(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.How are you currently feeling? if in your possession, may we have a copy of your operative report? 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.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.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 a patient underwent a sling procedure on an unknown date and mesh was implanted.The patient reported experiencing chronic inflammation, mesh erosion, big cell reaction, right side pain, lower back pain, leg pain, infections, cysts, bloating, fatigue, depression, and anxiety.The patient further reported experiencing painful intercourse, mesh erosion into vagina, bladder issues, internal damage, nerve damage and other issues to be diagnosed.The patient underwent a procedure on an unknown date to repair the erosion and to remove the mesh.Additional information has been requested.
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