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Model Number AB63181002 |
Device Problems
Contamination /Decontamination Problem (2895); Manufacturing, Packaging or Shipping Problem (2975)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence.Once our evaluation is complete, a follow-up report will be submitted.
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Event Description
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According to the available information, a hair was found on the primary packaging of the device.The device was not used.
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Manufacturer Narrative
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Visual examination of the returned product revealed a hair inside the embossed sheath.
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Search Alerts/Recalls
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