Model Number 72404310 |
Device Problems
Failure to Cycle (1142); Mechanical Problem (1384); Connection Problem (2900)
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Patient Problems
Discomfort (2330); No Known Impact Or Consequence To Patient (2692)
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Event Date 07/22/2019 |
Event Type
Injury
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Event Description
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It was reported that the patient experienced connector disorder with an inflatable penile prosthesis (ipp).The ipp pump was explanted and a new ipp pump was implanted.Further information has been requested and not yet received.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 connector disorder with an inflatable penile prosthesis (ipp).The ipp pump was explanted and a new ipp pump was implanted.Further information has been requested and not yet received.Should additional relevant details become available or the product was returned, a supplemental report will be submitted upon completion of product analysis.Additional information was reported that there was a minor abrasion causing the connector had worn down, and the patient had some discomfort when the patient attempted to cycle the device.
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Manufacturer Narrative
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Device analysis: a connector disorder was reported.There were three window quick connectors (wqc) returned attached to the ms pump tubing.The wqc's were visually inspected.All three wqc performed within specifications.A ms pump was also returned.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 was not confirmed.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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Manufacturer Narrative
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Additional information:b5.
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Event Description
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It was reported that the patient experienced connector disorder with an inflatable penile prosthesis (ipp).The ipp pump was explanted and a new ipp pump was implanted.Further information has been requested and not yet received.Should additional relevant details become available or the product was returned, a supplemental report will be submitted upon completion of product analysis.Additional information was reported that there was a minor abrasion causing the connector had worn down, and the patient had some discomfort when the patient attempted to cycle the device.
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Search Alerts/Recalls
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