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.
4 linked reportsMalfunction 3Injury 1
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-06 | 0 | 1 |
| 2019-07 | 0 | 1 |
| 2020-11 | 0 | 1 |
| 2020-12 | 0 | 1 |
| 2021-03 | 0 | 1 |
| 2021-04 | 0 | 2 |
| 2021-10 | 0 | 1 |
| 2022-01 | 1 | 1 |
| 2022-02 | 0 | 1 |
| 2022-03 | 3 | 3 |
| 2022-06 | 0 | 1 |
| 2023-01 | 0 | 1 |
| 2023-03 | 0 | 2 |
| 2023-04 | 0 | 2 |
| 2024-04 | 0 | 1 |
| 2025-11 | 0 | 1 |
| 2025-12 | 0 | 1 |
| 2026-01 | 0 | 1 |
| 2026-02 | 0 | 1.5 |
| 2026-03 | 0 | 1.5 |
| 2026-04 | 0 | 2 |
| 2026-05 | 0 | 2 |
Failure-mode summaryAI-generated
4 linked report narratives available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2022-03-03 | 9615005-2022-80006 | Malfunction | Available | catalog number |
| 2022-01-26 | MW5107005 | Injury | Available | catalog number |
Showing the most recent 2 of 4 linked reports.
Regulatory clearances
Predicate lineage
Lineage each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2026-03-12 | NAI | No action indicated | Fehling Instruments GmbH & Co. KG | 1 |
| 2019-05-23 | NAI | No action indicated | Fehling Instruments GmbH & Co. KG | 0 |
| 2015-06-18 | OAI | Official action indicated | Fehling Instruments GmbH & Co. KG | 9 |
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