A patient had their system explanted due to a suspected infection was reported to abbott.As a result, a device history record was performed to review and confirm the sterility of devices.Based on the documents reviewed, the source of the infection remains unknown.Date of event is estimated.
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Related manufacturer reference number: 3006705815-2021-05983.Related manufacturer reference number: 1627487-2021-18647.Related manufacturer reference number: 1627487-2021-18648.Related manufacturer reference number: 1627487-2021-18659.It was reported that the patient was experiencing drainage and redness at the midline and pocket incision sites.Reportedly, the surrounding tissue was red and inflamed and the patient experienced a fever that resolved on (b)(6) 2021.As a result, the physician administered antibiotics and explanted the patient's system, as infection was noted when the patient was taken to the operating room.
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