Model Number 72404232-10 |
Device Problem
Defective Device (2588)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 01/06/2020 |
Event Type
malfunction
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Event Description
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It was reported that the patient experienced a malfunctioning inflatable penile prosthesis(ipp) pump.The pump is as hard as a rock, and the patient is concerned that the physician wants to replace the pump.Additional information received that the doctor is going ahead with the valve replacement.The patient reported that the deflate button slowly retracted when trying techniques that the liaison suggested upon his reported malfunctioning device.
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Manufacturer Narrative
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Additional information received that the revision surgery was scheduled for (b)(6) 2020 and was cancelled by the patient because the patient began to be able to pump up the device.
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Event Description
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It was reported that the patient experienced a malfunctioning inflatable penile prosthesis(ipp) pump.The pump is as hard as a rock, and the patient is concerned that the physician wants to replace the pump.Additional information received that the doctor is going ahead with the valve replacement.The patient reported that the deflate button slowly retracted when trying techniques that the liaison suggested upon his reported malfunctioning device.
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Search Alerts/Recalls
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