Catalog Number 1012268-12 |
Device Problem
Device Markings/Labelling Problem (2911)
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Patient Problem
No Patient Involvement (2645)
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Event Date 04/23/2020 |
Event Type
malfunction
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Manufacturer Narrative
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The device location was not provided, and it is unknown if the device is returning for analysis.
A follow-up report will be submitted with all additional relevant information.
The additional mini trek referenced is filed under a separate medwatch report number.
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Event Description
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It was reported that the distributor received a mini trek (part number 1012268-12, lot number 80615g1), which was not registered in (b)(6).
There was no patient involvement.
No additional information was provided.
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Search Alerts/Recalls
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