Self-Cath 50183 / 116Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05708932575782), received between Mar 1, 2022 and Mar 1, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Sharp Edges” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMar 1, 2022Sharp Edges; Sharp Edges

  ACCORDING TO THE INFORMATION AVAILABLE, THIS COMPLAINT CONCERNS A MALE END USER WHO HAD BEEN CATHETERIZING FOR ALMOST 3-4 YEARS WITH THE SELF-CATH SOFT CATHETER PRIOR TO THE INCIDENT. THE END USER STATED THAT HE WOULD USUALLY EXPERIENCE MINOR BLEEDING WHEN CATHETERIZING BUT HAD A DIFFERENT EXPERIENCE UPON THE INCIDENT REPORTED. THE END USER FELT PAIN DURING INSERTION OF THE CATHETER, WHICH HE TRIED TO EASE BY APPLYING MORE LUBRICANT. IT DID NOT HELP, AND THE END USER REPORTED BLEEDING TO THE POINT THAT BLOOD WENT INTO THE CATHETER TUBE CAUSING THE FLOW OF URINE TO STOP. HE WAS NOT ABLE TO INSERT THE CATHETER TO REACH THE BLADDER BECAUSE OF PAIN IN THE URETHRA. THE END USER WAS ADMITTED TO A HOSPITAL FOR URINE RETENTION THE END USER HAD LATER CONFIRMED THAT HE HAD NO SYMPTOMS FROM THE BLEEDING AND DID RECOVER FROM IT AND WAS ADMITTED IN THE HOSPITAL FOR 4 DAYS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Dysuria; Hematuria; Urinary Retention

  MAUDE report 13637952 ↗