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Model Number UGYKP |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Erosion (1750); Bradycardia (1751); Micturition Urgency (1871); High Blood Pressure/ Hypertension (1908); Failure of Implant (1924); Incontinence (1928); Pain (1994); Electrolyte Imbalance (2196); Discharge (2225); Anxiety (2328); Discomfort (2330); Injury (2348); Depression (2361); Prolapse (2475); No Code Available (3191)
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).A good faith effort will be made to obtain the applicable information relevant to the report.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.Pre-op diagnosis: recurrent cystocele, incomplete emptying, urinary frequency, rectal splinting, enterocele.Post-op diagnosis: recurrent cystocele, incomplete emptying, urinary frequency, rectal splinting, enterocele.Name of procedure: anterior posterior repair with repair of enterocele, paravaginal repair, proctopexy, cystoscopy, and placement of anterior and posterior vaginal mesh.Concomitant therapy: pelvisoft alleged complications post implant include recurrent cystocele and rectocele with anterior mesh failure, mesh exposure, incontinence, occasional urge, decreased libido, recurrent prolapse including anterior and apical prolapse.Mesh revision surgery (b)(6) 2007.
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Manufacturer Narrative
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(b)(4) - unspecified urinary problems, pressure, post void residuals, decreased libido, vaginal rugae, soreness, nonsurgical and additional surgical interventions.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, the patient has experienced mesh exposure, pain, erosion, unspecified urinary problems, leakage, pelvic pressure, urinary incontinence, opening in epithelium, enterocele/cystourethrocele/rectocele (prolapse), pelvic support defect, discharge, failure of implant, post void residuals, decreased libido, discomfort, urinary urgency, vaginal rugae, elevated blood urea nitrogen/creatinine, low blood urea nitrogen/creatinine, low calcium/sodium (electrolyte imbalance), bradycardia, elevated white blood cells, low hematocrit/hemoglobin/red blood cells, elevated blood pressure, anxiety, soreness, depression, nonsurgical and additional surgical interventions.
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Search Alerts/Recalls
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