MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-01-14 for TRACER EX TREX manufactured by Invamex.
[186842857]
There is no product malfunction associated with the injury. The adverse event appears to have been an accident that resulted from user error. The tracer wheelchair user manuals state, "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. 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. " the hospital quality and risk manager advised that the wheelchair is owned by the hospital and is kept folded up in a closed position by the front entrance for family members to use when they need to transport a patient into or out of the hospital. No medical personnel supervise the use of this chair. Since the chair is being used in a public place by individuals who have not read the manual, the users may not be mindful of the warnings addressed within the manual. Because of this, invacare recommends that a non-folding device be installed to keep the wheelchair from being folded when left unoccupied in a public place. The hospital quality and risk manager stated that they have considered getting non-folding devices for the chairs being used at the hospital entrance; however, they have limited space, so they may instead put up a sign that instructs the users to open the chair fully before use. A replacement wheelchair was sent to the hospital, and it was suggested that they put up a sign immediately to prevent any further injuries with the other chairs in their fleet. The subject wheelchair was returned to invacare for an evaluation. It was confirmed that it is possible for an individual to pinch their fingers between the seat rail and side frame. However, the chair functioned as designed.
Patient Sequence No: 1, Text Type: N, H10
[186842858]
A quality and risk manager at an outpatient hospital reported that a patient fractured the middle finger on their right hand while they were attempting to sit down in the tracer wheelchair. She indicated that the patient put their hands on the seat rails of the chair and sat down before the chair was completely opened, using their weight to open up the chair the rest of the way. She stated that x-rays were taken, which confirmed the fracture, and the patient underwent physical therapy.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9616091-2020-00003 |
| MDR Report Key | 9586191 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-01-14 |
| Date of Report | 2018-01-05 |
| Date Mfgr Received | 2018-01-05 |
| Device Manufacturer Date | 2001-05-01 |
| Date Added to Maude | 2020-01-14 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. JASON FIEST |
| Manufacturer Street | ONE INVACARE WAY |
| Manufacturer City | ELYRIA OH 44035 |
| Manufacturer Country | US |
| Manufacturer Postal | 44035 |
| Manufacturer Phone | 8003336900 |
| Manufacturer G1 | INVAMEX |
| Manufacturer Street | 102 PARQUE INDUSTRIAL MANIMEX |
| Manufacturer City | REYNOSA, TAMAULIPAS 88780 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 88780 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRACER EX |
| Generic Name | WHEELCHAIR, MECHANICAL |
| Product Code | IOR |
| Date Received | 2020-01-14 |
| Returned To Mfg | 2018-01-25 |
| Model Number | TREX |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INVAMEX |
| Manufacturer Address | 102 PARQUE INDUSTRIAL MANIMEX REYNOSA, TAMAULIPAS 88780 MX 88780 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-01-14 |