MalfunctionFAD
VORTEK HYDRO-COATED DOUBLE LOOP URETERAL STENT KIT
Received Jun 10, 2026
Report 9610711-2026-00171 · MDR key 25463875
Device
Generic name
Urological Surgical Procedure Kit, Non-medicated, Single Use
Manufacturer
Coloplast A/sCatalog number
BCFG64
Lot number
10799610_BCFG644002
Product problems
- Device Contaminated During Manufacture or Shipping
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
ACCORDING TO THE AVAILABLE INFORMATION, ADHESIVE RESIDUE IN THE PACKAGED DOUBLE J.
Additional Manufacturer Narrative
THE INVESTIGATION IS NOT YET COMPLETE, A FOLLOW UP REPORT WILL BE SUBMITTED ON COMPLETION OF THE INVESTIGATION.