MalfunctionFAD
IMAJIN SILICONE HYDROGEL DOUBLE LOOP URETERAL STENT KIT
Received Jun 29, 2026 · Event occurred May 29, 2026
Report 9610711-2026-00211 · MDR key 25658573
Device
Generic name
Urological Surgical Procedure Kit, Non-medicated, Single Use
Manufacturer
Coloplast A/sCatalog number
BCHF75
Lot number
10014408_BCHF754400
Product problems
- Use of Device Problem
Patient
41 YR · Male
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
ACCORDING TO THE AVAILABLE INFORMATION, DURING DIRECT DELIVERY RECEIPT PROCESSING, INTERNAL COLOPLAST EMPLOYEES IDENTIFIED EXPIRED PRODUCT HAD BEEN USED ON A PATIENT. ADDITIONAL INFORMATION INDICATES THE PATIENT IS OK, STENT HAS BEEN REMOVED, AND PRODUCT WAS DELIVERED APPROXIMATELY A MONTH AGO.
Additional Manufacturer Narrative
THE INVESTIGATION IS NOT YET COMPLETE, A FOLLOW UP REPORT WILL BE SUBMITTED ON COMPLETION OF THE INVESTIGATION.