The reported product is an unknown gem flow coupler device.The device was not returned, and the lot number is unknown; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.
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It was reported from an anonymous survey result that the approximate percentage of patients that experienced blood vessel damage caused by a gem flow coupler device was 11-15%.The physician reported "minimal damage" (no further details).At the time of this report, no further detail was provided regarding if hospitalization was required, treatment for the event or the patient¿s outcome.No additional information is available.
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