InjuryFAF
TOROSA
Received Apr 30, 2012 · Event occurred Apr 3, 2012
Report 2125050-2012-00022 · MDR key 2822180
Device
Generic name
Saline Filed Testicular Prosthesis
Manufacturer
Coloplast A/sModel number
5206302400Catalog number
5206302400
Lot number
3000205
Product problems
- Material Erosion
Patient
Not reported
- Tissue Damage
Narrative
Description of Event or Problem
DEVICE ERODED THROUGH THE SCROTUM.
Additional Manufacturer Narrative
ONE TESTICULAR DEVICE WAS RETURNED FOR EVALUATION. EXAMINATION OF THE RETURNED COMPONENT REVEALED NO ABNORMALITIES THAT WOULD HAVE CONTRIBUTED TO THE REPORT OF EROSION. COLOPLAST ACCEPTS THE PHYSICIAN'S OBSERVATIONS OF SUCH AS THE REASON FOR SURGICAL INTERVENTION. THE PRODUCT LITERATURE THAT ACCOMPANIES THIS DEVICE ADDRESSES THE POTENTIAL POST OPERATIVE COMPLICATIONS SUCH AS THIS.