STATSEAL POWDER

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-11-21 for STATSEAL POWDER manufactured by Biolife, Llc.

MAUDE Entry Details

Report Number1066421-2019-00001
MDR Report Key9356507
Report SourceHEALTH PROFESSIONAL
Date Received2019-11-21
Date of Report2019-11-06
Date of Event2019-11-01
Date Mfgr Received2019-11-06
Date Added to Maude2019-11-21
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 CLAUDIA MASSELINK
Manufacturer Street8163 25TH COURT EAST
Manufacturer CitySARASOTA FL 34243
Manufacturer CountryUS
Manufacturer Postal34243
Manufacturer Phone9413601300
Manufacturer G1BIOLIFE, LLC
Manufacturer Street8163 25TH COURT EAST
Manufacturer CitySARASOTA FL 34243
Manufacturer CountryUS
Manufacturer Postal Code34243
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSTATSEAL POWDER
Generic NameSTATSEAL POWDER
Product CodeFRO
Date Received2019-11-21
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerBIOLIFE, LLC
Manufacturer Address8163 25TH COURT EAST SARASOTA FL 342433424 US 342433424


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2019-11-21

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