SOFRADIM PRODUCTION SAS MESH SOFRADIM - URETEX; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR
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Model Number UNKNOWN URETEX |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Micturition Urgency (1871); Hematoma (1884); Scarring (2061); Urinary Retention (2119); Injury (2348)
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Event Type
Injury
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Manufacturer Narrative
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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 of symptomatic cystocele and urodynamic stress urinary incontinence.It was reported that after implant, the patient experienced hematoma, urgency and straining to urinate and scarring in the area of bladder neck.Post-operative patient treatment included additional surgery.
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Search Alerts/Recalls
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