MAUDE Adverse Event Report: ORASURE TECHNOLOGIES INC INTELISWAB COVID-19 RAPID TEST

Catalog Number 1001-0616

Device Problem Insufficient Information (3190)

Patient Problem Headache (1880)

Event Date 09/15/2022

Event Type  Injury  

Event Description

Consumer reported to oti call center that after using the inteliswab test (lot: covay-1342), the consumers son had a bad headache.The consumer felt that the inteliswab test caused the headache.The consumer's son took medication for the headache.The consumer wanted to ensure that there was nothing harmful on the inteliswab test swab.

Manufacturer Narrative

No additional follow up is to be expected with the complaint file, and the incident will be closed internally.

Event Description

Consumer reported to oti call center that after using the inteliswab test (lot: covay-1342), the consumers son had a bad headache.The consumer felt that the inteliswab test caused the headache.The consumer's son took medication for the headache.The consumer wanted to ensure that there was nothing harmful on the inteliswab test swab.

• Brand Name: INTELISWAB COVID-19 RAPID TEST
• Type of Device: INTELISWAB
• Manufacturer (Section D): ORASURE TECHNOLOGIES INC; 220 east first street; bethlehem PA 18015
• Manufacturer (Section G): ORASURE TECHNOLOGIES, INC.; 220 east first street; bethlehem PA 18015
• Manufacturer Contact: jennifer krause ; 220 east first street; bethlehem, PA 18015 ; 6108821820
• MDR Report Key: 15471151
• MDR Text Key: 300453948
• Report Number: 3004142665-2022-00028
• Device Sequence Number: 1
• Product Code: QKP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EUA210378
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/17/2022
• Device Catalogue Number: 1001-0616
• Device Lot Number: COVAY-1342
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/15/2022
• Initial Date FDA Received: 09/23/2022
• Supplement Dates Manufacturer Received: 09/15/2022
• Supplement Dates FDA Received: 09/26/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/12/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 22 YR
• Patient Sex: Male