DR COMFORT 4415-M-08.0

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 2017-04-25 for DR COMFORT 4415-M-08.0 manufactured by De Comfort, A Djo, Llc Compant.

Event Text Entries

[73604105] Not returned.
Patient Sequence No: 1, Text Type: N, H10


[73604106] Complaint received that alleges "patient was experiencing a ulcer on her left ankle and pain in her left foot from the shoe rubbing. Patient experienced drainage from the wound". Questionnaire not received from customer or clinician. Device not returned to manufacturer for evaluation.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3008579854-2017-00001
MDR Report Key6518617
Report SourceHEALTH PROFESSIONAL
Date Received2017-04-25
Date of Report2017-04-25
Date of Event2017-04-11
Date Added to Maude2017-04-25
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 Street1430 DECISION STREET
Manufacturer CityVISTA CA 920819663
Manufacturer CountryUS
Manufacturer Postal920819663
Manufacturer G1DR COMFORT, A DJO, LLC COMPANY
Manufacturer Street10300 ENTERPRISE DRIVE
Manufacturer CityMEQUON WI 53092
Manufacturer CountryUS
Manufacturer Postal Code53092
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameDR COMFORT
Generic NameMERRY JANE LYCRA 8 MED
Product CodeKNP
Date Received2017-04-25
Model Number4415-M-08.0
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerDE COMFORT, A DJO, LLC COMPANT
Manufacturer Address10300 ENTERPRISE DRIVE MEQUON WI 53092 US 53092


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2017-04-25

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