LEGEND XT 4CH COMBO PKG 2788

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2011-10-26 for LEGEND XT 4CH COMBO PKG 2788 manufactured by Djo, Llc.

Event Text Entries

[2342053] Unit reported to have burned pts.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9616086-2011-00126
MDR Report Key2314888
Report Source05
Date Received2011-10-26
Date of Report2011-10-25
Date of Event2011-09-28
Date Mfgr Received2011-09-28
Date Added to Maude2011-11-01
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 FDA0
Event Location0
Manufacturer Street1430 DECISION ST.
Manufacturer CityVISTA CA 92081
Manufacturer CountryUS
Manufacturer Postal92081
Manufacturer Phone7607271280
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 NameLEGEND XT 4CH COMBO PKG
Generic NameELECTROTHERAPY - CLINIC
Product CodeGZI
Date Received2011-10-26
Model Number2788
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerDJO, LLC
Manufacturer Address1430 DECISION ST. VISTA CA 92081 US 92081


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2011-10-26

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