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.
|
As reported to coloplast, though not verified, the patient with this device experienced bacterial vaginosis, pain, burning, urgency incontinence, left arm of mesh palpable and migrated down but not exposed and urinary incontinence.Which resulted in removal of midurethral sling and diagnostic cystoscopy under general anesthesia for left side groin pain and left arm of mesh palpable.Pathology showed foreign body type giant cell reaction.
|