InjuryFAF
TOROSA
Received Dec 19, 2013 · Event occurred Jul 22, 2013
Report 2125050-2013-00363 · MDR key 3536499
Device
Generic name
Saline Filled Testicular Prosthesis, Product Code: Faf
Manufacturer
Coloplast A/sModel number
5206502400Catalog number
5206502400
Lot number
3660017
Product problems
- Leak/Splash
Patient
Not reported
- No Information
Narrative
Description of Event or Problem
AS REPORTED TO COLOPLAST BUT NOT VERIFIED, LEAKAGE WAS REPORTED DURING FILLING OF THE IMPLANT. A SECOND IMPLANT WAS USED AND ALSO WAS FOUND TO HAVE A LEAK. THEREFORE SURGERY WAS NOT COMPLETED.
Additional Manufacturer Narrative
AFTER FURTHER INVESTIGATION COLOPLAST WAS ABLE TO CONFIRM THE DAMAGE TO THE PROTHESIS WHICH CONTRIBUTING TO THE LEAK. BASED ON THIS EVALUATION THE ROOT CAUSE APPEARS TO BE ATTRIBUTED TO USER ERROR.