Device evaluated by mfr: it is indicated that the device will not be returned for evaluation.A review of the batch history, historical trending, and similar complaint trending review for the product family will be conducted.If there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).
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It was reported the sterility was compromised.A 16-4/5.8/75 xxl¿ esophageal balloon catheter was selected for use to dilate the lesion.However, during unpacking, there was a visible hole in the package.The procedure was completed with a different device.No patient complications were reported.
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