Person who experienced the adverse event (patient)
| Event ID | CASEID | CASEVERSION | I F COD | EVENT DT | MFR DT | INIT FDA DT | FDA DT | REPT COD | AUTH NUM | MFR NUM | MFR SNDR | LIT REF | AGE | AGE COD | AGE GRP | GNDR COD | E SUB | WT | WT COD | REPT DT | TO MFR | OCCP COD | REPORTER COUNTRY | OCCR COUNTRY |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 111953832 | 11195383 | 2 | F | 20160726 | 20150617 | 20160809 | EXP | US-AUROBINDO-AUR-APL-2015-05171 | AUROBINDO | MUSIELAK M, MCCALL J.. LIPID RESCUE IN A PEDIATRIC BURN PATIENT. JOURNAL OF BURN CARE AND RESEARCH. 2016;37(4):E380-E382 | 6.00 | YR | M | Y | 0.00000 | 20160809 | OT | US | US |
Drug(s) used by person
| Event ID | CASEID | DRUG SEQ | ROLE COD | DRUGNAME | PROD AI | VAL VBM | ROUTE | DOSE VBM | CUM DOSE CHR | CUM DOSE UNIT | DECHAL | RECHAL | LOT NUM | EXP DT | NDA NUM | DOSE AMT | DOSE UNIT | DOSE FORM | DOSE FREQ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 111953832 | 11195383 | 1 | PS | BUPIVACAINE HYDROCHLORIDE. | BUPIVACAINE HYDROCHLORIDE | 1 | Subcutaneous | UNK, 0.5% BUPIVACAIN AT 3MG/KG | 203895 | INJECTION | |||||||||
| 111953832 | 11195383 | 2 | SS | EPINEPHRINE. | EPINEPHRINE | 1 | Unknown | 2 MG, UNK | 0 | 2 | MG | INJECTION | |||||||
| 111953832 | 11195383 | 3 | SS | EPINEPHRINE. | EPINEPHRINE | 1 | 0 | 2 | MG | INJECTION |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 111953832 | 11195383 | 1 | Product used for unknown indication |
| 111953832 | 11195383 | 2 | Local anaesthesia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 111953832 | 11195383 | OT |
| 111953832 | 11195383 | LT |
| 111953832 | 11195383 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 111953832 | 11195383 | Bradycardia | |
| 111953832 | 11195383 | Cardiac arrest | |
| 111953832 | 11195383 | End-tidal CO2 decreased | |
| 111953832 | 11195383 | Hepatic failure | |
| 111953832 | 11195383 | Hypoalbuminaemia | |
| 111953832 | 11195383 | Incorrect route of drug administration | |
| 111953832 | 11195383 | Toxicity to various agents |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |