No product or photographic evidence was provided to aid in this investigation.The complaint report offered insufficient details to determine whether this product functioned as intended or was used in a manner consistent with its instructions for use ifu or failed to meet product specifications.Lacking any additional evidence, this complaint has been closed as unconfirmed.If the product is returned, the complaint will be reopened for further investigation.No lot or serial number was provided therefore, a device history record dhr review could not be performed.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).
|