SOFRADIM PRODUCTION SAS MESH SOFRADIM - URETEX; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR
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Model Number UNKNOWN URETEX |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
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Patient Problems
Micturition Urgency (1871); Incontinence (1928); Pain (1994); 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 resulting in an unspecified adverse outcome.Product was used for therapeutic treatment.Procedure: cystoscopy/marshall test with transvaginal periurethral sling.Diagnosis: type ii stress urinary incontinence.Complications include, pain and recurrence of symptoms, urgency, frequency of urination with urge related incontinence, diagnosed with minimal loss of bladder support, mixed urinary incontinence with increasing stress component.
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Search Alerts/Recalls
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