inforMED
InjuryJCW

AMS 700 CX MS PUMP

Received Jul 21, 2026 · Event occurred Jun 26, 2026

Report 2124215-2026-39431 · MDR key 25898794

Device

Generic name

Prosthesis, Penis, Inflatable

Model number

72404231

Catalog number

72404231

Lot number

1100395218

Product problems

  • Adverse Event Without Identified Device or Use Problem

Patient

66 YR · Male

  • Pain
  • Discomfort

Narrative

Additional Manufacturer Narrative

MODEL NUMBER/CATALOG NUMBER: 720185-01 SERIAL NUMBER: N/A BATCH/LOT NUMBER: 1100508193 MODEL/CATALOG DESCRIPTION: RESERVOIR FLAT IZ 100 ML UNIQUE IDENTIFIER (UDI) #: (B)(4).

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) EXPERIENCED PAIN IN SCROTUM AND DISCOMFORT. AS A RESULT, THE DEVICE WAS EXPLANTED AND REPLACED WITH A MALLEABLE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.