Lot Number 3197243005 63 00:03 |
Device Problem
No Apparent Adverse Event (3189)
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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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Product investigation is in progress.
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Event Description
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Half the string comes off, string already detached (device breakage).Case narrative: consumer reported via phone that the string was detached and hanging.No injury reported.
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Manufacturer Narrative
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Product investigation is in progress.
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Event Description
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Half the string comes off, string already detached [device breakage].Case narrative: consumer reported via phone that the string was detached and hanging.No injury reported.
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Manufacturer Narrative
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Cause was traced to manufacturing.Action plan is in place.
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Event Description
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Half the string comes off, string already detached [device breakage].Probable manufacturing cause [manufacturing issue].Case narrative: consumer reported via phone that the string was detached and hanging.No injury reported.
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Search Alerts/Recalls
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