DONJOY COOL, TROM ADVANCE 11-9114-9

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-10-28 for DONJOY COOL, TROM ADVANCE 11-9114-9 manufactured by Djo, Llc.

MAUDE Entry Details

Report Number9616086-2019-00079
MDR Report Key9243964
Report SourceCONSUMER
Date Received2019-10-28
Date of Report2019-10-28
Date of Event2019-10-02
Date Mfgr Received2019-10-04
Date Added to Maude2019-10-28
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional0
Initial Report to FDA0
Report to FDA3
Event Location3
Manufacturer ContactMR. BRIAN 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 COOL, TROM ADVANCE
Generic NameJOINT, KNEE, EXTERNAL BRACE
Product CodeITQ
Date Received2019-10-28
Model Number11-9114-9
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerDJO, LLC
Manufacturer Address1430 DECISION STREET VISTA CA 920819663 US 920819663


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2019-10-28

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