Description of Event or Problem · 1
A REPORT WAS SENT BY THE INITIAL REPORTER TO FDA THROUGH THE MEDWATCH PROGRAM (REPORT#MW5097371). COPAN DIAGNOSTICS, AS COPAN (B)(4) US AGENT, BECAME AWARE OF THE EVENT ON (B)(6) 2020. THE REPORT WAS RECEVIED IN THE MAILBOX AS FIRST AND SOLE NOTIFICATION OF THE EVENT. THE DESCRIPTION OF THE EVENT WAS AS FOLLOWS: "COVID SWAB TEST PERFORMED. PT EXPERIENCED HEADACHE, TRACE BLEEDING AND TEARING OF THE EYES. PT ALSO COMPLAINED THAT SHE "FELT SOMETHING IN HER NOSE". LATER THAT DAY PT HAD RINGING IN HER EARS. PT ALSO NOTED THAT AFTER 4 DAYS FOLLOWING THE TEST HER LEFT NOSTRIL "STILL HURTS". THE FLOQSWABS COPAN FLOCKED WAS USED. LOT # 192020, EXP 05/2024. FDA SAFETY REPORT ID # (B)(4)". ON THE MEDWATCH PROGRAM THE LOT# REPORTED WAS 1920240 OF CAT. # 503CS01.BD10. SINCE NO EMAIL OR PHONE CONTACT WAS REPORTED IN MEDWATCH, ON NOVEMBER 9TH, 2020 COPAN CONTACTED THE DISTRIBUTOR OF CAT. # TO ASK ADDITIONAL INFORMATION AND TO CONFIRM THE LOT #, SINCE IN MEDWATCH DESCRIPTION WAS REPORTED 192020 AND IN LOT FIELD 1920240. ON NOVEMBER 13TH, 2020 COPAN CONTACTED THE DISTRIBUTOR ASKING TO RETRIEVE INFORMATION OF THE INITIAL REPORTER AND SENDING A QUESTIONNAIRE TO FURTHER INVESTIGATE THE EVENT WITH THE INITIAL REPORTER. COPAN MADE 3 ADDITIONAL ATTEMPTS WITH DISTRIBUTOR TO OBTAIN MISSING INFORMATION (ON THE 16TH NOV, 18TH NOV AND 24TH NOV). NO ADDITIONAL INFORMATION WAS RECEIVED TILL NOW.