Model Number 72404310 |
Device Problem
Connection Problem (2900)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 08/05/2019 |
Event Type
Injury
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Event Description
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It was reported that the patient experienced a connector disorder with an inflatable penile prosthesis (ipp).The ipp pump was explanted and a new ipp pump was implanted.Additional information was reported that the connector wore down.Should additional relevant details become available or the product was returned, a supplemental report will be submitted upon completion of product analysis.
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Event Description
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It was reported that the patient experienced a connector disorder with an inflatable penile prosthesis (ipp).The ipp pump was explanted and a new ipp pump was implanted.Additional information was reported that the connector wore down.Should additional relevant details become available or the product was returned, a supplemental report will be submitted upon completion of product analysis.
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Manufacturer Narrative
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Device analysis: connector disorder was reported.No connectors were received.The ams700 momentary squeeze pump was visually inspected.No leak was found.The pump was not functionally tested due to contamination.The allegation of connector disorder could not be confirmed as no connectors were returned.Based on the results of this investigation, no escalation is required.If further information is received at a later date, the product investigation will be reopened to address the additional information.
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Search Alerts/Recalls
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