Model Number ASKU |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Skin Inflammation/ Irritation (4545)
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Event Date 01/01/2018 |
Event Type
Injury
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Manufacturer Narrative
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This report is submitted on january 11, 2021.
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Event Description
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Per the clinic, the patient experienced chronic skin irritation and inflammation at the abutment site.It was noted during several clinical follow-up appointments since 2018, that the patient was treated with topical antibiotic ointments and oral antibiotics on multiple occasions.The implanted device remains.
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Manufacturer Narrative
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It was reported that the patient underwent skin revision surgery, silver nitrate was used to cauterise the granulation tissue at site, the patient was administered oral antibiotics due to the recurrence of infection.The implanted device remains.This report is submitted on 3 february 2021.
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Search Alerts/Recalls
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