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
Abdominal Pain (1685); Incontinence (1928); Pain (1994); Urinary Tract Infection (2120); Urinary Frequency (2275); Injury (2348); Fungal Infection (2419); Dysuria (2684)
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Event Type
Injury
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Manufacturer Narrative
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Manufacturer reference number: (b)(4).Incident date was not provided.Lot number not provided.Udi not provided.Re-processing information not provided.Since the lot number was not provided, this information cannot be determined.
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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.The preoperative and postoperative diagnosis was stress urinary incontinence with urgency.The procedure performed was a cystourethroscopy and a suburethral sling with mesh.The patient returned for an office visit on (b)(6) 2005 complaining of incontinence.The patient returned for an office visit on (b)(6) 2006 for urge incontinence.The patient returned for an office visit on (b)(6) 2006 for urge incontinence.The patient returned for an office visit on (b)(6) 2006 for severe lower pelvic pain.The patient returned for an office visit on (b)(6) 2006 for suprapubic pain.The patient returned for an office visit on (b)(6) 2008 for interstitial cystitis.The patient returned for an office visit on (b)(6) 2008 for interstitial cystitis.
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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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Manufacturer Narrative
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(b)(4).If information is provided in the future, a supplemental report will be issued.
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Event Description
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Per additional information received, complications post implant include interstitial cystitis symptoms, occasional bladder infections, suprapubic abdominal pain, low back pain, moderate dysuria, frequency, nocturia, stress incontinence, occasional urgency, occasional urgency incontinence.
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Search Alerts/Recalls
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