DR COMFORT 17-0002-0-00000

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-07-09 for DR COMFORT 17-0002-0-00000 manufactured by Dr Comfort, A Djo, Llc Company.

Event Text Entries

[113439749] Complaint received that alleges "patient experienced staph infection because the insert is an inch smaller than the shoes"
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3008579854-2018-00007
MDR Report Key7670309
Report SourceHEALTH PROFESSIONAL
Date Received2018-07-09
Date of Report2018-07-09
Date of Event2018-06-20
Date Added to Maude2018-07-09
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 ContactWILLIAM FISHER
Manufacturer Street1460 DECISION STREET
Manufacturer CityVISTA CA 920819663
Manufacturer CountryUS
Manufacturer Postal920819663
Manufacturer G1DR COMFORT, A DJO, LLC COMPANY
Manufacturer Street10300 ENTERPRISE DRIVE
Manufacturer CityMEQUON CA 53092
Manufacturer CountryUS
Manufacturer Postal Code53092
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameDR COMFORT
Generic NameK0903 SPECIAL ACCOMM CUSTOM INSOLES
Product CodeKYS
Date Received2018-07-09
Model Number17-0002-0-00000
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerDR COMFORT, A DJO, LLC COMPANY
Manufacturer Address10300 ENTERPRISE DRIVE MEQUON CA 53092 US 53092


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2018-07-09

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