Description of Event or Problem · 1
MY SISTER BOUGHT A FETAL DOPPLER FROM (B)(6) AND WHEN SHE USED IT, SHE IMMEDIATELY HAD AN ELECTRIC SHOCK THAT WAS PAINFUL AND FELT LIKE IT BURNT HER SKIN. WE WERE IMMEDIATELY WORRIED AND DIDN'T KNOW AND CONTACTED HER DOCTOR, AND DOCTOR ASKED WHERE AND WHY WE BOUGHT THIS. HER DOCTOR WAS SURPRISED THAT SHE WAS EASILY ABLE TO BUY THIS AS WE WERE TOLD THAT IT NEEDED A PRESCRIPTION TO BUY. I LATER DID MORE RESEARCH AND REALIZED THAT THIS WAS IN FACT THE CASE. I DIDN'T KNOW WHAT TO DO AND TRIED TO CONTACT (B)(6) BUT DID NOT RECEIVE ANY RESPONSE OTHER THAN THE INDICATION THAT THE PRODUCT WAS FDA APPROVED. I DIDN'T FIND ANY FDA APPROVAL IN THE FDA WEBSITE. BUT THE (B)(6) WEBSITE HAS FDA 510(K) NUMBER: K082480 LISTED ON IT AND IT STATES THAT THE MANUFACTURER IS CONTEC MEDICAL SYSTEMS. I HAVE ALSO FOUND OUT THAT THIS WAS ON THE (B)(6) BUT I WAS NOT ABLE TO COMMUNICATE WITH (B)(6) AS TO WHY THIS PRODUCT IS ALLOWED ON THEIR (B)(6) WHEN IT REQUIRES A PRESCRIPTION, I HAVE TRIED TO CONTACT BOTH (B)(6) THE SELLER AND (B)(6) VIA THE INFORMATION BELOW BUT IT DOESN'T SEEM LIKE THEY HAVE A LOCAL US OFFICE. (B)(6). FDA SAFETY REPORT ID# (B)(4).