Catalog Number IGTCFS-65-JUG |
Device Problem
Insufficient Information (3190)
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Patient Problem
No Information (3190)
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).Catalog# is unknown but referred to as cook gunther tulip filter.(b)(4).Since catalog# is unknown 510(k) could be either k090140, k112119 or k121057.(b)(4).It has not been possible to investigate or evaluate this alleged event based on the limited information provided to date.Cook will reopen its investigation if further information is receiving warranting supplementation in accordance with 21 c.F.R.803.56.
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Event Description
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Description of event according to short form complaint filed: it is alleged that "[pt] received a cook gunther tulip filter on (b)(6) 2014".Patient outcome: it is alleged that [pt] was injured without further explanation.Hospital and medical records have been requested but not yet provided.
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Manufacturer Narrative
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Additional information provided determined that this device was manufactured by cook inc.With the submission of this follow up report, william cook (b)(4) informs that this complaint has been transferred from william cook (b)(4) to cook inc.
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Search Alerts/Recalls
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