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
Dermatome - Product Code GFD
원인
Blade can shift during shipping which makes the product ineffective.
조치
KCI sent an Urgent - Voluntary Medical Device Field Notification letter dated June 6, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
The firm is sending Field Notifications to affected customers instructing them to complete appropriate actions.
Option I: Contact your local KCI Representative or KCI Customer Technical Support at 1-800-275-4524 and select Option 3 to arrange for return and replacement of the affected harvester(s).
Option 2: If you prefer, you may re-set the blade after removal from the packaging by gently tapping the curved end of the harvester against the palm of your hand, as shown in Figure 3, until the blade is no longer visible in the harvester top plate, as shown in Figure 4.