Model Number UNK-P-IPP |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)
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Patient Problems
Erosion (1750); Pain (1994)
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Event Date 01/31/2024 |
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 (ifu).Based on the information available, a conclusion code of known inherent risk of device was assigned to this investigation.Field b3 date of event: despite good faith efforts exact event date is unknown.Approximate date has been used.
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Event Description
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It was reported that three years ago the patient with this inflatable penile prosthesis (ipp) experienced pain due to the reservoir eroding into the bladder, a revision surgery took place to remove the reservoir.Now that the bladder has healed, a new revision surgery has been performed to explant the remaining cylinders and place a new device.No additional 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 (ifu).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 (ipp) experienced pain due to the reservoir eroding and migrating into the bladder without tissue perforation; therefore, a revision surgery took place to remove the reservoir.At a later date, a new revision surgery was performed to explant the remaining cylinders and pump and place a new ambicor penile prosthesis (app).No additional patient complications were reported.
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Search Alerts/Recalls
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