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.
No adverse-event reports are linked to this device.
Recall history
No recalls linked.
Regulatory clearances
None linked.
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2024-08-01 | VAI | Voluntary action indicated | A&D Vietnam Limited | 3 |
| 2023-03-17 | VAI | Voluntary action indicated | A&D Company Manufacturing, Ltd. | 3 |
| 2023-03-13 | NAI | No action indicated | A&D Company, Limited - Tech Center | 0 |
| 2019-06-21 | VAI | Voluntary action indicated | A&D Engineering, Inc. | 1 |
| 2018-06-21 | NAI | No action indicated | A&D Company Manufacturing, Ltd. | 0 |
| 2016-07-22 | VAI | Voluntary action indicated | A&D Company Manufacturing, Ltd. | 2 |
| 2015-04-28 | NAI | No action indicated | A&D Engineering, Inc. | 0 |
| 2014-06-06 | VAI | Voluntary action indicated | A&D Company Manufacturing, Ltd. | 1 |
| 2014-06-03 | VAI | Voluntary action indicated | A&D Company, Limited - Tech Center | 1 |
| 2012-11-13 | WL | Warning Letter | A & D Electronics (Shenzhen) Co., Ltd. | — |
| 2012-08-09 | VAI | Voluntary action indicated | A & D Electronics (Shenzhen) Co., Ltd. | 0 |
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