Description of Event or Problem · 1
INITIAL AND FINAL REPORT ON 28 JULY 2020, HOLOGIC RECEIVED A LETTER FROM FDA MEDWATCH WITH REFERENCE NUMBER MW5095517, CONCERNING AN EVENT WHERE A PATIENT'S MIGRAINE WAS TRIGGERED WHEN USING A NASAL SWAB FOR SARS-COV-2 TEST. THE EVENT DATE WAS NOTED AS (B)(6) 2020 AND THE PATIENT'S VOLUNTARY REPORT WAS RECEIVED BY THE FDA ON 14 JULY 2020. IN THE MEDWATCH REPORT, IT WAS NOTED THAT THE PRODUCT CODE USED WAS AN "APPLICATOR, ABSORBENT TIPPED, STERILE (KXG). THE BRAND IS A "NASOPHARYNGEAL SWAB". NO FURTHER INFORMATION WAS PROVIDED ABOUT THE PATIENT AND THE PRODUCT INVOLVED IN THE COMPLAINT. HOLOGIC PERFORMED AN INVESTIGATION INTO THE ISSUE. WE REVIEWED THE MDR, MW5095517, AND DETERMINED THAT THE PRODUCT CODE ASSOCIATED WITH THE MDR IS "APPLICATOR, ABSORBENT TIPPED, STERILE (KXG)". UPON SEARCHING THE FDA WEBSITE IT WAS REALIZED THAT THE STERILE ABSORBENT TIP IS MADE BY UC-CARE: PROPRIETARY NAME: SMARTBX CLASSIFICATION NAME: APPLICATOR ABSORBENT TIPPED, STERILE PRODUCT CODE: KXG; DEVICE CLASS: 1; REGULATION NUMBER: (B)(4); MEDICAL SPECIALTY: (B)(6) HOSPITAL. REGISTERED ESTABLISHMENT NAME: (B)(4). REGISTERED ESTABLISHMENT NUMBER: (B)(4). OWNER/OPERATOR: (B)(4). OWNER/OPERATOR NUMBER: (B)(4). ESTABLISHMENT OPERATIONS: MANUFACTURER. HOLOGIC DOES NOT SELL OR PRODUCE SWABS FOR NASOPHARYNGEAL COLLECTION. HOLOGIC IS IN NO MANNER CONNECTED WITH UC-CARE. THEREFORE THIS MDR IS NOT A RESULT OF HOLOGIC PRODUCT AND NO FURTHER ACTION IS NEEDED FOR THIS COMPLAINT.