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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARDINAL HEALTH RAPID TEST HCG CASS. 30T; HCG PREGNANCY TEST
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CARDINAL HEALTH RAPID TEST HCG CASS. 30T; HCG PREGNANCY TEST Back to Search Results
Model Number FHC-A102-OBC554
Device Problem Insufficient Information (3190)
Patient Problem Pregnancy (3193)
Event Date 12/23/2015
Event Type  malfunction  
Manufacturer Narrative
Investigation conclusion: further investigation cannot be pursued because there is no lot number.
 
Event Description
Report from distributor - customer alleging receiving fn hcg.(b)(6) 2016 fn hcg result received.Exact details were not provided but reporter remembers patient was in early stage of pregnancy at 4-5 weeks and received a depo shot.Confirmation of pregnancy with blood work was received a few weeks later.According to reporter, no patient injury occurred and no further treatment and/or hospitalization was necessary.Patient's last menstrual period is unknown, patient has irregular menses.Blood work was drawn on (b)(6) 2016 21,739 (no units of measure provided).No reported adverse patient sequela.
 
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Brand Name
CARDINAL HEALTH RAPID TEST HCG CASS. 30T
Type of Device
HCG PREGNANCY TEST
Manufacturer Contact
ya-ling king
9975 summers ridge road
san diego, CA 92121
8588052084
MDR Report Key5399944
MDR Text Key37720808
Report Number2027969-2016-00059
Device Sequence Number1
Product Code JHI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K062361
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Reporter Occupation Other
Type of Report Initial
Report Date 01/21/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/29/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberFHC-A102-OBC554
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received01/21/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age25 YR
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