ETHICON INC. TENSION FREE VAGINAL TAPE UNKNOWN PRODUCT; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGICAL
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Device Problem
Migration or Expulsion of Device (1395)
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Patient Problems
Erosion (1750); Fatigue (1849); Neuropathy (1983); Pain (1994); Urinary Tract Infection (2120)
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Event Date 11/07/2017 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).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.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.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?.
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Event Description
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It was reported by the patient that they underwent a gynecological procedure on an unknown date and mesh was implanted the patient reported numerous side effects from device including pain, extreme fatigue, pins and needles in hands, ibs, uti¿s and an erosion into vagina.The device remains implanted.Additional information has been requested.
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Search Alerts/Recalls
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