SURGIFOAM? SPONGE SIZE 12-7 PRODUCT CODE 1972

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2020-03-04 for SURGIFOAM? SPONGE SIZE 12-7 PRODUCT CODE 1972 manufactured by Ferrosan Medical Devices A/s.

MAUDE Entry Details

Report Number3008478369-2020-00003
MDR Report Key9784623
Report SourceDISTRIBUTOR
Date Received2020-03-04
Date of Report2020-03-04
Date Mfgr Received2020-02-17
Date Added to Maude2020-03-04
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag0
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer StreetSYDMARKEN 5
Manufacturer CitySOEBORG, 2860
Manufacturer CountryDA
Manufacturer Postal2860
Manufacturer G1FERROSAN MEDICAL DEVICES A/S
Manufacturer StreetSYDMARKEN 5
Manufacturer CitySOEBORG, 2860
Manufacturer CountryDA
Manufacturer Postal Code2860
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSURGIFOAM? SPONGE SIZE 12-7 PRODUCT CODE 1972
Generic NameSURGIFOAM? SPONGE
Product CodeLMF
Date Received2020-03-04
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerFERROSAN MEDICAL DEVICES A/S
Manufacturer AddressSYDMARKEN 5 SOEBORG, 2860 DA 2860


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-03-04

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