TOROSA
Received Jun 20, 2018 · Event occurred Oct 4, 2017
Report 7619770 · MDR key 7619770
Device
Generic name
Prosthesis, Testicular
Manufacturer
Coloplast Manufacturing Us, LlcCatalog number
450-1327
Lot number
5675336
Product problems
- Defective Component
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
THIS IS A PATIENT THAT WAS DIAGNOSED WITH TESTICULAR CANCER AND HAD AN ORCHIECTOMY. HE HAD A TESTICULAR PROSTHESIS IMPLANTED WHEN THE ORCHIECTOMY WAS PERFORMED. A FEW DAYS LATER IT WAS FLAT. THE PATIENT ENDED UP SEEING THE UROLOGIST IN THE OFFICE AND THE SURGEON HAD NEVER SEEN THAT HAPPEN BEFORE. THE UROLOGIST FEELS LIKE THE DEVICE IS DEFECTIVE. THE PATIENT WAS HAVING TO GO THROUGH CHEMOTHERAPY AND RECOVERING. THE PATIENT NOW FEELS LIKE HE IS READY TO HAVE THIS POTENTIALLY DEFECTIVE DEVICE REPLACED. HE IS GOING TO GO THROUGH A PROCEDURE AT A CANCER INSTITUTE AND WOULD LIKE THIS DONE AT THE SAME TIME.