Catalog Number 254401006 |
Device Problem
Break (1069)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 05/22/2018 |
Event Type
malfunction
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Manufacturer Narrative
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If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Event Description
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Visual examination of the product confirmed the device is broken. .
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Manufacturer Narrative
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Product complaint # = > pc-(b)(4).Investigation summary = > the investigation confirmed the reported event.The complaint shall be closed with a justified conclusion; it will be entered into the complaint database and monitored through trend analysis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Manufacturer Narrative
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Product complaint: (b)(4).Investigation summary: the investigation confirmed the reported event.The complaint shall be closed with a justified conclusion; it will be entered into the complaint database and monitored through trend analysis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Search Alerts/Recalls
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