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 the available information, the device was implanted on a friday and the following monday, the patient's post-void residual (pvr) was 900cc.The patient went back to surgery the next day.The physician opened the incision, dissected the sling away from the urethra, and traced the implant as far lateral on the dynamic side as she could.She then clamped onto the implant and turned the clamp ever so slightly to loosen the adjustment suture 1 or 2 mm.The following day, the patient voided 350cc and retained 125cc.The physician was happy with this, but was going to follow up with the patient the following week.
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