InjuryEZD
LUJA FEMALE CATHETER
Received May 16, 2025 · Event occurred May 1, 2025
Report MW5170515 · MDR key 22039190
Device
Product problems
- Patient-Device Incompatibility
- Patient Device Interaction Problem
Patient
59 YR · Female
- Erythema
- Hypersensitivity/Allergic reaction
- Inflammation
- Itching Sensation
- Erythema
- Hypersensitivity/Allergic reaction
- Inflammation
- Itching Sensation
Narrative
Description of Event or Problem
I EXPERIENCED A SIGNIFICANT ALLERGIC-TYPE REACTION AFTER USING THE COLOPLAST LUJA FEMALE CATHETER, WHICH I BELIEVE WAS CAUSED BY THE LUBRICANT OR SURFACE COATING. SYMPTOMS INCLUDED INTENSE ITCHING, REDNESS, AND INFLAMMATION IN THE PERINEAL AND ANAL REGION, WHICH PROGRESSIVELY WORSENED WITH CONTINUED USE. THE REACTION BEGAN TO RESOLVE WITHIN 36 HOURS OF DISCONTINUING USE AND FULLY SUBSIDED AFTER 4 DAYS. I HAVE SINCE RESUMED USING THE SPEEDICATH PLUS FEMALE CATHETER, WHICH I HAD USED PREVIOUSLY WITHOUT ISSUE, AND HAVE EXPERIENCED NO ADVERSE REACTIONS.