CHATTANOOGA APPLICATOR 9CLS 5X200MW 1040MW 27812

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-03-09 for CHATTANOOGA APPLICATOR 9CLS 5X200MW 1040MW 27812 manufactured by Djo, Llc.

MAUDE Entry Details

Report Number3012446970-2020-00008
MDR Report Key9805356
Report SourceUSER FACILITY
Date Received2020-03-09
Date of Report2020-03-08
Date of Event2020-02-24
Date Mfgr Received2020-02-24
Date Added to Maude2020-03-09
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 ContactBRIAN BECKER
Manufacturer Street2900 LAKE VISTA DRIVE
Manufacturer CityLEWISVILLE, TX
Manufacturer CountryUS
Manufacturer G1DJO, LLC
Manufacturer Street3151 SCOTT ST.
Manufacturer CityVISTA, CA
Manufacturer CountryUS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCHATTANOOGA APPLICATOR 9CLS 5X200MW 1040MW
Generic NameLAMP, INFRARED, THERAPEUTIC HEATING
Product CodeILY
Date Received2020-03-09
Model Number27812
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerDJO, LLC
Manufacturer Address1430 DECISION STREET VISTA, CA US


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-09

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