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Model Number 810081 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pain (1994); Ambulation Difficulties (2544)
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Event Date 03/12/2018 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.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? if so, please provide your surgeon¿s name, contact information and sign release of medical information form attached.
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Event Description
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It was reported that a patient underwent a sling procedure on (b)(6) 2018 and the mesh was implanted.It was reported that the patient had placement of urinary strip.It was reported that for more than three years the problems that arisen are that the patient had difficulty walking as there was intense pain in the legs, pelvis, lower abdomen, and back.Additional information was requested.
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Search Alerts/Recalls
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