Adverse-event reports (MAUDE)
Read this first: MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.
1,834 linked reportsMalfunction 1,722Injury 111Death 1
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2021-05 | 3 | 3 |
| 2021-06 | 4 | 4 |
| 2021-07 | 29 | 29 |
| 2021-08 | 48 | 48 |
| 2021-09 | 65 | 65 |
| 2021-10 | 19 | 19 |
| 2021-11 | 24 | 24 |
| 2021-12 | 44 | 44 |
| 2022-01 | 59 | 30 |
| 2022-02 | 43 | 15.33 |
| 2022-03 | 21 | 11.5 |
| 2022-04 | 36 | 19 |
| 2022-05 | 40 | 20.5 |
| 2022-06 | 56 | 15.25 |
| 2022-07 | 39 | 14 |
| 2022-08 | 48 | 13 |
| 2022-09 | 63 | 22 |
| 2022-10 | 44 | 44 |
| 2022-11 | 114 | 39.33 |
| 2022-12 | 58 | 30 |
| 2023-01 | 107 | 54.5 |
| 2023-02 | 76 | 26 |
| 2023-03 | 67 | 34.5 |
| 2023-04 | 45 | 45 |
| 2023-05 | 69 | 35 |
| 2023-06 | 18 | 18 |
| 2023-07 | 17 | 17 |
| 2023-08 | 37 | 20 |
| 2023-09 | 39 | 14.67 |
| 2023-10 | 75 | 75 |
| 2023-11 | 58 | 58 |
| 2023-12 | 51 | 17.67 |
| 2024-01 | 93 | 32 |
| 2024-02 | 61 | 31.5 |
| 2024-03 | 25 | 14 |
| 2024-04 | 6 | 6 |
| 2024-05 | 7 | 4 |
| 2024-06 | 2 | 1.5 |
| 2024-07 | 15 | 6 |
| 2024-08 | 20 | 7.75 |
| 2024-09 | 7 | 4 |
| 2024-10 | 6 | 5 |
| 2024-11 | 6 | 2.75 |
| 2024-12 | 9 | 5.5 |
| 2025-01 | 10 | 6.75 |
| 2025-02 | 2 | 1.5 |
| 2025-03 | 8 | 4.5 |
| 2025-04 | 5 | 3 |
| 2025-05 | 1 | 1 |
| 2025-06 | 4 | 3 |
| 2025-07 | 1 | 1 |
| 2025-08 | 2 | 2 |
| 2025-09 | 2 | 1.5 |
| 2025-10 | 5 | 5 |
| 2025-11 | 4 | 5.5 |
| 2025-12 | 4 | 4 |
| 2026-01 | 2 | 2 |
| 2026-02 | 4 | 4 |
| 2026-03 | 3 | 3 |
| 2026-04 | 2 | 2 |
| 2026-05 | 2 | 2 |
Failure-mode summaryAI-generated
40 linked report narratives available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2026-05-14 | 1221359-2026-00172 | Malfunction | Available | exact di |
| 2026-05-01 | 1221359-2026-00063 | Malfunction | Available | exact di |
| 2026-04-20 | 1221359-2026-00054 | Malfunction | Available | exact di |
| 2026-04-20 | 1221359-2026-00053 | Malfunction | Available | exact di |
| 2026-03-31 | 1221359-2026-00048 | Malfunction | Available | exact di |
| 2026-03-25 | 1221359-2026-00039 | Malfunction | Available | exact di |
| 2026-03-23 | 1221359-2026-00035 | Malfunction | Available | exact di |
| 2026-02-24 | 1221359-2026-00022 | Malfunction | Available | exact di |
| 2026-02-18 | 1221359-2026-00021 | Malfunction | Available | exact di |
| 2026-02-13 | 1221359-2026-00020 | Malfunction | Available | exact di |
| 2026-02-11 | 1221359-2026-00018 | Malfunction | Available | exact di |
| 2026-01-19 | 1221359-2026-00013 | Malfunction | Available | exact di |
| 2026-01-05 | 1221359-2026-00001 | Malfunction | Available | exact di |
| 2025-12-12 | 1221359-2025-00851 | Malfunction | Available | exact di |
| 2025-12-09 | 1221359-2025-00847 | Malfunction | Available | exact di |
Showing the most recent 200 of 1,834 linked reports.
Showing 1–15 of 200
Regulatory clearances
None linked.
Manufacturer compliance record
None in the loaded window.
Similar devices
- CASE SpeedySwab Rapid COVID_19 + Flu A&B Antigen Self-Test 1 Test/Box WatMIND USA
- CASE SpeedySwab Rapid COVID_19 + Flu A&B Antigen Self-Test 2 Tests/Box WatMIND USA
- CASE SpeedySwab Rapid COVID_19 + Flu A&B Antigen Self-Test 25 Tests/Box WatMIND USA
- CASE SpeedySwab Rapid COVID_19 + Flu A&B Antigen Self-Test 4 Tests/Box WatMIND USA
- CASE-RDB-SpeedySwab Rapid COVID_19 + Flu A&B Antigen Self-Test 1 Test/Box WatMIND USA
- CASE-RDB-SpeedySwab Rapid COVID_19 + Flu A&B Antigen Self-Test 2 Tests/Box WatMIND USA
- COVID-19 Detect™ Rapid Self -Test INBIOS INTERNATIONAL, INC
- CVS Health At Home COVID-19 Test Kit DIAGNOSTIC HYBRIDS, INC.
- CVS Health At Home COVID-19 Test Kit DIAGNOSTIC HYBRIDS, INC.
- CareSuperb COVID-19 Antigen Home Test Access Bio Inc.
- CareSuperb COVID-19 Antigen Home Test Access Bio Inc.
- CareSuperb COVID-19 Antigen Home Test Access Bio Inc.
Select up to two to place side-by-side with this device.