The patient's attorney alleged a deficiency against the device.Per additional information received, the patient has experienced a postoperative drop in hematocrit with shortness of breath requiring two units of blood, recurrent cystocele with pain, severe bladder neck hypermobility, rectocele, stress incontinence, poor emptying, and chronic urinary tract infections.She has required non-surgical interventions and one surgical intervention.
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Correction: f2 per email received from the fda on 11dec2020, a correction is being submitted for f2 as the initial mdr report inadvertently included the manufacture report no.H11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
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