TOROSA SALINE-FILLED TESTICULAR PROSTHESIS
Received May 27, 2025 · Event occurred May 6, 2025
Report 2125050-2025-00873 · MDR key 22087243
Device
Generic name
Prosthesis, Testicular
Manufacturer
Coloplast A/sCatalog number
450-1327
Lot number
10055592_5206302400
Product problems
- Fluid/Blood Leak
- Fluid/Blood Leak
Patient
33 YR · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
ACCORDING TO THE AVAILABLE INFORMATION, DURING PREP, THE SURGEON SAID, WHEN HE FILLED THE TOROSA HE NOTICED IT WAS WET ON THE OUTSIDE. SO, HE SLIGHTLY SQUEEZED THE TOROSA AND SALINE SHOT OUT OF THE LOWER SIDE.
Additional Manufacturer Narrative
THE LOT NUMBER WAS REVIEWED FOR COMPLAINT TREND, NONCONFORMING REPORT AND CAPA. DEVICES MET SPECIFICATION PRIOR TO RELEASE. NO TRENDS WERE NOTED FOR COMPLAINTS AND THERE WERE NO NONCONFORMING REPORTS OR CAPAS THAT WERE CONFIRMED TO BE ASSOCIATED.
Description of Event or Problem
ACCORDING TO THE AVAILABLE INFORMATION, DURING PREP, THE SURGEON SAID, WHEN HE FILLED THE TOROSA HE NOTICED IT WAS WET ON THE OUTSIDE. SO, HE SLIGHTLY SQUEEZED THE TOROSA AND SALINE SHOT OUT OF THE LOWER SIDE.
Additional Manufacturer Narrative
THE LOT NUMBER WAS REVIEWED FOR COMPLAINT TREND, NONCONFORMING REPORT AND CAPA. DEVICES MET SPECIFICATION PRIOR TO RELEASE. NO TRENDS WERE NOTED FOR COMPLAINTS AND THERE WERE NO NONCONFORMING REPORTS OR CAPAS THAT WERE CONFIRMED TO BE ASSOCIATED.