Product complaint #: (b)(4).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.The patient demographic info: age, weight, bmi at the time of index procedure.Date and name of initial surgical procedure.The diagnosis and indication for the initial surgical procedure? what are the patient comorbidities/concomitant medications? patient symptoms manifestations (location, severity, appearance, systemic or local reaction).Date - time of onset of infection and vaginal discharge from the surgical procedure? were there any pre-existing signs/symptoms of active infection prior to this surgical procedure? did the patient receive any prophylactic antibiotics pre-, intra- or post-operation? were cultures performed? results? product lot #.Please provide date and details of the re-operation.What is physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient's current status?.
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Product complaint#: (b)(4).Date sent to the fda: 03/04/2022.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, 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.H3: evaluation: one device was received in unoriginal packaging.Lot number was not verified.A visual inspection was performed, and the clear sheath had a melted appearance and was split open.A two-year review of similar events revealed an occurrence (b)(4) for this device.Based on the product history, there are no confirmed units above the upper limit in the past three months, and it does not indicate a trend, therefore no further investigation is required.A two-year lot history review cannot be conducted as no lot number was provided.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.
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