABLE INFORMATION, THIS COMPLAINT CONCERNS A MALE END USER DIAGNOSED WITH BENIGN PROSTATE HYPERPLASIA (BPH) (ENLARGED PROSTATE), CAUSING RETENTION, FOR WHICH HE NEEDS TO USE CATHETERS. HE HAS BEEN USING SC STANDARD COUDÉ (TIEMANN). SOMETIMES, HE IS UNABLE TO GET THE CATHETER AROUND THE PROSTATE, AND SCRATCHES UP AGAINST THE PROSTATE, WHICH CAUSES BLEEDING. UPON REMOVAL, ABOUT 2-3 INCHES OF BLOOD IS SEEN ON THE CATHETER TIP, BUT HE DOES NOT EVER HAVE BLOOD IN HIS URINE, AND NO PROFUSE BLEEDING OCCURS IN BETWEEN CATHETERISATIONS. WHEN HE EXPERIENCES BLEEDING, THIS IS USUALLY ALSO ASSOCIATED WITH DEEP PAIN AND DISCOMFORT. THE PAIN FROM USING THESE CATHETERS LEAVES HIM FEELING TOO RAW AND UNCOMFORTABLE TO CONTINUE USING CATHETERS REGULARLY, AND HE USUALLY HAS TO WAIT A COUPLE OR FEW DAYS BEFORE USING HIS CATHETERS AGAIN. HE HAS A HISTORY OF DEVELOPING A UTI ABOUT EVERY 2 MONTHS OR SO. THE LAST TIME HE SCRATCHED HIS PROSTATE, HE ENDED UP IN THE HOSPITAL DUE TO HAVING A URINARY TRACT INFECTION (UTI) THAT BECAME SEPTIC. HE WAS ADMITTED TO THE HOSPITAL AROUND ON (B)(6)2021 AND WAS DISCHARGED ON (B)(6) 2022. HE HAD A FOLEY CATHETER PLACED AND GOT MEDICATION FOR THE INFE
Patient problems: Hematuria; Sepsis
MAUDE report 13652399 ↗InjuryDec 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE AVAILABLE INFORMATION, THIS COMPLAINT DESCRIBES A (B)(6) -YEAR-OLD MALE END-USER WHO WAS USING SPEEDICATH STANDARD INTERMITTENT CATHETER FOR A CATHETERISATION. HE HAD USED ABOUT 15 CATHETERS, THE OTHERS WITHOUT PROBLEMS, BUT WITH THE LAST ONE HE EXPERIENCED BLEEDING, FOR WHICH HE NEEDED TREATMENT AT THE EMERGENCY ROOM. THE END-USE DESCRIBES THAT HE INSERTS THE CATHETER SLOWLY ON BOTH THE INSERTION AND ON THE WAY OUT OF THE URETHRA, BUT WHEN INSERTING THIS LAST CATHETER, HE FELT LIKE HE HAD TO PUSH THE CATHETER HARD TO GET IT INTO THE BLADDER. HE FELT PAIN AFTER A WHILE. THE AMOUNT OF BLOOD IS STATED TO BE MEASURED BY THE END-USER HIM-SELF TO ABOUT 2 LITERS. THE END-USER WAS AT THE HOSPITAL FOR ABOUT AN HOUR AND AN INDWELLING CATHETER (FOLEY CATHETER) WAS PLACED. HE WILL SEE HIS MEDICAL DOCTOR SOON AND KEEP THE INDWELLING CATHETER UNTIL FURTHER NOTICE. THE END-USER STATES THAT THIS IS THE THIRD TIME HE IS BEING PRESCRIBED INTERMITTENT URINARY CATHETERS AND THE PREVIOUS ATTEMPTS WITH INTERMITTENT CATHETER DID ALSO RESULT IN BLEEDING AND AN INDWELLING CATHETER, BUT THE BLEEDING AT THIS INCIDENT WAS WORSE THAN THE PREVIOUS EVENTS. THE END-USER STATES THAT THE CATHETERS
Patient problems: Exsanguination
MAUDE report 13059731 ↗InjuryDec 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE AVAILABLE INFORMATION, THIS COMPLAINT IS FOR A (B)(6) MALE END-USER. THE END-USER HAD BEEN PERFORMING INTERMITTENT SELF-CATHETERIZATIONS FOR 10 YEARS AND HAD UNTIL RECENTLY USED SELF-CATH COUDÉ (TIEMANN). NOW HE WANTED PRE-LUBRICATED CATHETERS AND WAS SENT SAMPLES OF SPEEDICATH TIEMANN. THE FIRST SPEEDICATH CATHETER HE INSERTED WENT IN SMOOTHLY AND WITHOUT PROBLEMS, BUT THE SECOND WAS PAINFUL AND HE STARTED BLEEDING BEFORE HE ENTERED BLADDER. THE END-USER STATES THAT AFTER THIS HE COULD NOT INSERT ANY CATHETER, SELF-CATH NOR SPEEDICATH, AND HE HAD TO GO TO THE EMERGENCY ROOM. AT THE EMERGENCY ROOM THE STAFF WERE UNABLE TO CATHETERIZE HIM VIA THE URETHRA, AND A PASSAGE TO THE BLADDER VIA THE ABDOMEN WAS CREATED AND AN INDWELLING CATHETER WAS PLACED IN THAT PASSAGE. THE END-USER HAD AN APPOINTMENT WITH HIS UROLOGIST THE DAY AFTER, AND THE UROLOGIST WAS ABLE TO CATHARIZED VIA THE URETHRA. THE UROLOGIST PLACED AN INDWELLING CATHETER VIA THE URETHRA THAT STAYED FOR 14 DAYS. HEREAFTER THE END-USER WAS ABLE TO SELF-CATHETERIZE AGAIN WITH THE SELF-CATH CATHETERS, WHICH HE WILL CONTINUE WITH. THE END-USER STATES THAT HE WAS USING THE CATHETERS PER INSTRUCTION FOR USE (IFU)
Patient problems: Hemorrhage/Blood Loss/Bleeding; Pain
MAUDE report 13010652 ↗InjuryDec 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE AVAILABLE INFORMATION, THIS COMPLAINT IS FOR A (B)(6) MALE END-USER. THE END-USER IS NEW TO PERFORMING INTERMITTENT CATHETERIZATIONS. HE HAD USED THE CATHETERS FOR APPROXIMATELY 7 DAYS WITH MINOR BLEEDINGS TO BEGIN WITH, WHICH HE WAS INFORMED BY HIS UROLOGIST WAS NORMAL. ON THE (B)(6) HE EXPERIENCED MORE BLEEDING AFTER CATHETERIZING, WENT TO THE EMERGENCY ROOM AND WAS ADMITTED TO THE HOSPITAL FOR 3 DAYS, DURING WHICH A FOLEY CATHETER WAS INSERTED, AND SEVERAL BLADDER WASHOUTS WAS PERFORMED. THE FOLEY CATHETER WAS REMOVED THE (B)(6), AND THE UROLOGIST HAS ENCOURAGED THE END-USER TO TRY AND VOID ON HIS OWN, BUT IF THIS IS UNSUCCESSFUL, HE SHOULD CONTINUE WITH THE CATHETERIZATIONS. FOR NOW, HE IS VOIDING ON HIS OWN AND HAVE A FOLLOW-UP WITH HIS UROLOGIST LATER. THE END-USER WAS ON BLOOD THINNER MEDICATION WHEN THE INCIDENT HAPPENED. THE END-USER HAD NOT NOTICED ANY DAMAGE TO THE CATHETER, OR PACKAGING. IT IS STATED THAT THE CATHETER WAS PROPERLY LUBRICATED AND NO SHARP EDGES. THE-USER CONFIRMS THAT HE WAS TRAINED IN USED THE CATHETERS CORRECTLY AND STATES HE USED THEM CORRECTLY.
Patient problems: Hematuria; Hemorrhage/Blood Loss/Bleeding
MAUDE report 12915761 ↗InjuryNov 2, 2021Insufficient Device Problem Information; Insufficient Device Problem Information
ACCORDING TO THE INFORMATION PROVIDED, THE COMPLAINT DESCRIBES HARMS CAUSED TO A (B)(6)-YEAR-OLD MALE END-USER. THE END-USER WAS USING SPEEDICATH STANDARD CATHETERS FROM A SAMPLE-PACK. WHEN CATHETERISING HE EXPERIENCED BLEEDING, WHICH WAS SEVERE ENOUGH FOR HIM TO VISIT THE EMERGENCY ROOM (ER), WHERE HE WAS ADMITTED. THE EVALUATION FROM THE ER IS STATED TO BE TRAUMA TO THE PROSTATE WHEN INSERTING THE CATHETER. THE END-USER WAS PUT ON ANTIBIOTICS, BLOOD THINNERS AND INDWELLING CATHETER. IT IS STATED THAT HE WE STAY ON THE INDWELLING CATHETER UNTIL SURGERY, AND HEREAFTER IC MIGHT NOT BE NECESSARY FOR HIM. THE END-USER WAS IN HOSPITAL FROM (B)(6) OCTOBER AND WAS RE-ADMITTED THE SAME DAY DUE TO BLEEDING STARTING AGAIN. THE END-USER HAS A SCHEDULED PROSTATE SURGERY (B)(6) OCTOBER AFTER WHICH INTERMITTENT CATHETERIZATION MAY NOT BE NEEDED. THE END-USER STATES THAT HE DID NOT NOTICE ANY SHARP EDGES OR OTHER ON THE CATHETER ITSELF. HE THINKS THAT IT IS A USE ERROR (MAYBE HE INSERTED IT TOO FORCEFUL). THE MEDICAL DOCTOR STATES THAT HE BELIEVES THAT THE BLEEDING WAS CAUSED BY THE BLOOD THINNER MEDICATION. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Hematuria; Hemorrhage/Blood Loss/Bleeding
MAUDE report 12738984 ↗
Other Coloplast A/S products
All Coloplast A/S devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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