Model Number N/A |
Device Problems
Migration or Expulsion of Device (1395); Insufficient Information (3190)
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Patient Problems
Nausea (1970); Pain (1994); Thrombus (2101); No Information (3190)
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Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The event is currently under investigation.A supplemental report will be submitted upon completion.
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Event Description
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It is alleged that the plaintiff received a gunther filter on (b)(6) 2007 and another manufacturer's filter was implanted on (b)(6) 2010.It is alleged that the plaintiff 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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It has not been possible to further investigate or evaluate this alleged event based on the limited information provided to date.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.
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Manufacturer Narrative
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Correction(s): adverse event to product problem implant date: other to blank, blank to (b)(6) 2007, explant date (b)(6) 2007 to blank, serious injury to malfunction.(b)(4).The event is currently under investigation.A supplemental report will be submitted upon completion.
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Event Description
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This additional information received on 13dec2017 as follows: ¿patient [pt] allegedly received an implant (gunther tulip) on (b)(6) 2007 via the left common femoral vein due to deep vein thrombosis and pulmonary embolism, another manufacturer's filter (mfr3002808486-2017-01994) ) was implanted on (b)(6) 2010.[pt] is alleging migration, stomach pains, imbalance and nausea.Patient also alleges anxiety and depression.Plaintiff attributes the inability to move about freely, exercise and work with the filter.
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Search Alerts/Recalls
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