UPPER MODULE, COM1 BRZ-CG1-CUD-110 201665

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-03-17 for UPPER MODULE, COM1 BRZ-CG1-CUD-110 201665 manufactured by Allergan (pleasanton).

MAUDE Entry Details

Report Number3007215625-2020-00021
MDR Report Key9838948
Report SourceCONSUMER
Date Received2020-03-17
Date of Report2020-03-16
Date Mfgr Received2019-10-29
Date Added to Maude2020-03-17
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional0
Initial Report to FDA0
Report to FDA3
Event Location3
Manufacturer ContactMS. JENNIFER CLETO
Manufacturer Street4410 ROSEWOOD DRIVE
Manufacturer CityPLEASANTON CA 94588
Manufacturer CountryUS
Manufacturer Postal94588
Manufacturer Phone9256214130
Manufacturer G1ALLERGAN (PLEASANTON)
Manufacturer Street4410 ROSEWOOD DRIVE
Manufacturer CityPLEASANTON CA 94588
Manufacturer CountryUS
Manufacturer Postal Code94588
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameUPPER MODULE, COM1
Generic NameDERMAL COOLING PACK/VACUUM/MASSAGER
Product CodeOOK
Date Received2020-03-17
Model NumberBRZ-CG1-CUD-110
Catalog Number201665
Lot NumberNI
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerALLERGAN (PLEASANTON)
Manufacturer Address4410 ROSEWOOD DRIVE PLEASANTON CA 94588 US 94588


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-03-17

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