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
Support, patient position - Product Code CCX
원인
Straps may separate from the foam pad.
조치
Covidien Sales Representatives notified customers in person by beginning May 8, 2014. The Sales Representative will provided a copy of the Recall letter (attachment 4), and collect any remaining product at the site. The notification and recovery of the product is expected to be complete no later than May 14, 2014.
14085, 14086, 14092, 14095, 14101, 14106 *The original recall submission listed 14084 and 14094, these were reported by Covidien in error on the original submission.
US Nationwide Distribution in the states of NJ, CA, TX, IL, MO, PA, OH, IN, MI, MN, FL, IN, DC, PA, VA, MS, ME, NV, AR, KY, NY, KS, SC
제품 설명
Devon Supine, Lithotomy and Trendelenburg Positioning Kit; Product Code: 31151090 || Product Usage: The device is intended to provide padding under the patient, and help maintain the position of an anesthetized patient during surgery.
“If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.