Product complaint # (b)(4).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.(b)(4) - device not returned 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.Does ethicon have your permission to contact your 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 your surgeon¿s name, contact information and sign release of medical information form attached.
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It was reported that a patient underwent an unknown procedure on an unknown date three years ago and the mesh was implanted.It was reported that since the mesh insertion, the patient has been diagnosed with alpha gal syndrome.It was reported that the patient experiences allergic reaction.It was also reported that every time the patient eats, the patient gets abdominal cramps and it's so painful that the patient has to sit on the toilet in case the patient has diarrhea.Additional information has been requested.
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