InjuryJCW
AMS 700 LGX? TENACIO? PUMP
Received Apr 10, 2025 · Event occurred Apr 1, 2025
Report 2124215-2025-22434 · MDR key 21818728
Device
Generic name
Prosthesis, Penis, Inflatable
Manufacturer
Boston Scientific CorporationModel number
72404456Catalog number
72404456
Lot number
1100638714
Product problems
- Deflation Problem
- Deflation Problem
Patient
69 YR · Male
- Pain
- Discomfort
- Pain
- Discomfort
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE PATIENT IS NOT ABLE TO FULLY DEFLATE THIS INFLATABLE PENILE PROSTHESIS (IPP), RESULTING IN PAIN AND DISCOMFORT. A FOLLOW UP APPOINTMENT IS SCHEDULED FOR DEVICE EVALUATION. NO ADDITIONAL INFORMATION WAS REPORTED.
Additional Manufacturer Narrative
CONCOMITANT PRODUCT UDI FOR RESERVOIR IS (B)(4).