Model Number 72404310 |
Device Problem
Collapse (1099)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 11/20/2019 |
Event Type
Injury
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Manufacturer Narrative
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Device not returned for evaluation.
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Event Description
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It was reported that due to a dimpled pump the patient had his inflatable penile prosthesis (ipp) pump removed and replaced.It was further reported that the pump issues occurred 2 week ahead of this surgery.The pump issue occurred two weeks ahead of this surgery and there was no specific cause of the pump issues.The patient got well after this surgery.
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Manufacturer Narrative
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An allegation related to a collapsed or "dimpled" pump was reported.The ams 700 momentary squeeze (ms) pump was visually inspected; no leaks were found.The pump was functionally tested and performed within specification.Product analysis was unable to confirm a device malfunction.Correction to h2, h3, and h6: updated to include device analysis.
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Event Description
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It was reported that due to a dimpled pump the patient had his inflatable penile prosthesis (ipp) pump removed and replaced.It was further reported that the pump issues occurred 2 week ahead of this surgery.The pump issue occurred two weeks ahead of this surgery and there was no specific cause of the pump issues.The patient got well after this surgery.
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Search Alerts/Recalls
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