UNK VOLBELLA

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-25 for UNK VOLBELLA manufactured by Allergan (pringy).

MAUDE Entry Details

Report Number3005113652-2020-00168
MDR Report Key9880384
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-25
Date of Report2020-03-25
Date Mfgr Received2020-03-02
Date Added to Maude2020-03-25
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMRS. MICHELLE BURGESS
Manufacturer Street12331-A RIATA TRACE PARKWAY BUILDING 3
Manufacturer CityAUSTIN TX 78727
Manufacturer CountryUS
Manufacturer Postal78727
Manufacturer Phone7372473605
Manufacturer G1ALLERGAN (PRINGY)
Manufacturer StreetROUTE DE PROMERY ZONE ARTISANALE DE PRE-MAIRY
Manufacturer CityPRINGY 74370
Manufacturer CountryFR
Manufacturer Postal Code74370
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameUNK VOLBELLA
Generic NameIMPLANT, DERMAL, FOR AESTHETIC USE
Product CodeLMH
Date Received2020-03-25
Catalog NumberUNK VOLBELLA
Lot NumberNI
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerALLERGAN (PRINGY)
Manufacturer AddressROUTE DE PROMERY ZONE ARTISANALE DE PRE-MAIRY PRINGY 74370 FR 74370


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-25

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