Conclusions: without the return of the product and/or images provided, the complaint could not be confirmed.Per report, the hospital checks once every shift at minimum, which does not meet the ifu specified to check at least every two hours.It is possible that this caused the reported breakdown on the outside of the foot and small deep tissue issue.Note: all complaints are trended and reviewed by management on a monthly basis.As a part of the monthly review, any excursion above the control limits for this failure mode will be assessed, documented and acted upon as warranted.No corrective or preventative actions are necessary at this time.
|