This event was previously reported to the fda on an alternative summary report (asr approval #: e2013038) which is no longer in effect.Because of additionally received complaint information, this and all further updates will be submitted through the 3500a form.(b)(4).If information is provided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 urinary stress incontinence.It was reported that after implant, the patient experienced persistent discomfort, bladder spasms with urination, obstructive voiding, tenderness, pain, nocturia, weak urinary stream, leakage with full bladder, abdominal pain, uti's, urethral spasms, intermittent sharp pain in anterior vagina, urinary frequency, and dyspareunia.
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