inforMED
InjuryJCW

AMS 700 LGX MS PUMP

Received Jul 7, 2026 · Event occurred Jun 9, 2026

Report 2124215-2026-36499 · MDR key 25742690

Device

Generic name

Prosthesis, Penis, Inflatable

Model number

72404252

Catalog number

72404252

Lot number

828276002

Product problems

  • Adverse Event Without Identified Device or Use Problem

Patient

Not reported

  • Unspecified Infection
  • Pain

Narrative

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) EXPERIENCED PAIN UPON ACTIVATION OF THE DEVICE. DURING REVISION SURGERY, THE PHYSICIAN CONFIRMED THE PRESENCE OF INFECTION. THE DEVICE WAS EXPLANTED AND REPLACED WITH A MALLEABLE PENILE PROSTHESIS. THERE WERE NO FURTHER PATIENT COMPLICATIONS.

Additional Manufacturer Narrative

MODEL NUMBER/CATALOG NUMBER: 72404156. SERIAL NUMBER: N/A. BATCH/LOT NUMBER: 843566001. MODEL/CATALOG DESCRIPTION: RESERVOIR PARYLENE COATED WITH IZ. UNIQUE IDENTIFIER (UDI) #: (B)(4). THE DEVICE IS NOT AVAILABLE FOR ANALYSIS; THEREFORE, NO PHYSICAL OR VISUAL ANALYSIS OF THE PRODUCT COULD BE PERFORMED. THERE WAS NO REPORT OF A DEVICE PERFORMANCE ALLEGATION. INFECTION AND PAIN ARE ACKNOWLEDGED WITHIN THE INSTRUCTIONS FOR USE (IFU) AND ARE NOT RELATED TO OFF-LABEL USE OR FAILURE TO FOLLOW INSTRUCTIONS. THE REPORTED PATIENT SYMPTOM OF INFECTION AND PAIN ARE KNOWN RISKS ASSOCIATED WITH THIS DEVICE TYPE AND INDICATED AS SUCH IN THE INSTRUCTIONS FOR USE.