Catalog Number 5400702000 |
Device Problem
Biocompatibility (2886)
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Patient Problem
No Patient Involvement (2645)
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Event Date 03/02/2017 |
Event Type
malfunction
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Manufacturer Narrative
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This mdr report is part of the malfunction summary reporting program, exemption number (b)(4).1 device was received for evaluation.1 device evaluation is in progress.There were no remedial actions taken.This device is labeled for single-use.
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Event Description
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This report summarizes 1 malfunction event in which the device had white dust in the package.There was patient involvement; no patient impact.
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Manufacturer Narrative
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(b)(4).1 device was received for evaluation.1 event was confirmed.The internal part of the packaging had evidence of friction.There were no remedial actions taken.This device is labeled for single-use.
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Event Description
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This report summarizes 1 malfunction event in which the device had white dust in the package.There was patient involvement; no patient impact.
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Search Alerts/Recalls
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