ODR

3 FDA 510(k) clearances · Product code

FDA profile

Official device name

Electrosurgical Patient Return Electrode

Device class

Class II (moderate risk)

Regulation

21 CFR 878.4400

Medical specialty

General, Plastic Surgery

Flags

Third-party review eligible

FDA definition

Ground pad used to finish circuit during electrosurgery. A single use, non-sterile dispersive electrode with a pre-attached cord used to adhere to the patient over the entire pad surface to complete the electrosurgical circuit between the generator, the active electrode, and the patient.

Adverse events (MAUDE)

2007: 3 · 2008: 94 · 2009: 118 · 2010: 23 · 2011: 6
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.

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