Model Number 70130791 |
Device Problem
Unsealed Device Packaging (1444)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 08/20/2015 |
Event Type
No Answer Provided
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Manufacturer Narrative
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At the time of this report, the device has not yet been returned for evaluation.As a result, a determination cannot be made at this time.If further information becomes available, gyrus acmi will continue the investigation and update the agency accordingly.
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Event Description
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It was reported that some packages were found unsealed at one end.
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Manufacturer Narrative
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The customer's complaint of an unseal pouch was confirmed.The returned product was reviewed and found that 100% of the lot was unsealed with no visible indications that the product had been run through the sealer.(b)(4) has been initiated to further investigate into the root cause of the issue.A review of the distribution data for the affected item and lot found that no affected product shipped to customers in the us.
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Event Description
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It was reported that some packages were found unsealed at one end.
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Search Alerts/Recalls
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