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Model Number UGYKP |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Unspecified Tissue Injury (4559)
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Event Type
Injury
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Event Description
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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, anterior wall prolapse, posterior wall prolapse.It was reported that after the implant, the patient experienced an unspecified adverse outcome.Post-operative patient treatment included required intervention to prevent permanent impairment/damage.
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Manufacturer Narrative
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Concomitant medical products: unk pelvicol unknown pelvicol product unk ugyka ugyka parietex ugytex pp ant kit x1 zgj00162 unkuretexto unknown uretex transobturator mesh sgl00473.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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