(b)(4).D10 - associated medical devices: m2a-magnum recap cup 56odx50id; item# 157856; lot# 1488514 tprloc 12/14 por lat 11x142; item# 650-0264; lot# 1476477 magnum tpr adpr ti 42-50/+8mm; item# 130832; lot# 1338003 multiple mdr reports were filed for this event, please see the associated report: 3002806535-2023-00137.G2 - foreign: italy the device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
|