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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DJO LLC. CHATTANOOGA INTELECT LEGEND XT COMBOUS STD; STIMULATOR, ULTRASOUND AND MUSCLE, FOR USE IN APPLYING THERAPEUTIC DEEP HEAT

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DJO LLC. CHATTANOOGA INTELECT LEGEND XT COMBOUS STD; STIMULATOR, ULTRASOUND AND MUSCLE, FOR USE IN APPLYING THERAPEUTIC DEEP HEAT Back to Search Results
Model Number 2760
Device Problem Intermittent Energy Output (4025)
Patient Problem Burn(s) (1757)
Event Date 08/18/2020
Event Type  malfunction  
Manufacturer Narrative
Health professional: occupation: unknown.Device not received manufacturer at this time.Manufacturer is in the process of obtaining additional information concerning this event and the complaint is still under investigation.A final report will be submitted once the investigation is complete.
 
Event Description
It was reported that "it is believed to have received burns during electrical stimulation treatment.The unit reportedly ramped up intensity on its own." device not received manufacturer at this time.Manufacturer is in the process of obtaining additional information concerning this event and the complaint is still under investigation.A final report will be submitted once the investigation is complete.
 
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Brand Name
CHATTANOOGA INTELECT LEGEND XT COMBOUS STD
Type of Device
STIMULATOR, ULTRASOUND AND MUSCLE, FOR USE IN APPLYING THERAPEUTIC DEEP HEAT
Manufacturer (Section D)
DJO LLC.
1430 decision street
vista CA 92081
Manufacturer (Section G)
DJ ORTHOPEDICS DE MEXICO, S. A. DE C. V.
carretera libre tijuana tecate
20230 submetropoli el florido
tijuana, b.c., mx 22244
MX   22244
Manufacturer Contact
christine bonczyk
2900 lake vista drive
lewisville, TX 75067
MDR Report Key11634000
MDR Text Key258657217
Report Number9616086-2020-00031
Device Sequence Number1
Product Code IMG
UDI-Device Identifier00888912292740
UDI-Public00888912292740
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K031077
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Other
Type of Report Initial
Report Date 04/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number2760
Initial Date Manufacturer Received 08/18/2020
Initial Date FDA Received04/08/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Other;
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