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.
Prevena incisional management system kit/dressing connector - the male connector on the tubing is difficult to connect to the female connector on the prevena canister tubing.
조치
KCL sent an Urgent Voluntary Medical Device Correction letter dated February 2014 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to locate, quarantine and return the affected device. For a replacement of the affected product and questions customers were instructed to contact KCL Customer Technical Support at 1-800-275-4524. A Product Reconciliation Form is attached to be completed and returned.
PRE1055: Prevena Dressing, 5 Pack || Product Usage: || The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy.