inforMED
InjuryJCW

AMS 700 LGX? TENACIO? PUMP

Received Jul 15, 2026 · Event occurred Jul 8, 2026

Report 2124215-2026-38008 · MDR key 25829153

Device

Generic name

Prosthesis, Penis, Inflatable

Model number

72404453

Catalog number

72404453

Lot number

1100553667

Product problems

  • Inflation Problem

Patient

75 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 INFLATE PAST 50 PERCENT. A SURGICAL PROCEDURE WAS PERFORMED DURING WHICH THE PUMP WAS EXPLANTED AND REPLACED. NO ADDITIONAL INFORMATION WAS PROVIDED.

Additional Manufacturer Narrative

MODEL NUMBER/CATALOG NUMBER: 720185-01. SERIAL NUMBER: N/A. BATCH/LOT NUMBER: 1100880349. MODEL/CATALOG DESCRIPTION: RESERVOIR FLAT IZ 100 ML. UNIQUE IDENTIFIER (UDI) #: (B)(4).