The product identification necessary to review manufacturing history was not provided.Current information is insufficient to permit a conclusion as to the cause of the event.The following sections could not be completed with the limited information provided.Device code - unknown; expiration date - unknown; pma/510(k) number/ manufacture date ¿ unknown.Event is being reported to fda on one medwatch as the limited information available indicates that a revision procedure occurred. should additional information be received regarding the revision procedure, the complaint will be reassessed and further medwatch reports will be submitted, if necessary.
|