Unknown if the following patient and device codes are listed in the ifu.Product information not provided.(b)(4).Corrected data based on new information received: adverse event to product malfunction.Serious injury to malfunction.Blank fields on this form indicate the information is unknown or unavailable, or unchanged.The event is currently under investigation.A supplemental report will be provided upon conclusion.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.Unknown if the following patient and device codes are listed in the ifu.Product information not provided.(b)(4).Corrected data based on new information received: adverse event to product malfunction.Serious injury to malfunction.Blank fields on this form indicate the information is unknown or unavailable, or unchanged.The event is currently under investigation.A supplemental report will be provided upon conclusion.
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This additional information received on 06/21/2017 as follows: plaintiff allegedly received an implant on (b)(6) 2004 via the right femoral vein due to bilateral pe and dvt in right femoral and popliteal veins.Plaintiff is alleging edema, pain, swelling, stiffness, vena cava perforation, and inability to stand for long periods.
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