Labeling and instructions for use or maintenance of device problem identified

Definition

Insufficient, inadequate, or incorrect information provided on a device's label or documentation regarding e.g. its intended use, directions for use, and characteristics of the device, including its maintenance.

3 subordinate codes

• XE3PVInadequate labelling or instructions for use of device identified
• XE4MRIncorrect labelling or instructions for use of device identified
• XE7Y7Inadequate or incorrect instructions for maintenance of device identified

Also indexed as

Nearby in Findings of investigations related to devices

• XE0WXBiological problem with device identified
• XE4CBElectrical problem with device identified
• XE6AQElectromagnetic compatibility problem with device identified
• XE02NInteroperability problem with device identified
• XE3RWMaterial or chemical problem with device identified
• XE640Mechanical problem with device identified
• XE4KNOptical problem with device identified
• XE05WClinical imaging problem with device identified