MalfunctionFAF
TOROSA SALINE-FILLED TESTICULAR PROSTHESIS
Received Jul 19, 2024 · Event occurred Jun 21, 2024
Report 2125050-2024-01061 · MDR key 19782669
Device
Product problems
- Fluid/Blood Leak
- Fluid/Blood Leak
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
AS NO LOT # WAS PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORD, COMPLAINT HISTORY DATABASE, NONCONFORMANCES AND CAPAS COULD NOT BE COMPLETED.
Description of Event or Problem
ACCORDING TO THE AVAILABLE INFORMATION, THE PATIENT REPORTS SEEING A DIMPLE ON THE IMPLANT THROUGH HIS SKIN. THE IMPLANT IS GETTING SMALLER WITH A POSSIBLE MICRO LEAK.