DISCOVERY ELBOW 114817

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-11 for DISCOVERY ELBOW 114817 manufactured by Encore Medical L.p..

Event Text Entries

[183086037] Additional reporting on this event will be provided as a supplemental report to these documents as soon as it becomes available.
Patient Sequence No: 1, Text Type: N, H10


[183086038] Revision surgery - due to infection. All implants were removed and nothing put back in.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1644408-2020-00232
MDR Report Key9818572
Report SourceCOMPANY REPRESENTATIVE
Date Received2020-03-11
Date of Report2020-03-09
Date of Event2020-02-11
Date Mfgr Received2020-02-11
Date Added to Maude2020-03-11
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 ContactTEFFANY HUTTO
Manufacturer Street9800 METRIC BLVD
Manufacturer CityAUSTIN, TX 78758-5445,
Manufacturer CountryUS
Manufacturer G1ENCORE MEDICAL L.P.
Manufacturer Street9800 METRIC BLVD
Manufacturer CityAUSTIN, TX 78758-5445,
Manufacturer CountryUS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameDISCOVERY ELBOW
Generic NameDISC ULNA 3X115MM RT W BRNG C
Product CodeJDC
Date Received2020-03-11
Catalog Number114817
Lot Number928220
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerENCORE MEDICAL L.P.
Manufacturer Address9800 METRIC BLVD AUSTIN, TX 78758-5445, US


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-03-11

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