MAUDE Adverse Event Report: UNKNOWN TRSX5/WD06/ADULT/28FB/BH16/1228/U2222C/COM/U240 9153637777; WHEELCHAIR, MECHANICAL

Model Number TRSX5

Device Problems Inadequacy of Device Shape and/or Size (1583); Improper or Incorrect Procedure or Method (2017); Component Missing (2306)

Patient Problems Fall (1848); Bone Fracture(s) (1870); Injury (2348)

Event Type  Injury  

Manufacturer Narrative

There is no alleged malfunction of this unit.The crossbraces not sitting into the socket cups is most likely due to the bent cross brace which in turn is most likely caused due to the end user being "well over" the weight capacity for this chair, which allegedly does not fit her size or medical needs.Mdr being filed based on serious injury reported.Should additional information become available, a supplemental record will be filed.

Event Description

Social worker for the end user reported that one of the wheel lock extensions on the trsx5 wheelchair is missing and the crossbraces are not sitting in the socket cups.It was stated that the user fell when transferring to the wheelchair, sustained a broken leg, torn flesh, open tibia fracture.User was hospitalized and had surgery.Invacare advised social worker that it looks like the cross braces are bent.Explained that the weight capacity for this chair is 250 lbs.Social worker stated that they are in the process of getting the user a new chair that will fit her size and medical needs.The patient was "well over" the weight capacity for the chair and was allegedly attempting to transfer on her own when the chair went out from under her and she fell and was injured.The social worker said it doesn't seem like the chair malfunctioned but that the user was improperly using it and transferring alone and shouldn't have been.

• Brand Name: TRSX5/WD06/ADULT/28FB/BH16/1228/U2222C/COM/U240 9153637777
• Type of Device: WHEELCHAIR, MECHANICAL
• Manufacturer (Section D): UNKNOWN; OH
• Manufacturer (Section G): UNKNOWN; OH
• Manufacturer Contact: jason fiest ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 6070492
• MDR Text Key: 58916289
• Report Number: 1525712-2016-02736
• 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: consumer
• Reporter Occupation: Nursing Assistant
• Type of Report: Initial
• Report Date: 10/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: TRSX5
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/10/2016
• 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): Hospitalization; Required Intervention