Based on the investigation, the device was not returned for analysis and there were no ncprs associated with the product return for this specific complaint.This investigation is considered as a no product return.As the complaint component was not returned for analysis, and the product record review revealed no additional information related to the complaint.The reported allegations could not be confirmed.The event cannot be reproduced or sustained; therefore, no escalation to ncep, cpa, or scar is required.
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It was reported that the patient underwent a surgical procedure to revise this inflatable penile prosthesis (ipp) due to the pump being stuck and is no longer able to use the device that started within a week of becoming aware of the event.The ipp cylinder, pump, and reservoir was explanted and replaced with a new ipp cylinder, pump, and reservoir.
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