MalfunctionFAF
TOROSA TESTICULAR PROSTHESIS
Received Dec 7, 2016 · Event occurred Mar 18, 2016
Report MW5066633 · MDR key 6166305
Device
Product problems
- Device Markings/Labelling Problem
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
WE WOULD LIKE TO BRING TO THE ATTENTION OF THE FDA A CONCERN OUR SYSTEM HAS WITH THE LABELING OF THE COLOPLAST TESTICULAR IMPLANT BOX. IN A PROCEDURE DONE IN (B)(6) OF 2016 THE BOX LABEL READS "SALINE FILLED TESTICULAR PROSTHESIS". IN REALITY THIS IMPLANT IS NOT SALINE FILLED. SALINE MUST BE DONE MANUALLY BY THE STAFF. THE LABELING WAS MISLEADING.