Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence.Once our evaluation is complete, a follow-up report will be submitted.Coloplast has not been provided any corroborating evidence to verify the information contained in this report.
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According to the available information, though not verified, per the territory manager: the physician placed the first static anchor on the patient.After retracting the introducer, he pulled on the sling to ensure the static anchor was secure.When he pulled, the sling detached itself from the static anchor.I was not able to attend the case and sling was discarded.
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