Model Number 720081-01 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Wound Dehiscence (1154); Purulent Discharge (1812); Unspecified Infection (1930)
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Event Date 01/17/2024 |
Event Type
Injury
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Event Description
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It was reported that the patient with this malleable device experienced purulent discharge and an open wound infection.It was noted that the infection was located in the corporal bodies and the incision site.A surgical procedure was performed to remove the prothesis and complete a wash-out.Post operatively, the patient was treated with antibiotics.There were no device issues and no additional patient complications 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 device 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 malleable device experienced purulent discharge and an open wound infection.It was noted that the infection was located in the corporal bodies and the incision site.A surgical procedure was performed to remove the prothesis and complete a wash-out.Post operatively, the patient was treated with antibiotics.There were no device issues and no additional patient complications reported.
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Search Alerts/Recalls
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