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Model Number 1608052 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Irritation (1941); Itching Sensation (1943); Local Reaction (2035)
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Event Date 01/18/2020 |
Event Type
Injury
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Manufacturer Narrative
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As the lot number for the device was provided, a manufacturing review will 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.(expiration date: 02/2021).
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Event Description
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It was reported that approximately two days post port implant, the patient allegedly experienced redness, irritation, hives and itches around the port insertion site and continued to spread to an ever larger area up the jaw, down the chest as time went on.Therefore, the patient received prescribed medication (antibiotics).Reportedly, the device was removed and another device was placed on the other side of the chest.The patient was reported as stable.
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Search Alerts/Recalls
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