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: INVAMEX TRACER TRANSPORT CHAIR 19 X 16 9153647029; WHEELCHAIR, MECHANICAL
  • 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
 

INVAMEX TRACER TRANSPORT CHAIR 19 X 16 9153647029; WHEELCHAIR, MECHANICAL Back to Search Results
Model Number TRSX5RC
Device Problem Component Missing (2306)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Event Description
The customer just got this chair and they noticed that on one of the rear wheels a part of the tire is missing.He said it is about a 4 piece of rubber that is missing.It looks like someone just cut a chunk of the tire out.
 
Manufacturer Narrative
A follow up will be sent if the product or additional information is obtained.
 
Manufacturer Narrative
The device was evaluated by the returns department which found that the tire split and rolled off the rim.
 
Event Description
The customer just got this chair and they noticed that on one of the rear wheels a part of the tire is missing.He said it is about a 4 piece of rubber that is missing.It looks like someone just cut a chunk of the tire out.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
TRACER TRANSPORT CHAIR 19 X 16 9153647029
Type of Device
WHEELCHAIR, MECHANICAL
Manufacturer (Section D)
INVAMEX
parque industrial manimex
reynosa 88780
MX  88780
Manufacturer (Section G)
INVAMEX
parque industrial manimex
reynosa 88780
MX   88780
Manufacturer Contact
kevin guyton
one invacare way
elyria, OH 44035
8003336900
MDR Report Key4856621
MDR Text Key5850326
Report Number9616091-2015-01609
Device Sequence Number1
Product Code IOR
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor,distributor
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial
Report Date 07/16/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberTRSX5RC
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/16/2015
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 05/21/2015
Initial Date FDA Received06/19/2015
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Other;
-
-