Initial reporter addr 2: (b)(6).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.Although requested, product has not been received.
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Omit: b17 - device not returned, c20 - no findings available, d15 - cause not established.Additional information: device available for eval?, returned to manufacturer on, device return to manuf.? , device eval by manufacturer?, if other specify, imdrf annex a,b,c,d codes and manufacturer narrative.Please note that the investigation was performed only on the components (pca front case), as these were the only samples provided by the customer.H3 other text : not applicable.Device evaluated by bd.
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