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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IHEALTH LABS, INC. / ANDON MEDICAL CO., LTD. IHEALTH COVID-19 ANTIGEN RAPID TEST; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
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IHEALTH LABS, INC. / ANDON MEDICAL CO., LTD. IHEALTH COVID-19 ANTIGEN RAPID TEST; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM Back to Search Results
Lot Number (10): 211CO21224
Device Problem Unexpected Therapeutic Results (1631)
Patient Problems Emotional Changes (1831); Headache (1880); High Blood Pressure/ Hypertension (1908); Chills (2191); Urinary Frequency (2275); Arthralgia (2355)
Event Date 05/21/2022
Event Type  Injury  
Event Description
Concern of covid-19 exposure without symptoms prompted me to take the i-health at home self-test at around 7:30pm.I used the premoistened swab included in the kit, to swab my nasal cavity as described in the instructions.I went to bed about 10 pm.At around midnight, i was awoken by the following: the bottom of my feet were both hot and cold, i was restless, i felt pain in all of my joints which persists as i compose this report, i could not find a comfortable position to sleep, my blood pressure is elevated which is resulting in a persistent headache and remains elevated; i am experiencing frequent elimination.Gtin(01): (b)(4), lot no.(10): 211co21224, serial no (b)(4) use by: 2022-06-23, barcode: (b)(4).Fda safety report id# (b)(4).
 
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Brand Name
IHEALTH COVID-19 ANTIGEN RAPID TEST
Type of Device
CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
Manufacturer (Section D)
IHEALTH LABS, INC. / ANDON MEDICAL CO., LTD.
MDR Report Key14488128
MDR Text Key292577730
Report NumberMW5109839
Device Sequence Number1
Product Code QKP
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 05/22/2022
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? Yes
Device Expiration Date06/23/2022
Device Lot Number(10): 211CO21224
Initial Date Manufacturer Received Not provided
Initial Date FDA Received05/23/2022
Patient Sequence Number1
Treatment
VITAMIN C
Patient Outcome(s) Other;
Patient SexMale
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