inforMED
InjuryJCW

AMS 700 CX MS PUMP

Received Jul 8, 2026 · Event occurred Jun 19, 2026

Report 2124215-2026-36627 · MDR key 25751082

Device

Generic name

Prosthesis, Penis, Inflatable

Model number

72404233

Catalog number

72404233

Lot number

0132327005

Product problems

  • Fluid/Blood Leak
  • Mechanical Problem

Patient

70 YR · Male

  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS NOT CYCLING. A SURGICAL PROCEDURE WAS PERFORMED DURING WHICH THE DEVICE WAS EXPLANTED. UPON EXPLANT THE PHYSICIAN IDENTIFIED A FLUID LEAK ON THE RIGHT CYLINDER. NO ADDITIONAL INFORMATION WAS PROVIDED.

Additional Manufacturer Narrative

MODEL NUMBER/CATALOG NUMBER: 720185-01. SERIAL NUMBER: N/A. BATCH/LOT NUMBER: 0135453010. MODEL/CATALOG DESCRIPTION: RESERVOIR FLAT IZ 100 ML. UNIQUE IDENTIFIER (UDI) #: (B)(4).