(b)(4).Multiple mdr's were filed for this event.Please see associated report(s): 0001825034 - 2019 - 02469, 0001825034 - 2019 - 02470, 0001825034 - 2019 - 02471, 0001825034 - 2019 - 02472, 0001825034 - 2019 - 02473, 0001825034 - 2019 - 02474, 0001825034 - 2019 - 02475, 0001825034 - 2019 - 02476, 0001825034 - 2019 - 02477, 0001825034 - 2019 - 02479, 0001825034 - 2019 - 02480,, 0001825034 - 2019 - 02481, 0001825034 - 2019 - 02482 0001825034 - 2019 - 02483,, 0001825034 - 2019 - 02484 0001825034 - 2019 - 02485, 0001825034 - 2019 - 02486, 0001825034 - 2019 - 02487.Concomitant medical products: primary di# item # item name lot number primary di# 51-104160 tprlc 133 t1 pps ho 16x152mm 3817553 00880304491854, 51-104160 tprlc 133 t1 pps ho 16x152mm 6028661 00880304491854, 51-104140 tprlc 133 t1 pps ho 14x148mm 3817531 00880304491847, 51-103180 tprlc 133 t1 pps so 18x156mm 3975978 00880304498358, 51-103180 tprlc 133 t1 pps so 18x156mm 6022911 00880304498358, 51-103170 tprlc 133 t1 pps so 17x154mm 6238743 00880304498341, 51-103170 tprlc 133 t1 pps so 17x154mm 6133628 00880304498341,, 51-103160 tprlc 133 t1 pps so 16x152mm 6309256 00880304489691 51-103150 tprlc 133 t1 pps so 15x150mm 6118653 00880304491861,, 51-103140 tprlc 133 t1 pps so 14x148mm 6075801 00880304491816, 51-103140 tprlc 133 t1 pps so 14x148mm 6170567 00880304491816 51-103130 tprlc 133 t1 pps so 13x146mmtp 6308779 00880304489677, 51-103090 tprlc 133 type1 pps so 9x137mm 6462370 00880304498334, 51-100080 tprlc 133 fp type1 pps so 8.0 6364712 00-88030489660, 51-100060 tprlc 133 fp type1 pps so 6.0 6289409 00880304498174, 51-100060 tprlc 133 fp type1 pps so 6.0 6273744 00880304498174, 51-100050 tprlc 133 fp type1 pps so 5.0 6241443 00880304498167, 51-100040 tprlc 133 fp type1 pps so 4.0 6246127 not released.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
|