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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT BINAXNOW CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

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ABBOTT BINAXNOW CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM Back to Search Results
Device Problem Patient Device Interaction Problem (4001)
Patient Problem Unspecified Eye / Vision Problem (4471)
Event Date 03/31/2022
Event Description
[binaxnow, product name] use for covid-19 under emergency use authorization (eua): my patient inadvertently used the binax ag drops in his eye instead of his usual eyedrop lubricant while on vacation in (b)(6). After over 1 hr and 37 minutes on either my third call or numerous emails on wait time, abbott has not responded. I have an ophthalmologist standing by in (b)(6). They request patient data rather than help.
 
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Brand NameBINAXNOW
Type of DeviceCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
Manufacturer (Section D)
ABBOTT
MDR Report Key14014787
MDR Text Key288799833
Report NumberMW5108753
Device Sequence Number1
Product Code QKP
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 03/31/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/04/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes

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