NEURO SPONGE 30-057

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2019-12-10 for NEURO SPONGE 30-057 manufactured by Medsorb Dominicana, S.a..

MAUDE Entry Details

Report Number1060680-2019-00010
MDR Report Key9445832
Report SourceUSER FACILITY
Date Received2019-12-10
Date of Report2020-02-25
Date of Event2019-11-07
Date Mfgr Received2019-11-11
Date Added to Maude2019-12-10
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 ContactSARAH BENNETT
Manufacturer Street200 DEBUSK LANE
Manufacturer CityPOWELL, TN TN 37849
Manufacturer CountryUS
Manufacturer Postal37849
Manufacturer Phone8653626112
Manufacturer G1DEROYAL INDUSTRIES, INC.
Manufacturer Street1703 HIGHWAY 33 SOUTH
Manufacturer CityNEW TAZEWELL, TN TN 37825
Manufacturer CountryUS
Manufacturer Postal Code37825
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameNEURO SPONGE
Generic NameGAUZE/SPONGE, INTERNAL
Product CodeEFQ
Date Received2019-12-10
Returned To Mfg2019-11-21
Model Number30-057
Lot Number19051556
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerMEDSORB DOMINICANA, S.A.
Manufacturer AddressZONA FRANCA INDUSTRIAL SAN PEDRO DE MACORIS SAN PEDRO DE MACORIS, DR


Patients

Patient NumberTreatmentOutcomeDate
10 2019-12-10

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