Product complaint # (b)(4).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.The lot/batch was not provided; therefore, a manufacturing record evaluation could not be performed.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.- was there any adverse consequence associated with the patient? - when was the needle snapped off from the suture (in the package, during removal from package, during handling prior to use on patient or during use on the patient)? please specify - please provide the product code and lot number - please provide the source or name of person providing answers to follow-up questions (not the person relaying/submitting answers to loc or chu).To date it has been reported that the device will not be returned.If the device or further details are received at a later date a supplemental medwatch will be sent.
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