This report is a response to medwatch report mw5095344.The initial reporter of the complaint is unknown to the manufacturer.Proximate concepts had received the complaint, but no device was returned for evaluation.Therefore we have limited information from the entity submitting the complaint.Based on the information provided, it is unknown what lot number to perform a manufacturing audit on.Proximate concepts performed an audit of relevant sterilization records and confirmed that devices shipped in the time-frame of this event were confirmed to be sterilized to documented procedures.Bioburden testing and sterilization logs confirm shipment of sterile product.As such, this file has been closed.Manufacturer's reference number: (b)(4).
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