MERZ NORTH AMERICA, INC RADIESSE(+) INJECTABLE IMPLANT; IMPLANT, DERMAL, FOR AESTHETIC USE
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Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Obstruction/Occlusion (2422)
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Event Type
Injury
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Event Description
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This spontaneous report was received from an us nurse and concerns a patient.The patient was injected with radiesse(+).Within 30 hours after the radiesse(+) injection, the patient experienced that it looked to be an occlusion, at the nasolabial fold, on the left side.It started small and got bigger.Due to the provided information, the outcome of the event was considered as not resolved.
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Manufacturer Narrative
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This case was assessed as reportable to the fda, as the event occlusion (pt: vascular occlusion), was deemed to meet the serious criteria of required intervention to prevent permanent damage.The device history record of radiesse(+) injectable implant could not be reviewed, as the lot number was not reported.
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Search Alerts/Recalls
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