H4 manufacturing date ¿ added.D4 expiration date - added.Due to the automated manufacturing execution system (mes) there are controls in the manufacturing process to ensure the product met specifications upon release.The subject device is not available; therefore, visual testing as well as functional testing cannot be performed.The reported event is covered in the device directions for use (dfu).As well, the risk of the reported event is documented in the risk documentation and there are current controls to mitigate the risk of the as reported event.The reported complaint could not be confirmed, and it could not be definitively determined if the device failed to meet specifications because the product was not returned.The safety officer reported "right frontal intracerebral hematoma 3 hours after the procedure".The reportable 'patient hematoma' is listed in the atlas stent dfu as an anticipated outcome of these types of procedures.Therefore, an assignable cause of anticipated procedural complication, will be assigned to the as reported event.
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