Medical Device Difficult to Prepare

Issue associated with the use of the device in terms of user experiencing difficulty in preparing the device for use, even if the operation is being performed according to labeled instructions for use. (Food and Drug Administration)

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Medical Device Deployment Issue

Issue associated with any deviations from device documented performance specifications relating to the sequence of events for activation and positioning of the…

Medical Device Deployment

The act of instantiating, positioning or activating a medical device inside of the body.

Medical Device Delivered As Unsterile Product

Issue associated with the device being received in such a manner to indicate that its sterility has been compromised (e.g. sterile packaging…

Medical Device Contamination during Use

Issue associated with the undesired introduction of impurities either chemical or microbiological in nature, or of foreign matter into or onto the…

Medical Device Contaminated during Manufacturing or Shipping

Issue associated with the presence of any unexpected foreign substance found on the surface or in the package materials, which may affect…

Medical Device Component Or Accessory Terminology FDA CDRH

Terminology used for medical components and accessories in safety reports and FDA CDRH documents during both pre and post approval periods of…