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 with this device experienced chronic pubic pain, urinary tract infection testing was positive for blood and leukocytes and urine culture was positive for e coli.A pelvic and abdominal scan was performed for hematuria.The patient also experienced itching and scraping when she bends over.It was discovered that the sling had eroded and a portion of it was excised.The residual mesh was excised.The patient also had severe pain from what was reportedly the ¿rejected sling¿.
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