• 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 SAUNDERS CERVICAL TRCTN DVCE ACCESSORIES, TRACTION

  • 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 SAUNDERS CERVICAL TRCTN DVCE ACCESSORIES, TRACTION Back to Search Results
Model Number 199594
Device Problem Mechanical Problem
Event Date 09/19/2019
Event Type  Malfunction  
Manufacturer Narrative

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 unit does not maintain pressure in the hold position; there is a loss of pressure of more than five pounds. During transition from hold to release, the device loses pressure abruptly and completely, resulting in reported discomfort to the patient's neck. No further information is currently available.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameCHATTANOOGA SAUNDERS CERVICAL TRCTN DVCE
Type of DeviceACCESSORIES, TRACTION
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  22244
Manufacturer Contact
brian becker
2900 lake vista drive
lewisville , TX 75067
MDR Report Key9202056
Report Number9616086-2019-00071
Device Sequence Number1
Product CodeILZ
Report Source Manufacturer
Source Type DISTRIBUTOR
Reporter Occupation
Type of Report Initial
Report Date 10/16/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/17/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device MODEL Number199594
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/20/2019
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 Unkown

-
-