This case was assessed as reportable to the fda as the event, nodules, was deemed to meet serious injury criteria of resulted in permanent impairment of a body function or permanent damage to a body structure.The device history record could not be reviewed as the lot number was not reported.
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This case was linked to mdr 3013840437-2020-00130, referring to the same reporter and the same reaction.This spontaneous report was received from a us physician and concerns a female patient (herself).She was injected with radiesse®, approximately 3 years prior this report.After the treatment with radiesse®, the patient experienced nodules.She tried to massage them, but they never went away.Due to provided information, the outcome of the event was considered as not resolved.
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