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.
3 linked reportsInjury 3
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-12 | 3 | 3 |
Failure-mode summaryAI-generated
3 linked report narratives available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2019-12-19 | 2242450-2019-00002 | Injury | Available | catalog number |
Showing the most recent 1 of 3 linked reports.
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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