CHATTANOOGA 2802

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-08-31 for CHATTANOOGA 2802 manufactured by Djo, Llc.

Event Text Entries

[25288972] Device not returned.
Patient Sequence No: 1, Text Type: N, H10


[25288975] Complaint received that alleges "customer stated that the unit had "exploded"". Questionnaire was not received from clinician and/or patient. Device not returned to manufacturer for evaluation. No indication event caused or contributed to permanent impairment or death.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9616086-2015-00024
MDR Report Key5042351
Date Received2015-08-31
Date of Report2015-08-31
Date of Event2015-08-24
Date Mfgr Received2015-08-24
Date Added to Maude2015-08-31
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationMEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactWILLIAM FISHER
Manufacturer Street1430 DECISION STREET
Manufacturer CityVISTA CA 92081
Manufacturer CountryUS
Manufacturer Postal92081
Manufacturer Phone7607313126
Manufacturer G1DJ ORTHOPEDICS DE MEXICO, S.A. DE C.V.
Manufacturer StreetCARRETERA LIBRE TIJUANA TECATE 20230 SUBMETROPOLI EL FLORIDO
Manufacturer CityTIJUANA, MEXICO 22244
Manufacturer CountryMX
Manufacturer Postal Code22244
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCHATTANOOGA
Generic NameHYDROCOLLATOR
Product CodeIRQ
Date Received2015-08-31
Model Number2802
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerDJO, LLC
Manufacturer Address1430 DECISION STREET VISTA CA 920819663 US 920819663


Patients

Patient NumberTreatmentOutcomeDate
10 2015-08-31

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