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 of 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 the available information medwatch5065549 - chief complaint was urinary problems.Patient was diagnosed with stress incontinence.Insertion of a pubovaginal sling dr.(b)(6) performed the surgery on (b)(6) 2014 at (b)(6) medical center.I experienced burning sensation, blood with catheterization, lower abdominal pain and bloating.On a return visit, dr.(b)(6) felt the sling might be too tight so she recommend i go in for a second surgical procedure called indwelling foley catheter placement due to the chronic retention of urine.Surgery was performed on (b)(6) 2014.I had a f/u visit to remove the packing in her office.I then said "but i still can't urinate, she told me to just continue to self cath and then walked away.The second surgery was suppose to reduce the tension on the sling but that surgery also went wrong.I had to continue to self catheter.I had to go to the er 3 different times.Prior to the er visit, i attempted to get an appt to see her only to find out i couldn't get in for an appt, so had to resort to go to the er.I strongly feel she messed up the surgery and now i have to deal with the consequences.After much frustration, pain and discomfort, i decided to get a second opinion and ultimately a third dr.(b)(6), md examined me on (b)(6) 2014 and said it appeared the sling had been removed but dr.(b)(6) told me she did not remove it.Test also found i had blood in my urine, blood clots, catheter infection, blood in foley.The catheter was replaced and i was put on more antibiotic.On another visit to dr.(b)(6) i brought in a piece of gauze that i had found on my pad.I had to continue to self cath, and was found to have a staph infection for which i was prescribed more medication.The infection lasted for months with 9 antibiotic prescribed during that time.On (b)(6) 2015 i was examined in the operating room by dr.(b)(6).It was found that i had bladder damage from the multiple sling surgeries, scar tissue and bulging urethra swelling.The dr cannot see the sling that dr.(b)(6) insists is still there (she told me that on the second surgery she cut and tied the sling.).
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