MalfunctionFAD
BIOSOFT DUO DOUBLE LOOP URETERAL STENT KIT
Received Jun 19, 2026
Report 9610711-2026-00198 · MDR key 25564400
Device
Generic name
Urological Surgical Procedure Kit, Non-medicated, Single Use
Manufacturer
Coloplast A/sCatalog number
BCAJ75
Lot number
10837210_BCAJ754002
Product problems
- Device Stenosis
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
ACCORDING TO THE AVAILABLE INFORMATION, REPEATED ENCRUSTATION AND A COMPLETE BLOCKAGE HAVE OCCURRED WITHIN A VERY SHORT TIMEFRAME, TYPICALLY WITHIN ONE TO TWO WEEKS. THIS NECESSITATES RETREATMENT OF THE AFFECTED PATIENTS AND, IN SOME CASES, REQUIRES ADDITIONAL INTERVENTIONS.
Additional Manufacturer Narrative
THE INVESTIGATION IS NOT YET COMPLETE, A FOLLOW UP REPORT WILL BE SUBMITTED ON COMPLETION OF THE INVESTIGATION.