PROCTO SWAB 31-249

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 2020-02-05 for PROCTO SWAB 31-249 manufactured by Goodwood Medical Care Ltd.

MAUDE Entry Details

Report Number3010452421-2020-00001
MDR Report Key9673511
Report SourceDISTRIBUTOR
Date Received2020-02-05
Date of Report2020-02-05
Date of Event2019-03-28
Date Mfgr Received2020-01-09
Date Added to Maude2020-02-05
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 37849
Manufacturer CountryUS
Manufacturer Postal37849
Manufacturer Phone8653626112
Manufacturer G1ORTHO AND SURGICAL PRODUCTS ENTERPRISES S.A.
Manufacturer StreetKM 20.5 CARRETERA A VILLA CANALES,ZONA 3 FINCA MORANCITO
Manufacturer CityVILLA CANALES, GUATEMALA 01065
Manufacturer CountryGT
Manufacturer Postal Code01065
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePROCTO SWAB
Generic NameAPPLICATOR, ABSORBENT TIPPED, STERILE
Product CodeKXG
Date Received2020-02-05
Model Number31-249
Lot Number47346703
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerGOODWOOD MEDICAL CARE LTD
Manufacturer Address1-2 FLOOR, 3-919 JIULICUN YONGZHENG STREET, JINZHOU DIST DALIAN, LIAONING 116100 CH 116100


Patients

Patient NumberTreatmentOutcomeDate
10 2020-02-05

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