Model Number 85-018-E140S |
Device Problem
Unsealed Device Packaging (1444)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/24/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The suspect device is expected to return for evaluation.A follow up will be submitted when the evaluation is complete.
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Event Description
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The account alleges that there was a breach in the packaging resulting in incomplete sterilization of the contents.No patient interaction or injury to report.
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Manufacturer Narrative
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The suspect device has been returned for evaluation.The complaint is confirmed.The root cause is attributed to the manufacturing process.A search of the complaint database was performed and no similar complaints for this lot number were found.The device history record was reviewed, and no exception documents were found.
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Search Alerts/Recalls
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