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

Model Number UNK-P-TACTRA

Device Problem Insufficient Information (3190)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/02/2020

Event Type  Injury  

Event Description

It was reported that the patient experienced an impending erosion on the right side of their penis involving this tactra malleable penile prosthesis.A procedure was performed wherein the device was removed on an unknown date.An inflatable penile prosthesis (ipp) was later implanted.No additional information was reported.

• Brand Name: TACTRA MALLEABLE PENILE PROTHESIS
• Type of Device: PROSTHESIS PENILE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 10700 bren road w; minnetonka MN 55343
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; cashel road; clonmel ; EI
• Manufacturer Contact: alyson harris ; 10700 bren road w; minnetonka, MN 55343 ; 4089353452
• MDR Report Key: 11120542
• MDR Text Key: 225253950
• Report Number: 2183959-2020-06268
• Device Sequence Number: 1
• Product Code: FAE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K183619
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/05/2021

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
• Device Operator: Lay User/Patient
• Device Model Number: UNK-P-TACTRA
• Device Catalogue Number: UNK-P-TACTRA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/11/2020
• Initial Date FDA Received: 01/05/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 62 YR