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
Pouch, colostomy - Product Code EZQ
원인
Mislabeled: the market units were incorrectly labeled as # 125339 activelife drainable pouch 25 mm; the product inside was actually activelife pouch small tan 32 mm, icc # 125333.
조치
ConvaTec, Inc. sent a Returned Goods Authorization form by e-mail dated September 3, 2010, to one customer. The form identified the product, the problem, and the action the customer should take. The customer was instructed to detach the label and affix it to the outside of the box, copy the RGA # and retain a copy for their records, enclose the completed form and return with the product,
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