inforMED
InjuryJCW

AMS 700 CX MS PUMP

Received Jul 3, 2026 · Event occurred Apr 1, 2026

Report 2124215-2026-35820 · MDR key 25704825

Device

Generic name

Prosthesis, Penis, Inflatable

Model number

72404238

Catalog number

72404238

Lot number

1100746584

Product problems

  • Migration

Patient

64 YR · Male

  • Deformity/ Disfigurement
  • Unspecified Tissue Injury

Narrative

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT'S INFLATABLE PENILE PROSTHESIS (IPP) WAS FUNCTIONING PROPERLY; HOWEVER, A SLIGHT UNEXPECTED CURVATURE WAS OBSERVED. UPON EVALUATION BY THE UROLOGIST, A PROXIMAL CROSSOVER WAS DIAGNOSED. A CORRECTIVE SURGICAL PROCEDURE WAS SUBSEQUENTLY PERFORMED, DURING WHICH THE CROSSOVER CYLINDER WAS PARTIALLY REMOVED, THE AFFECTED CORPORAL BODY WAS DILATED CORRECTLY, AND THE SAME CYLINDER INSERTED BACK IN. NO ADDITIONAL DEVICE ISSUES WERE IDENTIFIED, AND NO PATIENT COMPLICATIONS WERE REPORTED.