SOFRADIM PRODUCTION SAS UGYTEX; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN
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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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Manufacturer Narrative
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Concomitant device: miniarc (tm) product id: 720046-01, lot number: 523809020); ugyka parietex ugytex pp ant kit x1 (lot # zgk00107).If information is provided in the future, a supplemental report will be issued.
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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 stress urinary incontinence, cystocele, and rectocele.It was reported that after the implant, the patient experienced an unspecified adverse outcome.
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Search Alerts/Recalls
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