MAUDE Adverse Event Report: INVAMEX TREX2/WD86/ADULT/28/BH16/1255/U2222C/U67 9153653558; MECHANICAL (MANUAL) WHEELCHAIR

Model Number NA:TREX28RP

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Fracture, Arm (2351)

Event Date 12/03/2017

Event Type  Injury  

Manufacturer Narrative

No malfunction or defect of the chair has been alleged.The manager of the facility stated, "she believes the alleged incident was of no fault of the product, but was a customer usage error." she also stated, "she does not believe the product is defective." the nurse on duty at the time of the event relates that no one witnessed the actual event but stated "that everyone thinks she got her feet caught in the wheelchair." the patient¿s daughter said that her mother was in the hall and was asked to go back to her room.The daughter thinks that in her mother's haste to get back to her room she got tangled up with the chair and fell.Multiple attempts have been made to get the wheelchair returned.The end user continues to use the chair without issue, and will not be returning the chair.

Event Description

Invacare was notified of the following: patient was in wheelchair propelling herself in the hall.The staff stated they thought she caught her feet in the wheels, causing her to fall forward out of the wheelchair.Patient sustained fracture to right humerus and bruising to her face in the fall.

• Brand Name: TREX2/WD86/ADULT/28/BH16/1255/U2222C/U67 9153653558
• Type of Device: MECHANICAL (MANUAL) WHEELCHAIR
• 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 44036 ; 8003336900
• MDR Report Key: 7171773
• MDR Text Key: 96619990
• Report Number: 9616091-2018-00001
• 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: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 12/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: NA:TREX28RP
• Device Catalogue Number: TREX28RP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 90 YR
• Patient Weight: 59