All product features corresponded with the valid specifications of the waldemar link (b)(4) at the time period, when the product was delivered to the customer.Even though the rotational bushing is worn slightly the measurements comply with the valid specifications.The report is delayed due to inconsistencies with regard to foreign event reporting to fda.After re-evaluation of the complaint we determined that it is reportable.We have addressed the inconsistency in reporting foreign events to fda through capa-(b)(4).
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