Catalog Number K09-MS3049A |
Device Problem
Tear, Rip or Hole in Device Packaging (2385)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/07/2021 |
Event Type
malfunction
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Event Description
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The account alleges that during inspection a hole in the clear film packaging was discovered.No patient consequence to report.
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Manufacturer Narrative
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The suspect device has been returned for evaluation.A follow up will be submitted when the evaluation is complete.
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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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