Drentech Closed Silicone Reservoir 200 ml · recalls, adverse events, clearances

Regulatory presence across jurisdictions

The same device (matched on an identical UDI-DI) is registered in other jurisdictions. EU coverage (EUDAMED) is still phasing in — absence here does not mean a device is not marketed there.

European UnionDRENTECH CLOSED 200 ML C/SACCA 600 ML803413929BELPUMPDRAIN1aJT

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

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	2.14
2019-02	0	3
2019-03	0	2.33
2019-04	0	1.43
2019-05	0	1.67
2019-06	0	1
2019-07	0	1.78
2019-08	0	1.33
2019-09	0	2
2019-10	0	1
2019-11	0	1.25
2019-12	0	5.33
2020-01	0	2
2020-02	0	2.89
2020-03	0	1.8
2020-04	0	1.5
2020-05	0	2
2020-06	0	1.2
2020-07	0	4
2020-08	0	3.67
2020-09	0	2.8
2020-10	0	2
2020-11	0	3.56
2020-12	0	2.83
2021-01	0	5.8
2021-02	0	4
2021-03	0	4.5
2021-04	0	2.5
2021-05	0	2
2021-06	0	2.18
2021-07	0	2.4
2021-08	0	3
2021-09	0	2.75
2021-10	0	1.67
2021-11	0	2.25
2021-12	0	2.5
2022-01	0	4
2022-02	0	1.25
2022-03	0	1.25
2022-04	0	2.5
2022-05	0	1.29
2022-06	0	2
2022-07	0	1.5
2022-08	0	1.67
2022-09	0	1.75
2022-10	0	2.33
2022-11	0	1.75
2022-12	0	1.67
2023-01	0	1
2023-02	0	1
2023-03	0	1.25
2023-04	0	1.5
2023-05	0	5
2023-06	0	1.67
2023-07	0	1
2023-08	0	1.5
2023-09	0	2
2023-10	0	1.5
2023-11	0	1.67
2023-12	0	1.67
2024-01	0	1.33
2024-02	0	1
2024-03	0	2
2024-05	0	1.5
2024-06	0	1.67
2024-07	0	3
2024-08	0	4
2024-09	0	1.2
2024-10	1	2
2024-11	0	4
2024-12	0	1.67
2025-01	0	1.4
2025-02	0	3
2025-03	0	2.5
2025-04	0	2.6
2025-05	0	1.44
2025-06	0	3.8
2025-07	0	3.6
2025-08	0	1.86
2025-09	0	2.29
2025-10	0	1.43
2025-11	0	2.6
2025-12	0	2
2026-01	0	4
2026-02	0	2
2026-03	0	1.6
2026-04	0	1.83
2026-05	0	2.75
2026-06	0	2.5

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

Recall history

No recalls linked.

Regulatory clearances

None linked.

Manufacturer compliance record

None in the loaded window.

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