AMS 700 CXR
Received Jul 8, 2026 · Event occurred May 12, 2026
Report 2124215-2026-36630 · MDR key 25757021
Device
Generic name
Prosthesis, Penis, Inflatable
Manufacturer
Boston Scientific CorporationModel number
72404012Catalog number
72404012
Lot number
1000404174
Product problems
- Material Puncture/Hole
Patient
54 YR · Male
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
MODEL NUMBER/CATALOG NUMBER: 72404310. SERIAL NUMBER: N/A BATCH/LOT NUMBER: 1000554441. MODEL/CATALOG DESCRIPTION: PUMP MS. UNIQUE IDENTIFIER (UDI) #: (B)(4). MODEL NUMBER/CATALOG NUMBER: 72018201. SERIAL NUMBER: N/A BATCH/LOT NUMBER: 1000377326 MODEL/CATALOG DESCRIPTION: RESERVOIR FLAT 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 A DAMAGE IN THE BODY OF PENNIS, AS THE DEVICE WAS RUPTURED. AS A RESULT, THE DEVICE WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATION WAS REPORTED.