AIRCAST 01EP-S

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2017-07-28 for AIRCAST 01EP-S manufactured by Djo, Llc.

Event Text Entries

[81277580] Complaint received that alleges "large wound at heel, wounded skin is softened and white with black frame, looks like after a long bath, maceration". Questionnaire was received from customer or clinician. Clinician had directed patient wear the walker 14 days without opening, lay down the foot very often, not to walk too much, wear the white sock. Device not reviewed by manufacturer at this time.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9616086-2017-00013
MDR Report Key6750443
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2017-07-28
Date of Report2017-07-28
Date of Event2017-07-17
Date Mfgr Received2017-08-31
Date Added to Maude2017-07-28
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 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 NameFOLDERS SEARCHES GLOBAL SEARCHES WORKFLOW ROUTINGS PER
Product CodeITW
Date Received2017-07-28
Returned To Mfg2017-08-31
Model Number01EP-S
OperatorLAY USER/PATIENT
Device AvailabilityR
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 2017-07-28

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