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JUVEDERM VOLUMA (VOLUME/ADDITIVE UNKNOWN) Adverse Event — Injury (MDR 3005113652-2020-00233)

JUVEDERM VOLUMA (VOLUME/ADDITIVE UNKNOWN) Adverse Event — Injury (MDR 3005113652-2020-00233) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: JUVEDERM VOLUMA (VOLUME/ADDITIVE UNKNOWN); Generic name: IMPLANT, DERMAL, FOR AESTHETIC USE; Manufacturer: ALLERGAN (PRINGY).

DeviceJUVEDERM VOLUMA (VOLUME/ADDITIVE UNKNOWN)
Generic nameIMPLANT, DERMAL, FOR AESTHETIC USE
ManufacturerALLERGAN (PRINGY)
Report number3005113652-2020-00233
Event typeInjury
Product problemN
Date received2020-04-27
Report sourceCOMPANY REPRESENTATIVE, FOREIG
NarrativeFURTHER INFORMATION REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THE EVENT IS A PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. THIS IS A KNOWN POTENTIAL ADVERSE EVENT ADDRESSED IN THE PRODUCT LABELING.
SourceopenFDA MAUDE (device adverse events)

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