Model Number 720080-01 |
Device Problem
Defective Device (2588)
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Patient Problem
Discomfort (2330)
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Event Date 12/05/2022 |
Event Type
Injury
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Event Description
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It was reported that the patient experienced difficulty penetrating their partner and was dissatisfied with the tactra device.Additionally, the patient experienced discomfort as laxity of the glans was observed; a minor procedure to correct the issue was performed.The physician recommended to replace the device with an inflatable penile prosthesis (ipp) and scheduled a revision.No further patient complications were reported.
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Manufacturer Narrative
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There was no device available for analysis and there was no report of a device performance allegation during treatment.The reported patient symptom of discomfort is a known risk associated with implants of these devices as indicated in the instructions for use (ifu).The device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.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 experienced difficulty penetrating their partner and was dissatisfied with the tactra device.Additionally, the patient experienced discomfort as laxity of the glans was observed; a minor procedure to correct the issue was performed.The physician recommended to replace the device with an inflatable penile prosthesis (ipp) and scheduled a revision.No further patient complications were reported.
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Search Alerts/Recalls
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