Concomitant product: unknown align r urethral support system, unknown sofradim mesh (lot # unknown), unknown sofradim mesh (lot # unknown).(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.It was reported that after the implant, the patient experienced pain, suffering, disability, infection, sinus tract, chronic uterine drainage, fistula, and impairment.Post-operative patient treatment required intervention to prevent permanent impairment/ damage.
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