MAUDE Adverse Event Report: INVAMEX INVACARE TRACER IV WHEELCHAIR; WHEELCHAIR, MECHANICAL

Model Number T424RDAP

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Crushing Injury (1797); Laceration(s) (1946)

Event Date 04/18/2023

Event Type  Injury  

Manufacturer Narrative

Based on available information, it seems that the underlying cause of the event was user error and did not result from a product malfunction.The t4 user manual warns, "to avoid injury or damage from moving parts: always keep hands and fingers clear of moving parts.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.".

Event Description

Invacare received a medwatch report from the fda stating that the patient¿s home health aid was opening the t424rdap wheelchair, when the patient sat down.In the process of sitting, the patient¿s left ring finger and pinky finger were caught under the left side of the seat.The patient sustained a partial amputation of the left ring finger and a laceration to the left pinky finger.Details of medical treatment received were not provided.

• Brand Name: INVACARE TRACER IV WHEELCHAIR
• Type of Device: WHEELCHAIR, MECHANICAL
• Manufacturer (Section D): INVAMEX; 102 parque industrial manimex; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer (Section G): INVAMEX; 102 parque industrial manimex; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: jason fiest ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 17106047
• MDR Text Key: 317046441
• Report Number: 9616091-2023-00012
• Device Sequence Number: 1
• Product Code: IOR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: T424RDAP
• Device Catalogue Number: T424RDAP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/16/2023
• 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: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other