InjuryJCW
AMS 700 CX MS PUMP
Received Jul 21, 2026 · Event occurred May 23, 2026
Report 2124215-2026-39420 · MDR key 25898485
Device
Generic name
Prosthesis, Penis, Inflatable
Manufacturer
Boston Scientific CorporationModel number
72404232-10Catalog number
72404232-10
Lot number
1100500316
Product problems
- Fluid/Blood Leak
- Mechanical Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
MODEL NUMBER/CATALOG NUMBER: 720185-01 SERIAL NUMBER: N/A BATCH/LOT NUMBER: 1100571514 MODEL/CATALOG DESCRIPTION: RESERVOIR UNIQUE IDENTIFIER (UDI) # (B)(4).
Description of Event or Problem
IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS NOT WORKING AND HAD FLUID LOSS. AS A RESULT, THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.