Device was used for treatment, not diagnosis.Device is an instrument and is not implanted/explanted.The 510k#: device is not distributed in the united states, but is similar to device marketed in the usa.No nonconformance reports were generated during production.Review of the device history record showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.The visual inspection of the returned device performed as part of the manufacturing investigation reported the color coding of this article is red.The item was in the original package.Both articles (lot no f-14878 and lot no f-15727) were manufactured from the drawing (b)(4) index a and are made according to the specifications at the time of manufacturing if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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