DR COMFORT L5000 TOE FILLER CUSTOM INSOLE 17-0004-0-00000

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 2020-02-17 for DR COMFORT L5000 TOE FILLER CUSTOM INSOLE 17-0004-0-00000 manufactured by Djo, Llc.

Event Text Entries

[184332170] No device was returned for evaluation. If the device is received, a follow-up report will be submitted upon completion of product evaluation.
Patient Sequence No: 1, Text Type: N, H10


[184332171] It was reported that the "insert caused an ulcer at 1st metatarsal area... An open wound being treated by doctor". No further information is currently available.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3008579854-2020-00004
MDR Report Key9717307
Report SourceDISTRIBUTOR
Date Received2020-02-17
Date of Report2020-02-25
Date of Event2020-02-07
Date Mfgr Received2020-02-07
Date Added to Maude2020-02-17
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
Manufacturer CountryUS
Manufacturer G1DR. COMFORT, A DJO, LLC COMPANY
Manufacturer Street10300 ENTERPRISE DR.
Manufacturer CityMEQUON, WI
Manufacturer CountryUS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameDR COMFORT L5000 TOE FILLER CUSTOM INSOLE
Generic NameORTHOSIS, CORRECTIVE SHOE
Product CodeKNP
Date Received2020-02-17
Returned To Mfg2020-02-24
Model Number17-0004-0-00000
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerDJO, LLC
Manufacturer Address1430 DECISION STREET VISTA, CA US


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-02-17

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