Catalog Number IGTCFS-65-FEM |
Device Problem
Insufficient Information (3190)
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Patient Problems
Pain (1994); No Information (3190)
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Event Date 11/21/2016 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Catalog #: unknown but referred to as a cook günther tulip filter.Expiration date: unknown as lot # is unknown.Since catalog # is unknown the 510(k) could be either k090140, k112119 or k121057.Unknown as lot # is unknown.Investigation is still in progress.
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Event Description
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Description according to short form complaint filed: it is alleged that "[pt] received a gunther tulip filter on (b)(6) 2012." 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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(b)(4).Catalog#: unknown but referred to as a cook günther tulip filter.Since catalog# is unknown the 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 according to short form complaint filed: it is alleged that "[pt] received a gunther tulip filter on (b)(6) 2012." 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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(b)(4).The event is currently under investigation.
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Event Description
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Per additional information provided on 02/13/2017: it is alleged that since the filter was removed the patient has experienced constant pain in the neck.
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Manufacturer Narrative
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Lot # 3806168 was initially provided, however this information was incorrect.
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Manufacturer Narrative
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(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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Manufacturer Narrative
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Exemption number e2016032.William cook (b)(4) aps (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi) (importer).Manufacturer reference #(b)(4).Corrected data based on new information received: adverse event to product problem other to malfunction it has not been possible to further investigate or evaluate this alleged event based on the limited information provided to date via the operative note stating "it is alleged that since the filter was removed the patient has experienced constant pain in the neck." cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c.F.R.803.56.No evidence to suggest that this device was not manufactured according to specifications and nothing indicates that the filter did not perform as intended, e.G.Intended for the prevention of recurrent pulmonary embolism (pe) via placement in the vena cava.Exemption number e2016032.William cook (b)(4) aps (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi) (importer).
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Manufacturer Narrative
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Exemption number e2016032.(b)(4).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.Name and address for importer site: (b)(4).
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Search Alerts/Recalls
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