(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 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.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.H6 component code: g07002 ¿ device not returned.
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It was reported that a patient underwent an unknown procedure on (b)(6) 2016 and mesh was implanted.The patient reported experiencing pelvic pain that was noticed 2.5 years after surgery.It is worse at night.Prior to this, the patient had been on pain killers for previous spinal surgeries.The patient further reported experiencing fecal incontinence that started few months post mesh procedure, urine leakage on standing after finishing voiding and nocturia 1-2 times.The patient was seeing a pain specialist and pelvic floor physiotherapist.No further information is available as reporter details have not been disclosed (confidential).
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