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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IHEALTH LABS, INC. IHEALTH COVID-19 ANTIGEN RAPID TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

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IHEALTH LABS, INC. IHEALTH COVID-19 ANTIGEN RAPID TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM Back to Search Results
Model Number GTIN(01): 20856362005894
Device Problems Fluid/Blood Leak (1250); Material Puncture/Hole (1504)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/05/2022
Event Type  malfunction  
Event Description
One of the ihealth rapid covid tests i received free from the government had a hole in the bottom of the vial. I wasn't able to use it because the liquid leaked out. Fda safety report id# (b)(4).
 
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Brand NameIHEALTH COVID-19 ANTIGEN RAPID TEST
Type of DeviceCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
Manufacturer (Section D)
IHEALTH LABS, INC.
150c charcot ave
san jose CA 95131
MDR Report Key15192077
MDR Text Key297679373
Report NumberMW5111333
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 Patient
Type of Report Initial
Report Date 08/05/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/08/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Expiration Date08/19/2022
Device Model NumberGTIN(01): 20856362005894
Device Lot Number223CO20220
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No Answer provided

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