Catalog Number 21-7230-24 |
Device Problem
Patient Device Interaction Problem (4001)
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Patient Problem
Cellulitis (1768)
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Event Date 09/05/2022 |
Event Type
Injury
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Event Description
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It was reported that a patient had cellulitis at the infusion site.No medical or surgical intervention was reported.
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Manufacturer Narrative
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Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when required.Operator of device is unknown.No information has been provided to date.
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Manufacturer Narrative
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Health impact, and evaluation codes: updated.No product or photos were returned therefore no device analysis could be completed.A device history record (dhr) review reported no discrepancies or non-conformances during the manufacturing of the reported lot number.If the product is returned the manufacturer will re-open the complaint for further device analysis.
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Event Description
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Additional information was received: concomitant therapy had to be started for the patient.It was reported that the event was resolved.The exact concomitant therapy started was unknown.No further information was able to be provided.
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Search Alerts/Recalls
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