Model Number UNK-P-TACTRA |
Device Problem
Defective Device (2588)
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Patient Problem
Erosion (1750)
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Event Date 07/28/2023 |
Event Type
Injury
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Event Description
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It was reported that the patient underwent a surgical procedure to remove this malleable penile prosthesis due to erosion.Subsequently, once the tissue healed, a new inflatable penile prosthesis was implanted.There were no 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 device as indicated in the instructions for use (ifu).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 underwent a surgical procedure to remove this malleable penile prosthesis due to erosion.Subsequently, once the tissue healed, a new inflatable penile prosthesis was implanted.There were no patient complications reported.
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Search Alerts/Recalls
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