Model Number N/A |
Device Problem
Packaging Problem (3007)
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Patient Problem
No Patient Involvement (2645)
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Event Type
malfunction
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Manufacturer Narrative
|
(b)(4).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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Event Description
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It was reported during the distribution process packaging damage with sterility barrier potentially compromised was identified.No patient or surgical involvement.No further information available at this time.
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Manufacturer Narrative
|
Upon reassessment of the reported event, it was determined to be not reportable.The initial report was forwarded in error and should be voided.
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Event Description
|
Upon reassessment of the reported event, it was determined to be not reportable.The initial report was forwarded in error and should be voided.
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Search Alerts/Recalls
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