TACTRA MALLEABLE PENILE PROTHESIS
Received Jul 14, 2026 · Event occurred Jul 1, 2026
Report 2124215-2026-37709 · MDR key 25815608
Device
Generic name
Prosthesis Penile
Manufacturer
Boston Scientific CorporationModel number
UNK-P-TACTRACatalog number
UNK-P-TACTRA
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
69 YR · Male
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THIS TACTRA WAS EXPLANTED AND REPLACED WITH A THREE-PIECE INFLATABLE PENILE PROSTHESIS (IPP). THERE WERE NO DEVICE ISSUES, AND NO ADDITIONAL INFORMATION WAS PROVIDED.
Additional Manufacturer Narrative
D4: DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. WE COMPLETED A GOOD FAITH EFFORT TO OBTAIN THE INFORMATION. BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME, WE ARE UNABLE TO PROVIDE THE COMPLETE UNIQUE IDENTIFIER (UDI) # AND OTHER PRODUCT SPECIFIC INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.