MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-11 for MYON SWINGAWAY WHEELCHAIR NA:MYON manufactured by Invamex Manufacturing.
[183002609]
Invacare was made aware of this event that occurred in (b)(6, involving a rea spirea wheelchair which was manufacture by invacare (b)(4). This record was created due to the myon wheelchair, made at invacare owned invamex and sold in the us has been determined to be similar in design. The rea spirea wheelchair has an alber viamobil attached to the chair which, is a push and brake aid that is not offered in the us. This malfunction is consistent with someone driving the chair it too fast into a curb. An evaluation of the chair has not been completed as of the date of this filing.
Patient Sequence No: 1, Text Type: N, H10
[183002610]
The staff was walking with the patient, outside when the front fork mount broke off on the right side. The patient fell out of the wheelchair, got a cut above their left eye, and has pain in their left hip. The end-user was taken to the hospital where they received stitches.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9616091-2020-00011 |
| MDR Report Key | 9818105 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-11 |
| Date of Report | 2020-02-14 |
| Date Mfgr Received | 2020-02-14 |
| Date Added to Maude | 2020-03-11 |
| 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 44036 |
| Manufacturer Country | US |
| Manufacturer Postal | 44036 |
| Manufacturer Phone | 8003336900 |
| Manufacturer G1 | INVAMEX MANUFACTURING |
| 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 | 2020-03-11 |
| 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. Other | 2020-03-11 |