Auralis · recalls, adverse events, clearances

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 reportsInjury 4

Monthly adverse-event reports for this device versus the product-code average.
Month	This device (reports)	Product-code average (reports per device)
2019-01	0	3
2019-02	0	1.5
2019-03	0	2
2019-04	0	2
2019-05	0	2
2019-06	0	3
2019-07	0	3.25
2019-08	0	1.67
2019-10	0	2
2019-11	0	3
2019-12	0	1.67
2020-01	0	2
2020-02	0	1
2020-03	0	1
2020-04	0	1
2020-06	0	2
2020-07	0	1
2020-08	0	1
2020-09	0	2
2020-10	0	3
2020-11	0	1.25
2021-03	0	1
2021-04	0	1
2021-05	0	1.6
2021-06	0	5
2021-07	0	1
2021-09	0	1
2022-02	0	3
2022-03	0	1.5
2022-04	0	1
2022-06	0	1.5
2022-07	0	1.2
2022-08	0	1
2022-09	0	2
2022-10	0	1.25
2022-11	0	2
2022-12	0	2.5
2023-01	0	1
2023-02	0	1.4
2023-03	0	2
2023-04	0	1
2023-05	0	1.67
2023-06	0	1.29
2023-07	0	1
2023-08	0	1
2023-09	0	1.4
2023-10	0	2
2023-11	0	1.2
2023-12	0	1.5
2024-01	0	2
2024-02	0	1
2024-03	0	1.6
2024-04	0	2.4
2024-05	0	1
2024-06	0	1
2024-07	0	1.75
2024-08	0	1
2024-09	0	1.33
2024-10	0	2.13
2024-11	4	2.2
2024-12	0	1.11
2025-01	0	1.78
2025-02	0	2.83
2025-03	0	1.17
2025-04	0	1.5
2025-05	0	2
2025-06	0	1
2025-07	0	1.17
2025-08	0	4.25
2025-09	0	2.29
2025-10	0	2.86
2025-11	0	1.67
2026-01	0	1.5
2026-02	0	1
2026-03	0	2.67
2026-04	0	2.5
2026-05	0	5.5
2026-06	0	5.33

This device (reports/month)Average device in FNM (reports/device/month)

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
2024-11-19	1419652-2024-00067	Injury	Available	exact di
2024-11-19	3005619970-2024-00041	Injury	Available	exact di
2024-11-19	1419652-2024-00066	Injury	Available	exact di
2024-11-19	3005619970-2024-00042	Injury	Available	exact di

Regulatory clearances

None linked.

Manufacturer compliance record

Date	Type	Outcome	Facility	Citations
2015-04-23	NAI	No action indicated	Arjo (Suzhou) Co., Ltd.	0
2014-03-20	VAI	Voluntary action indicated	ARJOHUNTLEIGH POLSKA Sp. z.o.o.	3
2013-02-07	NAI	No action indicated	ARJOHUNTLEIGH AB	0
2013-02-07	NAI	No action indicated	ARJOHUNTLEIGH AB	0
2012-09-06	VAI	Voluntary action indicated	Huntleigh Healthcare Ltd.	0
2011-11-24	NAI	No action indicated	Arjo (Suzhou) Co., Ltd.	0

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