Personal Catheter™ Intermittent Catheter 61314Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741068959), received between Oct 17, 2019 and Nov 4, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device Damaged Prior to Use” (2 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 4, 2019Device Damaged Prior to Use; Scratched Material; Device Damaged Prior to Use

  IT WAS REPORTED THAT THE PATIENT SAID THE CATHETERS HAD A SHARP TIP AND CAUSED HER A LITTLE BLEEDING.

  Patient problems: Blood Loss; Patient Problem/Medical Problem

  MAUDE report 9272002 ↗
• MalfunctionOct 17, 2019Difficult to Insert; Device Damaged Prior to Use; Structural Problem; Device Damaged Prior to Use

  IT WAS REPORTED THAT THE CATHETERS HAD NUMBERS ON THEM WHICH MADE THEM ROUGH AND PATIENT COULD NOT INSERT THEM FOR USE. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 9202061 ↗