MalfunctionEZD

LUJA FEMALE

Received Mar 17, 2025

Report MW5167733 · MDR key 21621155

Device

Generic name

Catheter, Straight

Manufacturer

Coloplast Hungary Kft/coloplast Corp.

Patient

NA · Unknown

No Clinical Signs, Symptoms or Conditions
No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

MULTIPLE CATHETERS IN BOX DID NOT WORK -- PRODUCT WAS TWISTED WHEN OPENED. HOWEVER THE INNER CIRCLE DID NOT SEPARATE FROM OUTER RING; NOTHING COULD DRAIN FROM CATHETER AS CIRCLE AND HANDLE RING STUCK TOGETHER.