inforMED
InjuryFAF

TOROSA

Received Sep 4, 2015

Report 2125050-2015-00091 · MDR key 5058024

Device

Generic name

Saline Filled Testicular Prosthesis

Manufacturer

Coloplast A/s

Model number

5206302400

Catalog number

450-1327

Product problems

  • Appropriate Device Problem Term/Code Not Available

Patient

Not reported

  • Irritation
  • Pain

Narrative

Additional Manufacturer Narrative

COLOPLAST HAS NOT BEEN PROVIDED ANY CORROBORATING EVIDENCE TO VERIFY THE INFORMATION CONTAINED IN THIS REPORT.

Description of Event or Problem

AS REPORTED TO COLOPLAST, THOUGH NOT VERIFIED, THE PATIENT WAS IMPLANTED WITH A TOROSA SALINE FILLED TESTICULAR PROSTHESIS. LATER THE PATIENT EXPERIENCED SCROTAL PAIN AND IRRITATION AND THE IMPLANT WAS REMOVED.