Catalog Number 0250070520 |
Device Problem
Packaging Problem (3007)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 05/27/2015 |
Event Type
malfunction
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Event Description
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It was reported that black spots were noticed inside the package.
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Manufacturer Narrative
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Additional information will be provided once the investigation has been completed.
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Manufacturer Narrative
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The cosmetic appearance failure mode of black spots could not be confirmed since no unit was returned.Most probable root causes are: 1.Manufacturing/assembly error, 2.Incorrect or inadequate packaging, 3.Severe shipping conditions.The product was not returned for investigation therefore the reported failure mode was not confirmed.The failure mode will be monitored for future reoccurrence.
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Event Description
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It was reported that black spots were noticed inside the package.
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Search Alerts/Recalls
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