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Model Number GEN II |
Device Problem
Manufacturing, Packaging or Shipping Problem (2975)
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Patient Problem
Choking (2464)
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Event Date 09/03/2013 |
Event Type
Injury
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Event Description
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Consumer reported i checked the packaging and did not find anything indicating that the product had latex in it.Although i did not see anything indicating that it was latex-free either.At any rate, the product must have latex in it.I used it last night when i went to bed at 10 pm, and by 10:45 pm i was awake with a burning sensation in my mouth, blisters forming on my tongue and on the inside of the lips and having difficulty breathing (choking).Consumer followed up saying she is now using our ready-to-wear product.Product was returned to store for refund.
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Manufacturer Narrative
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The product was not returned to the mfr so that an investigation could be performed.Product was returned to the retail outlet, but cannot be located.Consumer did not seek medical attention.This product does not contain latex or silicone.However, an investigation determined that latex finger cots were used in packaging of this product.A correction action was performed to remove latex from the manufacturing process, and from the factory.
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Search Alerts/Recalls
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