GENTLECATH 421911Recalls & reported problems

Summary

The FDA's MAUDE database contains 234 adverse event reports that list this exact device (DI 30768455153832), received between Oct 31, 2023 and Sep 29, 2026 — classified as 234 malfunctions.

The most frequently reported specific device problem is “Device Misassembled During Manufacturing /Shipping” (208 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 234 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Unsealed Device Packaging

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50933724 ↗
• MalfunctionSep 23, 2026Sharp Edges

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50873332 ↗
• MalfunctionSep 23, 2026Sharp Edges

  It was reported the catheters were "stuck with the package as if they were glued. As a result, those catheters had an inch length of rough surface. In spite of the rough surface, I managed to use them but it was not comfortable to insert it into the urethra because of the rough surface."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50873331 ↗
• MalfunctionSep 23, 2026Sharp Edges

  End user reports possible structural irregularity with rough tip. Reports ¿some of the products did feel rough at the tip when trying to insert. The curve of the tip seemed to be different or even the size of the tube, it is not a difference you can see.¿ No photo available. There was no harm reported. No further information obtained.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50867484 ↗
• MalfunctionSep 22, 2026Entrapment of Device

  It was reported "catheters improperly stuck in individual packaging's heat seal."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50857968 ↗
• MalfunctionSep 22, 2026Entrapment of Device

  It was reported "catheters improperly stuck in individual packaging's heat seals. " No lot number provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50857818 ↗
• MalfunctionMar 9, 2026Device Misassembled During Manufacturing /Shipping

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24549926 ↗
• MalfunctionAug 29, 2025Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping

  END USER REPORTS AN UNKNOWN QUANTITY AND MARKET UNITS IN WHICH "THE ORANGE TIP IS NOT INDEXED PROPERLY AND CONSISTENTLY TO THE DIRECTION OF THE COUDE TIP. IF THE TIP IS NOT ALIGNED PROPERLY, THE CATHETER WON'T PASS THE PROSTATE." HE FURTHER STATES "IF HE IS LOOKING AT THE COUDE TIP STRAIGHT UP THE NOTCH IS AT ABOUT A 9 O'CLOCK. HE SAID THIS HAS NOT BEEN "A BIG DEAL" TO HIM, MORE OF AN IRRITATING INCONVENIENCE FOR HIM. HE HAS TO TAKE INTO CONSIDERATION THE DIFFERENCE AND ADJUST ACCORDINGLY WITH MAKING SURE THE COUDE TIP IS UPWARDS WITH PLACEMENT OR ELSE HE HAS DIFFICULTY PASSING IT THROUGH HIS PROSTATE. HE DENIED ANY HARM OR BLEEDING WITH USE OF THESE." THIS EMDR COVERS THE UNKNOWN QUANTITY AND MARKET UNITS CATHETERS ASSOCIATED WITH THE DEFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22921082 ↗
• MalfunctionAug 29, 2025Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping

  END USER REPORTS AN UNKNOWN QUANTITY AND MARKET UNITS IN WHICH "THE ORANGE TIP IS NOT INDEXED PROPERLY AND CONSISTENTLY TO THE DIRECTION OF THE COUDE TIP. IF THE TIP IS NOT ALIGNED PROPERLY, THE CATHETER WON'T PASS THE PROSTATE." HE FURTHER STATES "IF HE IS LOOKING AT THE COUDE TIP STRAIGHT UP THE NOTCH IS AT ABOUT A 9 O'CLOCK. HE SAID THIS HAS NOT BEEN "A BIG DEAL" TO HIM, MORE OF AN IRRITATING INCONVENIENCE FOR HIM. HE HAS TO TAKE INTO CONSIDERATION THE DIFFERENCE AND ADJUST ACCORDINGLY WITH MAKING SURE THE COUDE TIP IS UPWARDS WITH PLACEMENT OR ELSE HE HAS DIFFICULTY PASSING IT THROUGH HIS PROSTATE. HE DENIED ANY HARM OR BLEEDING WITH USE OF THESE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22921021 ↗
• MalfunctionJul 25, 2025Sharp Edges; Sharp Edges

  END USER REPORTS COUDE TIP NOT ALIGNED WITH NOTCH INDICATOR ON FUNNEL. HE IS A 68 YR OLD MALE, NEW TO CIC. HE JUST STARTED CIC TO DUE SCAR TISSUE IN HIS DISTAL URETHRA (RIGHT PAST HIS MEATUS HE SAID) HE SUSPECTS ORIGINATED FROM A PREVIOUS TRAUMATIC CATHETERIZATION 1.5 YRS AGO. HE RECENTLY HAD SURGERY ON HIS NECK TO REMOVE A LUMP AND HE WENT INTO RETENTION. A NURSE WAS ONLY ABLE TO PLACE AN 8 FR IN HIS URETHRA AND LATER A UROLOGIST WAS ABLE TO DILATE HIM UP TO A 20 FR AND WAS GIVEN THE CHOICE TO INITIATE CIC 3 X A DAY OR WEAR A FOLEY. HE WAS ABLE TO SUCCESSFULLY CIC WITH A 16 FR COUDE. HE SAID HE HAS TO CATH TO KEEP HIS DILATION OPEN BUT HIS MD SAID IF HE FEELS LIKE HE IS RETAINING URINE HE CAN CATH FULLY INTO HIS BLADDER WHICH HE HAS DONE EVERY FEW DAYS. HE SAID WHILE HE HAS TO PUT A BIT OF PRESSURE TO GET THROUGH HIS SCAR TISSUE IN URETHRA, CATHING HAS BEEN GOING WELL FOR HIM, TOLERATING IT WELL. THE END USER REPORTS WHEN HE LOOKS AT OUR GC GLIDE, AND HE HAS USED 20 NOW FROM 1 BOX OF THIS LOT (THIS IS HIS FIRST BOX) THE COUDE TIP IS NOT PERFECTLY ALIGNED WITH NOTCH WITH EACH ONE HE HAS USED. THEY ARE NOT TWISTED IN ANY WAY. HE FEELS THIS IS A MANUFACTURING ISSUE AND/ OR THIS LO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22608128 ↗
• MalfunctionJul 24, 2025Sharp Edges; Sharp Edges

  END USER REPORTS COUDE TIP NOT ALIGNED WITH NOTCH INDICATOR ON FUNNEL. HE IS A 68 YR OLD MALE, NEW TO CIC. HE JUST STARTED CIC DUE TO SCAR TISSUE IN HIS DISTAL URETHRA (RIGHT PAST HIS MEATUS HE SAID) HE SUSPECTS ORIGINATED FROM A PREVIOUS TRAUMATIC CATHETERIZATION 1.5 YRS AGO. HE RECENTLY HAD SURGERY ON HIS NECK TO REMOVE A LUMP AND HE WENT INTO RETENTION. A NURSE WAS ONLY ABLE TO PLACE AN 8 FR IN HIS URETHRA AND LATER A UROLOGIST WAS ABLE TO DILATE HIM UP TO A 20 FR AND WAS GIVEN THE CHOICE TO INITIATE CIC 3 X A DAY OR WEAR A FOLEY. HE WAS ABLE TO SUCCESSFULLY CIC WITH A 16 FR COUDE. HE SAID HE HAS TO CATH TO KEEP HIS DILATION OPEN BUT HIS MD SAID IF HE FEELS LIKE HE IS RETAINING URINE HE CAN CATH FULLY INTO HIS BLADDER WHICH HE HAS DONE EVERY FEW DAYS. HE SAID WHILE HE HAS TO PUT A BIT OF PRESSURE TO GET THROUGH HIS SCAR TISSUE IN URETHRA, CATCHING HAS BEEN GOING WELL FOR HIM, TOLERATING IT WELL. THE END USER REPORTS WHEN HE LOOKS AT OUR GC GLIDE, AND HE HAS USED 20 NOW FROM 1 BOX OF THIS LOT (THIS IS HIS FIRST BOX) THE COUDE TIP IS NOT PERFECTLY ALIGNED WITH NOTCH WITH EACH ONE HE HAS USED. THEY ARE NOT TWISTED IN ANY WAY. HE FEELS THIS IS A MANUFACTURING ISSUE AND/ OR THIS LOT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22584592 ↗
• MalfunctionJul 24, 2025Sharp Edges; Sharp Edges

  END USER REPORTS COUDE TIP NOT ALIGNED WITH NOTCH INDICATOR ON FUNNEL. HE IS A 68 YR OLD MALE, NEW TO CIC. HE JUST STARTED CIC DUE TO SCAR TISSUE IN HIS DISTAL URETHRA (RIGHT PAST HIS MEATUS HE SAID) HE SUSPECTS ORIGINATED FROM A PREVIOUS TRAUMATIC CATHETERIZATION 1.5 YRS AGO. HE RECENTLY HAD SURGERY ON HIS NECK TO REMOVE A LUMP AND HE WENT INTO RETENTION. A NURSE WAS ONLY ABLE TO PLACE AN 8 FR IN HIS URETHRA AND LATER A UROLOGIST WAS ABLE TO DILATE HIM UP TO A 20 FR AND WAS GIVEN THE CHOICE TO INITIATE CIC 3 X A DAY OR WEAR A FOLEY. HE WAS ABLE TO SUCCESSFULLY CIC WITH A 16 FR COUDE. HE SAID HE HAS TO CATH TO KEEP HIS DILATION OPEN BUT HIS MD SAID IF HE FEELS LIKE HE IS RETAINING URINE HE CAN CATH FULLY INTO HIS BLADDER WHICH HE HAS DONE EVERY FEW DAYS. HE SAID WHILE HE HAS TO PUT A BIT OF PRESSURE TO GET THROUGH HIS SCAR TISSUE IN URETHRA, CATCHING HAS BEEN GOING WELL FOR HIM, TOLERATING IT WELL. THE END USER REPORTS WHEN HE LOOKS AT OUR GC GLIDE, AND HE HAS USED 20 NOW FROM 1 BOX OF THIS LOT (THIS IS HIS FIRST BOX) THE COUDE TIP IS NOT PERFECTLY ALIGNED WITH NOTCH WITH EACH ONE HE HAS USED. THEY ARE NOT TWISTED IN ANY WAY. HE FEELS THIS IS A MANUFACTURING ISSUE AND/ OR THIS LOT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22584590 ↗
• MalfunctionJul 24, 2025Sharp Edges; Sharp Edges

  END USER REPORTS COUDE TIP NOT ALIGNED WITH NOTCH INDICATOR ON FUNNEL. HE IS A 68 YR OLD MALE, NEW TO CIC. HE JUST STARTED CIC TO DUE SCAR TISSUE IN HIS DISTAL URETHRA (RIGHT PAST HIS MEATUS HE SAID) HE SUSPECTS ORIGINATED FROM A PREVIOUS TRAUMATIC CATHETERIZATION 1.5 YRS AGO. HE RECENTLY HAD SURGERY ON HIS NECK TO REMOVE A LUMP AND HE WENT INTO RETENTION. A NURSE WAS ONLY ABLE TO PLACE AN 8 FR IN HIS URETHRA AND LATER A UROLOGIST WAS ABLE TO DILATE HIM UP TO A 20 FR AND WAS GIVEN THE CHOICE TO INITIATE CIC 3 X A DAY OR WEAR A FOLEY. HE WAS ABLE TO SUCCESSFULLY CIC WITH A 16 FR COUDE. HE SAID HE HAS TO CATH TO KEEP HIS DILATION OPEN BUT HIS MD SAID IF HE FEELS LIKE HE IS RETAINING URINE HE CAN CATH FULLY INTO HIS BLADDER WHICH HE HAS DONE EVERY FEW DAYS. HE SAID WHILE HE HAS TO PUT A BIT OF PRESSURE TO GET THROUGH HIS SCAR TISSUE IN URETHRA, CATCHING HAS BEEN GOING WELL FOR HIM, TOLERATING IT WELL. THE END USER REPORTS WHEN HE LOOKS AT OUR GC GLIDE, AND HE HAS USED 20 NOW FROM 1 BOX OF THIS LOT (THIS IS HIS FIRST BOX) THE COUDE TIP IS NOT PERFECTLY ALIGNED WITH NOTCH WITH EACH ONE HE HAS USED. THEY ARE NOT TWISTED IN ANY WAY. HE FEELS THIS IS A MANUFACTURING ISSUE AND/ OR THIS LOT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22584589 ↗
• MalfunctionJul 24, 2025Sharp Edges; Sharp Edges

  END USER REPORTS COUDE TIP NOT ALIGNED WITH NOTCH INDICATOR ON FUNNEL. HE IS A 68 YR OLD MALE, NEW TO CIC. HE JUST STARTED CIC TO DUE SCAR TISSUE IN HIS DISTAL URETHRA (RIGHT PAST HIS MEATUS HE SAID) HE SUSPECTS ORIGINATED FROM A PREVIOUS TRAUMATIC CATHETERIZATION 1.5 YRS AGO. HE RECENTLY HAD SURGERY ON HIS NECK TO REMOVE A LUMP AND HE WENT INTO RETENTION. A NURSE WAS ONLY ABLE TO PLACE AN 8 FR IN HIS URETHRA AND LATER A UROLOGIST WAS ABLE TO DILATE HIM UP TO A 20 FR AND WAS GIVEN THE CHOICE TO INITIATE CIC 3 X A DAY OR WEAR A FOLEY. HE WAS ABLE TO SUCCESSFULLY CIC WITH A 16 FR COUDE. HE SAID HE HAS TO CATH TO KEEP HIS DILATION OPEN BUT HIS MD SAID IF HE FEELS LIKE HE IS RETAINING URINE HE CAN CATH FULLY INTO HIS BLADDER WHICH HE HAS DONE EVERY FEW DAYS. HE SAID WHILE HE HAS TO PUT A BIT OF PRESSURE TO GET THROUGH HIS SCAR TISSUE IN URETHRA, CATHING HAS BEEN GOING WELL FOR HIM, TOLERATING IT WELL. THE END USER REPORTS WHEN HE LOOKS AT OUR GC GLIDE, AND HE HAS USED 20 NOW FROM 1 BOX OF THIS LOT (THIS IS HIS FIRST BOX) THE COUDE TIP IS NOT PERFECTLY ALIGNED WITH NOTCH WITH EACH ONE HE HAS USED. THEY ARE NOT TWISTED IN ANY WAY. HE FEELS THIS IS A MANUFACTURING ISSUE AND/ OR THIS LOT I

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22584537 ↗
• MalfunctionJul 24, 2025Sharp Edges; Sharp Edges

  END USER REPORTS COUDE TIP NOT ALIGNED WITH NOTCH INDICATOR ON FUNNEL. HE IS A 68 YR OLD MALE, NEW TO CIC. HE JUST STARTED CIC TO DUE SCAR TISSUE IN HIS DISTAL URETHRA (RIGHT PAST HIS MEATUS HE SAID) HE SUSPECTS ORIGINATED FROM A PREVIOUS TRAUMATIC CATHETERIZATION 1.5 YRS AGO. HE RECENTLY HAD SURGERY ON HIS NECK TO REMOVE A LUMP AND HE WENT INTO RETENTION. A NURSE WAS ONLY ABLE TO PLACE AN 8 FR IN HIS URETHRA AND LATER A UROLOGIST WAS ABLE TO DILATE HIM UP TO A 20 FR AND WAS GIVEN THE CHOICE TO INITIATE CIC 3 X A DAY OR WEAR A FOLEY. HE WAS ABLE TO SUCCESSFULLY CIC WITH A 16 FR COUDE. HE SAID HE HAS TO CATH TO KEEP HIS DILATION OPEN BUT HIS MD SAID IF HE FEELS LIKE HE IS RETAINING URINE HE CAN CATH FULLY INTO HIS BLADDER WHICH HE HAS DONE EVERY FEW DAYS. HE SAID WHILE HE HAS TO PUT A BIT OF PRESSURE TO GET THROUGH HIS SCAR TISSUE IN URETHRA, CATHING HAS BEEN GOING WELL FOR HIM, TOLERATING IT WELL. THE END USER REPORTS WHEN HE LOOKS AT OUR GC GLIDE, AND HE HAS USED 20 NOW FROM 1 BOX OF THIS LOT (THIS IS HIS FIRST BOX) THE COUDE TIP IS NOT PERFECTLY ALIGNED WITH NOTCH WITH EACH ONE HE HAS USED. THEY ARE NOT TWISTED IN ANY WAY. HE FEELS THIS IS A MANUFACTURING ISSUE AND/ OR THIS LOT I

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22584536 ↗
• MalfunctionJul 24, 2025Sharp Edges; Sharp Edges

  END USER REPORTS COUDE TIP NOT ALIGNED WITH NOTCH INDICATOR ON FUNNEL. HE IS A 68 YR OLD MALE, NEW TO CIC. HE JUST STARTED CIC TO DUE SCAR TISSUE IN HIS DISTAL URETHRA (RIGHT PAST HIS MEATUS HE SAID) HE SUSPECTS ORIGINATED FROM A PREVIOUS TRAUMATIC CATHETERIZATION 1.5 YRS AGO. HE RECENTLY HAD SURGERY ON HIS NECK TO REMOVE A LUMP AND HE WENT INTO RETENTION. A NURSE WAS ONLY ABLE TO PLACE AN 8 FR IN HIS URETHRA AND LATER A UROLOGIST WAS ABLE TO DILATE HIM UP TO A 20 FR AND WAS GIVEN THE CHOICE TO INITIATE CIC 3 X A DAY OR WEAR A FOLEY. HE WAS ABLE TO SUCCESSFULLY CIC WITH A 16 FR COUDE. HE SAID HE HAS TO CATH TO KEEP HIS DILATION OPEN BUT HIS MD SAID IF HE FEELS LIKE HE IS RETAINING URINE HE CAN CATH FULLY INTO HIS BLADDER WHICH HE HAS DONE EVERY FEW DAYS. HE SAID WHILE HE HAS TO PUT A BIT OF PRESSURE TO GET THROUGH HIS SCAR TISSUE IN URETHRA, CATHING HAS BEEN GOING WELL FOR HIM, TOLERATING IT WELL. THE END USER REPORTS WHEN HE LOOKS AT OUR GC GLIDE, AND HE HAS USED 20 NOW FROM 1 BOX OF THIS LOT (THIS IS HIS FIRST BOX) THE COUDE TIP IS NOT PERFECTLY ALIGNED WITH NOTCH WITH EACH ONE HE HAS USED. THEY ARE NOT TWISTED IN ANY WAY. HE FEELS THIS IS A MANUFACTURING ISSUE AND/ OR THIS LOT I

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22584530 ↗
• MalfunctionJul 24, 2025Sharp Edges; Sharp Edges

  END USER REPORTS COUDE TIP NOT ALIGNED WITH NOTCH INDICATOR ON FUNNEL. HE IS A 68 YR OLD MALE, NEW TO CIC. HE JUST STARTED CIC TO DUE SCAR TISSUE IN HIS DISTAL URETHRA (RIGHT PAST HIS MEATUS HE SAID) HE SUSPECTS ORIGINATED FROM A PREVIOUS TRAUMATIC CATHETERIZATION 1.5 YRS AGO. HE RECENTLY HAD SURGERY ON HIS NECK TO REMOVE A LUMP AND HE WENT INTO RETENTION. A NURSE WAS ONLY ABLE TO PLACE AN 8 FR IN HIS URETHRA AND LATER A UROLOGIST WAS ABLE TO DILATE HIM UP TO A 20 FR AND WAS GIVEN THE CHOICE TO INITIATE CIC 3 X A DAY OR WEAR A FOLEY. HE WAS ABLE TO SUCCESSFULLY CIC WITH A 16 FR COUDE. HE SAID HE HAS TO CATH TO KEEP HIS DILATION OPEN BUT HIS MD SAID IF HE FEELS LIKE HE IS RETAINING URINE HE CAN CATH FULLY INTO HIS BLADDER WHICH HE HAS DONE EVERY FEW DAYS. HE SAID WHILE HE HAS TO PUT A BIT OF PRESSURE TO GET THROUGH HIS SCAR TISSUE IN URETHRA, CATHING HAS BEEN GOING WELL FOR HIM, TOLERATING IT WELL. THE END USER REPORTS WHEN HE LOOKS AT OUR GC GLIDE, AND HE HAS USED 20 NOW FROM 1 BOX OF THIS LOT (THIS IS HIS FIRST BOX) THE COUDE TIP IS NOT PERFECTLY ALIGNED WITH NOTCH WITH EACH ONE HE HAS USED. THEY ARE NOT TWISTED IN ANY WAY. HE FEELS THIS IS A MANUFACTURING ISSUE AND/ OR THIS LOT I

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22584527 ↗
• MalfunctionJul 24, 2025Sharp Edges; Sharp Edges

  END USER REPORTS COULD TIP NOT ALIGNED WITH NOTCH INDICATOR ON FUNNEL. HE IS A 68 YR OLD MALE, NEW TO CIC. HE JUST STARTED CIC TO DUE SCAR TISSUE IN HIS DISTAL URETHRA (RIGHT PAST HIS MEATUS HE SAID) HE SUSPECTS ORIGINATED FROM A PREVIOUS TRAUMATIC CATHETERIZATION 1.5 YRS AGO. HE RECENTLY HAD SURGERY ON HIS NECK TO REMOVE A LUMP AND HE WENT INTO RETENTION. A NURSE WAS ONLY ABLE TO PLACE AN 8 FR IN HIS URETHRA AND LATER A UROLOGIST WAS ABLE TO DILATE HIM UP TO A 20 FR AND WAS GIVEN THE CHOICE TO INITIATE CIC 3 X A DAY OR WEAR A FOLEY. HE WAS ABLE TO SUCCESSFULLY CIC WITH A 16 FR COUDE. HE SAID HE HAS TO CATH TO KEEP HIS DILATION OPEN BUT HIS MD SAID IF HE FEELS LIKE HE IS RETAINING URINE HE CAN CATH FULLY INTO HIS BLADDER WHICH HE HAS DONE EVERY FEW DAYS. HE SAID WHILE HE HAS TO PUT A BIT OF PRESSURE TO GET THROUGH HIS SCAR TISSUE IN URETHRA, CATHING HAS BEEN GOING WELL FOR HIM, TOLERATING IT WELL. THE END USER REPORTS WHEN HE LOOKS AT OUR GC GLIDE, AND HE HAS USED 20 NOW FROM 1 BOX OF THIS LOT (THIS IS HIS FIRST BOX) THE COUDE TIP IS NOT PERFECTLY ALIGNED WITH NOTCH WITH EACH ONE HE HAS USED. THEY ARE NOT TWISTED IN ANY WAY. HE FEELS THIS IS A MANUFACTURING ISSUE AND/ OR THIS LOT I

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22584480 ↗
• MalfunctionJul 24, 2025Sharp Edges; Sharp Edges

  END USER REPORTS COUDE TIP NOT ALIGNED WITH NOTCH INDICATOR ON FUNNEL. HE IS A 68 YR OLD MALE, NEW TO CIC. HE JUST STARTED CIC TO DUE SCAR TISSUE IN HIS DISTAL URETHRA (RIGHT PAST HIS MEATUS HE SAID) HE SUSPECTS ORIGINATED FROM A PREVIOUS TRAUMATIC CATHETERIZATION 1.5 YRS AGO. HE RECENTLY HAD SURGERY ON HIS NECK TO REMOVE A LUMP AND HE WENT INTO RETENTION. A NURSE WAS ONLY ABLE TO PLACE AN 8 FR IN HIS URETHRA AND LATER A UROLOGIST WAS ABLE TO DILATE HIM UP TO A 20 FR AND WAS GIVEN THE CHOICE TO INITIATE CIC 3 X A DAY OR WEAR A FOLEY. HE WAS ABLE TO SUCCESSFULLY CIC WITH A 16 FR COUDE. HE SAID HE HAS TO CATH TO KEEP HIS DILATION OPEN BUT HIS MD SAID IF HE FEELS LIKE HE IS RETAINING URINE HE CAN CATH FULLY INTO HIS BLADDER WHICH HE HAS DONE EVERY FEW DAYS. HE SAID WHILE HE HAS TO PUT A BIT OF PRESSURE TO GET THROUGH HIS SCAR TISSUE IN URETHRA, CATHING HAS BEEN GOING WELL FOR HIM, TOLERATING IT WELL. THE END USER REPORTS WHEN HE LOOKS AT OUR GC GLIDE, AND HE HAS USED 20 NOW FROM 1 BOX OF THIS LOT (THIS IS HIS FIRST BOX) THE COUDE TIP IS NOT PERFECTLY ALIGNED WITH NOTCH WITH EACH ONE HE HAS USED. THEY ARE NOT TWISTED IN ANY WAY. HE FEELS THIS IS A MANUFACTURING ISSUE AND/ OR THIS LOT I

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22584443 ↗
• MalfunctionJul 23, 2025Sharp Edges; Sharp Edges

  END USER REPORTS COUDE TIP NOT ALIGNED WITH NOTCH INDICATOR ON FUNNEL. HE IS A 68 YR OLD MALE, NEW TO CIC. HE JUST STARTED CIC TO DUE SCAR TISSUE IN HIS DISTAL URETHRA (RIGHT PAST HIS MEATUS HE SAID) HE SUSPECTS ORIGINATED FROM A PREVIOUS TRAUMATIC CATHETERIZATION 1.5 YRS AGO. HE RECENTLY HAD SURGERY ON HIS NECK TO REMOVE A LUMP AND HE WENT INTO RETENTION. A NURSE WAS ONLY ABLE TO PLACE AN 8 FR IN HIS URETHRA AND LATER A UROLOGIST WAS ABLE TO DILATE HIM UP TO A 20 FR AND WAS GIVEN THE CHOICE TO INITIATE CIC 3 X A DAY OR WEAR A FOLEY. HE WAS ABLE TO SUCCESSFULLY CIC WITH A 16 FR COUDE. HE SAID HE HAS TO CATH TO KEEP HIS DILATION OPEN BUT HIS MD SAID IF HE FEELS LIKE HE IS RETAINING URINE HE CAN CATH FULLY INTO HIS BLADDER WHICH HE HAS DONE EVERY FEW DAYS. HE SAID WHILE HE HAS TO PUT A BIT OF PRESSURE TO GET THROUGH HIS SCAR TISSUE IN URETHRA, CATHING HAS BEEN GOING WELL FOR HIM, TOLERATING IT WELL. THE END USER REPORTS WHEN HE LOOKS AT OUR GC GLIDE, AND HE HAS USED 20 NOW FROM 1 BOX OF THIS LOT (THIS IS HIS FIRST BOX) THE COUDE TIP IS NOT PERFECTLY ALIGNED WITH NOTCH WITH EACH ONE HE HAS USED. THEY ARE NOT TWISTED IN ANY WAY. HE FEELS THIS IS A MANUFACTURING ISSUE AND/ OR THIS LOT I

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22579264 ↗
• MalfunctionJul 23, 2025Sharp Edges; Sharp Edges

  END USER REPORTS COUDE TIP NOT ALIGNED WITH NOTCH INDICATOR ON FUNNEL. HE IS A 68 YR OLD MALE, NEW TO CIC. HE JUST STARTED CIC DUE TO SCAR TISSUE IN HIS DISTAL URETHRA (RIGHT PAST HIS MEATUS HE SAID); HE SUSPECTS ORIGINATED FROM A PREVIOUS TRAUMATIC CATHETERIZATION 1.5 YRS AGO. HE RECENTLY HAD SURGERY ON HIS NECK TO REMOVE A LUMP AND HE WENT INTO RETENTION. A NURSE WAS ONLY ABLE TO PLACE AN 8 FR IN HIS URETHRA AND LATER A UROLOGIST WAS ABLE TO DILATE HIM UP TO A 20 FR AND WAS GIVEN THE CHOICE TO INITIATE CIC 3 X A DAY OR WEAR A FOLEY. HE WAS ABLE TO SUCCESSFULLY CIC WITH A 16 FR COUDE. HE SAID HE HAS TO CATH TO KEEP HIS DILATION OPEN BUT HIS MD SAID IF HE FEELS LIKE HE IS RETAINING URINE HE CAN CATH FULLY INTO HIS BLADDER WHICH HE HAS DONE EVERY FEW DAYS. HE SAID WHILE HE HAS TO PUT A BIT OF PRESSURE TO GET THROUGH HIS SCAR TISSUE IN URETHRA, CATCHING HAS BEEN GOING WELL FOR HIM, TOLERATING IT WELL. THE END USER REPORTS WHEN HE LOOKS AT OUR GC GLIDE, AND HE HAS USED 20 NOW FROM 1 BOX OF THIS LOT (THIS IS HIS FIRST BOX) THE COUDE TIP IS NOT PERFECTLY ALIGNED WITH NOTCH WITH EACH ONE HE HAS USED. THEY ARE NOT TWISTED IN ANY WAY. HE FEELS THIS IS A MANUFACTURING ISSUE AND/ OR THIS LOT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22579263 ↗
• MalfunctionJul 23, 2025Sharp Edges; Sharp Edges

  END USER REPORTS COUDE TIP NOT ALIGNED WITH NOTCH INDICATOR ON FUNNEL. HE IS A 68 YR OLD MALE, NEW TO CIC. HE JUST STARTED CIC TO DUE SCAR TISSUE IN HIS DISTAL URETHRA (RIGHT PAST HIS MEATUS HE SAID) HE SUSPECTS ORIGINATED FROM A PREVIOUS TRAUMATIC CATHETERIZATION 1.5 YRS AGO. HE RECENTLY HAD SURGERY ON HIS NECK TO REMOVE A LUMP AND HE WENT INTO RETENTION. A NURSE WAS ONLY ABLE TO PLACE AN 8 FR IN HIS URETHRA AND LATER A UROLOGIST WAS ABLE TO DILATE HIM UP TO A 20 FR AND WAS GIVEN THE CHOICE TO INITIATE CIC 3 X A DAY OR WEAR A FOLEY. HE WAS ABLE TO SUCCESSFULLY CIC WITH A 16 FR COUDE. HE SAID HE HAS TO CATH TO KEEP HIS DILATION OPEN BUT HIS MD SAID IF HE FEELS LIKE HE IS RETAINING URINE HE CAN CATH FULLY INTO HIS BLADDER WHICH HE HAS DONE EVERY FEW DAYS. HE SAID WHILE HE HAS TO PUT A BIT OF PRESSURE TO GET THROUGH HIS SCAR TISSUE IN URETHRA, CATHING HAS BEEN GOING WELL FOR HIM, TOLERATING IT WELL. THE END USER REPORTS WHEN HE LOOKS AT OUR GC GLIDE, AND HE HAS USED 20 NOW FROM 1 BOX OF THIS LOT (THIS IS HIS FIRST BOX) THE COUDE TIP IS NOT PERFECTLY ALIGNED WITH NOTCH WITH EACH ONE HE HAS USED. THEY ARE NOT TWISTED IN ANY WAY. HE FEELS THIS IS A MANUFACTURING ISSUE AND/ OR THIS LOT I

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22579196 ↗
• MalfunctionJul 23, 2025Sharp Edges; Sharp Edges

  END USER REPORTS COUDE TIP NOT ALIGNED WITH NOTCH INDICATOR ON FUNNEL. HE IS A 68 YR OLD MALE, NEW TO CIC. HE JUST STARTED CIC DUE TO SCAR TISSUE IN HIS DISTAL URETHRA (RIGHT PAST HIS MEATUS HE SAID), HE SUSPECTS ORIGINATED FROM A PREVIOUS TRAUMATIC CATHETERIZATION 1.5 YRS AGO. HE RECENTLY HAD SURGERY ON HIS NECK TO REMOVE A LUMP AND HE WENT INTO RETENTION. A NURSE WAS ONLY ABLE TO PLACE AN 8 FR IN HIS URETHRA AND LATER A UROLOGIST WAS ABLE TO DILATE HIM UP TO A 20 FR AND WAS GIVEN THE CHOICE TO INITIATE CIC 3 X A DAY OR WEAR A FOLEY. HE WAS ABLE TO SUCCESSFULLY CIC WITH A 16 FR COUDE. HE SAID HE HAS TO CATH TO KEEP HIS DILATION OPEN BUT HIS MD SAID IF HE FEELS LIKE HE IS RETAINING URINE HE CAN CATH FULLY INTO HIS BLADDER WHICH HE HAS DONE EVERY FEW DAYS. HE SAID WHILE HE HAS TO PUT A BIT OF PRESSURE TO GET THROUGH HIS SCAR TISSUE IN URETHRA, CATCHING HAS BEEN GOING WELL FOR HIM, TOLERATING IT WELL. THE END USER REPORTS WHEN HE LOOKS AT OUR GC GLIDE, AND HE HAS USED 20 NOW FROM 1 BOX OF THIS LOT (THIS IS HIS FIRST BOX) THE COUDE TIP IS NOT PERFECTLY ALIGNED WITH NOTCH WITH EACH ONE HE HAS USED. THEY ARE NOT TWISTED IN ANY WAY. HE FEELS THIS IS A MANUFACTURING ISSUE AND/ OR THIS LOT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22579166 ↗
• MalfunctionJul 23, 2025Sharp Edges; Sharp Edges

  END USER REPORTS COUDE TIP NOT ALIGNED WITH NOTCH INDICATOR ON FUNNEL. HE IS A 68 YR OLD MALE, NEW TO CIC. HE JUST STARTED CIC TO DUE SCAR TISSUE IN HIS DISTAL URETHRA (RIGHT PAST HIS MEATUS HE SAID) HE SUSPECTS ORIGINATED FROM A PREVIOUS TRAUMATIC CATHETERIZATION 1.5 YRS AGO. HE RECENTLY HAD SURGERY ON HIS NECK TO REMOVE A LUMP AND HE WENT INTO RETENTION. A NURSE WAS ONLY ABLE TO PLACE AN 8 FR IN HIS URETHRA AND LATER A UROLOGIST WAS ABLE TO DILATE HIM UP TO A 20 FR AND WAS GIVEN THE CHOICE TO INITIATE CIC 3 X A DAY OR WEAR A FOLEY. HE WAS ABLE TO SUCCESSFULLY CIC WITH A 16 FR COUDE. HE SAID HE HAS TO CATH TO KEEP HIS DILATION OPEN BUT HIS MD SAID IF HE FEELS LIKE HE IS RETAINING URINE HE CAN CATH FULLY INTO HIS BLADDER WHICH HE HAS DONE EVERY FEW DAYS. HE SAID WHILE HE HAS TO PUT A BIT OF PRESSURE TO GET THROUGH HIS SCAR TISSUE IN URETHRA, CATHING HAS BEEN GOING WELL FOR HIM, TOLERATING IT WELL. THE END USER REPORTS WHEN HE LOOKS AT OUR GC GLIDE, AND HE HAS USED 20 NOW FROM 1 BOX OF THIS LOT (THIS IS HIS FIRST BOX) THE COUDE TIP IS NOT PERFECTLY ALIGNED WITH NOTCH WITH EACH ONE HE HAS USED. THEY ARE NOT TWISTED IN ANY WAY. HE FEELS THIS IS A MANUFACTURING ISSUE AND/ OR THIS LOT I

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22579164 ↗
• MalfunctionJul 23, 2025Sharp Edges; Sharp Edges

  END USER REPORTS COUDE TIP NOT ALIGNED WITH NOTCH INDICATOR ON FUNNEL. HE IS A 68 YR OLD MALE, NEW TO CIC. HE JUST STARTED CIC DUE TO SCAR TISSUE IN HIS DISTAL URETHRA (RIGHT PAST HIS MEATUS HE SAID), HE SUSPECTS ORIGINATED FROM A PREVIOUS TRAUMATIC CATHETERIZATION 1.5 YRS AGO. HE RECENTLY HAD SURGERY ON HIS NECK TO REMOVE A LUMP AND HE WENT INTO RETENTION. A NURSE WAS ONLY ABLE TO PLACE AN 8 FR IN HIS URETHRA AND LATER A UROLOGIST WAS ABLE TO DILATE HIM UP TO A 20 FR AND WAS GIVEN THE CHOICE TO INITIATE CIC 3 X A DAY OR WEAR A FOLEY. HE WAS ABLE TO SUCCESSFULLY CIC WITH A 16 FR COUDE. HE SAID HE HAS TO CATH TO KEEP HIS DILATION OPEN BUT HIS MD SAID IF HE FEELS LIKE HE IS RETAINING URINE HE CAN CATH FULLY INTO HIS BLADDER WHICH HE HAS DONE EVERY FEW DAYS. HE SAID WHILE HE HAS TO PUT A BIT OF PRESSURE TO GET THROUGH HIS SCAR TISSUE IN URETHRA, CATCHING HAS BEEN GOING WELL FOR HIM, TOLERATING IT WELL. THE END USER REPORTS WHEN HE LOOKS AT OUR GC GLIDE, AND HE HAS USED 20 NOW FROM 1 BOX OF THIS LOT (THIS IS HIS FIRST BOX) THE COUDE TIP IS NOT PERFECTLY ALIGNED WITH NOTCH WITH EACH ONE HE HAS USED. THEY ARE NOT TWISTED IN ANY WAY. HE FEELS THIS IS A MANUFACTURING ISSUE AND/ OR THIS LOT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22579157 ↗