(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, 0001825034-2019-02482, 0001825034-2019-02483, 0001825034-2019-02484, 0001825034-2019-02485, 0001825034-2019-02486, 0001825034-2019-02487.Concomitant medical products associated device(s): item #: 51-104160, item name: tprlc 133 t1 pps ho 16x152mm, lot number: 3817553, primary di#: 00880304491854.Item #: 51-104160, item name: tprlc 133 t1 pps ho 16x152mm, lot number: 6028661, primary di#: 00880304491854.Item #: 51-104140, item name: tprlc 133 t1 pps ho 14x148mm, lot number: 3817531, primary di#: 00880304491847.Item #: 51-103180, item name: tprlc 133 t1 pps so 18x156mm, lot number: 3975978, primary di#: 00880304498358.Item #: 51-103180, item name: tprlc 133 t1 pps so 18x156mm, lot number: 6022911, primary di#: 00880304498358.Item #: 51-103170, item name: tprlc 133 t1 pps so 17x154mm, lot number: 6238743, primary di#: 00880304498341.Item #: 51-103170, item name: tprlc 133 t1 pps so 17x154mm, lot number: 6133628, primary di#: 00880304498341.Item #: 51-103160, item name: tprlc 133 t1 pps so 16x152mm, lot number: 6309256, primary di#: 00880304489691.Item #: 51-103150, item name: tprlc 133 t1 pps so 15x150mm, lot number: 6118653, primary di#: 0880304491861.Item #: 51-103140, item name: tprlc 133 t1 pps so 14x148mm, lot number: 6075801, primary di#: 00880304491816.Item #: 51-103140, item name: tprlc 133 t1 pps so 14x148mm, lot number: 6170567, primary di#: 00880304491816.Item #: 51-103130, item name: tprlc 133 t1 pps so 13x146mmtp, lot number : 6308779, 00880304489677.Item #: 51-103090, item name: tprlc 133 type1 pps so 9x137mm, lot number: 6462370, 00880304498334.Item #: 51-100080, item name: tprlc 133 fp type1 pps so 8.0, lot number: 6364712, primary di#: 00-88030489660.Item #: 51-100060, item name: tprlc 133 fp type1 pps so 6.0, lot number: 6289409, primary di#: 00880304498174.Item #: 51-100060, item name: tprlc 133 fp type1 pps so 6.0, lot number: 6273744, primary di#: 00880304498174. item #: 51-100050, item name: tprlc 133 fp type1 pps so 5.0, lot number: 6241443, primary di#: 00880304498167. item #: 51-100040, item name: tprlc 133 fp type1 pps so 4.0, lot number: 6246127, primary di#: not released.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
|