MDT823296

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 2019-10-16 for MDT823296 manufactured by Medline Industries Inc..

MAUDE Entry Details

Report Number1417592-2019-00167
MDR Report Key9196730
Report SourceDISTRIBUTOR
Date Received2019-10-16
Date of Report2019-10-16
Date of Event2019-09-01
Date Mfgr Received2019-09-25
Date Added to Maude2019-10-16
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 ContactNIGEL VILCHES
Manufacturer StreetTHREE LAKES DRIVE
Manufacturer CityNORTHFIELD IL 600932753
Manufacturer CountryUS
Manufacturer Postal600932753
Manufacturer Phone2249311458
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Generic NamePROTECTOR, HEEL, HEEL RAISER, OSFM
Product CodeITW
Date Received2019-10-16
Returned To Mfg2019-10-07
Catalog NumberMDT823296
OperatorLAY USER/PATIENT
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerMEDLINE INDUSTRIES INC.
Manufacturer AddressTHREE LAKES DRIVE NORTHFIELD IL 600932753 US 600932753


Patients

Patient NumberTreatmentOutcomeDate
101. Other; 2. Required No Informationntervention 2019-10-16

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