(b)(4).This is a combination product, and the event has been reviewed for both the suture and the triclosan.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.How long after the procedure did the reaction begin? what kind of symptoms is your friend experiencing? is your friend able to provide a copy of their operative report? does ethicon have your permission to contact their surgeon, in the event ethicon would like to contact your surgeon for more clinical information to be used for a product quality complaint investigation? if so, please provide the patient¿s name, surgeon¿s name, surgeon¿s contact information and sign release of medical information form attached.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.(b)(4).Related events captured via 2210968-2021-05956, 2210968-2021-05957, 2210968-2021-05958.
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(b)(4).Date sent to fda: 07/12/2021.This report is being submitted pursuant to the provisions of 21 cfr, part 803, part 4 subpart b.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, or its employees that the report constitutes an admission that the product, ethicon, 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.Additional information was requested and the following was obtained: how long after the procedure did the reaction begin? redness emerged about a week after operation.What kind of symptoms is your friend experiencing? pain increased after the procedure.Mobility was impacted negative.Patient could not raise arms.Redness occurred near stiches is your friend able to provide a copy of their operative report? yes, if needed does ethicon have your permission to contact their surgeon, in the event ethicon would like to contact your surgeon for more clinical information to be used for a product quality complaint investigation? if so, please provide the patient¿s name, surgeon¿s name, surgeon¿s contact information and sign release of medical information form attached.Could be provided if necessary.Related events captured via 2210968-2021-05956, 2210968-2021-05957, 2210968-2021-05958 and 2210968-2021-05959.
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