(b)(4).Batch #: unknown.Additional information obtained: age range 61-100.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: what tissue(s) or vessel(s) was the device used on during the procedure? during the operation was there any device malfunction, deficiency or handling issues? what is the investigator's rational behind the possible device relationship with the e.Faecium in urine and with the paralyticileus? an analysis of the product could not be performed since a physical sample was not received for evaluation.An evaluation of the manufacturing record could not be performed as the required product identification number was not provided to complete the evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.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, 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.
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It was reported that after a clinical trial, eng_2020_03, cystectomy the patient experienced detection of e.Faecium in urine and paralytic ileus.The detection of e.Faecium in urine was moderate with a possible relationship to the device and a related relationship with the procedure.It required drug therapy and the patient recovered with sequelae.The paralytic ileus was mild with a possible relationship to the device and a related relationship with the procedure.It required drug therapy and a gastric tube.The patient recovered.
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(b)(4).Date sent: 9/12/2022.Additional information was requested and the following was obtained: what tissue(s) or vessel(s) was the device used on during the procedure? ¿ suspensions of the bladder, urethra underneath the prostate, dissection of the prostate pedicles, incision of the mesentery during the operation was there any device malfunction, deficiency or handling issues? - no what is the investigator's rational behind the possible device relationship with the e.Faecium in urine and with the paralytic ileus?- in general a relation to a paralytic ileus may be possible due to the incision of the mesentery with the enseal-device.
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