DR. COMFORT SHOE MODIFICATION 17-0050-0-00000

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 2019-06-27 for DR. COMFORT SHOE MODIFICATION 17-0050-0-00000 manufactured by Dr. Comfort, A Djo, Llc Company.

MAUDE Entry Details

Report Number3008579854-2019-00008
MDR Report Key8741144
Report SourceDISTRIBUTOR
Date Received2019-06-27
Date of Report2019-06-27
Date of Event2019-04-25
Date Mfgr Received2019-06-03
Date Added to Maude2019-06-27
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 53092
Manufacturer CountryUS
Manufacturer Postal Code53092
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameDR. COMFORT SHOE MODIFICATION
Generic NameORTHOSIS, CORRECTIVE SHOE
Product CodeKNP
Date Received2019-06-27
Returned To Mfg2019-06-04
Model Number17-0050-0-00000
OperatorLAY USER/PATIENT
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerDR. COMFORT, A DJO, LLC COMPANY
Manufacturer Address10300 ENTERPRISE DR. MEQUON, WI 53092 US 53092


Patients

Patient NumberTreatmentOutcomeDate
10 2019-06-27

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