AIRCAST 01ES-M

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2018-03-08 for AIRCAST 01ES-M manufactured by Djo, Llc.

Event Text Entries

[101949363] Complaint received that alleges patient had an allergic reaction to the foot : elephant foot syndrome, large swelling, deformed foot, pustules. Symptoms noticed after three days wearing device. Treatment with antibiotics / corticosteroids that immediately stopped the allergic reaction.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9616086-2018-00004
MDR Report Key7325031
Report SourceDISTRIBUTOR,FOREIGN
Date Received2018-03-08
Date of Report2018-03-08
Date of Event2018-02-27
Date Added to Maude2018-03-08
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 Phone7607343126
Manufacturer G1DJ ORTHOPEDICS DE MEXICO, S.A. DE C.V.
Manufacturer StreetCARRETERA LIBRE TIJUANA TECATE 20230 SUBMETROPOLI EL FLORIDO
Manufacturer CityTIJUANA, 22244
Manufacturer CountryMX
Manufacturer Postal Code22244
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameAIRCAST
Generic NameAIRSELECT, SHORT, MEDIUM
Product CodeITW
Date Received2018-03-08
Model Number01ES-M
OperatorLAY USER/PATIENT
Device AvailabilityY
Device AgeDA
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. Other 2018-03-08

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