Product complaint # (b)(4).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.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Please provide procedure name.Please clarify if there were any adverse patient consequences due to this event? if yes, please explain in detail.Are there any photos for visual analysis? a manufacturing record evaluation was performed for the finished device batch, and no non-conformances were identified.
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Product complaint # = > (b)(4) date sent to the fda: 01/18/2022 h6 component code: g07002 - device not returned this report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Additional information: h6 the following information was requested, but unavailable: * please provide procedure name¿¿ all answers above are unobtainable.Once there is any update, we will update the information.* please clarify if there were any adverse patient consequences due to this event? if yes, please explain in detail * are there any photos for visual analysis?.
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