(b)(4).A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.A photo of the product upon which this medwatch is based has been received, however, the product evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.
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Product complaint # (b)(4).Date sent to the fda: 5/1/2020.H3 evaluation: upon visual inspection of the picture, the tyvek was observed with all the information required as per manufacturing procedures.However, no conclusion could be reached as the device was not returned for analysis.
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