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 linked reportMalfunction 1
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-10 | 0 | 3 |
| 2021-04 | 0 | 1 |
| 2021-09 | 0 | 1 |
| 2022-09 | 1 | 1 |
| 2024-01 | 0 | 1 |
| 2025-05 | 0 | 3 |
| 2025-09 | 0 | 1 |
| 2026-04 | 0 | 2 |
Failure-mode summaryAI-generated
1 linked report narrative available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2022-09-19 | 2242450-2022-00002 | Malfunction | Available | procode brand trgm |
Regulatory clearances
None linked.
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2016-08-31 | NAI | No action indicated | Katena Products, Inc. | 0 |
| 2014-04-21 | NAI | No action indicated | Katena Products Inc. | 0 |
| 2012-02-22 | NAI | No action indicated | Katena Products, Inc. | 0 |
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