Drug adverse event reports (FAERS)

Stem cell transplant, Product advertising issue, Wrong technique in product usage process +3

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

SeriousOther seriousReport 25860238
Safetyreportversion
1
Safetyreportid
25860238
Primarysourcecountry
US
Transmissiondateformat
102
Transmissiondate
20251021
Reporttype
1
Serious
1
Seriousnessdeath
2
Seriousnesslifethreatening
2
Seriousnesshospitalization
2
Seriousnessdisabling
2
Seriousnesscongenitalanomali
2
Seriousnessother
1
Receivedateformat
102
Receivedate
20250927
Receiptdateformat
102
Receiptdate
20250927
Fulfillexpeditecriteria
3
Authoritynumb
FDA-CDER-CTU-2025-65042
Primarysource
Reportercountry
US
Qualification
3
Sender
Sendertype
6
Senderorganization
FDA-CTU
Receiver
Receivertype
6
Receiverorganization
FDA
Patient
Patientonsetage
74
Patientonsetageunit
801
Patientsex
2
Reaction
  1. Reactionmeddraversionpt
    28.0
    Reactionmeddrapt
    Stem cell transplant
  2. Reactionmeddraversionpt
    28.0
    Reactionmeddrapt
    Product advertising issue
  3. Reactionmeddraversionpt
    28.0
    Reactionmeddrapt
    Wrong technique in product usage process
  4. Reactionmeddraversionpt
    28.0
    Reactionmeddrapt
    Drug monitoring procedure not performed
  5. Reactionmeddraversionpt
    28.0
    Reactionmeddrapt
    Drug ineffective
  6. Reactionmeddraversionpt
    28.0
    Reactionmeddrapt
    Victim of abuse
Drug
  1. Drugcharacterization
    1
    Medicinalproduct
    STEM CELL, EXOSOME, OR GROWTH FACTOR DERIVED UNAPPROVED PRODUCTS
    Activesubstance
    Activesubstancename
    STEM CELL, EXOSOME, OR GROWTH FACTOR DERIVED UNAPPROVED PRODUCTS
Summary
Narrativeincludeclinical
CASE EVENT DATE: 20250528
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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.