Other text: additional information is provided in h.2., h.3., and h.6.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 since the product was not returned.If the product is returned the manufacturer will re-open the complaint for further device analysis.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.(b)(4) located in sections g.1., please direct those to the following: (b)(4).
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