Other, other text: the product was not returned, and no photographic evidence was provided to aid in this investigation.As a result, a complaint investigation/product evaluation and problem confirmation cannot be performed.The exact cause could not be determined.A device history record (dhr) review showed there were no discrepancies or non-conformances during the manufacturing of the reported lot number.If the product is returned the manufacturer will re-open the complaint for further device analysis.For all enquiries or follow-up questions related to the record, do not use regulatory.Responses@smiths-medical.Com located in sections g.1., please direct those to the following: regulatory.Responses@icumed.Com.
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