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

Model Number 720081-01

Device Problem Malposition of Device (2616)

Patient Problem Erosion (1750)

Event Date 12/01/2021

Event Type  Injury  

Event Description

It was reported that the patient underwent a tactra replacement surgery due to erosion.It was said that the device was not correctly placed.The device was removed and a new tactra was implanted.The patient fully recovered.

• Brand Name: TACTRA MALLEABLE PENILE PROTHESIS
• Type of Device: PROSTHESIS PENILE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; cashel road; clonmel ; EI
• Manufacturer Contact: alyson harris ; 4100 hamline avenue north; building c; saint paul, MN 55112 ; 4089353452
• MDR Report Key: 13021047
• MDR Text Key: 282381074
• Report Number: 2124215-2021-37959
• 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: 12/16/2021

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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 720081-01
• Device Catalogue Number: 720081-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/01/2021
• Initial Date FDA Received: 12/16/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male