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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We have been informed about a defect product, difficult to fit the catheter, on a vortek catheter.According to the complaint description lot number and sample are available.No other complaints were found regarding the lot number 8290362.Checking the quality databases did not reveal any anomaly in relation to the described defect.According to the complaint's description the issue described is "unperforated tube causing inability to mount the catheter".However we cannot consider this a defect, as this reference is a stent with one open side and one closed side.It therefore complies with the product description.What's more, the sample received complies with the specifications expected for this reference.
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