Model Number N/A |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
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Patient Problems
No Known Impact Or Consequence To Patient (2692); No Information (3190)
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Event Type
Injury
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Manufacturer Narrative
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Blank fields on this form indicate the information is unknown or unavailable.(b)(4).The event is currently under investigation.
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Event Description
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It is alleged that "[pt] received a gunther tulip/gunther (1820334-2016-01442) tulip mreye (1820334-2016-01441) on (b)(6) 06 at (b)(6) hospital in (b)(6)." it is alleged that the patient was injured without further explanation.Patient is seeking punitive damages.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 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.
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Event Description
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It is alleged that "[pt] received a gunther tulip (1820334-2016-01442)/ gunther tulip mreye (1820334-2016-01441) on (b)(6) 2006 at (b)(6)." it is alleged that the patient 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 confirmed the plaintiff received one filter (1820334-2016-01442) instead of two filters as originally alleged (1820334-2016-01441).Cook is cancelling the file related to 1820334-2016-01441.
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Search Alerts/Recalls
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