Model Number N/A |
Device Problem
Device Operates Differently Than Expected (2913)
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Patient Problem
Extravasation (1842)
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Event Type
Injury
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Manufacturer Narrative
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The event has been sent to the fda with the uf/importer report # (b)(4).It was reported that accufill appeared to have leaked into the joint space postoperatively; the device was unable to be evaluated as it is retained in the patient.It was also reported that preexisting characteristics may have contributed to the event.Once more information becomes available about the event, a supplemental report will be submitted.Device remains in patient.
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Event Description
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Mdr received via mail-extravasation reported to fda.
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Manufacturer Narrative
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Through the investigation it was determined the event had previously been reported under report number 3008812173-2018-00012.The details of the event can be found in the previously reported event: "a patient returned to the surgeon after the scp case with a hematoma after possible extravasation near the site of the surgery.Images were taken but not available for review.Per the investigation, it was determined that the patient did not follow post-operative instructions from surgeon, resulting in the complaint condition.".
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Event Description
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Mdr received via mail-extravasation reported to fda.
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Search Alerts/Recalls
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