(b)(4).To date the device has not been returned.If the device or further details are received at the later date a supplemental medwatch will be sent.Attempts are being made to clarify 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.Date of index surgical procedure? product lot number? were there any pre-existing signs/symptoms of active infection prior to this surgical procedure? did the patient receive any prophylactic antibiotics pre- or intra-operation? when was the re-opening procedure performed? were cultures performed? results? how infection was treated? what is physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient current status? other relevant patient history/concomitant medications? if applicable, will any suture be returned, return date, tracking information? the patient demographic info: age, weight, bmi at the time of index procedure? adverse events were submitted via 2210968-2020-03935, 2210968-2020-03937 and 2210968-2020-03938.
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Date sent to the fda: 06/09/2020.Additional information was requested, and the following was obtained: reached out to the obgyn who reported the event.He has advised he does not have this information.Date of index surgical procedure? product lot numbers of involved stratafix spiral monocryl plus, vicryl plus, stratafix symmetric pds and monocryl sutures? were there any pre-existing signs/symptoms of active infection prior to this surgical procedure? did the patient receive any prophylactic antibiotics pre- or intra-operation? when was the re-opening procedure performed? were cultures performed? results? how infection was treated? what is physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient current status? other relevant patient history/concomitant medications? if applicable, will any suture be returned, return date, tracking information? the patient demographic info: age, weight, bmi at the time of index procedure? 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.
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