The lot # was reviewed for complaint trend, nonconforming report and capa.Devices met specification prior to release and no trends were noted.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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According to available, although not verified, the patient with this device experienced constipation, pelvic pain and pressure, back pressure.She was treated for bacterial vaginitis and sling exposure [small piece of mesh was removed in office.].She experienced llq pain, follow-up for sharp pain in vagina, dyspareunia, pain with sitting, urinary frequency and urgency, incontinence and flank pain.Small piece of palpable sling in the left sulcus.Removed (b)(6) 2014 without difficulty in office.Partner c/o feeling ¿rubber bands and mesh¿ during intercourse; vaginal pain, swelling and bulging sensations; dyspareunia, inability to orgasm and vaginal spotting; intermittent low grade fever and nausea; recurrent sui and vaginal itching.
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