UPPER MODULE, COM1, 6.1 SW, DIRECT SA16789

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,health professional, report with the FDA on 2019-07-30 for UPPER MODULE, COM1, 6.1 SW, DIRECT SA16789 manufactured by Allergan (pleasanton).

MAUDE Entry Details

Report Number3007215625-2019-00036
MDR Report Key8842781
Report SourceCONSUMER,HEALTH PROFESSIONAL,
Date Received2019-07-30
Date of Report2019-10-15
Date of Event2018-11-15
Date Mfgr Received2019-09-16
Date Added to Maude2019-07-30
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 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, 6.1 SW, DIRECT
Generic NameDERMAL COOLING PACK/VACUUM/MASSAGER
Product CodeOOK
Date Received2019-07-30
Catalog NumberSA16789
Lot NumberNI
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
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 2019-07-30

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