DONJOY DEFIANCE FP CONV DEFIANCE FP

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 2020-03-23 for DONJOY DEFIANCE FP CONV DEFIANCE FP manufactured by Djo, Llc.

MAUDE Entry Details

Report Number3012446970-2020-00011
MDR Report Key9864810
Report SourceCONSUMER
Date Received2020-03-23
Date of Report2020-03-22
Date of Event2020-02-17
Date Mfgr Received2020-03-12
Device Manufacturer Date2019-09-25
Date Added to Maude2020-03-23
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 ContactBRIAN BECKER
Manufacturer Street2900 LAKE VISTA DRIVE
Manufacturer CityLEWISVILLE, TX
Manufacturer CountryUS
Manufacturer G1DJO, LLC
Manufacturer Street3151 SCOTT ST.
Manufacturer CityVISTA, CA
Manufacturer CountryUS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameDONJOY DEFIANCE FP
Generic NameJOINT, KNEE, EXTERNAL BRACE
Product CodeITQ
Date Received2020-03-23
Model NumberCONV DEFIANCE FP
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerDJO, LLC
Manufacturer Address1430 DECISION STREET VISTA, CA US


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-03-23

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