DR. COMFORT PERFORMANCE BLACK 10.0 WD 7611-W-10.0

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 2019-10-28 for DR. COMFORT PERFORMANCE BLACK 10.0 WD 7611-W-10.0 manufactured by Djo, Llc.

MAUDE Entry Details

Report Number3008579854-2019-00015
MDR Report Key9243966
Report SourceUSER FACILITY
Date Received2019-10-28
Date of Report2019-10-28
Date of Event2019-10-04
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 Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. BRIAN BECKER
Manufacturer Street2900 LAKE VISTA DRIVE
Manufacturer CityLEWISVILLE TX 75067
Manufacturer CountryUS
Manufacturer Postal75067
Manufacturer G1DR. COMFORT, A DJO, LLC COMPANY
Manufacturer Street10300 ENTERPRISE DR.
Manufacturer CityMEQUON WI 59092
Manufacturer CountryUS
Manufacturer Postal Code59092
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameDR. COMFORT PERFORMANCE BLACK 10.0 WD
Generic NameORTHOSIS, CORRECTIVE SHOE
Product CodeKNP
Date Received2019-10-28
Returned To Mfg2019-10-17
Model Number7611-W-10.0
OperatorLAY USER/PATIENT
Device AvailabilityR
Device Eval'ed by MfgrY
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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