PHOTOFIX PATCH PFP0.8X8

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,study, report with the FDA on 2019-06-20 for PHOTOFIX PATCH PFP0.8X8 manufactured by Cryolife, Inc..

MAUDE Entry Details

Report Number1063481-2019-00035
MDR Report Key8716251
Report SourceCOMPANY REPRESENTATIVE,STUDY,
Date Received2019-06-20
Date of Report2019-08-14
Date of Event2019-06-12
Date Mfgr Received2019-06-14
Date Added to Maude2019-06-20
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 ContactROCHELLE MANEY
Manufacturer Street1655 ROBERTS BLVD.
Manufacturer CityKENNESAW GA 30144
Manufacturer CountryUS
Manufacturer Postal30144
Manufacturer Phone7704193355
Manufacturer G1CRYOLIFE, INC.
Manufacturer Street1655 ROBERTS BLVD. NW
Manufacturer CityKENNESAW GA 30144
Manufacturer CountryUS
Manufacturer Postal Code30144
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePHOTOFIX PATCH
Generic NamePHOTOFIX DECELLULARIZED BOVINE PERICARDIUM
Product CodePSQ
Date Received2019-06-20
Model NumberPFP0.8X8
Catalog NumberPFP0.8X8
Lot Number31012519
Device AvailabilityN
Device AgeDA
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerCRYOLIFE, INC.
Manufacturer Address1655 ROBERTS BLVD. NW KENNESAW GA 30144 US 30144


Patients

Patient NumberTreatmentOutcomeDate
101. Life Threatening; 2. Required No Informationntervention 2019-06-20

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