MalfunctionFAD
BIOSOFT DUO DOUBLE LOOP URETERAL STENT KIT
Received Jun 19, 2026
Report 9610711-2026-00199 · MDR key 25564554
Device
Generic name
Urological Surgical Procedure Kit, Non-medicated, Single Use
Manufacturer
Coloplast A/sCatalog number
BCAJ75
Lot number
10815473_BCAJ754002
Product problems
- Device Stenosis
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE INVESTIGATION IS NOT YET COMPLETE, A FOLLOW UP REPORT WILL BE SUBMITTED ON COMPLETION OF THE INVESTIGATION.
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.