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Catalog Number UNKNOWN |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problems
Dyspnea (1816); Pain (1994); Discomfort (2330); Insufficient Information (4580)
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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.Initial reporter occupation: non-healthcare professional.Investigation.It has not been possible to further investigate or evaluate this alleged event based on the limited information and/or no device failure provided to date.Catalog number and lot number are unknown, however, the alleged celect is manufactured and inspected according to specifications.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.Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c.F.R.803.56.This report includes information known at this time.A follow-up medwatch report will be submitted if additional relevant information becomes available.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, or that any cook device caused or contributed to or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
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Event Description
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It is alleged that the patient received a celect inferior vena cava (ivc) filter on (b)(6) 2011, and the patient was injured without further explanation.Hospital and medical records have been requested, but not yet provided.
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Event Description
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Patient allegedly received an implant on (b)(6) 2011 due to back operation.The patient alleges shortness of breath (sob) and chest pain.The patient further alleges pain and discomfort.
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Manufacturer Narrative
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Investigation the following allegations have been investigated: sob, pain (chest), discomfort.Investigation is reopened due to additional information provided.The reported allegations have been further investigated based on the information provided to date.Unknown if the reported shortness of breath (sob), pain (chest), and discomfort are directly related to the filter and unable to identify a corresponding failure mode at this point in time.Catalog number and lot number are unknown; however, the alleged filter is manufactured and inspected according to controls.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.Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c.F.R.803.56.This report includes information known at this time.A follow-up medwatch report will be submitted if additional relevant information becomes available.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, or that any cook device caused or contributed to or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
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Search Alerts/Recalls
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