MAUDE Adverse Event Report: INVAMEX TRACER TRANSPORT CHAIR 19 X 16 9153647029; WHEELCHAIR, MECHANICAL

Model Number T4

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

Patient Problem Injury (2348)

Event Date 07/24/2015

Event Type  Injury  

Manufacturer Narrative

Should additional information become available a supplemental record will be filed.User¿s manual review 1110558 rev.H.(page 21) when tipping the wheelchair, an assistant should grasp the back of the wheelchair on a non-removable (non-detachable) part.Inform the wheelchair occupant before tipping the wheelchair and remind him/her to lean back.Be sure the occupant¿s feet and hands are clear of all wheels and/or pinch points.(page 38) warning - ensure hands and fingers are clear of elevating legrest mechanism before pushing release lever to lower the elevating legrest.Otherwise injury may occur due to pinch points.(page 25) warning - always keep hands and fingers clear of moving parts to avoid injury.Do not place hand or fingers on the underside of the seat frame rail when opening or closing the wheelchair.(page 27) every six months or as necessary, take your wheelchair to a qualified technician for a thorough inspection and servicing.Regular cleaning will reveal loose or worn parts and enhance the smooth operation of your wheelchair.To operate properly and safely, your wheelchair must be cared for just like any other vehicle.Routine maintenance will extend the life and efficiency of your wheelchair.

Event Description

A letter was sent to the legal department stating a consumer alleges she was sitting in the wheelchair supplied by (b)(6) and she allegedly severed her fingertip on the frame of the chair.No other information was available.

• 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 Key: 5428200
• MDR Text Key: 38019886
• Report Number: 9616091-2016-00189
• 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
• Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date: 02/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: T4
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/05/2016
• 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): Required Intervention