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.
|
According to available information, this device required replacement due to a broken introducer tip.The second device anchor was being placed on the patients right side when it bent and the tip broke off.Attempted to find the tip by x-ray imaging the patient, searching the patient, and searching the drape but it was not found.
|