DEVICE\POLYURETHANE: 52 Adverse Event Reports & Safety Profile
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52
Total FAERS Reports
1 (1.9%)
Deaths Reported
21
Hospitalizations
52
As Primary/Secondary Suspect
1
Life-Threatening
First Report: 20190101 · Latest Report: 20250731
What Are the Most Common DEVICE\POLYURETHANE Side Effects?
#1 Most Reported
Dermatitis contact
29 reports (55.8%)
#2 Most Reported
Infusion site pain
17 reports (32.7%)
#3 Most Reported
Infusion site erythema
14 reports (26.9%)
All DEVICE\POLYURETHANE Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Dermatitis contact | 29 | 55.8% | 1 | 12 |
| Infusion site pain | 17 | 32.7% | 0 | 4 |
| Infusion site erythema | 14 | 26.9% | 0 | 2 |
| Nausea | 12 | 23.1% | 1 | 6 |
| Diarrhoea | 10 | 19.2% | 1 | 6 |
| Dyspnoea | 10 | 19.2% | 0 | 8 |
| Infusion site swelling | 9 | 17.3% | 0 | 0 |
| Dizziness | 7 | 13.5% | 0 | 4 |
| Headache | 7 | 13.5% | 0 | 4 |
| Infusion site infection | 7 | 13.5% | 0 | 1 |
| Pain in extremity | 7 | 13.5% | 0 | 2 |
| Vomiting | 7 | 13.5% | 1 | 6 |
| Fatigue | 6 | 11.5% | 0 | 2 |
| Infusion site pruritus | 6 | 11.5% | 0 | 0 |
| Migraine | 6 | 11.5% | 0 | 2 |
| Peripheral swelling | 6 | 11.5% | 0 | 3 |
| Vascular device infection | 6 | 11.5% | 0 | 6 |
| Device dislocation | 5 | 9.6% | 0 | 3 |
| Dyspnoea exertional | 5 | 9.6% | 0 | 3 |
| Fluid retention | 5 | 9.6% | 0 | 4 |
Who Reports DEVICE\POLYURETHANE Side Effects? Age & Gender Data
Gender: 76.5% female, 23.5% male. Average age: 46.8 years. Most reports from: US. View detailed demographics →
Is DEVICE\POLYURETHANE Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2019 | 1 | 0 | 1 |
| 2022 | 6 | 1 | 4 |
| 2023 | 17 | 0 | 8 |
| 2024 | 11 | 0 | 6 |
| 2025 | 6 | 0 | 1 |
What Is DEVICE\POLYURETHANE Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 45 |
Official FDA Label for DEVICE\POLYURETHANE
Official prescribing information from the FDA-approved drug label.