Model Number NEU_LABEL_ACC |
Device Problem
Labelling, Instructions for Use or Training Problem (1318)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 02/02/2017 |
Event Type
malfunction
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Manufacturer Narrative
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A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Event Description
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Information was received from a healthcare professional (hcp) via a manufacturer representative (rep).It was reported that the hcp was viewing a document titled ¿why limit your options¿ and it said ¿no coil required¿ for full body.The document contained a picture of ¿all four companies¿ as well.No patient involvement was indicated.
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Event Description
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Additional information was received from the manufacturer representative.It was reported they could not recall the name of the mri tech or the facility where the mri tech was at who had notified them of the document.It was also reported that they no longer have the picture of the publication that was described nor could they recall it the document was contradicting.They noted they think they were reading or understanding it wrong.No further complications were reported or anticipated.
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Search Alerts/Recalls
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