This event was previously reported to the fda on an alternative summary report (asr approval #: e2013038) which is no longer in effect.Because of additionally received complaint information, this and all further updates will be submitted through the 3500a form.If information is provided in the future, a supplemental report will be issued.
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The patient¿s attorney alleged a deficiency against the device.The product was used for therapeutic treatment of stress urinary incontinence.It was reported that after implant, the patient experienced pain, infection, recurrence, dysuria, urinary leakage, urge incontinence, urinary frequency, dyspareunia, and bowel leakage, retention, painful frequent urination with swelling.The device had been used with align to urethral support system-hook.
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