Uresta Bladder Support (2018-11-04) — recall 58987
Health Canada — Medical Devices · Canada · 2018-11-28 · Type II
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Reported risk: Southmedic received notification of a customer complaint in which a patient with a previous mesh tape operation, which is still located internally, used the Uresta Bladder Support on the suggestion of a physician. Based on clinical feedback, the results of the investigation indicate that the complaint is most likely attributed to use in a way for which the device was not designed The reason for the recall is to provide an additional precaution statement to the IFU for further clarity to customers.
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