The user facility submitted medwatch (b)(4) for this event.H10: 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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Correcting the following fields to align with the information provided in the global unique device identification database (gudid): d1: brand name, d3: device manufacturer name, d4: model #, d4: unique identifier (udi) #, g4: combination product.The d4: unique device identifier (udi) # is based on the di information as no lot/serial number was provided by the reporter.Should additional relevant information become available, a supplemental report will be submitted.
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