A follow up report will be submitted with investigation results should the device be repaired or the device/logs be received for evaluation.Per 803.52(f)(11)(iii) the information provided represents all of the known information at this time.The complainant or reporter was unable or unwilling to provide any further patient, product, or procedural details to the manufacturer.H3 other text : device was not returned to manufacturing facility.
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Omit: if other specify, b17 - device not returned, c20 - no findings available, d15 - cause not established.Additional information: unique identifier (udi) #, medical device serial #, device available for eval, returned to manufacturer on, device return to manuf.?, reason code for no evaluation, device manufacture date, imdrf annex b, c, d codes and manufacturer narrative.A follow up report will be submitted once the failure investigation has been completed.
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