Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
Is Bupivacaine-Lidocaine approved in United States?
Yes. FDA has authorised it.
Who is the marketing authorisation holder for Bupivacaine-Lidocaine in United States?
Hospital de San Carlos Dr. Benicio Arzola Medina is the originator. The local marketing authorisation holder may differ — check the official source linked above.