MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-05-30 for MYON SWINGAWAY WHEELCHAIR NA:MYON manufactured by Invamex Manufacturing.
[146619709]
Invacare was made aware of an event in (b)(6) involving an action 3 junior wheelchair which was manufactured by invacare (b)(4). Invacare is filing this report because the myon wheelchair, made at invacare owned invamex and sold in the us has been determined to be similar in design to the action 3 junior. The chair has not been returned to invacare (b)(4), however, when the incident first happened the wheel clutch system was checked, and the event was not duplicated. If more information becomes available a follow-up will be done.
Patient Sequence No: 1, Text Type: N, H10
[146619710]
After using the wheelchair for several hours, the right rear wheel came off causing the child to fall. His right arm got stuck under the wheelchair fracturing his arm. The wheel clutch system has been checked and the event could not be reproduced.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9616091-2019-00007 |
| MDR Report Key | 8656080 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-05-30 |
| Date of Report | 2019-05-07 |
| Date of Event | 2019-01-24 |
| Date Mfgr Received | 2019-05-07 |
| Date Added to Maude | 2019-05-30 |
| 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 |
| 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 MANUFATURING |
| 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 | MYON SWINGAWAY WHEELCHAIR |
| Generic Name | WHEELCHAIR, MECHANICAL |
| Product Code | IOR |
| Date Received | 2019-05-30 |
| Model Number | NA:MYON |
| Catalog Number | MYON |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INVAMEX MANUFACTURING |
| Manufacturer Address | 102 PARQUE INDUSTRIAL MANIMEX REYNOSA, TAMAULIPAS 88780 MX 88780 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-05-30 |