InjuryMAL
HEMASHIELD PLATINUM WOVEN
Received Oct 20, 2017
Report 1640201-2017-00032 · MDR key 6964509
Device
Generic name
Vascular Polyester Graft
Manufacturer
Intervascular SasProduct problems
- Manufacturing, Packaging or Shipping Problem
- Manufacturing, Packaging or Shipping Problem
Patient
Not reported
- Blood Loss
- Blood Loss
Narrative
Additional Manufacturer Narrative
NO REVIEW OF THE COMPLAINT DEVICE HISTORY RECORDS AND NO DEVICE EVALUATION WERE PERFORMED SINCE THE PRODUCT IDENTIFIER COULD NOT BE OBTAINED AND THE INVOLVED GRAFT WAS NOT AVAILABLE FOR INVESTIGATION. NO CONCLUSION CAN BE DRAWN.
Description of Event or Problem
THE HOSPITAL REPORTED THAT ONE OF THEIR DOCTORS HAD A BAD EXPERIENCE WITH AN HEMASHIELD PLATINUM GRAFT AND THE PATIENT HAD A POSTOPERATIVE COMPLICATION OF BLEEDING. THEY DIDN'T KNOW IF THE GRAFT FAILED OR IF THE PATIENT WAS WEAK POSTOPERATIVE.