DEVICE\GELATIN: 48 Adverse Event Reports & Safety Profile
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48
Total FAERS Reports
6 (12.5%)
Deaths Reported
1
Hospitalizations
48
As Primary/Secondary Suspect
20
Life-Threatening
First Report: 20221001 · Latest Report: 20231124
What Are the Most Common DEVICE\GELATIN Side Effects?
#1 Most Reported
Tachycardia
20 reports (41.7%)
#2 Most Reported
Hypotension
20 reports (41.7%)
#3 Most Reported
Urticaria
19 reports (39.6%)
All DEVICE\GELATIN Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Hypotension | 20 | 41.7% | 0 | 0 |
| Tachycardia | 20 | 41.7% | 0 | 0 |
| Adverse reaction | 19 | 39.6% | 0 | 0 |
| Anaphylactic reaction | 19 | 39.6% | 0 | 0 |
| Anaphylactic shock | 19 | 39.6% | 0 | 0 |
| Angiopathy | 19 | 39.6% | 0 | 0 |
| Back pain | 19 | 39.6% | 0 | 0 |
| Blood pressure increased | 19 | 39.6% | 0 | 0 |
| Emphysema | 19 | 39.6% | 0 | 0 |
| Epistaxis | 19 | 39.6% | 0 | 0 |
| Face oedema | 19 | 39.6% | 0 | 0 |
| Flatulence | 19 | 39.6% | 0 | 0 |
| Haemorrhage | 19 | 39.6% | 0 | 0 |
| Haemothorax | 19 | 39.6% | 0 | 0 |
| Hypersensitivity | 19 | 39.6% | 0 | 0 |
| Hypovolaemia | 19 | 39.6% | 0 | 0 |
| Inspiratory capacity decreased | 19 | 39.6% | 0 | 0 |
| Mechanical ventilation complication | 19 | 39.6% | 0 | 0 |
| Pleural effusion | 19 | 39.6% | 0 | 0 |
| Pneumothorax | 19 | 39.6% | 0 | 0 |
Who Reports DEVICE\GELATIN Side Effects? Age & Gender Data
Gender: 9.4% female, 90.6% male. Average age: 29.6 years. Most reports from: CA. View detailed demographics →
Is DEVICE\GELATIN Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2022 | 1 | 0 | 0 |
| 2023 | 4 | 0 | 0 |
What Is DEVICE\GELATIN Used For?
| Indication | Reports |
|---|---|
| Tissue sealing | 18 |
| Transcatheter arterial chemoembolisation | 11 |
| Embolism | 6 |
| Product used for unknown indication | 5 |
Official FDA Label for DEVICE\GELATIN
Official prescribing information from the FDA-approved drug label.