Drug adverse event reports (FAERS)

Eye swelling, Eyelid thickening, Product use issue

Drugs: STEM CELL, EXOSOME, OR GROWTH FACTOR DERIVED UNAPPROVED PRODUCTS, HYALURONIC ACID

SeriousReport 26065122
Safetyreportversion
1
Safetyreportid
26065122
Primarysourcecountry
US
Transmissiondateformat
102
Transmissiondate
20260117
Reporttype
1
Serious
1
Seriousnessdeath
2
Seriousnesslifethreatening
2
Seriousnesshospitalization
2
Seriousnessdisabling
2
Seriousnesscongenitalanomali
2
Seriousnessother
2
Receivedateformat
102
Receivedate
20251118
Receiptdateformat
102
Receiptdate
20251118
Fulfillexpeditecriteria
3
Authoritynumb
788387
Primarysource
Reportercountry
US
Qualification
5
Sender
Sendertype
6
Senderorganization
FDA-CTU
Receiver
Receivertype
6
Receiverorganization
FDA
Patient
Patientonsetage
36
Patientonsetageunit
801
Patientsex
2
Reaction
  1. Reactionmeddraversionpt
    28.1
    Reactionmeddrapt
    Eye swelling
  2. Reactionmeddraversionpt
    28.1
    Reactionmeddrapt
    Eyelid thickening
  3. Reactionmeddraversionpt
    28.1
    Reactionmeddrapt
    Product use issue
Drug
  1. Drugcharacterization
    1
    Medicinalproduct
    STEM CELL, EXOSOME, OR GROWTH FACTOR DERIVED UNAPPROVED PRODUCTS
    Drugadditional
    2
    Activesubstance
    Activesubstancename
    STEM CELL, EXOSOME, OR GROWTH FACTOR DERIVED UNAPPROVED PRODUCTS
  2. Drugcharacterization
    1
    Medicinalproduct
    HYALURONIC ACID
    Activesubstance
    Activesubstancename
    HYALURONIC ACID
    Harmonized identifiers (openFDA)
    Application number
    M016
    Brand name
    CLEARSOOTHINGCREAM, EYEONE EYELID CLEANSING TOOLS, INTIMATE CAREGEL
    Generic name
    HYALURONIC ACID
    Manufacturer name
    Shengnan (Guangzhou) Cosmetics Co., LTD, IDO PHARM, Guangzhou Yilong Cosmetics.,Ltd
    Product NDC
    84019-023, 77039-031, 74458-189
    Product type
    HUMAN OTC DRUG
    Route
    CUTANEOUS, TOPICAL
    Substance name
    HYALURONIC ACID
    SPL ID
    2ac88f9a-a41c-1978-e063-6394a90a2421, 247dcdcb-0034-983f-e063-6394a90a7d83, 5918d204-52da-e6d0-e063-6394a90ab78c
    SPL set ID
    2ac88f9a-a41b-1978-e063-6394a90a2421, cba8f11b-3aeb-46c1-ad2a-7d2535cb1166, 5918d204-52db-e6d0-e063-6394a90ab78c
    Package NDC
    84019-023-01, 77039-031-01, 74458-189-05
    UNII
    S270N0TRQY
Summary
Narrativeincludeclinical
CASE EVENT DATE: 20250324
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How to read this: Each report says someone told FDA an event happened while a product was used. A report does not show the product caused it, and counts rise and fall with how many people report. Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.