TACTRA MALLEABLE PENILE PROTHESIS
Received Jul 6, 2026 · Event occurred May 8, 2026
Report 2124215-2026-36106 · MDR key 25727658
Device
Generic name
Prosthesis Penile
Manufacturer
Boston Scientific CorporationModel number
UNK-P-TACTRACatalog number
UNK-P-TACTRA
Product problems
- Insufficient Device Problem Information
Patient
48 YR · Male
- Unspecified Infection
Narrative
Additional Manufacturer Narrative
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.
Description of Event or Problem
IT WAS REPORTED THAT A PATIENT WITH A TACTRA DEVICE DEVELOPED AN INFECTION. A SURGICAL PROCEDURE WAS PERFORMED TO REMOVE THE TACTRA. NO ADDITIONAL INFORMATION WAS PROVIDED.