U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
데이터 추가 비고
Bone Wax - Product Code MTJ
원인
A hospital reported to their ethicon sales representative that they had an "unmarked" box of bone was on their shipping dock that they could not receive due to lack of appropriate documentation. upon investigation, this box was determined to be missing from a shipment between two steps of the manufacturing process. further checks determined that two other boxes were missing.
조치
Letters were sent via UPS next day air on October 28, 2008 to all customers who purchased finished product codes W31G and DW31B (on inner box labels) from January 1, 2008 through October 22, 2008.
Product code: W31; Lot # AG089. W31 is the product code for unfinished product. AG089 is the lot number assigned by Sharp Corp. DW31B is assigned on the inner box labels.
Bone Wax. || Ethicon, Inc. || Bone wax is available sterile in individual foil envelopes, each containing 2.5 grams, and then packaged in an individually sealed over wrap packet. || The device is indicated for use to control bleeding from the bone surface during surgical procedures.