Model Number 720081-01 |
Device Problem
Insufficient Information (3190)
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Patient Problem
Perforation (2001)
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Event Date 10/24/2023 |
Event Type
Injury
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Event Description
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It was reported that the patient with a tactra penile prosthesis presented to the physician with perforation of the corpus cavernosum.The physician determined that there was risk of extrusion, and the patient will be undergoing surgical intervention for grafting and replacement of the cylinders.There were no additional patient complications reported.
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Manufacturer Narrative
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There was no device available for analysis; therefore, no physical or visual analysis of the product could be performed.The reported patient symptoms are a known risk associated with implant of these devices as indicated in the instructions for use.Based on the information available, a conclusion code of known inherent risk of device was assigned to this investigation.
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Event Description
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It was reported that the patient with a tactra penile prosthesis presented to the physician with perforation of the corpus cavernosum.The physician determined that there was risk of extrusion, and the patient will be undergoing surgical intervention for grafting and replacement of cylinders.There were no additional patient complications reported.
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Search Alerts/Recalls
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