Model Number 1192 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Abscess (1690); Unspecified Infection (1930)
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Event Date 10/31/2017 |
Event Type
Injury
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Manufacturer Narrative
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Abbott has limited information related to the patient¿s medical history and is unable to form an opinion as to the relevancy of the patient¿s history to the event reported.Abbott defers to the patient¿s physician regarding medical history.
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Event Description
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Device reference 1 of 2: manufacturer report: 1627487-2017-07588.It was reported the patient went to the hospital to be treated for an abscess at the incision area.It was determined the area was infected, thereby the patient needed surgery to explant the entire scs system.
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Event Description
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Device 2 of 2: reference manufacturer report: 1627487-2017-07588.Additional information gathered via follow up revealed the patient was given oral antibiotics to address the infection.
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Search Alerts/Recalls
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