Self-Cath 50452 / 412Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05708932576314), received between Sep 17, 2015 and Oct 11, 2017 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Component Missing” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryOct 11, 2017Device Operates Differently Than Expected

  ACCORDING TOT HE AVAILABLE INFORMATION, PATIENT IS STATING THAT THE CATHETER WAS BUNCHING UP IN HIS URETHRA. PATIENT WENT TO THE HOSPITAL AND THEY PUT HIM IN A PERMANENT CATHETER. PATIENT ALSO STATED THAT HE HAS TRAUMA TO URETHRA AND A LOT OF BLEEDING. END USER ALSO SAID THAT WHEN HE WAS HAVING A BOWEL MOVEMENT EARLIER TODAY AND WHEN HE STRAINED BLOOD CAME OUT OF THE CATHETER. HE SAID HE BLED FOR 45 MINUTES. EU STATED THAT THE DOCTOR SAID THAT THE INSIDE TRACK HAS BEEN TORN BADLY. NO UTI.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Injury

  MAUDE report 6941872 ↗
• MalfunctionSep 23, 2015Component Missing

  ACCORDING TO THE INFORMATION RECEIVED, END USER HAS BEEN CATHING SINCE HE WAS (B)(6) AND WHEN HE PUTS THE LUBRICATION ON THE CATH AND INSERTS NOTHING COMES OUT. HE THEN REMOVES THE CATHETER AND THEN REALIZES THERE ARE NO EYELETS. EU HAS ABOUT 50 CATHS THAT DON'T HAVE EYELETS THAT HE HAS USED. END USER GETS THEM FROM J&B AND WILL GET HIS NEXT SHIPMENT THE FIRST OF THE MONTH OF 260 AND CATHS 6-10 TIMES A DAY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5099013 ↗
• InjurySep 17, 2015Adverse Event Without Identified Device or Use Problem

  PATIENT HAS BEEN SELF-CATHING SINCE 2001. IN OR AROUND (B)(6) 2015, PATIENT INSERTED A COLOPLAST CATHETER INTO HIS PENIS WHICH RESULTED IN SIGNIFICANT BLEEDING. UNABLE TO FEEL PAIN DUE TO HIS PARALYSIS, PATIENT WAS INITIALLY UNAWARE OF THE EXTENT OF THE DAMAGE CAUSED BY THE CATHETER. HE APPLIED GAUZE AND WAS ABLE TO GET THE BLEEDING UNDER CONTROL. DURING THE FOLLOWING DAYS, HIS PENIS AND PERINEUM BECAME SWOLLEN. HE CONTINUED TO EXPERIENCE BLEEDING WITH EACH SUBSEQUENT SELF-CATH. ON (B)(6),2015 HE WAS ADMITTED TO THE (B)(6) MEDICAL CENTER WHERE HE WAS DIAGNOSED WITH A URETHRAL INJURY, PENILE ABSCESS, AND SEVERE NECROTIZING FASCITIS SECONDARY TO CATHETER INJURY. ON (B)(6), 2015, THE PRESENCE OF EXTENSIVE INFECTED TISSUE REQUIRED SURGEONS TO SURGICALLY REMOVE HIS PENIS.

  Patient problems: Abscess; Fasciitis; Hemorrhage/Blood Loss/Bleeding; Injury; Tissue Breakdown

  MAUDE report 5084036 ↗