DONJOY REACTION KNEE BRACE M/L, GRAY 11-0215-3

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2020-01-02 for DONJOY REACTION KNEE BRACE M/L, GRAY 11-0215-3 manufactured by Djo, Llc.

MAUDE Entry Details

Report Number9616086-2020-00001
MDR Report Key9537782
Report SourceCOMPANY REPRESENTATIVE,USER F
Date Received2020-01-02
Date of Report2020-01-02
Date of Event2019-12-20
Date Mfgr Received2019-12-20
Date Added to Maude2020-01-02
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 ContactBRIAN BECKER
Manufacturer Street2900 LAKE VISTA DRIVE
Manufacturer CityLEWISVILLE TX 75067
Manufacturer CountryUS
Manufacturer Postal75067
Manufacturer G1DJ ORTHOPEDICS DE MEXICO, S.A. DE C.V.
Manufacturer StreetCARRETERA LIBRE TIJUANA TECATE 20230 SUBMETROPOLI EL FLORIDO
Manufacturer CityTIJUANA, B.C. 22244
Manufacturer CountryMX
Manufacturer Postal Code22244
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameDONJOY REACTION KNEE BRACE M/L, GRAY
Generic NameJOINT, KNEE, EXTERNAL BRACE
Product CodeITQ
Date Received2020-01-02
Model Number11-0215-3
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerDJO, LLC
Manufacturer Address1430 DECISION STREET VISTA CA 92081 US 92081


Patients

Patient NumberTreatmentOutcomeDate
10 2020-01-02

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