Alternative summary report attached for exemption (b)(4).Report includes the event specified within this mdr.-procode: ftl -reporting period: september 1, 2018 through october 31, 2018 -total number of events: 16 (0 new event reports, 16 supplemental event reports) -total events per brand name: pelvicol (10 events) ugytex (6 events).If information is provided in the future, a supplemental report will be issued.(b)(4).
|
Alternative summary reporting exemption (b)(4).The patient¿s attorney alleged a deficiency against the device.The product was used for therapeutic treatment of urinary stress incontinence.It was reported that after implant, the patient experienced dysuria, muscle weakness, joint pain, pelvic pain, dizziness, numbness, low back pain, hip pain, tingling, burning sensation, tenderness, swelling, urge incontinence, urinary frequency, muscle pain, muscle spasms, soreness, discomfort, erythema, bladder that doesn't empty, decreased physical activity, bowel obstruction, chronic constipation, unspecified neuromuscular disorder, additional surgical and nonsurgical interventions.
|