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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ANDON MEDICAL CO.,LTD IHEALTH COVID-19 ANTIGEN RAPID TEST

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ANDON MEDICAL CO.,LTD IHEALTH COVID-19 ANTIGEN RAPID TEST Back to Search Results
Model Number ICO-3000
Device Problem Unexpected Therapeutic Results (1631)
Patient Problems Emotional Changes (1831); Headache (1880); High Blood Pressure/ Hypertension (1908); Urinary Frequency (2275); Arthralgia (2355)
Event Date 05/21/2022
Event Type  Injury  
Manufacturer Narrative
The customer did not leave contact information, did not provide medical records, and could not confirm whether the customer had a history of allergies, and could not effectively determine whether there was a direct connection between the abnormality of the body and the nasal swab. According to the customer's description, a pre-wet nasal swab was used to wipe the nostrils; according to the requirements for the use of nasal swabs in the instructions: use the nasal swab to wipe the nostrils first, and then immerse the wiped nasal swab in the eluent for elution. Customer used nasal swab the wrong way. Check the sterilization report of the batch of specimen collection swab used by the customer, and the test results are all qualified. Check the biocompatibility report of the batch of specimen collection swab used by the client, and the test results are all qualified. Continue to collect information: is there any new allergy symptoms in lot 211co21224. The after-sales service department continues to contact the customer to confirm whether the correct operation is performed according to the instructions. Check the covid-19 antigen rapid test instruction for use, the instructions for use of swab are valid and executable, and the instructions do not need to be improved.
 
Event Description
Customer feedback: 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.
 
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Brand NameIHEALTH
Type of DeviceCOVID-19 ANTIGEN RAPID TEST
Manufacturer (Section D)
ANDON MEDICAL CO.,LTD
tianjin, airport economic area 30030 8
CH 300308
Manufacturer (Section G)
ANDON MEDICAL CO.,LTD
tianjin, airport economic area 30030 8
CH 300308
Manufacturer Contact
ren jun
tianjin, airport economic area 30030-8
CH   300308
MDR Report Key14787128
MDR Text Key295060830
Report Number3008573045-2022-00134
Device Sequence Number1
Product Code QKP
UDI-Device Identifier20856362005894
UDI-Public20856362005894
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
EUA210470
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation
Remedial Action Inspection
Type of Report Initial
Report Date 06/18/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/23/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Expiration Date09/23/2022
Device Model NumberICO-3000
Device Lot Number211CO21224
Was Device Available for Evaluation? No
Date Manufacturer Received05/26/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/24/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberMW5109839

Patient Treatment Data
Date Received: 06/23/2022 Patient Sequence Number: 1
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