InjuryJCW
CONCEAL
Received Jul 8, 2026 · Event occurred Jun 19, 2026
Report 2124215-2026-36616 · MDR key 25751073
Device
Generic name
Prosthesis, Penis, Inflatable
Manufacturer
Boston Scientific CorporationModel number
720185-01Catalog number
720185-01
Lot number
0159398006
Product problems
- Fluid/Blood Leak
- Mechanical Problem
- Material Puncture/Hole
Patient
69 YR · Male
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS UNABLE TO CYCLE. A SURGICAL PROCEDURE WAS PERFORMED DURING WHICH THE DEVICE WAS EXPLANTED AND REPLACED. UPON EXPLANT THE PHYSICIAN IDENTIFIED A HOLE AT THE JUNCTURE OF THE PUMP TUBING WHERE IT CONNECTED TO THE KINK RESISTANT TUBING (KRT), AND THERE WAS FLUID LEAKAGE. NO ADDITIONAL INFORMATION WAS PROVIDED.