Model Number 00884450476673 |
Device Problems
Unsealed Device Packaging (1444); No Apparent Adverse Event (3189)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/27/2020 |
Event Type
malfunction
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Manufacturer Narrative
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The suspect device is not expected to return for evaluation.The complaint is confirmed.The root cause is attributed to the manufacturing process.A review of the device history and complaint database could not be performed since the lot number was not provided.
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Event Description
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The account alleges that the inner blue table cover wrap has fallen out of the outer clear packaging because the pack was not sealed correctly at one end.Some packs also have a weak seal.The blue table cover will fall out onto the floor if the pack is held at the wrong end when removing the pack from the shipping box or the storage shelf.No patient injury to report.
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Search Alerts/Recalls
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