Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
데이터 추가 비고
원인
The non-coring needle included with the sets has the potential to dislodge silicone from the septum of the port component. hypothetically this could lead to embolization of a fragment or leakage of medication/injectable fluids into surrounding tissues. neither of these potential consequences has been reported.
Model Catalog: IP-S6118 (Lot serial: >10 contact mfr); Model Catalog: IP-S6110 (Lot serial: >10 contact mfr); Model Catalog: IP-S6113 (Lot serial: >10 contact mfr); Model Catalog: IP-S6118-MPIS-NT (Lot serial: >10 contact mfr); Model Catalog: IP-S5118 (Lot serial: >10 contact mfr); Model Catalog: IP-S7029 (Lot serial: >10 contact mfr); Model Catalog: IP-S7129 (Lot serial: >10 contact mfr); Model Catalog: IP-7112 (Lot serial: >10 contact mfr); Model Catalog: IP-9112 (Lot serial: >10 contact mfr); Model Catalog: IP-S6112 (Lot serial: >10 contact mfr); Model Catalog: IP-S7112 (Lot serial: >10 contact mfr); Model Catalog: IP-S9012 (Lot serial: >10 contact mfr); Model Catalog: IP-S9112 (Lot serial: >10 contact mfr); Model Catalog: IP-7110 (Lot serial: >10 contact mfr); Model Catalog: IP-S7010 (Lot serial: >10 contact mfr); Model Catalog: IP-S7110 (Lot serial: >10 contact mfr); Model Catalog: IP-S9010 (Lot serial: >10 contact mfr); Model Catalog: IP-S9110 (Lot serial: >10 contact mfr); Model Catalog: IP-S6010 (Lot
제품 설명
VITAL-PORT MRI PETITE VASCULAR ACCESS;VITAL-PORT VASCULAR ACCESS PORT;VITAL-PORT PETITE VASCULAR ACCESS PORT;VITAL-PORT PETITE DUAL LUMEN VASCULAR ACCESS;VITAL-PORT MRI VASCULAR ACCESS SYSTEM PORT;VITAL-PORT MINI VASCULAR ACCESS