Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DJO, LLC CHATTANOOGA FLUIDTHERAPY DOUBLE EXTREMITY; UNIT, FLUIDOTHERAPY
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

DJO, LLC CHATTANOOGA FLUIDTHERAPY DOUBLE EXTREMITY; UNIT, FLUIDOTHERAPY Back to Search Results
Model Number FLU115D
Device Problem Smoking (1585)
Patient Problem No Patient Involvement (2645)
Event Date 07/08/2019
Event Type  malfunction  
Manufacturer Narrative
Occupation: unknown.Device evaluated by mfr: no device was returned for evaluation.If the device is received, a follow-up report will be submitted upon completion of product evaluation.
 
Event Description
It was reported that the device was "creating smoke and burning smell." no further information was provided.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
CHATTANOOGA FLUIDTHERAPY DOUBLE EXTREMITY
Type of Device
UNIT, FLUIDOTHERAPY
Manufacturer (Section D)
DJO, LLC
1430 decision street
vista CA 92081 9663
Manufacturer (Section G)
DJ ORTHOPEDICS DE MEXICO, S.A. DE C.V.
carretera libre tijuana tecate
20230 submetropoli el florido
tijuana, b.c. 22244,
MX  
Manufacturer Contact
brian becker
2900 lake vista drive
lewisville, TX 75067
MDR Report Key8847961
MDR Text Key152849867
Report Number9616086-2019-00053
Device Sequence Number1
Product Code LSB
UDI-Device Identifier00190446305149
UDI-Public00190446305149
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K011243
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 07/31/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/31/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberFLU115D
Was Device Available for Evaluation? No
Date Manufacturer Received07/08/2019
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
-
-