inforMED
InjuryJCW

AMS 700 LGX? TENACIO? PUMP

Received Aug 8, 2025 · Event occurred Jul 18, 2025

Report 2124215-2025-55252 · MDR key 22750476

Device

Generic name

Prosthesis, Penis, Inflatable

Model number

72404456

Catalog number

72404456

Lot number

1100702383

Product problems

  • Mechanical Problem
  • Mechanical Problem

Patient

72 YR · Unknown

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Additional Manufacturer Narrative

D4. CONCOMITANT PRODUCT UDI FOR RESERVOIR IS (B)(4).

Description of Event or Problem

IT WAS REPORTED THAT THE PUMP OF THE INFLATABLE PENILE PROSTHESIS (IPP) EXHIBITED LIMPNESS. AS A RESULT, THE PUMP WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.