GELFOAM

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,l report with the FDA on 2020-02-04 for GELFOAM manufactured by Pfizer, Inc. (device).

MAUDE Entry Details

Report Number1810189-2020-00003
MDR Report Key9664927
Report SourceFOREIGN,HEALTH PROFESSIONAL,L
Date Received2020-02-04
Date of Report2019-04-30
Date Mfgr Received2019-04-30
Date Added to Maude2020-02-04
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 STELLA PIETRAFESA
Manufacturer Street235 E42ND STREET
Manufacturer CityNEW YORK NY 10017
Manufacturer CountryUS
Manufacturer Postal10017
Manufacturer G1PFIZER, INC. (DEVICE)
Manufacturer Street7000 PORTAGE ROAD
Manufacturer CityKALAMAZOO MI 49001
Manufacturer CountryUS
Manufacturer Postal Code49001
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameGELFOAM
Generic NameSPONGE, STERILE; CLASS III
Product CodeLMF
Date Received2020-02-04
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerPFIZER, INC. (DEVICE)
Manufacturer Address7000 PORTAGE ROAD KALAMAZOO, MI MI 49001 US 49001


Patients

Patient NumberTreatmentOutcomeDate
101. Other; 2. Required No Informationntervention 2020-02-04

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