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 |
|---|---|---|---|---|
| 2023-05-23 | VAI | Voluntary action indicated | Parker Laboratories, Inc. | 4 |
| 2023-05-23 | VAI | Voluntary action indicated | Parker Laboratories, Inc. | 4 |
| 2018-03-20 | VAI | Voluntary action indicated | Parker Laboratories, Inc. | 3 |
| 2018-03-20 | VAI | Voluntary action indicated | Parker Laboratories, Inc. | 3 |
| 2014-10-15 | VAI | Voluntary action indicated | Parker Laboratories, Inc. | 2 |
| 2014-10-15 | VAI | Voluntary action indicated | Parker Laboratories, Inc. | 2 |
| 2011-05-19 | NAI | No action indicated | Parker Laboratories, Inc. | 0 |
| 2011-05-19 | NAI | No action indicated | Parker Laboratories, Inc. | 0 |
Similar devices
- 3M™ 3M COMPANY
- 3M™ 3M COMPANY
- AC Cream - Conductive Paste SPES MEDICA SPA
- AUVON Shenzhen Yuwen E-Commerce Co., Ltd.
- AUVON Shenzhen Yuwen E-Commerce Co., Ltd.
- AUVON Shenzhen Yuwen E-Commerce Co., Ltd.
- AUVON Shenzhen Yuwen E-Commerce Co., Ltd.
- Axion Axion USA LLC
- Compumedics Quik-Gel COMPUMEDICS LIMITED
- Compumedics Quik-Gel COMPUMEDICS LIMITED
- Compumedics Quik-Gel COMPUMEDICS LIMITED
- Compumedics Quik-Gel COMPUMEDICS LIMITED
Select up to two to place side-by-side with this device.