Model Number 720081-01 |
Device Problem
Migration (4003)
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Patient Problems
Wound Dehiscence (1154); Pain (1994)
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Event Date 05/31/2023 |
Event Type
Injury
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Event Description
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It was reported that cylinder of this tactra malleable penile prosthesis migrated out of the left corporotomy which had opened resulting in a bulge on the distal left side of his penis and pain.The device was replaced with an inflatable penile prosthesis.There were no further patient complications.
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Event Description
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It was reported that cylinder of this tactra malleable penile prosthesis migrated out of the left corporotomy which had opened resulting in a bulge on the distal left side of his penis and pain.The device was replaced with an inflatable penile prosthesis.There were no further patient complications.
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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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Search Alerts/Recalls
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