MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION TACTRA; PROSTHESIS PENILE

Model Number	720082-01
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	12/06/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient with this tactra malleable prosthesis experienced infection in the penis.The patient was hospitalized for intravenous antibiotic therapy awaiting a surgical procedure to remove and replace the infected prosthesis.No further patient complications were reported.

• Brand Name: TACTRA
• Common Device Name: PROSTHESIS PENILE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 21054925
• Report Number: 2124215-2024-81902
• Device Sequence Number: 8758184
• Product Code: FAE
• UDI-Device Identifier: 08714729979364
• UDI-Public: 08714729979364
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K183619
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/02/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 720082-01
• Device Catalogue Number: 720082-01
• Device Lot Number: 0040163369
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/06/2024
• Initial Report FDA Received Date: 01/02/2025
• Date Device Manufactured: 01/02/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 67 YR
• Patient Sex: Male