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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INVAMEX INVACARE TRACER IV WHEELCHAIR; WHEELCHAIR, MECHANICAL
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INVAMEX INVACARE TRACER IV WHEELCHAIR; WHEELCHAIR, MECHANICAL Back to Search Results
Model Number T4X24RDAP
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Crushing Injury (1797); Laceration(s) (1946)
Event Type  Injury  
Manufacturer Narrative
The underlying cause of the alleged event is undetermined.The facility's maintenance department fully examined the chair and performed preventative maintenance, and they could not find a reason why this event happened.Based on available information, it seems that the event was an accident and did not result from a product malfunction.The wheelchair was returned to invacare for evaluation.Once the evaluation results are available, a supplemental record will be filed.
 
Event Description
A representative from a facility reported that a patient was found to have her left pinky finger stuck between the seat and armrest on the t4x24rdap wheelchair.When aides tried to assist her, she became impatient and pulled her hand up, which caused her fingertip to be severed.She was taken to a hospital emergency department where she was treated and released.Surgery was required to repair the finger.
 
Manufacturer Narrative
The evaluation of the wheelchair was completed on 08/29/2023.Visual observations identified the presence of residue, wear, and corrosion on both sides of the chair, likely due to the age of the device.It was also observed that the left seat rail was raised slightly out of the h-blocks on the left side frame.Functionally, the chair operated as intended.The complaint was not confirmed for the wheelchair causing a pinch during the functional test, but the chair does have moving parts that may create pinch points if caution is not observed.The t4 user manual warns, "to avoid injury or damage from moving parts: always keep hands and fingers clear of moving parts." it also states, "do not place hands or fingers on the underside of the seat frame rail when opening or closing the wheelchair.Do not sit or transfer into the wheelchair unless it is fully open and the seat frame rails are fully seated into the side frame h-blocks." since the left seat rail was not fully seated in the h-block, the chair should not have been used.
 
Event Description
A representative from a facility reported that a patient was found to have her left pinky finger stuck between the seat and armrest on the t4x24rdap wheelchair.When aides tried to assist her, she became impatient and pulled her hand up, which caused her fingertip to be severed.She was taken to a hospital emergency department where she was treated and released.Surgery was required to repair the finger.
 
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Brand Name
INVACARE TRACER IV WHEELCHAIR
Type of Device
WHEELCHAIR, MECHANICAL
Manufacturer (Section D)
INVAMEX
102 parque industrial manimex
reynosa, tamaulipas
Manufacturer (Section G)
INVAMEX
102 parque industrial manimex
reynosa, tamaulipas
Manufacturer Contact
jason fiest
one invacare way
elyria, OH 44035
8003336900
MDR Report Key17106037
MDR Text Key317114062
Report Number9616091-2023-00011
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 User Facility
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 05/15/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/12/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model NumberT4X24RDAP
Device Catalogue NumberT4X24RDAP
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/26/2023
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received08/29/2023
Was Device Evaluated by Manufacturer? No
Date Device Manufactured02/01/2014
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) Disability; Hospitalization;
Patient Age82 YR
Patient SexFemale
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