As reported to coloplast, though not verified, legal representative stated the patient with this device experienced left inguinal pain, left sided dyspareunia, mild recurrent stress urinary incontinence with urge incontinence, vaginal discharge, pain under urethral bulb on the left, vaginal spotting, urinary frequency, vaginal bleeding, bleeding, recurrent incontinence, palpable vaginal foreign body prominence on left side with 10/10 tenderness, presence of device exposure at the mid urethra with pinpoint granulation at the midline, bloody mucous drainage, midurethral exposure of device with small pus and foul odor drainage, left sided pain, persistent lower left abdominal pain, four sutures trimmed for the patient¿s comfort, removal of four suture knots, urinary leakage, left myofascial trigger point pain, intermittent pelvic pain, urinary tract infection, and positive for e.Coli.Mri report noted a moderate degree of urethral circumferential thickening of the wall anteriorly measuring up to 8 mm at the level of the urogenital diaphragm and persistent slight irregularity and elevated enhancement of the left paramedian vaginal fornix.
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Coloplast has not been provided any corroborating evidence to verify the information contained in this report.Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence.Should additional facts prompt us to alter or supplement any information or conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted.
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