Lot number: 1638156.This event was previously submitted via asr on 25apr2016 (exemption number e2014015).Follow-up coding was also submitted via asr on 24jun2019.This report appears to be an initial report, but is intended to be a follow-up report to the previously submitted asrs.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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As reported to coloplast, though not verified, the patient experienced recurrent stress urinary incontinence, pain, neuromuscular problems and vaginal scarring.Additional information received reported severe pain with daily activities and intercourse, physical deformity, and the loss of ability to perform sexually.Additional information later reported urgency, frequency, and nocturia.On (b)(6) 2016 excision of the vaginal sling took place.
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