(b)(4).A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Attempts to obtain the following information has been performed but not received.If the further details are received at a later date a supplemental medwatch will be sent confirm the initial procedure date was (b)(6) 2020? was there any wound dehiscence? what is the physicians opinion of the contributing factors to the prineo coming off prematurely? how was the wound treated (product removed; re operation; re closure; prescription steroids; antibiotics prescribed)? if so, please clarify.Please indicate any medical or surgical interventions performed.Please describe how was the adhesive was applied.What prep was used prior to, during or after prineo use? please describe the aquacel dressing? what is the most current patient status? is the product or representative sample (product from the same lot number) available for evaluation? patient demographics: initials / id; age; bmi; gender.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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