BARD ACCESS SYSTEMS POWERPORT MRI ISP ALTERNATIVE BUMPS, 8F CHRONOFLEX, SP; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
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Model Number 4808060 |
Device Problem
Patient-Device Incompatibility (2682)
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Patient Problems
Rash (2033); Local Reaction (2035); Swelling (2091)
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Event Date 11/12/2018 |
Event Type
Injury
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Manufacturer Narrative
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As the lot number for the device was not provided, a manufacturing review could not be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.
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Event Description
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It was reported the patient is allegedly having a local reaction (itchy, red, and swelling to her neck area) around the powerport implant.There was no reported patient injury.
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Search Alerts/Recalls
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