Model Number UNK-P-IPP |
Device Problem
Malposition of Device (2616)
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Patient Problems
Erosion (1750); Pain (1994)
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Event Date 02/22/2024 |
Event Type
Injury
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Manufacturer Narrative
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There was no device available for analysis; therefore, no physical or visual analysis of the product could be performed.The reported patient symptoms are a known risk associated with implant of these devices as indicated in the instructions for use.Based on the information available, a conclusion code of known inherent risk of device was assigned to this investigation.
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Event Description
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It was reported that the patient with this inflatable penile prosthesis experienced erosion, and also experienced pain during intercourse.It was noted that there was thin tissue under corona and the cylinders were too lateral.The device was explanted and replaced.No further patient complications were reported.
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Manufacturer Narrative
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There was no device available for analysis; therefore, no physical or visual analysis of the product could be performed.The reported patient symptoms are a known risk associated with implant of these devices as indicated in the instructions for use.Based on the information available, a conclusion code of known inherent risk of device was assigned to this investigation.
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Event Description
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It was reported that the patient with this inflatable penile prosthesis experienced erosion, and also experienced pain during intercourse.It was noted that there was thin tissue under corona and the cylinders were too lateral.The device was explanted and replaced.No further patient complications were reported.
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Search Alerts/Recalls
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