X-ALT HIGHLY HIP 932-32-750

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 2019-11-29 for X-ALT HIGHLY HIP 932-32-750 manufactured by Encore Medical L.p..

MAUDE Entry Details

Report Number1644408-2019-01163
MDR Report Key9391997
Report SourceCOMPANY REPRESENTATIVE
Date Received2019-11-29
Date of Report2019-11-29
Date of Event2019-10-30
Date Mfgr Received2019-10-30
Device Manufacturer Date2017-10-14
Date Added to Maude2019-11-29
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 787585445
Manufacturer CountryUS
Manufacturer Postal787585445
Manufacturer G1ENCORE MEDICAL L.P.
Manufacturer Street9800 METRIC BLVD
Manufacturer CityAUSTIN TX 787585445
Manufacturer CountryUS
Manufacturer Postal Code787585445
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameX-ALT HIGHLY HIP
Generic NameLINER 10 HOODED NEU, MP6, HXE-PLUS, 32MM
Product CodeLPH
Date Received2019-11-29
Model Number932-32-750
Catalog Number932-32-750
Lot Number811N1948
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 787585445 US 787585445


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2019-11-29

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